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management of advanced cases of advanced melanoma is complex&#46; The current standard treatment of both isolated and multiple tumor nodules is surgical excision&#44; isolated limb perfusion&#44; or radiotherapy&#46; Some therapeutic alternatives in the treatment of metastatic lesions include cryotherapy&#44; laser ablation&#44; and radiofrequency ablation&#44; with the choice of technique varying according to the nature of the lesion&#46; After appropriate treatment&#44; local recurrence of the tumor is hard to manage&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Electrochemotherapy<a class="elsevierStyleCrossRefs" href="#bib0105"><span class="elsevierStyleSup">5&#44;6</span></a> is an emerging treatment modality for cutaneous and subcutaneous lesions originating from melanoma or other primary and metastatic tumors&#46; The procedure consists of intravenous or intratumoral administration of cytotoxic agents &#40;bleomycin and cisplatin&#41; followed by short and intense local electric pulses to achieve an effect called electroporation or electropermeabilization&#46; The local application of electric pulses of a certain intensity&#44; amplitude&#44; and frequency temporarily destabilizes the cell membrane to allow transient and reversible formation of nonselective pores with a size of about 1 Angstr&#246;m without any impact on cell viability&#44; thereby increasing permeability&#46; Exposure of the cell membrane to electric pulses may lead to cell necrosis due to irreversible changes&#44; whereas application of intense but short electrical pulses induces reversible electroporation&#44; maintaining its viability&#46; After application&#44; the cytotoxic drugs that&#44; given their structure and molecular weight would not easily diffuse across the cell membrane&#44; can move from the intercellular space to the cytosol&#44; resulting in increased in cytotoxicity at a lower dose&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The aim of this review is to evaluate the evidence supporting the use of electrochemotherapy as a therapeutic strategy for the treatment of unresectable&#44; 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at any site in adults&#63; This question was analyzed and transferred to the Population Intervention Comparator Outcome &#40;PICO&#41; format &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Results</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Search Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">After checking titles and abstracts&#44; and applying the aforementioned criteria&#44; 37 articles were selected to read the full text&#46; Seven studies met the inclusion criteria&#44; were considered appropriate and relevant&#44; and were analyzed for this review&#46; The flow diagram for article handling and selection is shown in <a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#46; References to studies were coded to facilitate their handling in the drafting of the manuscript&#58; Spratt&#95;2014&#44;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> AETS&#95;2011&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a> Mali&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> Caraco&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a> Riccoti&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> Solari&#95;2014&#44;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> and Skarlatos&#95;2011&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">As no clinical trials or cohort studies have analyzed the effectiveness of electrochemotherapy&#44; we decided to include case series not included in systematic reviews or in the evaluation reports selected for assessment&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The search returned a National Institute for Health and Care Excellence &#40;NICE&#41; report from 2013&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">15</span></a> Although this report was a procedure guideline and so did not meet our inclusion criteria&#44; it was nevertheless used for drafting the present article&#46; Six studies were included in the meta-analysis of Spratt&#95;2014&#46; The remaining studies were excluded because of language of the report or type of study&#46; Five articles could not be located&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Study Results</span><p id="par0060" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> summarizes the most relevant data for the studies analyzed and their evidence level&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0065" class="elsevierStylePara elsevierViewall">We found 3 systematic reviews<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">4&#44;9&#44;10</span></a> that were analyzed according to the SIGN<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a> and AMSTAR<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> criteria&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The Spratt&#95;2014 review found a high but heterogenous response rate and an improved quality of life&#46; The authors recommended defining treatment algorithms and further studies to establish the specific characteristics of the patients and cutaneous metastases&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">All the meta-analyses included in the AETS&#95;2011 review show results clearly in favor of electrochemotherapy versus chemotherapy&#46; The studies took the percentage of patients with complete response &#40;CR&#41; verus other types of response as the outcome measure&#46; The best outcomes were obtained in the late assessment of electrochemotherapy &#40;bleomycin or cisplatin&#41; versus chemotherapy &#40;bleomycin or cisplatin&#41;&#44; with a relative risk &#40;RR&#41; of 8&#46;05 &#40;95&#37; CI&#44; 3&#46;43-18&#46;88&#41;&#44; as well as in the late assessment &#40;mean follow-up&#44; 9&#46;7 months&#41; of electrochemotherapy &#40;bleomycin&#41; versus chemotherapy &#40;bleomycin&#41;&#44; with a RR of 8&#46;48 &#40;95&#37; CI&#44; 3&#46;46-20&#46;79&#41;&#46; In the early assessments &#40;mean follow-up&#44; 2&#46;2 months&#41;&#44; the RR values were low&#58; 5&#46;01 &#40;95&#37; CI&#44; 2&#46;70-9&#46;32&#41; and 7&#46;56 &#40;95&#37; CI&#44; 2&#46;64-21&#46;60&#41;&#44; respectively&#46; In the meta-analysis performed in patients with single diagnosis of melanoma&#44; the outcomes were also in favor of electrochemotherapy versus chemotherapy&#46; In the early assessment of electrochemotherapy &#40;bleomycin or cisplatin&#41; versus chemotherapy &#40;bleomycin or cisplatin&#41;&#44; the RR was 4&#46;03 &#40;95&#37; CI&#44; 2&#46;05-7&#46;92&#41; in favor of electrochemotherapy&#46; Likewise&#44; in the later assessment&#44; the RR was 5&#46;95 &#40;95&#37; CI&#44; 1&#46;83-19&#46;33&#41; in favor of electrochemotherapy versus chemotherapy in patients with a single melanoma&#46; With regards the safety of electrochemotherapy&#44; of the 26 studies&#44; 2 did not report the appearance of complications&#46; In the remaining 24 studies&#44; mild complications and side effects were reported&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">In a systematic literature review &#40;SLR&#41;&#44; Mali&#95;2013 focused on the correlation between tumor size and outcome&#46; The data were obtained from nonrandomized studies&#46; The results show lower effectiveness in tumors larger than 3<span class="elsevierStyleHsp" style=""></span>cm than in smaller tumors &#40;CR and objective response &#91;OR&#93;&#44; 59&#37; and 85&#37;&#44; versus 33&#46;3&#37; and 68&#37;&#44; respectively&#41;&#46; The authors suggested that the explanation could be the lower drug concentration because of an insufficient application time&#46; The pulses were applied 2<span class="elsevierStyleHsp" style=""></span>min after intratumoral infusion of bleomycin or cisplatin&#44; or within the therapeutic window of 8 to 28<span class="elsevierStyleHsp" style=""></span>min after intravenous bleomycin&#46; Administration of bleomycin to the interstitial space around the tumor attains sufficiently high concentrations&#44; but the plasma concentration declines biexponentially with a mean half-life of distribution of 24 to 30<span class="elsevierStyleHsp" style=""></span>min and a mean clearance of 2-4<span class="elsevierStyleHsp" style=""></span>h&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">16</span></a> The second explanation suggested by the authors was insufficient exposure to the tumor in those larger than 3<span class="elsevierStyleHsp" style=""></span>cm given the irregular vascularization&#46; A third explanation is that a stronger electric field is required&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">We identified 4 observational studies with prospective follow-up&#44; with evidence level 3&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">11&#8211;14</span></a> Carac&#242;&#95;2013 and Solari&#95;2014 found a significant correlation between response and both number of lesions &#40;fewer than or more than 10&#41; and size &#40;smaller or larger than 2<span class="elsevierStyleHsp" style=""></span>cm&#41;&#44; whereas Ricotti&#95;2013 obtained apparently contradictory data&#44; as a higher CR rate was associated with more lesions after the second session&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">These are retrospective studies&#44; with a small sample size &#40;n between 5 and 60&#41; and without a comparator group&#46; Solari&#95;2014 provided demographic data on sex and age of the patients&#46; Men tended to be treated more often&#44; perhaps because this is a disease more prevalent among males&#46; All patients were elderly when they received the study treatment&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">In Solari&#95;2014 and in Riccoti&#95;2013&#44; criteria for administration were established according to the size of the tumor and the number of nodules to be treated&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">They all used a similar protocol&#58; administration of intravenous bleomycin 15 000<span class="elsevierStyleHsp" style=""></span>IU&#47;m<span class="elsevierStyleSup">2</span> prior to the electrochemotherapy pulses&#46; Only Skarlatos&#95;2011 also used intratumoral bleomycin in large lesions&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">All reported CR rates after treatment of between 10&#37; and 48&#37;&#44; and partial response rates of between 38&#46;3&#37; and 80&#37;&#46; Solari&#95;2014 reported a percentage of patients who did not respond to treatment &#40;15&#37;&#41; or whose diseases progressed &#40;30&#37;&#41;&#46; For their part&#44; Carac&#242;&#95;2013 reported a combined response rate for both variables of 13&#46;3&#37;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">None of these authors reported serious side effects&#59; those that were reported were mild and manageable&#46; Follow-up times were short&#44; from 6 to 20 months&#46;</p></span></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Discussion</span><p id="par0115" class="elsevierStylePara elsevierViewall">The evidence levels of the studies assessed in this review&#44; 4 cases series and 3 SLRs were medium to low&#44; according to the SIGN classification followed &#40;level 3 for all case series and 1&#8211; to 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; for SLR&#41;&#46; The series did not include a control group and were not analyzed in the same time period&#44; the study populations were small&#44; and the studies were not designed to compare effectiveness with other alternatives&#46; The studies were therefore subject to the biases of this type of study&#46; Follow-up was&#44; in general&#44; short&#44; and for this reason&#44; perhaps not all the complications actually caused by the treatment were reported&#46; The internal validity might have been affected by observer bias&#44; as there was no blinding in the reading of the results in any of the studies&#46; No quality-of-life variables were either described or measured&#44; even though these aspects impact health resource use and patient preference&#46; Likewise&#44; we did not find any studies that compared electrochemotherapy with other local or regional therapeutic alternatives&#46; Such a comparison would be of great interest to assess the clinical relevance of the procedure&#46; Nevertheless&#44; alignment of the results for some of the outcome variables analyzed lends consistency to the findings&#46; In fact&#44; the meta-analyses show results in favor of electrochemotherapy compared with chemotherapy&#44; and so these findings could be applicable in Spain&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">In this review&#44; we did not find any studies that assessed the organizational or economic impact of the use of electrochemotherapy in clinical practice&#46; Nevertheless&#44; the literature highlights the feasibility&#44; rapid and simple nature of electrochemotherapy&#44; good patient acceptance&#44; and the acceptable cost of treatment&#46; The technique can be considered of great therapeutic potential&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The conclusions of this systematic review are as follows&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0130" class="elsevierStylePara elsevierViewall">Electrochemotherapy could be an effective procedure in local treatment of malignant tumor nodules in terms of objective response&#44; whether complete or partial&#46; Evidence level 3 &#40;low&#44; case series&#41; and 1&#8211; to 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0135" class="elsevierStylePara elsevierViewall">Electrochemotherapy is easily administered&#44; economical&#44; and well tolerated in that it achieves OR in a high percentage of patients&#44; particularly if there are fewer than 10 lesions and the size is less than 2<span class="elsevierStyleHsp" style=""></span>cm&#46; The procedure can be repeated according to the response of the patient&#46; Evidence level 1&#8211;&#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0140" class="elsevierStylePara elsevierViewall">Although the findings show that electrochemotherapy is effective in local control of the tumor lesion&#44; we did not find any evidence that it may influence the natural course of the disease or patient survival&#44; and so it should be considered merely a palliative treatment&#46; Evidence level 3 &#40;low&#44; case series&#41; and 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0145" class="elsevierStylePara elsevierViewall">Electrochemotherapy is a safe procedure&#44; without serious adverse effects for the patient&#46; The most frequently reported complications are pain&#44; erythema&#44; muscle contractions&#44; and local edema&#46; Evidence level 1&#8211;a 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li></ul></p><p id="par0150" class="elsevierStylePara elsevierViewall">Based on the level of evidence&#44; we can recommend incorporation of electrochemotherapy as palliative therapy for unresectable metastatic melanoma &#40;strength of recommendation&#58; B&#41;&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Ethical Responsibilities</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Protection of human and animal subjects</span><p id="par0155" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this investigation&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Confidentiality of data</span><p id="par0160" class="elsevierStylePara elsevierViewall">The authors declare that they have followed their hospital&#39;s protocol on the publication of data concerning patients&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Right to privacy and informed consent</span><p id="par0165" class="elsevierStylePara elsevierViewall">The authors declare that patient data do not appear in this article&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Conflicts of Interest</span><p id="par0170" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Electrochemotherapy is a therapeutic option for the treatment of cutaneous and subcutaneous metastases from melanoma and other tumors&#46; The procedure consists of the administration of anticancer drugs followed by locally applied electrical impulses to achieve an effect known as <span class="elsevierStyleItalic">electroporation</span>&#44; which facilitates entry into the cytosol of drugs that cannot cross the cell membrane&#46; The aim of this review is to evaluate the evidence that supports the use of electrochemotherapy as a therapeutic strategy in melanoma&#46; We conducted a qualitative systematic review of the literature using advanced searches of bibliographic databases and full text reviews&#46; Seven studies &#40;3 systematic reviews and 4 cases series&#41; were selected&#46; The quality of the evidence was not good&#44; but the coincidence of results for certain variables supports their consistency&#46; Results of the meta-analyses favored electrochemotherapy over chemotherapy&#46; Electrochemotherapy appears to be an effective procedure for the local treatment of malignant tumor nodules &#40;evidence of intermediate or low quality&#41;&#46; This inexpensive method is simple to apply&#44; well tolerated&#44; and achieves objective responses under certain circumstances&#46; There is no evidence that electrochemotherapy alters the natural course of the disease and it should therefore be considered a palliative treatment&#46; With an evidence level of 1- &#40;minus&#41;&#44; electrochemotherapy can be recommended for the palliative treatment of unresectable&#44; locoregionally advanced melanoma &#40;grade B recommendation&#41;&#46;</p></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">La electroquimioterapia &#40;EQT&#41; es una modalidad de tratamiento de lesiones cut&#225;neas y subcut&#225;neas originadas por melanoma u otros tumores&#46; El procedimiento consiste en la administraci&#243;n de agentes antineopl&#225;sicos&#44; seguido de impulsos el&#233;ctricos locales&#44; para conseguir un efecto conocido como electroporaci&#243;n&#44; que permite la entrada al citosol de medicamentos que no difunden a trav&#233;s de la membrana celular&#46; El objetivo de esta revisi&#243;n es establecer la evidencia que sustenta la incorporaci&#243;n de la EQT como estrategia terap&#233;utica en el melanoma&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Adem&#225;s&#44; se ha llevado a cabo una revisi&#243;n sistem&#225;tica de la literatura con s&#237;ntesis cualitativa&#46; Se ha realizado una b&#250;squeda cualificada de la literatura en bases de datos referenciales y a texto completo&#46; Fueron seleccionados 7 estudios&#58; 3 revisiones sistem&#225;ticas y 4 series de casos&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La calidad de la evidencia encontrada no es buena&#44; pero la coincidencia de sus resultados en algunas las variables le da consistencia&#46; Los metaan&#225;lisis muestran resultados a favor de la EQT frente a la quimioterapia&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La EQT parece un procedimiento efectivo en el tratamiento local de n&#243;dulos tumorales malignos &#40;nivel medio o bajo de calidad de la evidencia&#41;&#46; Es un tratamiento f&#225;cil de administrar&#44; econ&#243;mico y bien tolerado con el que se consigue respuesta objetiva en circunstancias determinadas&#46; No hay evidencia de que pueda afectar el curso natural de la enfermedad&#44; por lo que debe considerarse un tratamiento paliativo&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Con un <span class="elsevierStyleItalic">nivel de la evidencia 1&#8211;</span>&#40;1 menos&#41;&#44; puede recomendarse la incorporaci&#243;n de la EQT para el tratamiento paliativo del melanoma locorregionalmente avanzado irresecable <span class="elsevierStyleItalic">&#40;fuerza de la recomendaci&#243;n&#58; B&#41;</span>&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Aguado-Romeo MJ&#44; Benot-L&#243;pez S&#44; Romero-Tabares A&#46; Electroquimioterapia para el tratamiento del melanoma cut&#225;neo locorregionalmente avanzado irresecable&#46; Revisi&#243;n sistem&#225;tica&#46; Actas Dermosifiliogr&#46; 2017&#59;108&#58;91&#8211;97&#46;</p>"
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          "leyenda" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">In this study&#44; we used the criteria for unresectability and TNM corresponding to locally advanced melanoma according to the American Joint Committee of Cancer &#40;AJCC&#41; classification&#46;</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Abbreviations&#58; GM-CSF&#44; granulocyte-macrophage colony-stimulating factor&#59; INAHTA&#44; International Network of Agencies of Health Technology Assessment&#59; PICO&#44; population &#40;P&#41;&#44; intervention &#40;I&#41;&#44; comparison &#40;C&#41; and outcome&#40;s&#41; &#40;O&#41;&#59; SLR&#44; systematic literature review&#46;</p>"
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                  \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Inclusion criteria</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Types of study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Clinical trials&#44; cohort studies&#44; SLR&#44; meta-analyses that assess one of the outcomes included in the research question&#46; In the event that no studies with these criteria were retrieved&#44; the inclusion of nonanalytic studies and case-control studies was considered&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Languages&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">English&#44; Spanish&#44; French&#44; and German&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Other conditions&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Technology assessment reports that analyzed details on the search strategy and methodological assessment of the studies were included&#46; Agency assessment reports had to meet the checklist drawn up by the expert group in the 2001 INAHTA meeting&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Exclusion criteria</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Types of study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Animal or in vitro experiments&#44; narrative reviews&#44; series&#44; case-control studies published prior to studies of higher evidence level&#46;<br>Studies of any design that had not assessed the variables specified in the research question or whose publication date was prior to the year 2000&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " colspan="2" align="left" valign="top" scope="col" style="border-bottom: 2px solid black">The PICO format of the research question</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Population&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Patients aged over 18 years with&#58;<br>unresectable cutaneous and&#47;or subcutaneous metastatic melanoma &#40;in transit&#44; satellite&#44; distant&#41; at any site&#46; TNM stages IIIB &#40;N2c&#41;&#44; IIIC &#40;N2c and N3&#41;&#44; and IV &#40;M1a for cutaneous-subcutaneous metastasis&#41;<br>Unresectable primary cutaneous melanoma &#40;involvement of vessels&#44; nerves&#44; or other structures&#41; or resectable only with mutilating surgery<br>Patients with visceral metastasis and those receiving palliative treatment&#44; to improve quality of life&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Intervention&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Electrochemotherapy as monotherapy and as therapy combined with isolated limb perfusion in patients with high tumor load&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Comparator&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">There are 3 therapeutic strategies for unresectable melanomas&#58;<br>Hyperthermic isolated limb perfusion<br>Intralesional administration of interleukin 2&#44; bleomycin&#44; or perilesional administration of GM-CSF<br>Locoregional radiotherapy<br>Systemic treatment&#58; chemotherapy&#44; biochemotherapy&#44; immunotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Outcome&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Effectiveness<br>Clinical response can be measured as complete response &#40;CR&#41;&#44; partial response &#40;PR&#41;&#44; disease-free period &#40;DFP or similar outcomes&#41;&#44; overall survival &#40;OS&#41;&#44; recurrence rate &#40;RR&#41;&#44; stable disease &#40;SD&#41;<br>Safety<br>Adverse effects associated with the procedure<br>Local or regional toxicity or systemic toxicity&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Inclusion and Exclusion Criteria for Article Selection &#40;Using Abstracts&#41; and Research Question in the PICO Format&#46;</p>"
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          "leyenda" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Abbreviations&#58; CR&#44; complete response&#59; EP&#44; electroporation&#59; OR&#44; objective response&#59; PR&#44; partial response&#59; RCT&#44; randomized clinical trial&#59; SLR&#44; systematic literature review</p>"
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                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Patients<br>N&#47;Sex&#47;Age&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Type of Study &#40;Methodology&#41;&#47;Follow-up&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intervention &#40;Route of Administration and Chemotherapy&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Results&#47;Evidence Level&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Spratt &#95;2014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">915 patients with 4313 cutaneous metastases of which 3591 &#40;83&#46;3&#37;&#41; were derived from melanoma&#46; Median age&#44; 61 y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Meta-analysis of 47 studies &#40;8 RCT&#44; 38 nonrandomized studies&#44; and one prospective series&#41;&#46; Patients with primary malignant skin tumor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Various treatments<br>11 studies with electrochemotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR rate&#44; 61&#46;7&#37; &#40;95&#37; CI&#44; 52&#46;5&#37;-70&#46;1&#37;&#41; &#40;after adjusting for imbalances&#41;&#59; OR rate&#44; 60&#46;2&#37; &#40;95&#37; CI&#44; 50&#46;6&#37;-69&#37;&#41;<br>Evidence level 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">AETS&#95;2011&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">693 patients with 2730 tumor nodules&#46; Mean &#40;SD&#41; age 56&#46;9 &#40;11&#46;3&#41; y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">The review included 26 publications and 195 references identified initially&#46; Of these&#44; 13 were cases series and 13 studies with a control group&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">The most frequent treatment was bleomycin &#40;76&#37;&#41;&#44; IT 48&#37;&#44; IV 36&#37;&#44; and both routes 16&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">After mean &#40;SD&#41; follow-up of 9&#46;7 &#40;1&#46;39&#41; months&#44; CR was attained in 60&#37; of nodules&#44; PR in 22&#46;8&#37;&#44; with no change in 10&#46;5&#37; and progression in 5&#46;6&#37;<br>Evidence level 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Mali&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">197 patients &#40;1466 tumors&#41;&#44; 17&#46;2&#37; with diameter<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm and 82&#46;8&#37;<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">SLR of the effectiveness of electrochemotherapy in different tumor sizes between January 1991 and November 2011&#46; Of the 132 relevant studies&#44; 9 were included in the meta-analysis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">A single application of electrochemotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 59&#37; and OR 85&#37; in<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm versus 33&#46;3&#37; and 68&#37;&#44; respectively&#44; in<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm<br>Level of evidence 1&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Carac&#242;&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">60 patients&#46; Mean age 62 y &#40;range&#44; 27 to 89 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Descriptive retrospective study of a series of 60 patients who received a mean of 73 electrochemotherapy applications and who were followed for mean of 27&#46;5 mo &#40;range 6 to 67 mo&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">From 1 to 5 sessions of electrochemotherapy with intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 28<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">After 3 months&#44; 38&#46;3&#37; &#40;23 patients&#41; PR and 48&#37; &#40;29&#41; CR&#46; Eight patients had disease progression with no response<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Ricotti&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">30 patients &#40;654 lesions&#41;&#46; Mean age 75 y &#40;range&#44; 56 to 85 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective nonrandomized study<br>Follow-up 20 mo&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 28<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR in 20&#37; &#40;6 patients&#41;&#44; PR in 80&#37; &#40;24 patients&#41;<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Solari&#95;2014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">20 patients&#46; Mean age 72 y &#40;47 to 91 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective nonrandomized study<br>6 mo follow-up&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 30<span class="elsevierStyleHsp" style=""></span>min<br>Nonserious adverse effects were reported&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 10&#37; &#40;2 patients&#41;&#44; PR 45&#37; &#40;9&#41;&#44; no response 15&#37; &#40;3&#41;&#44; progression 30&#37; &#40;6&#41;<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Skarlatos&#95;2011&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">5 patients &#40;7 lesions&#41; Mean age 69&#46;8 y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective&#44; multicenter&#44; nonrandomized study&#44; 52 patients with metastatic and progressive disease&#44; 9 cutaneous tumors&#44; 5 of which were melanomas &#40;7 applications&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU&#47;cm<span class="elsevierStyleSup">2</span> of 1000<span class="elsevierStyleHsp" style=""></span>IU&#47;cm<span class="elsevierStyleSup">3</span> followed by EP pulses of 8 to 20<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 3 patients&#44; PR 2 patients<br>Side effects were not reported<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Epidemiolog&#237;a del melanoma en Espa&#241;a"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "S&#46; S&#225;enz"
                            1 => "J&#46; Conejo-Mir"
                            2 => "A&#46; Cayuela"
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                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Actas Dermosifiliogr"
                        "fecha" => "2005"
                        "volumen" => "96"
                        "paginaInicial" => "411"
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                        "link" => array:1 [
                          0 => array:2 [
                            "url" => "https://www.ncbi.nlm.nih.gov/pubmed/16476268"
                            "web" => "Medline"
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            1 => array:3 [
              "identificador" => "bib0090"
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              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "La situaci&#243;n del c&#225;ncer en Espa&#241;a"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "G&#46; L&#243;pez-Abente"
                            1 => "M&#46; Poll&#225;n"
                            2 => "N&#46; Aragon&#233;s"
                            3 => "B&#46; P&#233;rez"
                            4 => "V&#46; Hern&#225;ndez"
                            5 => "V&#46; Lope"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Libro" => array:5 [
                        "fecha" => "2005"
                        "paginaInicial" => "38"
                        "paginaFinal" => "65"
                        "editorial" => "Ministerio de Sanidad y Consumo"
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              "identificador" => "bib0095"
              "etiqueta" => "3"
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                0 => array:3 [
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                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "GLOBOCAN 2012 v1&#46;0&#44; Cancer Incidence and Mortality Worldwide&#58; IARC CancerBase No&#46; 11 &#91;Internet&#93;"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46; Ferlay"
                            1 => "I&#46; Soerjomataram"
                            2 => "M&#46; Ervik"
                            3 => "R&#46; Dikshit"
                            4 => "S&#46; Eser"
                            5 => "C&#46; Mathers"
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                  "host" => array:1 [
                    0 => array:1 [
                      "Libro" => array:3 [
                        "fecha" => "2013"
                        "editorial" => "International Agency for Research on Cancer"
                        "editorialLocalizacion" => "Lyon&#44; France"
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                ]
              ]
            ]
            3 => array:3 [
              "identificador" => "bib0100"
              "etiqueta" => "4"
              "referencia" => array:1 [
                0 => array:3 [
                  "comentario" => "Dic&#46; IPE 2011&#47;65"
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Evaluaci&#243;n de la efectividad y seguridad de la electroquimioterapia para el tratamiento de tumores&#58; revisi&#243;n sistem&#225;tica y metaan&#225;lisis"
                      "autores" => array:1 [
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                          "autores" => array:6 [
                            0 => "L&#46;M&#46; S&#225;nchez G&#243;mez"
                            1 => "S&#46; Luengo Matos"
                            2 => "M&#46;M&#46; Polo de Santos"
                            3 => "A&#46; Borda Olivas"
                            4 => "R&#46; Carmona Alf&#233;rez"
                            5 => "A&#46; Fern&#225;ndez Ramos"
                          ]
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                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Libro" => array:3 [
                        "fecha" => "2011"
                        "editorial" => "Agencia de Evaluaci&#243;n de Tecnolog&#237;as Sanitarias&#46; ISCIII&#46; Ministerio de Ciencia e Innovaci&#243;n"
                        "editorialLocalizacion" => "Madrid"
                      ]
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                  ]
                ]
              ]
            ]
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              "identificador" => "bib0105"
              "etiqueta" => "5"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Electrochemotherapy of tumours"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "G&#46; Sersa"
                            1 => "M&#46; Cemazar"
                            2 => "M&#46; Snoj"
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                        ]
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                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:6 [
                        "tituloSerie" => "Curr Oncol"
                        "fecha" => "2009"
                        "volumen" => "16"
                        "paginaInicial" => "34"
                        "paginaFinal" => "35"
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Electrochemotherapy for the Treatment of Unresectable Locoregionally Advanced Cutaneous Melanoma: A Systematic Review
Electroquimioterapia para el tratamiento del melanoma cutáneo locorregionalmente avanzado irresecable. Revisión sistemática
M.J. Aguado-Romeoa,
Autor para correspondencia
, S. Benot-Lópezb, A. Romero-Tabaresc
a Centro Regional de Transfusión Sanguínea, Banco Sectorial de Tejidos Sevilla-Huelva, Spain
b Comisión Provincial de Evaluación de Tecnologías Sanitarias, Sevilla, Spain
c Sector de Evaluación, Servicio Andaluz de Salud, Sevilla, Spain
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    "textoCompleto" => "<span class="elsevierStyleSections"><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0025">Introduction</span><p id="par0005" class="elsevierStylePara elsevierViewall">Changes in the epidemiology of cutaneous melanoma have followed a characteristic pattern in Spain&#46; In the last 30 years of the twentieth century&#44; there was an acceleration in the increase&#44; from 0&#46;3 and 0&#46;2 cases per 100&#160;000 men and women&#44; respectively&#44; in 1972 to 3 and 3&#46;8 cases&#44; respectively&#44; in 1992<a class="elsevierStyleCrossRef" href="#bib0085"><span class="elsevierStyleSup">1</span></a> then to 5&#46;85 and 7&#46;50&#44; respectively&#44; in 1998&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">2</span></a> Subsequently&#44; the curve appears to reach a plateau&#44; with incidence rates of 6&#46;6 and 7&#46;2&#44; respectively&#44; according to the GLOBOCAN source in 2012 and an overall mortality of 1&#47;100 000 inhabitants&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">3</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">Although not the most frequent tumor nor responsible for most deaths&#44; management of advanced cases of advanced melanoma is complex&#46; The current standard treatment of both isolated and multiple tumor nodules is surgical excision&#44; isolated limb perfusion&#44; or radiotherapy&#46; Some therapeutic alternatives in the treatment of metastatic lesions include cryotherapy&#44; laser ablation&#44; and radiofrequency ablation&#44; with the choice of technique varying according to the nature of the lesion&#46; After appropriate treatment&#44; local recurrence of the tumor is hard to manage&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">Electrochemotherapy<a class="elsevierStyleCrossRefs" href="#bib0105"><span class="elsevierStyleSup">5&#44;6</span></a> is an emerging treatment modality for cutaneous and subcutaneous lesions originating from melanoma or other primary and metastatic tumors&#46; The procedure consists of intravenous or intratumoral administration of cytotoxic agents &#40;bleomycin and cisplatin&#41; followed by short and intense local electric pulses to achieve an effect called electroporation or electropermeabilization&#46; The local application of electric pulses of a certain intensity&#44; amplitude&#44; and frequency temporarily destabilizes the cell membrane to allow transient and reversible formation of nonselective pores with a size of about 1 Angstr&#246;m without any impact on cell viability&#44; thereby increasing permeability&#46; Exposure of the cell membrane to electric pulses may lead to cell necrosis due to irreversible changes&#44; whereas application of intense but short electrical pulses induces reversible electroporation&#44; maintaining its viability&#46; After application&#44; the cytotoxic drugs that&#44; given their structure and molecular weight would not easily diffuse across the cell membrane&#44; can move from the intercellular space to the cytosol&#44; resulting in increased in cytotoxicity at a lower dose&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">The aim of this review is to evaluate the evidence supporting the use of electrochemotherapy as a therapeutic strategy for the treatment of unresectable&#44; locoregionally advanced cutaneous melanoma&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0030">Methodology</span><p id="par0025" class="elsevierStylePara elsevierViewall">In this systematic review of the literature with qualitative synthesis&#44; an online search was undertaken of the literature in the reference databases Embase&#44; Medline&#44; and Expanded Science Citation Index&#44; as well as the Cochrane Library and Centre for Research and Dissemination &#40;CRD&#41;&#46; The search was performed during February 2015&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">The articles were selected independently by 2 investigators&#46; The overall assessment of the evidence for each outcome variable was made by reviewing the study design&#44; internal validity&#44; consistency&#44; and precision of the results&#44; as well as other factors such as possible publication bias&#46; For classification of evidence and recommendation grades&#44; the Scottish Intercollegiate Guidelines Network &#40;SIGN&#41; classification was used&#46;<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a> The Assessing Methodological Quality of Systematic Reviews &#40;AMSTART&#41; checklist was also applied&#46;<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a></p><p id="par0035" class="elsevierStylePara elsevierViewall">The predefined inclusion and exclusion criteria for selection of abstracts are shown in <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#46; The full text of the articles that met the inclusion criteria for title and abstract was reviewed independently by 2 investigators&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0040" class="elsevierStylePara elsevierViewall">The research question posed was as follows&#58; Is electrochemotherapy effective and safe for the treatment of unresectable melanoma &#40;primary and metastatic&#41; at any site in adults&#63; This question was analyzed and transferred to the Population Intervention Comparator Outcome &#40;PICO&#41; format &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41;&#46;</p></span><span id="sec0015" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0035">Results</span><span id="sec0020" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0040">Search Results</span><p id="par0045" class="elsevierStylePara elsevierViewall">After checking titles and abstracts&#44; and applying the aforementioned criteria&#44; 37 articles were selected to read the full text&#46; Seven studies met the inclusion criteria&#44; were considered appropriate and relevant&#44; and were analyzed for this review&#46; The flow diagram for article handling and selection is shown in <a class="elsevierStyleCrossRef" href="#fig0005">Figure 1</a>&#46; References to studies were coded to facilitate their handling in the drafting of the manuscript&#58; Spratt&#95;2014&#44;<a class="elsevierStyleCrossRef" href="#bib0125"><span class="elsevierStyleSup">9</span></a> AETS&#95;2011&#44;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">4</span></a> Mali&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0130"><span class="elsevierStyleSup">10</span></a> Caraco&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0135"><span class="elsevierStyleSup">11</span></a> Riccoti&#95;2013&#44;<a class="elsevierStyleCrossRef" href="#bib0140"><span class="elsevierStyleSup">12</span></a> Solari&#95;2014&#44;<a class="elsevierStyleCrossRef" href="#bib0145"><span class="elsevierStyleSup">13</span></a> and Skarlatos&#95;2011&#46;<a class="elsevierStyleCrossRef" href="#bib0150"><span class="elsevierStyleSup">14</span></a></p><elsevierMultimedia ident="fig0005"></elsevierMultimedia><p id="par0050" class="elsevierStylePara elsevierViewall">As no clinical trials or cohort studies have analyzed the effectiveness of electrochemotherapy&#44; we decided to include case series not included in systematic reviews or in the evaluation reports selected for assessment&#46;</p><p id="par0055" class="elsevierStylePara elsevierViewall">The search returned a National Institute for Health and Care Excellence &#40;NICE&#41; report from 2013&#46;<a class="elsevierStyleCrossRef" href="#bib0155"><span class="elsevierStyleSup">15</span></a> Although this report was a procedure guideline and so did not meet our inclusion criteria&#44; it was nevertheless used for drafting the present article&#46; Six studies were included in the meta-analysis of Spratt&#95;2014&#46; The remaining studies were excluded because of language of the report or type of study&#46; Five articles could not be located&#46;</p></span><span id="sec0025" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0045">Study Results</span><p id="par0060" class="elsevierStylePara elsevierViewall"><a class="elsevierStyleCrossRef" href="#tbl0010">Table 2</a> summarizes the most relevant data for the studies analyzed and their evidence level&#46;</p><elsevierMultimedia ident="tbl0010"></elsevierMultimedia><p id="par0065" class="elsevierStylePara elsevierViewall">We found 3 systematic reviews<a class="elsevierStyleCrossRefs" href="#bib0100"><span class="elsevierStyleSup">4&#44;9&#44;10</span></a> that were analyzed according to the SIGN<a class="elsevierStyleCrossRef" href="#bib0115"><span class="elsevierStyleSup">7</span></a> and AMSTAR<a class="elsevierStyleCrossRef" href="#bib0120"><span class="elsevierStyleSup">8</span></a> criteria&#46;</p><p id="par0070" class="elsevierStylePara elsevierViewall">The Spratt&#95;2014 review found a high but heterogenous response rate and an improved quality of life&#46; The authors recommended defining treatment algorithms and further studies to establish the specific characteristics of the patients and cutaneous metastases&#46;</p><p id="par0075" class="elsevierStylePara elsevierViewall">All the meta-analyses included in the AETS&#95;2011 review show results clearly in favor of electrochemotherapy versus chemotherapy&#46; The studies took the percentage of patients with complete response &#40;CR&#41; verus other types of response as the outcome measure&#46; The best outcomes were obtained in the late assessment of electrochemotherapy &#40;bleomycin or cisplatin&#41; versus chemotherapy &#40;bleomycin or cisplatin&#41;&#44; with a relative risk &#40;RR&#41; of 8&#46;05 &#40;95&#37; CI&#44; 3&#46;43-18&#46;88&#41;&#44; as well as in the late assessment &#40;mean follow-up&#44; 9&#46;7 months&#41; of electrochemotherapy &#40;bleomycin&#41; versus chemotherapy &#40;bleomycin&#41;&#44; with a RR of 8&#46;48 &#40;95&#37; CI&#44; 3&#46;46-20&#46;79&#41;&#46; In the early assessments &#40;mean follow-up&#44; 2&#46;2 months&#41;&#44; the RR values were low&#58; 5&#46;01 &#40;95&#37; CI&#44; 2&#46;70-9&#46;32&#41; and 7&#46;56 &#40;95&#37; CI&#44; 2&#46;64-21&#46;60&#41;&#44; respectively&#46; In the meta-analysis performed in patients with single diagnosis of melanoma&#44; the outcomes were also in favor of electrochemotherapy versus chemotherapy&#46; In the early assessment of electrochemotherapy &#40;bleomycin or cisplatin&#41; versus chemotherapy &#40;bleomycin or cisplatin&#41;&#44; the RR was 4&#46;03 &#40;95&#37; CI&#44; 2&#46;05-7&#46;92&#41; in favor of electrochemotherapy&#46; Likewise&#44; in the later assessment&#44; the RR was 5&#46;95 &#40;95&#37; CI&#44; 1&#46;83-19&#46;33&#41; in favor of electrochemotherapy versus chemotherapy in patients with a single melanoma&#46; With regards the safety of electrochemotherapy&#44; of the 26 studies&#44; 2 did not report the appearance of complications&#46; In the remaining 24 studies&#44; mild complications and side effects were reported&#46;</p><p id="par0080" class="elsevierStylePara elsevierViewall">In a systematic literature review &#40;SLR&#41;&#44; Mali&#95;2013 focused on the correlation between tumor size and outcome&#46; The data were obtained from nonrandomized studies&#46; The results show lower effectiveness in tumors larger than 3<span class="elsevierStyleHsp" style=""></span>cm than in smaller tumors &#40;CR and objective response &#91;OR&#93;&#44; 59&#37; and 85&#37;&#44; versus 33&#46;3&#37; and 68&#37;&#44; respectively&#41;&#46; The authors suggested that the explanation could be the lower drug concentration because of an insufficient application time&#46; The pulses were applied 2<span class="elsevierStyleHsp" style=""></span>min after intratumoral infusion of bleomycin or cisplatin&#44; or within the therapeutic window of 8 to 28<span class="elsevierStyleHsp" style=""></span>min after intravenous bleomycin&#46; Administration of bleomycin to the interstitial space around the tumor attains sufficiently high concentrations&#44; but the plasma concentration declines biexponentially with a mean half-life of distribution of 24 to 30<span class="elsevierStyleHsp" style=""></span>min and a mean clearance of 2-4<span class="elsevierStyleHsp" style=""></span>h&#46;<a class="elsevierStyleCrossRef" href="#bib0160"><span class="elsevierStyleSup">16</span></a> The second explanation suggested by the authors was insufficient exposure to the tumor in those larger than 3<span class="elsevierStyleHsp" style=""></span>cm given the irregular vascularization&#46; A third explanation is that a stronger electric field is required&#46;</p><p id="par0085" class="elsevierStylePara elsevierViewall">We identified 4 observational studies with prospective follow-up&#44; with evidence level 3&#46;<a class="elsevierStyleCrossRefs" href="#bib0135"><span class="elsevierStyleSup">11&#8211;14</span></a> Carac&#242;&#95;2013 and Solari&#95;2014 found a significant correlation between response and both number of lesions &#40;fewer than or more than 10&#41; and size &#40;smaller or larger than 2<span class="elsevierStyleHsp" style=""></span>cm&#41;&#44; whereas Ricotti&#95;2013 obtained apparently contradictory data&#44; as a higher CR rate was associated with more lesions after the second session&#46;</p><p id="par0090" class="elsevierStylePara elsevierViewall">These are retrospective studies&#44; with a small sample size &#40;n between 5 and 60&#41; and without a comparator group&#46; Solari&#95;2014 provided demographic data on sex and age of the patients&#46; Men tended to be treated more often&#44; perhaps because this is a disease more prevalent among males&#46; All patients were elderly when they received the study treatment&#46;</p><p id="par0095" class="elsevierStylePara elsevierViewall">In Solari&#95;2014 and in Riccoti&#95;2013&#44; criteria for administration were established according to the size of the tumor and the number of nodules to be treated&#46;</p><p id="par0100" class="elsevierStylePara elsevierViewall">They all used a similar protocol&#58; administration of intravenous bleomycin 15 000<span class="elsevierStyleHsp" style=""></span>IU&#47;m<span class="elsevierStyleSup">2</span> prior to the electrochemotherapy pulses&#46; Only Skarlatos&#95;2011 also used intratumoral bleomycin in large lesions&#46;</p><p id="par0105" class="elsevierStylePara elsevierViewall">All reported CR rates after treatment of between 10&#37; and 48&#37;&#44; and partial response rates of between 38&#46;3&#37; and 80&#37;&#46; Solari&#95;2014 reported a percentage of patients who did not respond to treatment &#40;15&#37;&#41; or whose diseases progressed &#40;30&#37;&#41;&#46; For their part&#44; Carac&#242;&#95;2013 reported a combined response rate for both variables of 13&#46;3&#37;&#46;</p><p id="par0110" class="elsevierStylePara elsevierViewall">None of these authors reported serious side effects&#59; those that were reported were mild and manageable&#46; Follow-up times were short&#44; from 6 to 20 months&#46;</p></span></span><span id="sec0030" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0050">Discussion</span><p id="par0115" class="elsevierStylePara elsevierViewall">The evidence levels of the studies assessed in this review&#44; 4 cases series and 3 SLRs were medium to low&#44; according to the SIGN classification followed &#40;level 3 for all case series and 1&#8211; to 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; for SLR&#41;&#46; The series did not include a control group and were not analyzed in the same time period&#44; the study populations were small&#44; and the studies were not designed to compare effectiveness with other alternatives&#46; The studies were therefore subject to the biases of this type of study&#46; Follow-up was&#44; in general&#44; short&#44; and for this reason&#44; perhaps not all the complications actually caused by the treatment were reported&#46; The internal validity might have been affected by observer bias&#44; as there was no blinding in the reading of the results in any of the studies&#46; No quality-of-life variables were either described or measured&#44; even though these aspects impact health resource use and patient preference&#46; Likewise&#44; we did not find any studies that compared electrochemotherapy with other local or regional therapeutic alternatives&#46; Such a comparison would be of great interest to assess the clinical relevance of the procedure&#46; Nevertheless&#44; alignment of the results for some of the outcome variables analyzed lends consistency to the findings&#46; In fact&#44; the meta-analyses show results in favor of electrochemotherapy compared with chemotherapy&#44; and so these findings could be applicable in Spain&#46;</p><p id="par0120" class="elsevierStylePara elsevierViewall">In this review&#44; we did not find any studies that assessed the organizational or economic impact of the use of electrochemotherapy in clinical practice&#46; Nevertheless&#44; the literature highlights the feasibility&#44; rapid and simple nature of electrochemotherapy&#44; good patient acceptance&#44; and the acceptable cost of treatment&#46; The technique can be considered of great therapeutic potential&#46;</p><p id="par0125" class="elsevierStylePara elsevierViewall">The conclusions of this systematic review are as follows&#58;<ul class="elsevierStyleList" id="lis0005"><li class="elsevierStyleListItem" id="lsti0005"><span class="elsevierStyleLabel">&#8226;</span><p id="par0130" class="elsevierStylePara elsevierViewall">Electrochemotherapy could be an effective procedure in local treatment of malignant tumor nodules in terms of objective response&#44; whether complete or partial&#46; Evidence level 3 &#40;low&#44; case series&#41; and 1&#8211; to 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0010"><span class="elsevierStyleLabel">&#8226;</span><p id="par0135" class="elsevierStylePara elsevierViewall">Electrochemotherapy is easily administered&#44; economical&#44; and well tolerated in that it achieves OR in a high percentage of patients&#44; particularly if there are fewer than 10 lesions and the size is less than 2<span class="elsevierStyleHsp" style=""></span>cm&#46; The procedure can be repeated according to the response of the patient&#46; Evidence level 1&#8211;&#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0015"><span class="elsevierStyleLabel">&#8226;</span><p id="par0140" class="elsevierStylePara elsevierViewall">Although the findings show that electrochemotherapy is effective in local control of the tumor lesion&#44; we did not find any evidence that it may influence the natural course of the disease or patient survival&#44; and so it should be considered merely a palliative treatment&#46; Evidence level 3 &#40;low&#44; case series&#41; and 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li><li class="elsevierStyleListItem" id="lsti0020"><span class="elsevierStyleLabel">&#8226;</span><p id="par0145" class="elsevierStylePara elsevierViewall">Electrochemotherapy is a safe procedure&#44; without serious adverse effects for the patient&#46; The most frequently reported complications are pain&#44; erythema&#44; muscle contractions&#44; and local edema&#46; Evidence level 1&#8211;a 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43; &#40;medium&#44; SLR&#41;&#46;</p></li></ul></p><p id="par0150" class="elsevierStylePara elsevierViewall">Based on the level of evidence&#44; we can recommend incorporation of electrochemotherapy as palliative therapy for unresectable metastatic melanoma &#40;strength of recommendation&#58; B&#41;&#46;</p></span><span id="sec0035" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0055">Ethical Responsibilities</span><span id="sec0040" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0060">Protection of human and animal subjects</span><p id="par0155" class="elsevierStylePara elsevierViewall">The authors declare that no experiments were performed on humans or animals for this investigation&#46;</p></span><span id="sec0045" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0065">Confidentiality of data</span><p id="par0160" class="elsevierStylePara elsevierViewall">The authors declare that they have followed their hospital&#39;s protocol on the publication of data concerning patients&#46;</p></span><span id="sec0050" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0070">Right to privacy and informed consent</span><p id="par0165" class="elsevierStylePara elsevierViewall">The authors declare that patient data do not appear in this article&#46;</p></span></span><span id="sec0055" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0075">Conflicts of Interest</span><p id="par0170" class="elsevierStylePara elsevierViewall">The authors declare that they have no conflicts of interest&#46;</p></span></span>"
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            2 => "Melanoma"
            3 => "Therapy"
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        "resumen" => "<span id="abst0005" class="elsevierStyleSection elsevierViewall"><p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Electrochemotherapy is a therapeutic option for the treatment of cutaneous and subcutaneous metastases from melanoma and other tumors&#46; The procedure consists of the administration of anticancer drugs followed by locally applied electrical impulses to achieve an effect known as <span class="elsevierStyleItalic">electroporation</span>&#44; which facilitates entry into the cytosol of drugs that cannot cross the cell membrane&#46; The aim of this review is to evaluate the evidence that supports the use of electrochemotherapy as a therapeutic strategy in melanoma&#46; We conducted a qualitative systematic review of the literature using advanced searches of bibliographic databases and full text reviews&#46; Seven studies &#40;3 systematic reviews and 4 cases series&#41; were selected&#46; The quality of the evidence was not good&#44; but the coincidence of results for certain variables supports their consistency&#46; Results of the meta-analyses favored electrochemotherapy over chemotherapy&#46; Electrochemotherapy appears to be an effective procedure for the local treatment of malignant tumor nodules &#40;evidence of intermediate or low quality&#41;&#46; This inexpensive method is simple to apply&#44; well tolerated&#44; and achieves objective responses under certain circumstances&#46; There is no evidence that electrochemotherapy alters the natural course of the disease and it should therefore be considered a palliative treatment&#46; With an evidence level of 1- &#40;minus&#41;&#44; electrochemotherapy can be recommended for the palliative treatment of unresectable&#44; locoregionally advanced melanoma &#40;grade B recommendation&#41;&#46;</p></span>"
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        "resumen" => "<span id="abst0010" class="elsevierStyleSection elsevierViewall"><p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">La electroquimioterapia &#40;EQT&#41; es una modalidad de tratamiento de lesiones cut&#225;neas y subcut&#225;neas originadas por melanoma u otros tumores&#46; El procedimiento consiste en la administraci&#243;n de agentes antineopl&#225;sicos&#44; seguido de impulsos el&#233;ctricos locales&#44; para conseguir un efecto conocido como electroporaci&#243;n&#44; que permite la entrada al citosol de medicamentos que no difunden a trav&#233;s de la membrana celular&#46; El objetivo de esta revisi&#243;n es establecer la evidencia que sustenta la incorporaci&#243;n de la EQT como estrategia terap&#233;utica en el melanoma&#46;</p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Adem&#225;s&#44; se ha llevado a cabo una revisi&#243;n sistem&#225;tica de la literatura con s&#237;ntesis cualitativa&#46; Se ha realizado una b&#250;squeda cualificada de la literatura en bases de datos referenciales y a texto completo&#46; Fueron seleccionados 7 estudios&#58; 3 revisiones sistem&#225;ticas y 4 series de casos&#46;</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">La calidad de la evidencia encontrada no es buena&#44; pero la coincidencia de sus resultados en algunas las variables le da consistencia&#46; Los metaan&#225;lisis muestran resultados a favor de la EQT frente a la quimioterapia&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall">La EQT parece un procedimiento efectivo en el tratamiento local de n&#243;dulos tumorales malignos &#40;nivel medio o bajo de calidad de la evidencia&#41;&#46; Es un tratamiento f&#225;cil de administrar&#44; econ&#243;mico y bien tolerado con el que se consigue respuesta objetiva en circunstancias determinadas&#46; No hay evidencia de que pueda afectar el curso natural de la enfermedad&#44; por lo que debe considerarse un tratamiento paliativo&#46;</p><p id="spar0030" class="elsevierStyleSimplePara elsevierViewall">Con un <span class="elsevierStyleItalic">nivel de la evidencia 1&#8211;</span>&#40;1 menos&#41;&#44; puede recomendarse la incorporaci&#243;n de la EQT para el tratamiento paliativo del melanoma locorregionalmente avanzado irresecable <span class="elsevierStyleItalic">&#40;fuerza de la recomendaci&#243;n&#58; B&#41;</span>&#46;</p></span>"
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        "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as&#58; Aguado-Romeo MJ&#44; Benot-L&#243;pez S&#44; Romero-Tabares A&#46; Electroquimioterapia para el tratamiento del melanoma cut&#225;neo locorregionalmente avanzado irresecable&#46; Revisi&#243;n sistem&#225;tica&#46; Actas Dermosifiliogr&#46; 2017&#59;108&#58;91&#8211;97&#46;</p>"
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          "en" => "<p id="spar0035" class="elsevierStyleSimplePara elsevierViewall">Flow diagram for article handling and selection&#46;</p>"
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          "leyenda" => "<p id="spar0045" class="elsevierStyleSimplePara elsevierViewall">In this study&#44; we used the criteria for unresectability and TNM corresponding to locally advanced melanoma according to the American Joint Committee of Cancer &#40;AJCC&#41; classification&#46;</p><p id="spar0050" class="elsevierStyleSimplePara elsevierViewall">Abbreviations&#58; GM-CSF&#44; granulocyte-macrophage colony-stimulating factor&#59; INAHTA&#44; International Network of Agencies of Health Technology Assessment&#59; PICO&#44; population &#40;P&#41;&#44; intervention &#40;I&#41;&#44; comparison &#40;C&#41; and outcome&#40;s&#41; &#40;O&#41;&#59; SLR&#44; systematic literature review&#46;</p>"
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                  \t\t\t\t" class=""><tbody title="tbody"><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Inclusion criteria</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Types of study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Clinical trials&#44; cohort studies&#44; SLR&#44; meta-analyses that assess one of the outcomes included in the research question&#46; In the event that no studies with these criteria were retrieved&#44; the inclusion of nonanalytic studies and case-control studies was considered&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Languages&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">English&#44; Spanish&#44; French&#44; and German&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Other conditions&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Technology assessment reports that analyzed details on the search strategy and methodological assessment of the studies were included&#46; Agency assessment reports had to meet the checklist drawn up by the expert group in the 2001 INAHTA meeting&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td" title="table-entry  " colspan="2" align="left" valign="top"><span class="elsevierStyleItalic">Exclusion criteria</span></td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top"><span class="elsevierStyleHsp" style=""></span>Types of study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Animal or in vitro experiments&#44; narrative reviews&#44; series&#44; case-control studies published prior to studies of higher evidence level&#46;<br>Studies of any design that had not assessed the variables specified in the research question or whose publication date was prior to the year 2000&#46;&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " colspan="2" align="left" valign="top" scope="col" style="border-bottom: 2px solid black">The PICO format of the research question</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Population&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Patients aged over 18 years with&#58;<br>unresectable cutaneous and&#47;or subcutaneous metastatic melanoma &#40;in transit&#44; satellite&#44; distant&#41; at any site&#46; TNM stages IIIB &#40;N2c&#41;&#44; IIIC &#40;N2c and N3&#41;&#44; and IV &#40;M1a for cutaneous-subcutaneous metastasis&#41;<br>Unresectable primary cutaneous melanoma &#40;involvement of vessels&#44; nerves&#44; or other structures&#41; or resectable only with mutilating surgery<br>Patients with visceral metastasis and those receiving palliative treatment&#44; to improve quality of life&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Intervention&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Electrochemotherapy as monotherapy and as therapy combined with isolated limb perfusion in patients with high tumor load&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Comparator&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">There are 3 therapeutic strategies for unresectable melanomas&#58;<br>Hyperthermic isolated limb perfusion<br>Intralesional administration of interleukin 2&#44; bleomycin&#44; or perilesional administration of GM-CSF<br>Locoregional radiotherapy<br>Systemic treatment&#58; chemotherapy&#44; biochemotherapy&#44; immunotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Outcome&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Effectiveness<br>Clinical response can be measured as complete response &#40;CR&#41;&#44; partial response &#40;PR&#41;&#44; disease-free period &#40;DFP or similar outcomes&#41;&#44; overall survival &#40;OS&#41;&#44; recurrence rate &#40;RR&#41;&#44; stable disease &#40;SD&#41;<br>Safety<br>Adverse effects associated with the procedure<br>Local or regional toxicity or systemic toxicity&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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          "en" => "<p id="spar0040" class="elsevierStyleSimplePara elsevierViewall">Inclusion and Exclusion Criteria for Article Selection &#40;Using Abstracts&#41; and Research Question in the PICO Format&#46;</p>"
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          "leyenda" => "<p id="spar0060" class="elsevierStyleSimplePara elsevierViewall">Abbreviations&#58; CR&#44; complete response&#59; EP&#44; electroporation&#59; OR&#44; objective response&#59; PR&#44; partial response&#59; RCT&#44; randomized clinical trial&#59; SLR&#44; systematic literature review</p>"
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                0 => """
                  <table border="0" frame="\n
                  \t\t\t\t\tvoid\n
                  \t\t\t\t" class=""><thead title="thead"><tr title="table-row"><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Patients<br>N&#47;Sex&#47;Age&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Type of Study &#40;Methodology&#41;&#47;Follow-up&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Intervention &#40;Route of Administration and Chemotherapy&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th><th class="td" title="table-head  " align="left" valign="top" scope="col" style="border-bottom: 2px solid black">Results&#47;Evidence Level&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Spratt &#95;2014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">915 patients with 4313 cutaneous metastases of which 3591 &#40;83&#46;3&#37;&#41; were derived from melanoma&#46; Median age&#44; 61 y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Meta-analysis of 47 studies &#40;8 RCT&#44; 38 nonrandomized studies&#44; and one prospective series&#41;&#46; Patients with primary malignant skin tumor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Various treatments<br>11 studies with electrochemotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR rate&#44; 61&#46;7&#37; &#40;95&#37; CI&#44; 52&#46;5&#37;-70&#46;1&#37;&#41; &#40;after adjusting for imbalances&#41;&#59; OR rate&#44; 60&#46;2&#37; &#40;95&#37; CI&#44; 50&#46;6&#37;-69&#37;&#41;<br>Evidence level 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">AETS&#95;2011&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">693 patients with 2730 tumor nodules&#46; Mean &#40;SD&#41; age 56&#46;9 &#40;11&#46;3&#41; y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">The review included 26 publications and 195 references identified initially&#46; Of these&#44; 13 were cases series and 13 studies with a control group&#46;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">The most frequent treatment was bleomycin &#40;76&#37;&#41;&#44; IT 48&#37;&#44; IV 36&#37;&#44; and both routes 16&#37;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">After mean &#40;SD&#41; follow-up of 9&#46;7 &#40;1&#46;39&#41; months&#44; CR was attained in 60&#37; of nodules&#44; PR in 22&#46;8&#37;&#44; with no change in 10&#46;5&#37; and progression in 5&#46;6&#37;<br>Evidence level 2<span class="elsevierStyleHsp" style=""></span>&#43;<span class="elsevierStyleHsp" style=""></span>&#43;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Mali&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">197 patients &#40;1466 tumors&#41;&#44; 17&#46;2&#37; with diameter<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm and 82&#46;8&#37;<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">SLR of the effectiveness of electrochemotherapy in different tumor sizes between January 1991 and November 2011&#46; Of the 132 relevant studies&#44; 9 were included in the meta-analysis&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">A single application of electrochemotherapy&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 59&#37; and OR 85&#37; in<span class="elsevierStyleHsp" style=""></span>&#8805;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm versus 33&#46;3&#37; and 68&#37;&#44; respectively&#44; in<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>3<span class="elsevierStyleHsp" style=""></span>cm<br>Level of evidence 1&#8211;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Carac&#242;&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">60 patients&#46; Mean age 62 y &#40;range&#44; 27 to 89 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Descriptive retrospective study of a series of 60 patients who received a mean of 73 electrochemotherapy applications and who were followed for mean of 27&#46;5 mo &#40;range 6 to 67 mo&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">From 1 to 5 sessions of electrochemotherapy with intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 28<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">After 3 months&#44; 38&#46;3&#37; &#40;23 patients&#41; PR and 48&#37; &#40;29&#41; CR&#46; Eight patients had disease progression with no response<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Ricotti&#95;2013&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">30 patients &#40;654 lesions&#41;&#46; Mean age 75 y &#40;range&#44; 56 to 85 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective nonrandomized study<br>Follow-up 20 mo&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 28<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR in 20&#37; &#40;6 patients&#41;&#44; PR in 80&#37; &#40;24 patients&#41;<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Solari&#95;2014&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">20 patients&#46; Mean age 72 y &#40;47 to 91 y&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective nonrandomized study<br>6 mo follow-up&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU followed by EP pulses of 8 to 30<span class="elsevierStyleHsp" style=""></span>min<br>Nonserious adverse effects were reported&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 10&#37; &#40;2 patients&#41;&#44; PR 45&#37; &#40;9&#41;&#44; no response 15&#37; &#40;3&#41;&#44; progression 30&#37; &#40;6&#41;<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="table-entry ; entry_with_role_rowhead " align="left" valign="top">Skarlatos&#95;2011&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">5 patients &#40;7 lesions&#41; Mean age 69&#46;8 y&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Prospective&#44; multicenter&#44; nonrandomized study&#44; 52 patients with metastatic and progressive disease&#44; 9 cutaneous tumors&#44; 5 of which were melanomas &#40;7 applications&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Intravenous bleomycin 15&#160;000<span class="elsevierStyleHsp" style=""></span>IU&#47;cm<span class="elsevierStyleSup">2</span> of 1000<span class="elsevierStyleHsp" style=""></span>IU&#47;cm<span class="elsevierStyleSup">3</span> followed by EP pulses of 8 to 20<span class="elsevierStyleHsp" style=""></span>min&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">CR 3 patients&#44; PR 2 patients<br>Side effects were not reported<br>Evidence level 3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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ISSN: 15782190
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