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cases of exceptionally aggressive squamous cell carcinoma &#40;SCC&#41; have been reported in patients on ruxolitinib&#46;<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">5&#8211;7</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">We describe the cases of 3 men who developed high-risk SCC while on ruxolitinib administered for hematological conditions&#46; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the patients&#8217; clinical and demographic characteristics&#46; Patient &#35;1 and patient &#35;3 died due to the progression of their skin neoplasms&#44; initially located in both patients in the pinna &#40;<a class="elsevierStyleCrossRefs" href="#fig0005">figs&#46; 1 and 2</a>&#41;1&#46; Although patient &#35;2 died shortly after the initial intervention of an unrelated medical problem&#44; the presence of poor prognostic tumor factors&#44; such as perineural invasion or nasal cartilage infiltration&#44; is significant &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Ruxolitinib is one of the most widely used drugs to treat patients with myeloproliferative syndromes and corticoid-refractory GVHD as it is one of the very few treatments that has proven capable of improving overall survival &#40;in both MF and PV&#41; and disease-free survival &#40;in GVHD&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2&#44;3&#44;8</span></a> The 5-year assessment of the COMFORT-II clinical trial&#8212;which ultimately led to the approval of the indication for MF treatment&#8212;confirmed a 17&#46;1&#37; incidence rate of NMSC &#40;25 out of 146&#41; in patients on ruxolitinib vs a 2&#46;7&#37; incidence rate &#40;2 out of 73&#41; in the control group on the optimal medical therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> However&#44; after adjusting for exposure &#40;patient-years&#41;&#44; this difference did not reach statistical significance&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Recently&#44; clinical practice data from the largest cohort to date of 188 patients on ruxolitinib for MF or PV and controls adjusted for age&#44; sex&#44; race&#44; time from diagnosis&#44; and previous treatments&#8212;including hydroxyurea&#8212;have been published1&#46; In this study&#44; a hazard ratio &#40;HR&#41; for the development of SCC in patients on ruxolitinib of 3&#46;2 &#40;95&#37; confidence interval &#91;CI&#93;&#44; 1&#46;5-7&#41; was found&#46; In patients without the JAK2 mutation&#44; this HR went up to 7&#46;4 &#40;95&#37;CI&#44; 2&#46;5-21&#46;6&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> The authors hypothesized that this difference could be explained by the absence of the JAK2 mutation&#44; which may have conditioned a more intense ruxolitinib inhibition of the tissue lymphocytes responsible for preventing the development of skin neoplasms1&#46; Unexpectedly&#44; no significant differences were found in the development of SCC in patients on hydroxyurea vs those who were treatment-na&#239;ve &#40;HR&#44; 1&#46;1&#41;&#46; However&#44; having received a &#62; 2-week regimen of cyclosporine&#44; azathioprine&#44; or systemic corticosteroids was associated with a higher risk of SCC&#46; Most SCCs appeared between the 1<span class="elsevierStyleSup">st</span> and 2<span class="elsevierStyleSup">nd</span> year after starting ruxolitinib&#44; with a median of 66&#46;5 weeks &#40;range&#44; 11-245&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Regarding GVHD&#44; long-term data on the development of skin neoplasms in patients on ruxolitinib are still lacking&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> Patient &#35;3 is the only case we could find in the published literature of a SCC in a patient with GVHD while on ruxolitinib&#46; Given the fatal outcome&#44; it seems advisable to be aware of the possible appearance of aggressive SCC in this group of patients&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">For the topical use of ruxolitinib&#44; no cases of SCC have ever been reported in patients on this topical therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> Furthermore&#44; in a review of the pharmacokinetics of ruxolitinib cream for atopic dermatitis&#8212;which included 1139 patients from clinical trials&#8212;no blood concentrations capable of having a systemic effect or causing hematological changes were found&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> This makes it very likely that the safety profile of the topical presentation is very different from that of the systemic drug&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In conclusion&#44; we recommend the dermatological follow-up of patients on ruxolitinib for hematological problems&#44; a recommendation that is currently included in the drug technical sheet&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> We should be aware of the aggressive and lethal course of the disease these patients may present&#46; Future post-marketing studies&#44; with longer follow-up periods than those collected in clinical trials&#44; may shed more light on the risk of patients with GVHD on ruxolitinib&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0040" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0045" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span></span>"
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Images from patient &#35;1&#46; A and B&#41; Clinical appearance of SCC affecting the upper and middle thirds of the right pinna&#46; C&#41; Functional neck dissection&#46; The image shows the external jugular vein&#44; the parotid gland&#44; and the facial nerve&#46; D&#41; Hematoxylin and eosin stain&#44; 200x&#46; Moderately differentiated keratinizing tumor forming keratin pearls&#46; E&#41; Coronal image&#44; contrast-enhanced computed tomography &#40;CT&#41; showing right supraclavicular lymphadenopathy &#40;circle&#41;&#59; asterisk indicates pleural effusion&#46; F&#41; Cross-sectional image&#44; contrast-enhanced CT&#44; asterisk indicates pleural effusion&#46;</p>"
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          "en" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">A&#41; Patient &#35;2&#44; squamous tumor on the nasal wall&#46; B and C&#41; Intraoperative appearance suggesting deep infiltration of nasal cartilages&#46; D&#41; Hematoxylin and eosin stain&#44; 200x&#44; showing tumor with perineural infiltration&#46; E and F&#41; Patient &#35;3&#44; large fleshy tumor with spontaneous bleeding affecting almost the entire pinna&#46;</p>"
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          "leyenda" => "<p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">GVHD&#44; graft-versus-host disease&#59; M&#44; male&#59; MF&#44; myelofibrosis&#59; PV&#44; polycythemia vera&#59; RT&#44; radiotherapy&#59; SCC&#44; squamous cell carcinoma&#46;</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="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Patient &#35;1&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Patient &#35;2&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th><th class="td" title="\n
                  \t\t\t\t\ttable-head\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t" scope="col" style="border-bottom: 2px solid black">Patient &#35;3&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t\t\t</th></tr></thead><tbody title="tbody"><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Age and sex&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">77 years&#46; M&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">85 years&#46; M&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">69 years&#46; M&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Hematological history&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">JAK2 positive MF&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">JAK2 positive PV&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Bone marrow transplant for mantle cell lymphoma&#44; non-Hodgkin typeGVHD&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Ruxolitinib &#40;dose&#59; prior exposure time&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 19 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 26 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 2 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Clinical presentation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Infiltrating tumor &#40;3&#46;5<span class="elsevierStyleHsp" style=""></span>cm in diameter&#41; located in the upper and middle thirds of the right pinna &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>A and 1B&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Rapidly growing crusty tumor &#40;15<span class="elsevierStyleHsp" style=""></span>mm in diameter&#41; located on the right nasal wall &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>A&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Rapidly appearing and bleeding lesion on the right pinna over a previous GVHD angiomatous location &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>E and 2F&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Treatments&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Complete amputation of the pinna&#44; right superficial parotidectomy&#44; and right functional neck dissection &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>C&#41; &#43; RT to surgical bed and lymph node chains &#40;62&#46;5<span class="elsevierStyleHsp" style=""></span>Gy and 49&#46;5<span class="elsevierStyleHsp" style=""></span>Gy&#44; respectively&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Lesion excision&#44; during surgery massive macroscopic deep infiltration was seen &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>B and 2C&#41;&#44; so total skin graft coverage was decided&#44; with subsequent evaluation for RT&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Initially treated with RT at 16<span class="elsevierStyleHsp" style=""></span>Gy&#46; Due to persistent lesion&#44; surgical amputation and ipsilateral functional neck dissection were decided&#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="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Histological study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Moderately differentiated SCC &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>D&#41;&#44; 15<span class="elsevierStyleHsp" style=""></span>mm deep infiltration&#44; and presence of lymphovascular invasion&#46; Surgical margins&#44; 8 cervical nodes removed&#44; and tumor infiltration-free parotid&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">SCC contacting deep margin and perineural infiltration of a 0&#46;13mm nerve &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>D&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Moderately differentiated SCC&#44; with clear margins and lymph nodes without metastatic involvement&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Outcome&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 months later&#44; appearance of bilateral cervicothoracic lymphadenopathy and metastatic pleural effusion &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>E and 1F&#41;&#46;Deceased&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Further studies or treatments were not possible after the patient&#39;s death from another unrelated medical issue&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 month after surgery&#44; the patient developed metastasis a few centimeters from the operated region and treatment with cetuximab was initiated&#44; passing away after 2 sessions of treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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    "bibliografia" => array:2 [
      "titulo" => "References"
      "seccion" => array:1 [
        0 => array:2 [
          "identificador" => "bibs0015"
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            0 => array:3 [
              "identificador" => "bib0055"
              "etiqueta" => "1"
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                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "A 10-year retrospective cohort study of ruxolitinib and association with nonmelanoma skin cancer in patients with polycythemia vera and myelofibrosis"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => true
                          "autores" => array:6 [
                            0 => "J&#46;Q&#46; Lin"
                            1 => "S&#46;Q&#46; Li"
                            2 => "S&#46; Li"
                            3 => "E&#46;F&#46; Kiamanesh"
                            4 => "S&#46;Z&#46; Aasi"
                            5 => "B&#46;Y&#46; Kwong"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:1 [
                      "Revista" => array:5 [
                        "tituloSerie" => "J Am Acad Dermatol&#46;"
                        "fecha" => "2022"
                        "volumen" => "86"
                        "paginaInicial" => "339"
                        "paginaFinal" => "344"
                      ]
                    ]
                  ]
                ]
              ]
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            1 => array:3 [
              "identificador" => "bib0060"
              "etiqueta" => "2"
              "referencia" => array:1 [
                0 => array:2 [
                  "contribucion" => array:1 [
                    0 => array:2 [
                      "titulo" => "Janus Kinase Inhibitors and Non-Melanoma Skin Cancer"
                      "autores" => array:1 [
                        0 => array:2 [
                          "etal" => false
                          "autores" => array:3 [
                            0 => "C&#46;S&#46; Greif"
                            1 => "D&#46; Srivastava"
                            2 => "R&#46;I&#46; Nijhawan"
                          ]
                        ]
                      ]
                    ]
                  ]
                  "host" => array:1 [
                    0 => array:2 [
                      "doi" => "10.1007/s11864-020-00815-y"
                      "Revista" => array:5 [
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Case and Research Letter
Ruxolitinib and Squamous Cell Carcinoma
Ruxolitinib y carcinoma de células escamosas
D. Soto-Garcíaa,b,
Corresponding author
diego.soto.garcia@gmail.com

Corresponding author.
, B. González-Sixtoa,b, H.J. Suh-Oha,b, M. Llamas-Velascoc, N. Rodríguez-Acevedod, Á. Flóreza,b
a Servicio de Dermatología, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
b Grupo de Investigación DIPO, Instituto de Investigación Sanitaria Galicia Sur (IIS Galicia Sur), SERGAS-UVIGO, Pontevedra, Spain
c Servicio de Dermatología, Hospital Universitario de La Princesa, Madrid, Spain
d Servicio de Otorrinolaringología, Complejo Hospitalario Universitario de Pontevedra, Pontevedra, Spain
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          "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Images from patient &#35;1&#46; A and B&#41; Clinical appearance of SCC affecting the upper and middle thirds of the right pinna&#46; C&#41; Functional neck dissection&#46; The image shows the external jugular vein&#44; the parotid gland&#44; and the facial nerve&#46; D&#41; Hematoxylin and eosin stain&#44; 200x&#46; Moderately differentiated keratinizing tumor forming keratin pearls&#46; E&#41; Coronal image&#44; contrast-enhanced computed tomography &#40;CT&#41; showing right supraclavicular lymphadenopathy &#40;circle&#41;&#59; asterisk indicates pleural effusion&#46; F&#41; Cross-sectional image&#44; contrast-enhanced CT&#44; asterisk indicates pleural effusion&#46;</p>"
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">Ruxolitinib is a JAK1 and JAK2 inhibitor approved in 2011 to treat myelofibrosis &#40;MF&#41;&#44; polycythemia vera &#40;PV&#41; &#40;in 2014&#41;&#44; and graft-versus-host disease &#40;GVHD&#41; &#40;in 2019&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0055"><span class="elsevierStyleSup">1&#44;2</span></a> Since the initial clinical trials with ruxolitinib&#44; a possible increase in the incidence of non-melanoma skin cancer &#40;NMSC&#41; has been observed&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2&#44;3</span></a> Of note that this drug is used in patients who have a higher risk in relation to the overall population of developing NMSC due to their hematological neoplasms and previous treatments &#40;e&#46;g&#46;&#44; hydroxyurea&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0070"><span class="elsevierStyleSup">4</span></a> In addition to this increased incidence&#44; cases of exceptionally aggressive squamous cell carcinoma &#40;SCC&#41; have been reported in patients on ruxolitinib&#46;<a class="elsevierStyleCrossRefs" href="#bib0075"><span class="elsevierStyleSup">5&#8211;7</span></a></p><p id="par0010" class="elsevierStylePara elsevierViewall">We describe the cases of 3 men who developed high-risk SCC while on ruxolitinib administered for hematological conditions&#46; <a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a> shows the patients&#8217; clinical and demographic characteristics&#46; Patient &#35;1 and patient &#35;3 died due to the progression of their skin neoplasms&#44; initially located in both patients in the pinna &#40;<a class="elsevierStyleCrossRefs" href="#fig0005">figs&#46; 1 and 2</a>&#41;1&#46; Although patient &#35;2 died shortly after the initial intervention of an unrelated medical problem&#44; the presence of poor prognostic tumor factors&#44; such as perineural invasion or nasal cartilage infiltration&#44; is significant &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>&#41;&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><elsevierMultimedia ident="fig0005"></elsevierMultimedia><elsevierMultimedia ident="fig0010"></elsevierMultimedia><p id="par0015" class="elsevierStylePara elsevierViewall">Ruxolitinib is one of the most widely used drugs to treat patients with myeloproliferative syndromes and corticoid-refractory GVHD as it is one of the very few treatments that has proven capable of improving overall survival &#40;in both MF and PV&#41; and disease-free survival &#40;in GVHD&#41;&#46;<a class="elsevierStyleCrossRefs" href="#bib0060"><span class="elsevierStyleSup">2&#44;3&#44;8</span></a> The 5-year assessment of the COMFORT-II clinical trial&#8212;which ultimately led to the approval of the indication for MF treatment&#8212;confirmed a 17&#46;1&#37; incidence rate of NMSC &#40;25 out of 146&#41; in patients on ruxolitinib vs a 2&#46;7&#37; incidence rate &#40;2 out of 73&#41; in the control group on the optimal medical therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0065"><span class="elsevierStyleSup">3</span></a> However&#44; after adjusting for exposure &#40;patient-years&#41;&#44; this difference did not reach statistical significance&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">Recently&#44; clinical practice data from the largest cohort to date of 188 patients on ruxolitinib for MF or PV and controls adjusted for age&#44; sex&#44; race&#44; time from diagnosis&#44; and previous treatments&#8212;including hydroxyurea&#8212;have been published1&#46; In this study&#44; a hazard ratio &#40;HR&#41; for the development of SCC in patients on ruxolitinib of 3&#46;2 &#40;95&#37; confidence interval &#91;CI&#93;&#44; 1&#46;5-7&#41; was found&#46; In patients without the JAK2 mutation&#44; this HR went up to 7&#46;4 &#40;95&#37;CI&#44; 2&#46;5-21&#46;6&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> The authors hypothesized that this difference could be explained by the absence of the JAK2 mutation&#44; which may have conditioned a more intense ruxolitinib inhibition of the tissue lymphocytes responsible for preventing the development of skin neoplasms1&#46; Unexpectedly&#44; no significant differences were found in the development of SCC in patients on hydroxyurea vs those who were treatment-na&#239;ve &#40;HR&#44; 1&#46;1&#41;&#46; However&#44; having received a &#62; 2-week regimen of cyclosporine&#44; azathioprine&#44; or systemic corticosteroids was associated with a higher risk of SCC&#46; Most SCCs appeared between the 1<span class="elsevierStyleSup">st</span> and 2<span class="elsevierStyleSup">nd</span> year after starting ruxolitinib&#44; with a median of 66&#46;5 weeks &#40;range&#44; 11-245&#41;&#46;</p><p id="par0025" class="elsevierStylePara elsevierViewall">Regarding GVHD&#44; long-term data on the development of skin neoplasms in patients on ruxolitinib are still lacking&#46;<a class="elsevierStyleCrossRef" href="#bib0090"><span class="elsevierStyleSup">8</span></a> Patient &#35;3 is the only case we could find in the published literature of a SCC in a patient with GVHD while on ruxolitinib&#46; Given the fatal outcome&#44; it seems advisable to be aware of the possible appearance of aggressive SCC in this group of patients&#46;</p><p id="par0030" class="elsevierStylePara elsevierViewall">For the topical use of ruxolitinib&#44; no cases of SCC have ever been reported in patients on this topical therapy&#46;<a class="elsevierStyleCrossRef" href="#bib0095"><span class="elsevierStyleSup">9</span></a> Furthermore&#44; in a review of the pharmacokinetics of ruxolitinib cream for atopic dermatitis&#8212;which included 1139 patients from clinical trials&#8212;no blood concentrations capable of having a systemic effect or causing hematological changes were found&#46;<a class="elsevierStyleCrossRef" href="#bib0100"><span class="elsevierStyleSup">10</span></a> This makes it very likely that the safety profile of the topical presentation is very different from that of the systemic drug&#46;</p><p id="par0035" class="elsevierStylePara elsevierViewall">In conclusion&#44; we recommend the dermatological follow-up of patients on ruxolitinib for hematological problems&#44; a recommendation that is currently included in the drug technical sheet&#46;<a class="elsevierStyleCrossRef" href="#bib0055"><span class="elsevierStyleSup">1</span></a> We should be aware of the aggressive and lethal course of the disease these patients may present&#46; Future post-marketing studies&#44; with longer follow-up periods than those collected in clinical trials&#44; may shed more light on the risk of patients with GVHD on ruxolitinib&#46;</p><span id="sec0005" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0005">Funding</span><p id="par0040" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span><span id="sec0010" class="elsevierStyleSection elsevierViewall"><span class="elsevierStyleSectionTitle" id="sect0010">Conflicts of interest</span><p id="par0045" class="elsevierStylePara elsevierViewall">None declared&#46;</p></span></span>"
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                  \t\t\t\t">77 years&#46; M&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">85 years&#46; M&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">69 years&#46; M&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t">Ruxolitinib &#40;dose&#59; prior exposure time&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 19 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 26 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">10 mg&#47;12 h&#59; 2 months&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Clinical presentation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Infiltrating tumor &#40;3&#46;5<span class="elsevierStyleHsp" style=""></span>cm in diameter&#41; located in the upper and middle thirds of the right pinna &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>A and 1B&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Rapidly growing crusty tumor &#40;15<span class="elsevierStyleHsp" style=""></span>mm in diameter&#41; located on the right nasal wall &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>A&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Rapidly appearing and bleeding lesion on the right pinna over a previous GVHD angiomatous location &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>E and 2F&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Treatments&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Complete amputation of the pinna&#44; right superficial parotidectomy&#44; and right functional neck dissection &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>C&#41; &#43; RT to surgical bed and lymph node chains &#40;62&#46;5<span class="elsevierStyleHsp" style=""></span>Gy and 49&#46;5<span class="elsevierStyleHsp" style=""></span>Gy&#44; respectively&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Lesion excision&#44; during surgery massive macroscopic deep infiltration was seen &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>B and 2C&#41;&#44; so total skin graft coverage was decided&#44; with subsequent evaluation for RT&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Initially treated with RT at 16<span class="elsevierStyleHsp" style=""></span>Gy&#46; Due to persistent lesion&#44; surgical amputation and ipsilateral functional neck dissection were decided&#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="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Histological study&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Moderately differentiated SCC &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>D&#41;&#44; 15<span class="elsevierStyleHsp" style=""></span>mm deep infiltration&#44; and presence of lymphovascular invasion&#46; Surgical margins&#44; 8 cervical nodes removed&#44; and tumor infiltration-free parotid&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">SCC contacting deep margin and perineural infiltration of a 0&#46;13mm nerve &#40;<a class="elsevierStyleCrossRef" href="#fig0010">fig&#46; 2</a>D&#41;&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Moderately differentiated SCC&#44; with clear margins and lymph nodes without metastatic involvement&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr><tr title="table-row"><td class="td-with-role" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t ; entry_with_role_rowhead " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Outcome&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">12 months later&#44; appearance of bilateral cervicothoracic lymphadenopathy and metastatic pleural effusion &#40;<a class="elsevierStyleCrossRef" href="#fig0005">fig&#46; 1</a>E and 1F&#41;&#46;Deceased&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">Further studies or treatments were not possible after the patient&#39;s death from another unrelated medical issue&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="\n
                  \t\t\t\t\ttable-entry\n
                  \t\t\t\t  " align="left" valign="\n
                  \t\t\t\t\ttop\n
                  \t\t\t\t">1 month after surgery&#44; the patient developed metastasis a few centimeters from the operated region and treatment with cetuximab was initiated&#44; passing away after 2 sessions of treatment&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
                  """
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