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The estimated overall survival rate was 86&#37; and 77&#37;&#44; respectively &#40;HR&#44; 0&#46;57&#59; 95&#37; CI&#44; 0&#46;42-0&#46;79&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;0006&#41;&#46; Distant metastasis&#8211;free survival was also higher with CTT&#46; At the time of the statistical analysis&#44; 60 patients had died in the CTT group &#40;14&#37;&#41; and 93 patients had died in the placebo group &#40;22&#37;&#41;&#46; Severe adverse events were recorded in 36&#37; of CTT patients &#40;114 had to interrupt treatment and 1 died of pneumonia&#41; and in 10&#37; of placebo patients&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">Weber et al&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> reported the results of a randomized&#44; double-blind&#44; phase III clinical trial in patients with disease-free stage IIIB-C and IV melanoma in which they compared the anti-PD1 agent nivolumab &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>453&#41; 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                  \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">Agent&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">Target&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">Mechanism of Action&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">Adverse Effects&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">FDA Approvals&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">Vemurafenib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Inhibitor of the <span class="elsevierStyleItalic">BRAF</span> V600E mutation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Inhibits activation of the intracellular pathway of MAPK&#44; which is responsible for cell proliferation and survival</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Dermatologic&#58; rash&#44; photosensitivity reactions&#44; pruritus&#44; hyperkeratosis&#44; xeroderma&#44; xerosis&#44; papular rash&#44; palmoplantar erythrodysesthesia&#44; de novo melanoma&#44; cutaneous papilloma<span class="elsevierStyleItalic">&#44;</span> basal cell carcinoma&#44; squamous cell carcinoma&#44; and keratoacanthoma<br>Gastrointestinal&#58; vomiting&#44; diarrhea&#44; anorexia&#44; and increased GGT<br>Neurological and musculoskeletal&#58; headache&#44; fatigue&#44; joint pain&#44; muscle pain&#44; and insomnia<br>Renal&#58; increased serum creatinine and interstitial nephritis<br>Hematological&#58; lymphopenia and anemia<br>Endocrine-metabolic&#58; hyperglycemia&#44; hypophosphatemia&#44; hyponatremia&#44; hypoalbuminemia&#44; hypokalemia&#44; and hyperkalemia<br>Cardiovascular&#58; peripheral edema&#44; prolonged QT interval&#44; atrial fibrillation&#44; and hypotension<br>Respiratory&#58; cough<br>Ophthalmological&#58; photophobia&#44; uveitis&#44; blindness&#44; and detached retina</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E mutation &#40;2011&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">Dabrafenib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Inhibitor of the <span class="elsevierStyleItalic">BRAF</span> V600E mutation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E mutation &#40;2013&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">Trametinib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Specific MEK1&#47;MEK2 inhibitor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Inhibits MEK&#44; thus preventing activation of the MAPK pathway and inhibiting the proliferation and survival of mutated cells</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Dermatological&#58; rash&#44; acneiform reactions&#44; palmoplantar erythrodysesthesia&#44; and photosensitivity<br>Gastrointestinal&#58; diarrhea&#44; stomatitis&#44; abdominal pain&#44; and altered liver test values<br>Neurological and musculoskeletal&#58; headache&#44; intracranial hemorrhage&#44; and rhabdomyolysis<br>Endocrine-metabolic&#58; hypoalbuminemia&#44; hyperglycemia&#44; hypokalemia&#44; hyponatremia&#44; hypophosphemia&#44; and hypocalcemia<br>Renal&#58; elevated creatinine in blood<br>Hematologic&#58; lymphedema&#44; anemia&#44; and bleeding<br>Cardiovascular&#58; hypertension&#44; cardiomyopathy&#44; heart failure&#44; and bradycardia<br>Respiratory&#58; pneumonia</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation &#40;2013&#41;<br><br>- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation in combination with dabrafenib &#40;2017&#41;<span class="elsevierStyleSup">a</span>&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">Cobimetinib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Specific MEK1&#47;MEK2 inhibitor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation in combination with vemurafenib &#40;2015&#41;<span class="elsevierStyleSup">&#42;</span>&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td></tr></tbody></table>
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Resident's Forum
Good News on Adjuvant Therapy for Advanced Cutaneous Melanoma
FR-Novedades en la terapia adyuvante del melanoma cutáneo avanzado
D. Morgado-Carrasco
Corresponding author
danielmorgado@yahoo.com.ar

Corresponding author.
, F. Terc, S.S. Ertekin, L. Ferrandiz
Unidad de Melanoma, Departamento de Dermatología, Hospital Clínic de Barcelona, Barcelona, España
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    "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">At present&#44; the approved adjuvant drugs for advanced melanoma are interferon&#44; which has very limited activity&#44; and ipilimumab&#44; which is associated with considerable toxicity and up to 1&#37; mortality&#46;<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> Targeted therapy &#40;anti-BRAF antibody&#44; anti-MEK antibody&#44; and their combinations&#41; &#40;<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>&#41; and immunotherapy with anti-PD1 antibodies have modified the prognosis of metastatic melanoma&#44;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> although no sufficient evidence has become available to date on their effectiveness as adjuvant approaches&#46; Long et al&#46;<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> recently published the results of a phase III&#44; double-blind clinical trial in patients with stage IIIA-C BRAF-mutated melanoma&#46; The authors compared placebo &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>432&#41; with oral combination targeted therapy &#40;CTT&#41; &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>438&#41; based on dabrafenib &#40;anti-BRAF&#44; 300<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#41; and trametinib &#40;anti-MEK&#44; 2<span class="elsevierStyleHsp" style=""></span>mg&#47;d&#41; for 12 months&#46; At a median follow-up of 2&#46;8 years&#44; CTT had led to a 53&#37; reduction in the risk of relapse compared with placebo&#46; The estimated recurrence-free survival rate &#40;RFSR&#41; at 3 years was 58&#37; in the CTT group compared with 39&#37; in the placebo group &#40;HR&#44; 0&#46;47&#59; 95&#37; CI&#44; 0&#46;39-0&#46;58&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41;&#46; The estimated overall survival rate was 86&#37; and 77&#37;&#44; respectively &#40;HR&#44; 0&#46;57&#59; 95&#37; CI&#44; 0&#46;42-0&#46;79&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>&#46;0006&#41;&#46; Distant metastasis&#8211;free survival was also higher with CTT&#46; At the time of the statistical analysis&#44; 60 patients had died in the CTT group &#40;14&#37;&#41; and 93 patients had died in the placebo group &#40;22&#37;&#41;&#46; Severe adverse events were recorded in 36&#37; of CTT patients &#40;114 had to interrupt treatment and 1 died of pneumonia&#41; and in 10&#37; of placebo patients&#46;</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">Weber et al&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> reported the results of a randomized&#44; double-blind&#44; phase III clinical trial in patients with disease-free stage IIIB-C and IV melanoma in which they compared the anti-PD1 agent nivolumab &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>453&#41; &#40;3<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;2 wk&#41; with ipilimumab &#40;n<span class="elsevierStyleHsp" style=""></span>&#61;<span class="elsevierStyleHsp" style=""></span>453&#41; &#40;10<span class="elsevierStyleHsp" style=""></span>mg&#47;kg&#47;3 wk&#44; 4 doses then every 12 weeks&#41;&#46; Both treatments were administered for 12 months with a minimum follow-up of 18 months&#46; The RFSR at 12 months was 70&#46;5&#37; with nivolumab and 60&#46;8&#37; with ipilimumab &#40;HR&#44; 0&#46;65&#59; 97&#46;56&#37; CI&#44; 0&#46;51-0&#46;83&#59; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>&#46;001&#41;&#46; Nivolumab was seen to be superior to ipilimumab in almost all of the subgroups analyzed&#44; including those with expression of PD-1<span class="elsevierStyleHsp" style=""></span>&#60;<span class="elsevierStyleHsp" style=""></span>5&#37; &#40;RFSR&#44; 64&#46;3&#37; and 53&#46;7&#37;&#44; respectively&#41;&#44; stages IIIB-C &#40;RFSR&#44; 72&#46;3&#37; and 61&#46;6&#37;&#44; respectively&#41;&#44; ulcerated tumors&#44; macroscopic and microscopic nodal disease&#44; and tumors with&#40;out&#41; mutations in BRAF&#46; The severe adverse effect rate &#40;grades 3 and 4&#41; was 14&#46;4&#37; with nivolumab and 45&#46;9&#37; with ipilimumab&#46; Two patients died as a result of treatment with ipilimumab &#40;marrow aplasia and colitis&#41;&#46;<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a></p><p id="par0015" class="elsevierStylePara elsevierViewall">The results of these clinical trials show a significant increase in disease-free survival in patients with advanced melanoma treated with CTT or nivolumab&#46; The toxicity associated with these drugs could be considered acceptable if the results are eventually reproducible in the long term&#46;</p><p id="par0020" class="elsevierStylePara elsevierViewall">We are living in an age of enormous changes in the treatment of melanoma&#46; Dermatologists must become familiar with these new drugs&#44; their indications&#44; and their adverse effects&#46;</p></span>"
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          "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Source&#58; Luke et al&#46;<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> and Carlos et al&#46;&#46;<a class="elsevierStyleCrossRef" href="#bib0045"><span class="elsevierStyleSup">4</span></a></p><p id="spar0015" class="elsevierStyleSimplePara elsevierViewall">Abbreviations</p><p id="spar0020" class="elsevierStyleSimplePara elsevierViewall">FDA&#44; United States Food and Drug Administration&#59; GGT&#44; &#947;-glutamyl transferase&#59; MAPK&#44; mitogen-activated protein kinase&#59; MEK&#44; MAPK extracellular&#160;signal-regulated kinase&#46;</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleSup">a</span>Combination target therapy with anti-BRAF and anti-MEK &#40;vemurafenib-cobimetinib&#44; dabrafenib-trametinib&#41; provides a better response to therapy and significantly fewer adverse effects than anti-BRAF or anti-MEK agents in monotherapy&#46;<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">2&#44;4</span></a></p>"
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                  \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">Agent&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Inhibitor of the <span class="elsevierStyleItalic">BRAF</span> V600E mutation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Inhibits activation of the intracellular pathway of MAPK&#44; which is responsible for cell proliferation and survival</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Dermatologic&#58; rash&#44; photosensitivity reactions&#44; pruritus&#44; hyperkeratosis&#44; xeroderma&#44; xerosis&#44; papular rash&#44; palmoplantar erythrodysesthesia&#44; de novo melanoma&#44; cutaneous papilloma<span class="elsevierStyleItalic">&#44;</span> basal cell carcinoma&#44; squamous cell carcinoma&#44; and keratoacanthoma<br>Gastrointestinal&#58; vomiting&#44; diarrhea&#44; anorexia&#44; and increased GGT<br>Neurological and musculoskeletal&#58; headache&#44; fatigue&#44; joint pain&#44; muscle pain&#44; and insomnia<br>Renal&#58; increased serum creatinine and interstitial nephritis<br>Hematological&#58; lymphopenia and anemia<br>Endocrine-metabolic&#58; hyperglycemia&#44; hypophosphatemia&#44; hyponatremia&#44; hypoalbuminemia&#44; hypokalemia&#44; and hyperkalemia<br>Cardiovascular&#58; peripheral edema&#44; prolonged QT interval&#44; atrial fibrillation&#44; and hypotension<br>Respiratory&#58; cough<br>Ophthalmological&#58; photophobia&#44; uveitis&#44; blindness&#44; and detached retina</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E mutation &#40;2011&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">Dabrafenib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Inhibitor of the <span class="elsevierStyleItalic">BRAF</span> V600E mutation&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E mutation &#40;2013&#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="table-entry ; entry_with_role_rowhead " align="left" valign="top">Trametinib&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">Specific MEK1&#47;MEK2 inhibitor&nbsp;\t\t\t\t\t\t\n
                  \t\t\t\t</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Inhibits MEK&#44; thus preventing activation of the MAPK pathway and inhibiting the proliferation and survival of mutated cells</td><td class="td" title="table-entry  " rowspan="2" align="left" valign="top">Dermatological&#58; rash&#44; acneiform reactions&#44; palmoplantar erythrodysesthesia&#44; and photosensitivity<br>Gastrointestinal&#58; diarrhea&#44; stomatitis&#44; abdominal pain&#44; and altered liver test values<br>Neurological and musculoskeletal&#58; headache&#44; intracranial hemorrhage&#44; and rhabdomyolysis<br>Endocrine-metabolic&#58; hypoalbuminemia&#44; hyperglycemia&#44; hypokalemia&#44; hyponatremia&#44; hypophosphemia&#44; and hypocalcemia<br>Renal&#58; elevated creatinine in blood<br>Hematologic&#58; lymphedema&#44; anemia&#44; and bleeding<br>Cardiovascular&#58; hypertension&#44; cardiomyopathy&#44; heart failure&#44; and bradycardia<br>Respiratory&#58; pneumonia</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation &#40;2013&#41;<br><br>- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation in combination with dabrafenib &#40;2017&#41;<span class="elsevierStyleSup">a</span>&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">Cobimetinib&nbsp;\t\t\t\t\t\t\n
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                  \t\t\t\t</td><td class="td" title="table-entry  " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation in combination with vemurafenib &#40;2015&#41;<span class="elsevierStyleSup">&#42;</span>&nbsp;\t\t\t\t\t\t\n
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Article information
ISSN: 15782190
Original language: English
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