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Good News on Adjuvant Therapy for Advanced Cutaneous Melanoma
FR-Novedades en la terapia adyuvante del melanoma cutáneo avanzado
D. Morgado-Carrasco
, F. Terc, S.S. Ertekin, L. Ferrandiz
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Unidad de Melanoma, Departamento de Dermatología, Hospital Clínic de Barcelona, Barcelona, España
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Morgado-Carrasco, F. Terc, S.S. Ertekin, L. Ferrandiz" "autores" => array:4 [ 0 => array:4 [ "nombre" => "D." "apellidos" => "Morgado-Carrasco" "email" => array:1 [ 0 => "danielmorgado@yahoo.com.ar" ] "referencia" => array:1 [ 0 => array:2 [ "etiqueta" => "<span class="elsevierStyleSup">*</span>" "identificador" => "cor0005" ] ] ] 1 => array:2 [ "nombre" => "F." "apellidos" => "Terc" ] 2 => array:2 [ "nombre" => "S.S." "apellidos" => "Ertekin" ] 3 => array:2 [ "nombre" => "L." "apellidos" => "Ferrandiz" ] ] "afiliaciones" => array:1 [ 0 => array:2 [ "entidad" => "Unidad de Melanoma, Departamento de Dermatología, Hospital Clínic de Barcelona, Barcelona, España" "identificador" => "aff0005" ] ] "correspondencia" => array:1 [ 0 => array:3 [ "identificador" => "cor0005" "etiqueta" => "⁎" "correspondencia" => "Corresponding author." ] ] ] ] "titulosAlternativos" => array:1 [ "es" => array:1 [ "titulo" => "FR-Novedades en la terapia adyuvante del melanoma cutáneo avanzado" ] ] "textoCompleto" => "<span class="elsevierStyleSections"><p id="par0005" class="elsevierStylePara elsevierViewall">At present, the approved adjuvant drugs for advanced melanoma are interferon, which has very limited activity, and ipilimumab, which is associated with considerable toxicity and up to 1% mortality.<a class="elsevierStyleCrossRef" href="#bib0030"><span class="elsevierStyleSup">1</span></a> Targeted therapy (anti-BRAF antibody, anti-MEK antibody, and their combinations) (<a class="elsevierStyleCrossRef" href="#tbl0005">Table 1</a>) and immunotherapy with anti-PD1 antibodies have modified the prognosis of metastatic melanoma,<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. Long et al.<a class="elsevierStyleCrossRef" href="#bib0040"><span class="elsevierStyleSup">3</span></a> recently published the results of a phase III, double-blind clinical trial in patients with stage IIIA-C BRAF-mutated melanoma. The authors compared placebo (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>432) with oral combination targeted therapy (CTT) (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>438) based on dabrafenib (anti-BRAF, 300<span class="elsevierStyleHsp" style=""></span>mg/d) and trametinib (anti-MEK, 2<span class="elsevierStyleHsp" style=""></span>mg/d) for 12 months. At a median follow-up of 2.8 years, CTT had led to a 53% reduction in the risk of relapse compared with placebo. The estimated recurrence-free survival rate (RFSR) at 3 years was 58% in the CTT group compared with 39% in the placebo group (HR, 0.47; 95% CI, 0.39-0.58; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001). The estimated overall survival rate was 86% and 77%, respectively (HR, 0.57; 95% CI, 0.42-0.79; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>.0006). Distant metastasis–free survival was also higher with CTT. At the time of the statistical analysis, 60 patients had died in the CTT group (14%) and 93 patients had died in the placebo group (22%). Severe adverse events were recorded in 36% of CTT patients (114 had to interrupt treatment and 1 died of pneumonia) and in 10% of placebo patients.</p><elsevierMultimedia ident="tbl0005"></elsevierMultimedia><p id="par0010" class="elsevierStylePara elsevierViewall">Weber et al.<a class="elsevierStyleCrossRef" href="#bib0050"><span class="elsevierStyleSup">5</span></a> reported the results of a randomized, double-blind, phase III clinical trial in patients with disease-free stage IIIB-C and IV melanoma in which they compared the anti-PD1 agent nivolumab (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>453) (3<span class="elsevierStyleHsp" style=""></span>mg/kg/2 wk) with ipilimumab (n<span class="elsevierStyleHsp" style=""></span>=<span class="elsevierStyleHsp" style=""></span>453) (10<span class="elsevierStyleHsp" style=""></span>mg/kg/3 wk, 4 doses then every 12 weeks). Both treatments were administered for 12 months with a minimum follow-up of 18 months. The RFSR at 12 months was 70.5% with nivolumab and 60.8% with ipilimumab (HR, 0.65; 97.56% CI, 0.51-0.83; <span class="elsevierStyleItalic">P</span><span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>.001). Nivolumab was seen to be superior to ipilimumab in almost all of the subgroups analyzed, including those with expression of PD-1<span class="elsevierStyleHsp" style=""></span><<span class="elsevierStyleHsp" style=""></span>5% (RFSR, 64.3% and 53.7%, respectively), stages IIIB-C (RFSR, 72.3% and 61.6%, respectively), ulcerated tumors, macroscopic and microscopic nodal disease, and tumors with(out) mutations in BRAF. The severe adverse effect rate (grades 3 and 4) was 14.4% with nivolumab and 45.9% with ipilimumab. Two patients died as a result of treatment with ipilimumab (marrow aplasia and colitis).<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. The toxicity associated with these drugs could be considered acceptable if the results are eventually reproducible in the long term.</p><p id="par0020" class="elsevierStylePara elsevierViewall">We are living in an age of enormous changes in the treatment of melanoma. Dermatologists must become familiar with these new drugs, their indications, and their adverse effects.</p></span>" "pdfFichero" => "main.pdf" "tienePdf" => true "fechaRecibido" => "2017-10-03" "fechaAceptado" => "2017-10-29" "PalabrasClave" => array:1 [ "en" => array:1 [ 0 => array:4 [ "clase" => "keyword" "titulo" => "Keywords" "identificador" => "xpalclavsec1097965" "palabras" => array:6 [ 0 => "Melanoma" 1 => "Anti-PD1" 2 => "Targeted therapy" 3 => "Dabrafenib" 4 => "Trametinib" 5 => "Nivolumab" ] ] ] ] "NotaPie" => array:1 [ 0 => array:2 [ "etiqueta" => "☆" "nota" => "<p class="elsevierStyleNotepara" id="npar0005">Please cite this article as: Morgado-Carrasco D, Terc F, Ertekin SS, Ferrandiz L. FR-Novedades en la terapia adyuvante del melanoma cutáneo avanzado. Actas Dermosifiliogr. 2019;110:238–240.</p>" ] ] "multimedia" => array:1 [ 0 => array:8 [ "identificador" => "tbl0005" "etiqueta" => "Table 1" "tipo" => "MULTIMEDIATABLA" "mostrarFloat" => true "mostrarDisplay" => false "detalles" => array:1 [ 0 => array:3 [ "identificador" => "at1" "detalle" => "Table " "rol" => "short" ] ] "tabla" => array:2 [ "leyenda" => "<p id="spar0010" class="elsevierStyleSimplePara elsevierViewall">Source: Luke et al.<a class="elsevierStyleCrossRef" href="#bib0035"><span class="elsevierStyleSup">2</span></a> and Carlos et al..<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, United States Food and Drug Administration; GGT, γ-glutamyl transferase; MAPK, mitogen-activated protein kinase; MEK, MAPK extracellular signal-regulated kinase.</p><p id="spar0025" class="elsevierStyleSimplePara elsevierViewall"><span class="elsevierStyleSup">a</span>Combination target therapy with anti-BRAF and anti-MEK (vemurafenib-cobimetinib, dabrafenib-trametinib) provides a better response to therapy and significantly fewer adverse effects than anti-BRAF or anti-MEK agents in monotherapy.<a class="elsevierStyleCrossRefs" href="#bib0035"><span class="elsevierStyleSup">2,4</span></a></p>" "tablatextoimagen" => array:1 [ 0 => array:2 [ "tabla" => array:1 [ 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">Agent \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 \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 \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 \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 \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 \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 \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, which is responsible for cell proliferation and survival</td><td class="td" title="table-entry " rowspan="2" align="left" valign="top">Dermatologic: rash, photosensitivity reactions, pruritus, hyperkeratosis, xeroderma, xerosis, papular rash, palmoplantar erythrodysesthesia, de novo melanoma, cutaneous papilloma<span class="elsevierStyleItalic">,</span> basal cell carcinoma, squamous cell carcinoma, and keratoacanthoma<br>Gastrointestinal: vomiting, diarrhea, anorexia, and increased GGT<br>Neurological and musculoskeletal: headache, fatigue, joint pain, muscle pain, and insomnia<br>Renal: increased serum creatinine and interstitial nephritis<br>Hematological: lymphopenia and anemia<br>Endocrine-metabolic: hyperglycemia, hypophosphatemia, hyponatremia, hypoalbuminemia, hypokalemia, and hyperkalemia<br>Cardiovascular: peripheral edema, prolonged QT interval, atrial fibrillation, and hypotension<br>Respiratory: cough<br>Ophthalmological: photophobia, uveitis, blindness, and detached retina</td><td class="td" title="table-entry " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E mutation (2011) \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 \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 \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 (2013) \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 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Specific MEK1/MEK2 inhibitor \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, 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: rash, acneiform reactions, palmoplantar erythrodysesthesia, and photosensitivity<br>Gastrointestinal: diarrhea, stomatitis, abdominal pain, and altered liver test values<br>Neurological and musculoskeletal: headache, intracranial hemorrhage, and rhabdomyolysis<br>Endocrine-metabolic: hypoalbuminemia, hyperglycemia, hypokalemia, hyponatremia, hypophosphemia, and hypocalcemia<br>Renal: elevated creatinine in blood<br>Hematologic: lymphedema, anemia, and bleeding<br>Cardiovascular: hypertension, cardiomyopathy, heart failure, and bradycardia<br>Respiratory: pneumonia</td><td class="td" title="table-entry " align="left" valign="top">- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation (2013)<br><br>- Unresectable or metastatic melanoma with the BRAF V600E or V600K mutation in combination with dabrafenib (2017)<span class="elsevierStyleSup">a</span> \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 \t\t\t\t\t\t\n \t\t\t\t</td><td class="td" title="table-entry " align="left" valign="top">Specific MEK1/MEK2 inhibitor \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 (2015)<span class="elsevierStyleSup">*</span> \t\t\t\t\t\t\n \t\t\t\t</td></tr></tbody></table> """ ] "imagenFichero" => array:1 [ 0 => "xTab2003840.png" ] ] ] ] "descripcion" => array:1 [ "en" => "<p id="spar0005" class="elsevierStyleSimplePara elsevierViewall">Anti-BRAF and Anti-MEK Drugs Used in the Treatment of Melanoma.</p>" ] ] ] "bibliografia" => array:2 [ "titulo" => "References" "seccion" => array:1 [ 0 => array:2 [ "identificador" => "bibs0015" "bibliografiaReferencia" => array:5 [ 0 => array:3 [ "identificador" => "bib0030" "etiqueta" => "1" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): A randomised, double-blind, phase 3 trial" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "A.M.M. 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Chou" ] ] ] ] ] "host" => array:1 [ 0 => array:2 [ "doi" => "10.1001/jamadermatol.2015.1745" "Revista" => array:6 [ "tituloSerie" => "JAMA Dermatol" "fecha" => "2015" "volumen" => "151" "paginaInicial" => "1103" "paginaFinal" => "1109" "link" => array:1 [ 0 => array:2 [ "url" => "https://www.ncbi.nlm.nih.gov/pubmed/26200476" "web" => "Medline" ] ] ] ] ] ] ] ] 4 => array:3 [ "identificador" => "bib0050" "etiqueta" => "5" "referencia" => array:1 [ 0 => array:2 [ "contribucion" => array:1 [ 0 => array:2 [ "titulo" => "Adjuvant Nivolumab versus Ipilimumab in Resected Stage III or IV Melanoma" "autores" => array:1 [ 0 => array:2 [ "etal" => true "autores" => array:6 [ 0 => "J. Weber" 1 => "M. Mandala" 2 => "M. del Vecchio" 3 => "H.J. Gogas" 4 => "A.M. Arance" 5 => "C.L. 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| año/Mes | Html | Total | |
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| 2020 Junio | 25 | 19 | 44 |
| 2020 Mayo | 40 | 17 | 57 |
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