Purpose <p>Anti-PD-1-based immunotherapy and targeted therapies (TT) are the current standard of care for patients with advanced melanoma. However, some patients die in less than a year from diagnosis and others become long-survivors. An accurate description of systemic treatments and patients’ characteristics of long-term survivors are needed to guide treatment decisions in clinical practice.</p> Methods <p>GEM-1801 is a multi-cohort prospective study from the Spanish Multidisciplinary Melanoma Group that includes patients with resectable stage III or unresectable stage III/IV melanoma. Patients surviving at least 5 years and patients surviving less than 1 year since diagnosis were selected. Baseline characteristics and first and second-line systemic treatments are described and compared between groups.</p> Results <p>From Aug 2018 to Dec 2023, 60 patients with long-term survival and 216 patients with short-term survival were included. Long-term survivors received immunotherapy (65%), including anti-PD-1 in 86% and combination of an anti-PD-1 and anti-CTLA-4 in 14%; and TT (35%). The Objective Response Rate (ORR) was 76% for anti-PD-1, 80% for combination immunotherapy and 83% for TT. Short-term survivors received immunotherapy (58%), including anti-PD-1 (70%), anti-CTLA-4 (1%), and anti-PD-1 plus anti-CTLA-4 (29%); TT (36%); and chemotherapy (2%). ORR was 7% for anti-PD-1, 0% for anti-CTLA-4, 14% for combination immunotherapy, 53% for TT and 0% for chemotherapy.</p> Conclusions <p>Response to first or second-line systemic treatment may be a surrogate for long-term survival patients with advanced melanoma.</p> Clinical trial identification <p>Clinicaltrials.gov: NCT03605771</p>

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Response rate and long-term survival in patients with advanced melanoma: data from the prospective cohort study gem-1801

  • Enrique Espinosa,
  • Miguel-Ángel Berciano-Guerrero,
  • Eva Muñoz-Couselo,
  • Teresa Puértolas,
  • José Luis Manzano,
  • Ainara Soria,
  • Pablo Ayala de Miguel,
  • Guillermo Crespo,
  • Lourdes Gutiérrez Sanz,
  • Pablo Cerezuela-Fuentes,
  • Carlos Aguado de la Rosa,
  • Margarita Majem,
  • Almudena García Castaño,
  • Alfonso Berrocal,
  • Francisco Ramon García Arroyo,
  • María Rodríguez de la Borbolla,
  • Lorena Bellido,
  • Javier Medina Martínez,
  • Luis Antonio Fernández,
  • Alfonso Martin Carnicero,
  • Rafael López Castro,
  • Aida Bujosa Rodríguez,
  • Mª José Lecumberri,
  • José Carlos Villa Guzmán,
  • Begoña Campos Balea,
  • Joaquín Fra Rodríguez,
  • Javier Valdivia Bautista,
  • Victor Navarro Pérez,
  • Karmele Mujika,
  • Mónica Corral Subias,
  • Berta Hernández,
  • Salvador Martín Algarra,
  • Iván Márquez-Rodas

摘要

Purpose

Anti-PD-1-based immunotherapy and targeted therapies (TT) are the current standard of care for patients with advanced melanoma. However, some patients die in less than a year from diagnosis and others become long-survivors. An accurate description of systemic treatments and patients’ characteristics of long-term survivors are needed to guide treatment decisions in clinical practice.

Methods

GEM-1801 is a multi-cohort prospective study from the Spanish Multidisciplinary Melanoma Group that includes patients with resectable stage III or unresectable stage III/IV melanoma. Patients surviving at least 5 years and patients surviving less than 1 year since diagnosis were selected. Baseline characteristics and first and second-line systemic treatments are described and compared between groups.

Results

From Aug 2018 to Dec 2023, 60 patients with long-term survival and 216 patients with short-term survival were included. Long-term survivors received immunotherapy (65%), including anti-PD-1 in 86% and combination of an anti-PD-1 and anti-CTLA-4 in 14%; and TT (35%). The Objective Response Rate (ORR) was 76% for anti-PD-1, 80% for combination immunotherapy and 83% for TT. Short-term survivors received immunotherapy (58%), including anti-PD-1 (70%), anti-CTLA-4 (1%), and anti-PD-1 plus anti-CTLA-4 (29%); TT (36%); and chemotherapy (2%). ORR was 7% for anti-PD-1, 0% for anti-CTLA-4, 14% for combination immunotherapy, 53% for TT and 0% for chemotherapy.

Conclusions

Response to first or second-line systemic treatment may be a surrogate for long-term survival patients with advanced melanoma.

Clinical trial identification

Clinicaltrials.gov: NCT03605771