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Background <p>Cutaneous melanoma (CM) is an aggressive cancer since early stages. Stage IIB/C CM present significant recurrence risk. Recently, adjuvant immunotherapy demonstrated to increase recurrence-free survival (RFS) in this setting.</p> Objective <p>Assess safety and efficacy of adjuvant immunotherapy for stage IIB/C CM in a real-world setting.</p> Methods <p>Stage IIB/C CM patients treated with adjuvant immunotherapy in eight centers from the “Gruppo Oncologico Italia Meridionale” (GOIM) were retrospectively investigated. Data were collected over a median follow-up of 16&#xa0;months.</p> Results <p>Ninety-six patients with a median age of 59&#xa0;years were included. Most participants were male (64.6%). Approximately 60.4% were classified stage IIB and 39.6% stage IIC, with the majority of tumors localized on the trunk (54.2%). Toxicity occurred in 63.5% of patients with 79.7% of these events classified as grade 1–2 (CTCAE v5.0). The most reported events were thyroid dysfunction, fatigue, gastrointestinal disorders and itchiness. Recurrence was observed only in 7 patients (7.3%).</p> Conclusions <p>The 12-month and 24-month RFS were respectively 98.7% and 82.6%. The toxicity profile was generally manageable in a real-life population, however 17.6% of all patients experienced grade 3–4 AEs, underscoring the importance of evaluating adjuvant therapy in a multidisciplinary setting.</p>

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Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月17日

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  • Vincenzo De Falco,
  • Antonino Colloca,
  • Giuseppe Argenziano,
  • Marcella Scala,
  • Michele Guida,
  • Margaret Ottaviano,
  • Maria Chiara Sergi,
  • Mariacarmela Santarpia,
  • Teresa Del Giudice,
  • Antonio Maria Grimaldi,
  • Silvana Cozzolino,
  • Miriam Forte,
  • Francesco Caraglia,
  • Eleonora Cioli,
  • Alfonso Esposito,
  • Maria Cristina Giugliano,
  • Francesca Sparano,
  • Francesco Iovino,
  • Salvatore Tolone,
  • Giovanni Docimo,
  • Giuseppe Colella,
  • Mario Faenza,
  • Renato Franco,
  • Camila Scharf,
  • Anna Russo,
  • Luigi Formisano,
  • Davide Ciardiello,
  • Paolo Antonio Ascierto,
  • Fortunato Ciardiello,
  • Teresa Troiani

摘要

Background

Cutaneous melanoma (CM) is an aggressive cancer since early stages. Stage IIB/C CM present significant recurrence risk. Recently, adjuvant immunotherapy demonstrated to increase recurrence-free survival (RFS) in this setting.

Objective

Assess safety and efficacy of adjuvant immunotherapy for stage IIB/C CM in a real-world setting.

Methods

Stage IIB/C CM patients treated with adjuvant immunotherapy in eight centers from the “Gruppo Oncologico Italia Meridionale” (GOIM) were retrospectively investigated. Data were collected over a median follow-up of 16 months.

Results

Ninety-six patients with a median age of 59 years were included. Most participants were male (64.6%). Approximately 60.4% were classified stage IIB and 39.6% stage IIC, with the majority of tumors localized on the trunk (54.2%). Toxicity occurred in 63.5% of patients with 79.7% of these events classified as grade 1–2 (CTCAE v5.0). The most reported events were thyroid dysfunction, fatigue, gastrointestinal disorders and itchiness. Recurrence was observed only in 7 patients (7.3%).

Conclusions

The 12-month and 24-month RFS were respectively 98.7% and 82.6%. The toxicity profile was generally manageable in a real-life population, however 17.6% of all patients experienced grade 3–4 AEs, underscoring the importance of evaluating adjuvant therapy in a multidisciplinary setting.