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

Authors

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

Published in

Cancer immunology, immunotherapy : CII. Jul 17, 2026. Epub Jul 17, 2026.

Abstract

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

PMID:
42467079
Bibliographic data and abstract were imported from PubMed on 17 Jul 2026.

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