Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study
12 affiliations
- 1Department of Precision Medicine, Università Degli Studi Della Campania Luigi Vanvitelli, Via Sergio Pansini 5, 80131 Naples, Italy
- 2Department of Mental and Physical Health and Preventive Medicine, University of Campania Luigi Vanvitelli, 80138 Naples, Italy
- 3Clinical Medicine and Surgery, University of Naples Federico II, Naples, Italy
- 4Istituto Tumori IRCCS Giovanni Paolo II, Bari, Italy
- 5Unit of Melanoma, Cancer Immunotherapy and Development Therapeutics, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Naples, Italy
- 6San Paolo Hospital, Bari, Apulia Italy
- 7Department of Human Pathology “G. Barresi”, University of Messina, 98125 Messina, Italy
- 8Oncology Department, Oncology Unit, “Azienda Ospedaliero Universitaria (AOU) Dulbecco” Hospital, Catanzaro, Italy
- 9Medical Oncology Unit, AORN San Pio, Benevento, Italy
- 10Department of Translational Medical Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy
- 11Multidisciplinary Department of Surgical and Dental Sciences, University of Campania Luigi Vanvitelli, 80138 Naples, Italy
- 12Division of Gastrointestinal Medical Oncology and Neuroendocrine Tumors, European Institute of Oncology, IRCCS, Milan, Italy
Abstract
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.
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00262-026-04466-0 .
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BibTeX
@article{falco2026adjuvant,
title = {{Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study}},
author = {Vincenzo De Falco and Antonino Colloca and Giuseppe Argenziano and Marcella Scala and Michele Guida and Margaret Ottaviano and Maria Chiara Sergi and Mariacarmela Santarpia and Teresa Del Giudice and Antonio Maria Grimaldi and Silvana Cozzolino and Miriam Forte and Francesco Caraglia and Eleonora Cioli and Alfonso Esposito and Maria Cristina Giugliano and Francesca Sparano and Francesco Iovino and Salvatore Tolone and Giovanni Docimo and Giuseppe Colella and Mario Faenza and Renato Franco and Camila Scharf and Anna Russo and Luigi Formisano and Davide Ciardiello and Paolo Antonio Ascierto and Fortunato Ciardiello and Teresa Troiani},
journal = {Cancer Immunology, Immunotherapy : CII},
year = {2026},
month = jul,
doi = {10.1007/s00262-026-04466-0},
url = {https://doi.org/10.1007/s00262-026-04466-0},
note = {CC BY 4.0},
}
RIS
TY - JOUR
TI - Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study
AU - Vincenzo De Falco
AU - Antonino Colloca
AU - Giuseppe Argenziano
AU - Marcella Scala
AU - Michele Guida
AU - Margaret Ottaviano
AU - Maria Chiara Sergi
AU - Mariacarmela Santarpia
AU - Teresa Del Giudice
AU - Antonio Maria Grimaldi
AU - Silvana Cozzolino
AU - Miriam Forte
AU - Francesco Caraglia
AU - Eleonora Cioli
AU - Alfonso Esposito
AU - Maria Cristina Giugliano
AU - Francesca Sparano
AU - Francesco Iovino
AU - Salvatore Tolone
AU - Giovanni Docimo
AU - Giuseppe Colella
AU - Mario Faenza
AU - Renato Franco
AU - Camila Scharf
AU - Anna Russo
AU - Luigi Formisano
AU - Davide Ciardiello
AU - Paolo Antonio Ascierto
AU - Fortunato Ciardiello
AU - Teresa Troiani
PY - 2026
DA - 2026/07/17
JO - Cancer Immunology, Immunotherapy : CII
DO - 10.1007/s00262-026-04466-0
UR - https://doi.org/10.1007/s00262-026-04466-0
AB - 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. Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1007/s00262-026-04466-0 .
SN - 0340-7004
SN - 1432-0851
ER -