Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study
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.
Authors
- Francesca Sparano (ORCID: https://orcid.org/0000-0003-3348-6281)
- Eleonora Cioli (ORCID: https://orcid.org/0000-0002-8788-6574)
- Teresa Del Giudice
- Maria Chiara Sergi (ORCID: https://orcid.org/0000-0002-3093-6841)
- Antonio Maria Grimaldi (ORCID: https://orcid.org/0000-0002-0126-1267)
- Margaret Ottaviano (ORCID: https://orcid.org/0000-0001-9589-0808)
- Michele Guida (ORCID: https://orcid.org/0000-0001-8411-0319)
- Giovanni Docimo
- Renato Franco (ORCID: https://orcid.org/0000-0002-8340-3184)
- Maria Cristina Giugliano
- Mario Faenza (ORCID: https://orcid.org/0000-0002-0077-8977)
- Miriam Forte
- Antonino Colloca
- Luigi Formisano
- Francesco Iovino
- Vincenzo De Falco
- Marcella Scala
- Silvana Cozzolino
- Davide Ciardiello
- Giuseppe Colella
- Francesco Caraglia
- Salvatore Tolone
- Teresa Troiani
- Camila Scharf
- Anna Russo
- Paolo Antonio Ascierto
- Alfonso Esposito
- Mariacarmela Santarpia
- Giuseppe Argenziano
- Fortunato Ciardiello
Institutions
- University of Messina (IT)
- Ospedale San Paolo (IT)
- University of Campania "Luigi Vanvitelli" (IT)
- Istituto Tumori Bari (IT)
- Azienda Ospedaliero-Universitaria "Renato Dulbecco" (IT)
- Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" (IT)
- Istituti di Ricovero e Cura a Carattere Scientifico (IT)
- European Institute of Oncology (IT)
- University of Naples Federico II (IT)
Publication Details
- Journal
- Cancer Immunology Immunotherapy
- Published
- 2026-07-17
- DOI
- https://doi.org/10.1007/s00262-026-04466-0
- Primary Topic
- Cutaneous Melanoma Detection and Management
- Type
- article
- Field-Weighted Citation Impact
- 0.00
Funders
- Università degli Studi della Campania Luigi Vanvitelli