Adjuvant immunotherapy in high-risk stage II melanoma: real-world outcomes from a large multicenter retrospective study.
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De Falco Vincenzo, Colloca Antonino, Argenziano Giuseppe, Scala Marcella, Guida Michele, Ottaviano Margaret, Sergi Maria Chiara, Santarpia Mariacarmela, Del Giudice Teresa, Grimaldi Antonio Maria, Cozzolino Silvana, Forte Miriam, Caraglia Francesco, Cioli Eleonora, Esposito Alfonso, Giugliano Maria Cristina, Sparano Francesca, Iovino Francesco, Tolone Salvatore, Docimo Giovanni, Colella Giuseppe, Faenza Mario, Franco Renato, Scharf Camila, Russo Anna, Formisano Luigi, Ciardiello Davide, Ascierto Paolo Antonio, Ciardiello Fortunato, Troiani Teresa
Аннотация
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.