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- Title
Real-Life Outcomes of Adjuvant Targeted Therapy and Anti-PD1 Agents in Stage III/IV Resected Melanoma.
- Authors
Roccuzzo, Gabriele; Fava, Paolo; Astrua, Chiara; Brizio, Matteo Giovanni; Cavaliere, Giovanni; Bongiovanni, Eleonora; Santaniello, Umberto; Carpentieri, Giulia; Cangiolosi, Luca; Brondino, Camilla; Pala, Valentina; Ribero, Simone; Quaglino, Pietro
- Abstract
Simple Summary: Adjuvant therapy with targeted therapy or immunotherapy has become the standard of care for fully resected stage III–IV melanoma. In this scenario, real-world data are needed to relate the actual effectiveness and safety of these regimens with the evidence provided in the clinical trials. This study provides clinicians and researchers with the results of an Italian single-center real-world experience on the use of adjuvant therapy in resected stage III–IV melanoma patients. Our findings confirm the real-world effectiveness and safety of adjuvant regimens, yet underscores the need for further research to explore biomarker-based predictors for relapse and to assess the translation of improved relapse-free survival into long-term overall survival benefit. This study was carried out at the Dermatologic Clinic of the University of Turin, Italy, to assess the effectiveness and safety of adjuvant therapy in patients who received either targeted therapy (TT: dabrafenib + trametinib) or immunotherapy (IT: nivolumab or pembrolizumab) for up to 12 months. A total of 163 patients participated, including 147 with stage III and 19 with stage IV with no evidence of disease. The primary outcomes were relapse-free survival (RFS), distant metastasis-free survival (DMFS), and overall survival (OS). At 48 months, both TT and IT approaches yielded comparable outcomes in terms of RFS (55.6–55.4%, p = 0.532), DMFS (58.2–59.8%, p = 0.761), and OS (62.4–69.5%, p = 0.889). Whilst temporary therapy suspension was more common among TT-treated patients compared to IT-treated individuals, therapy discontinuation due to adverse events occurred at comparable rates in both groups. Predictors of relapse included mitoses, lymphovascular invasion, ulceration, and positive sentinel lymph nodes. Overall, the proportion of BRAF-mutated patients receiving IT stood at 7.4%, lower than what was observed in clinical trials.
- Subjects
ITALY; THERAPEUTIC use of antineoplastic agents; MELANOMA prognosis; THERAPEUTIC use of monoclonal antibodies; MELANOMA; PATIENT safety; CANCER invasiveness; RESEARCH funding; IMMUNOTHERAPY; SENTINEL lymph nodes; TREATMENT effectiveness; DESCRIPTIVE statistics; ADJUVANT chemotherapy; TUMOR classification; NIVOLUMAB; PROGRESSION-free survival; GENETIC mutation; OVERALL survival
- Publication
Cancers, 2024, Vol 16, Issue 17, p3095
- ISSN
2072-6694
- Publication type
Article
- DOI
10.3390/cancers16173095