Retrospective study of the efficacy and safety of fotemustine in 170 patients with metastatic melanoma.

Abstract

e19011 Background: Fotemustine is a third-generation nitrosourea authorized in Europe for the treatment of metastatic melanoma. Fotemustine crosses the brain-blood barrier with a relevant activity on brain metastases (BM) and it is authorized in some European countries for primary brain tumors. Methods: We assessed the pattern of use, efficacy (tumor response, median progression-free survival [PFS], and median overall survival [OS]) and toxicity of fotemustine in Spain through a retrospective study on medical record data of 170 patients (pts) (56% male, 44% female). Median age: 61 years (range 20–87). ECOG PS: 0 in 28% of pts, 1 in 55%, ≥ 2 in 17%. High LDH values: 42 pts. Results: The most used scheme was induction at a 100 mg/m2 i.v. dose (days 1, 8, 15), 4-5 weeks of therapeutic rest and maintenance (100 mg/m2 i.v. every 3 weeks). 41% of pts were treated in first line, 38% in second, and 21% in third or higher. The median number of cycles was 3 (range 1-10). 160 pts were evaluable for efficacy. Tumor response: 3% complete response (CR), 14% partial response (PR), 31% stable disease (SD), 52% progression disease (PD). The clinical benefit in first line was 61% (CR=5%, PR=14%, SD=42%) and 39% (CR=3%, PR=14%, SD=22%) in second line. PFS was 84 days (95% CI 71-109), 100 days (95% CI 72-127) in first line and 77 days (95% CI 63-110) in second line. OS was 200 days (6.5 months) (95% CI 172–284). In 17 pts (10.3%) with BM the tumor response was CR=6% (1 pt), PR=18% (3 pts), SD=35% (6 pts), PD=41% (7 pts). 165 pts were evaluable for toxicity. The most common grade 3/4 toxicities were hematological and included neutropenia (40 pts, 24.2%), thrombocytopenia (39 pts, 23.6%), and anemia (14 pts, 8.5%). Conclusions: Fotemustine is an active and well-tolerated agent in metastatic melanoma, including brain metastases. Tumor response n % CR 5 3 PR 23 14 SD 49 31 Clinical benefit (CR+PR+SD) 77 48 PD 83 52 Total 160 100 Author Disclosure Employment or Leadership Position Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Italfarmaco, S.A.