Multicentric ipilimumab experience in Turkish patients with metastatic melanoma: MIPI-TURK at 30 months of follow-up.

Abstract

e20006 Background: Ipilimumab, an anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen) monoclonal antibody has been shown to enhance immune responses and improve overall survival in patients with metastatic melanoma. The authors report retrospectively on metastatic melanoma patients treated under the Expanded Access Program in Turkey among 13 centers. Methods: Patients with metastatic melanoma were treated with ipilimumab 3 mg/kg every 3 week for 4 doses. Response evaluation was done on week 12. Patients with complete response (CR), partial response (PR), and stable disease (SD) at week 12 were eligible for re-treatment. Results: A total of 97 patients enrolled with 77 evaluable. Ipilimumab treatment was given as 2nd (20.0%), 3rd (64.3%), and 4th(15.7%) line. The rate of the patients receiving ipilimumab for 1, 2, 3, and 4 doses were 5.2%, 11.7%, 16.9%, and 62.3%, respectively. Seven of 77 patients were eligible for re-treatment. G1/2, G3/4, and G5 adverse events were reported in 23.4% (18/77), 14.3% (11/77), and 2.6% (2/77) of the patients, respectively. The most common G1/2 immune related adverse events were rash (14.3%), muscle weakness (10.0%), and gastrointestinal side effects (8.6%). There were seven G3 side effects (diarrhea in 4, muscle weakness in 1, hypothyroidism in 1, and GI bleeding in 1 patient) and four G4 side effects (thrombocytopenia in 1, diarrhea in 1, sinus tachycardia in 1, and multiple organ failure in 1 patient). Two deaths (G5) were associated with hepatic AEs. Regarding the response evaluation, there was no CR within 16 months of follow-up period and the median overall progression free survival duration was 2 months (95% CI, 1.6-2.5). The disease control rate was 38.8% (PR: 16.3% and SD: 22.5%). Median time to progression was 2 months (95% CI, 1.8-3.1 months). Of the patients, 31.9%, 22.2%, and 19.2% survived within 12, 24, and 30 months of follow-up period, respectively, and the median overall survival duration was 6 months (95% CI, 3.5-8.5). Conclusions: Ipilimumab treatment resulted in favorable clinical benefit for metastatic melanoma patients. Data generated by 13 centers revealed an efficacy and safety profile consistent with the currently available ipilimumab trials.