The survival rate at 5 years in Turkish metastatic melanoma patients treated with ipilimumab: Final analysis of MIPI-TURK.
Bildiriler > Özet Bildiri
Yazarlar: Alper Sevinc, Hande Turna, Mustafa Ozdogan, Suleyman Buyukberber, Nil Molinas Mandel, Gokhan Demir, Erhan GÖKMEN, Semra Paydas, Hakan Akbulut, Ismail Celik
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 33, ss e20072-e20072
DOI: 10.1200/jco.2015.33.15_suppl.e20072
Özet
e20072 Survival rate at 5 years in Turkish metastatic melanoma patients treated with ipilimumab: final analysis of MIPI-TURK. Background: Ipilimumab has been shown to improve immune responses and overall survival in metastatic melanoma patients. This study aimed to provide national data on metastatic melanoma patients treated under an expanded access program in 13 centers in Turkey. Methods: Patients were treated with ipilimumab 3 mg/kg every 3 weeks for 4 doses. Response evaluation was performed at week 12. Patients with complete response (CR), partial response (PR), and stable disease (SD) were eligible for retreatment. Results: Of 97 patients enrolled, 77 were evaluable. Ipilimumab was given as second-, third-, and fourth-line treatments in 20.0%, 64.3%, and 15.7% of patients, respectively. Ipilimumab was given at 1, 2, 3, and 4 doses in 5.2%, 11.7%, 16.9%, and 62.3% of patients, respectively. Seven patients were eligible for retreatment. Grade 1 and 2 adverse events (AEs) were reported in 23.4%, grade 3 and 4 in 14.3%, and grade 5 in 2.6% of patients. The most common grade 1 and 2 immune-related AEs were rash (14.3%), muscle weakness (10.0%), and gastrointestinal AEs (8.6%). Seven patients had grade 3 AEs (diarrhea in 4, muscle weakness in 1, hypothyroidism in 1, and gastrointestinal bleeding in 1) and 4 patients had grade 4 AEs (thrombocytopenia in 1, diarrhea in 1, sinus tachycardia in 1, and multiple organ failure in 1). Two deaths (grade 5) were associated with hepatic AEs. There was no CR within 16 months of follow-up and the median progression-free survival 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). Of patients, 31.9%, 22.2%, and 19.2% survived to 12, 24, and 30 months of follow-up, respectively, and median overall survival was 6 months (95% CI:3.5–8.5). According to current status, 5.2% of patients (n = 4) were lost to follow-up and 14.2% of patients (n = 11) survived. Conclusions: Ipilimumab treatment resulted in favorable clinical benefit for metastatic melanoma patients. Data from 13 centers revealed an efficacy and safety profile consistent with the currently available ipilimumab trials.