Multicentric ipilimumab experience in Turkish patients with metastatic melanoma: MIPI-TURK.
Bildiriler > Özet Bildiri
Yazarlar: Alper Sevinc, Hande Turna, Mustafa Ozdogan, Suleyman Buyukberber, Gokhan Demir, Erhan GÖKMEN, Nil Molinas Mandel, Semra Paydas, Hakan Akbulut, Ismail Celik
Journal of Clinical Oncology, , , Uluslararası, Özet Bildiri, Wos, cilt 30, ss e19024-e19024
DOI: 10.1200/jco.2012.30.15_suppl.e19024
Özet
e19024 Background: Ipilimumab, an anti-CTLA-4 (cytotoxic T lymphocyte-associated antigen) monoclonal antibody has been shown to enhance immune responses and induce durable clinical responses in patients with metastatic melanoma. The authors report retrospectively on metastatic melanoma patients treated under Expanded Access Program in Turkey among 13 centers. Methods: Patients with metastatic melanoma were treated with ipilimumab 3 mg/kg for 4 doses on weeks 1, 4, 7, 10 as induction. 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-induction. Results: A total of 75 patients enrolled with 70 evaluable. Ipilumumab treatment was given as 2nd, 3rd and 4th line in 20.0%, 64.3% and 15.7% of patients respectively. The numbers of patients receiving ipilimumab for 1, 2, 3 and 4 doses were 9, 12, 13 and 36, respectively. Seven of 70 patients were eligible for re-induction. G1/2 adverse events were reported in 32.8% (23/70) of patients whereas G3/4 was 14.3% (10/70). The most common G1/2 immune related adverse event was skin rash (14.3%) followed by 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). There was one reversible G4 thrompocytopenia and two deaths were associated with hepatic AEs. Thirty-six of 70 patients (51.4%) completed 4 doses ipilimumab treatment were available for response evaluation. There was no CR. The disease control rate (DCR) was 36.1% (PR: 8.3% and SD 27.8%). Median time to progression (TTP) was 2.7 months (95% CI, 2.1-4.2 months). Median overall survival was not reached with 61.3% of patients surviving within 12 months of follow up period. Conclusions: As a conclusion, ipilimumab treatment resulted in favorable clinical benefit for metastatic melanoma patients. Data generated by our 13 centers revealed an efficacy and safety profile consistent with the currently avaliable knowledge.