Pemetrexed alone or in combination with cisplatin in previously treated patients with malignant pleural mesothelioma (MPM): Outcomes of an expanded access program (EAP)

Abstract

7195 Background: The improved efficacy of pemetrexed (ALIMTA, Eli Lilly and Co) in combination with cisplatin versus cisplatin alone, in a phase 3 trial of patients with MPM, has led to a demand for patient access to pemetrexed prior to regulatory approval. An Eli Lilly and Co EAP was opened to allow access to all eligible patients with malignant mesothelioma. This non-randomized study was designed to gather additional efficacy and safety data on pemetrexed alone and in combination with cisplatin. The experience of those previously treated patients with MPM is reported here. Methods: Previously treated patients with malignant mesothelioma were enrolled in this study. Treatment consisted of pemetrexed 500mg/m2 alone or in combination with cisplatin 75mg/m2. Treatment was administered once every 21 days for a maximum of 6 cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. Serious adverse events (SAEs) were reported by investigators and compiled in a pharmacovigilence database. Results: To date, 127 previously treated patients (97M/30F) with pleural mesothelioma have been enrolled. Median age was 65.0 (range = 25.0 to 83.0). An analysis of best tumor response included 31 evaluable patients, which included 4 PRs (12.9%), 6 SDs (19.3%), and 21 PDs (67.7%). The SAE database includes all patients from the EAP with either pleural or peritoneal mesothelioma. SAEs, irrespective of causality, were reported by number of events: nausea (44), vomiting (41), diarrhea (21), renal insufficiency (21), asthenia (13), atrial fibrillation (13), cellulitis (9), constipation (8), dysphagia (4), rash (2), neuropathy (2), stomatitis (2), anemia (12), thrombocytopenia (7), neutropenia (7), and neutropenic fever (4). Conclusions: Pemetrexed with or without cisplatin in previously treated patients with pleural mesothelioma has a favorable safety profile. The clinical benefit rate of 32.2% indicates activity in this poor prognostic patient population. This trial will conclude in early 2004, and all response and safety data will be forthcoming. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Eli Lilly & Co. Eli Lilly & Co.