Pemetrexed alone or in combination with cisplatin in the treatment of patients with peritoneal mesothelioma (PM): Outcomes of an expanded access program (EAP) in patients with malignant mesothelioma (MM)

Abstract

7198 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 malignant pleural mesothelioma, 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 MM. 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 patients with PM is reported here. Methods: From 6/12/2002 to the present, > 650 patients with mesothelioma were enrolled at 462 sites in the US. Of these patients, 43 (6.65%) had PM. Patients received pemetrexed 500mg/m2 alone or in combination with cisplatin 75mg/m2, both of which were administered once every 21 days for a maximum of 6 cycles. All patients received folic acid, vitamin B12, and steroid prophylaxis. Results: Demographic information is currently available for 43 patients (26 M, 17 F). Median age was 61.1 (range: 25 - 81) years. To date, 14 patients have been evaluated with a current objective response rate of 21.5%: 1 CR (7.2%), 2 PRs (14.3%), 4 SDs (28.5%), and 7 PDs (50%). Serious adverse events (SAEs) were reported by investigators and compiled in a pharmacovigilance database. This database included 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 has a favorable safety profile and the clinical benefit rate of 50% indicates activity in this subset of patients with peritoneal mesothelioma. This trial will conclude early in 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.