Survival update on a subset of peritoneal mesothelioma (PM) patients in an expanded access program (EAP) of pemetrexed (P) alone or combined with cisplatin in the treatment of malignant mesothelioma (MM)

7174 Background: A phase III trial of mesothelioma pts showed improved efficacy for P with cisplatin versus cisplatin alone, leading to a demand for patient access to P prior to regulatory approval. In order to gather additional efficacy and safety data, an Eli Lilly and Company EAP was opened to allow access to P for all eligible pts with MM. Methods: Patients were treated once every 21 days with P 500mg/m2 alone or with cisplatin 75mg/m2, for a maximum of 6 cycles. Chemotherapy naive pts received the combination of cisplatin plus P, while pre-treated pts received P alone. All pts were supplemented with folic acid, vitamin B12, and received steroid prophylaxis. Results: There were 1056 pts with MM that received at least one dose of study drug at 462 sites in the United States. Of the 98 pts with PM there were 38 chemotherapy naive pts (M 74%, F 26%; Median age: 65), 57 previously treated pts (M 56%, F 42%; Median age: 58), and 3 missing. The most commonly reported serious adverse events in the EAP regard...