Pemetrexed Alone or in Combination with Cisplatin in Previously Treated Malignant Pleural Mesothelioma: Outcomes from a Phase IIIB Expanded Access Program

摘要: Background In a randomized phase III trial, pemetrexed plus cisplatin was associated with improved survival compared alone for patients malignant pleural mesothelioma (MPM). However, there are limited data available on the efficacy of these and other chemotherapy regimens in who have received previous systemic chemotherapy. To gather additional safety pemetrexed/cisplatin previously treated patients, we examined Eli Lilly Company expanded access program (EAP). Patients Methods were enrolled this trial. Of 1056 receiving at least one dose study drug, 187 (17.7%) MPM. every 21 days 500 mg/m 2 ( n = 91) or combination 75 96) maximum six cycles. All folic acid vitamin B12 supplementation steroid prophylaxis. Serious adverse events (SAEs) reported by investigators compiled pharmaco-vigilance database all EAP. Results Median age subset 66 years (range, 27–87 years). Based 153 evaluable (a larger intent-to-treat population 187), overall response rate 32.5% 5.5% alone. The disease control (response + stable disease) 68.7% 46.6% 7.6 months (67% censored) 4.1 (55% censored). most commonly serious EAP irrespective causality dehydration (7.2%), nausea (5.2%), vomiting (4.9%), dyspnea (3.8%), pulmonary embolism (2.4%). Conclusions from suggest that MPM can benefit treatment cisplatin. is acceptable toxicity.