Pemetrexed (P) alone or in combination with platinum for malignant pleural mesothelioma (MPM): Efficacy and toxicity of the International Expanded Access Program (EAP) in Spanish patients (p)

Abstract

19038 Background: A landmark phase III study reported a significant survival benefit for P+cisplatin (cis) versus cis alone in MPM (Vogelzang et al. JCO 2003). EAP provided access to P alone or P plus a platinum for 3311 MPM p in 13 countries. Safety and efficacy data for Spanish p are summarized in this abstract. Methods: From Feb 2003 to May 2005, 225 advanced MPM p were enrolled at 26 sites in Spain. P 500 mg/m2 was given alone or in combination with either cis 75 mg/m2 or carboplatin (Cb) AUC 5 once every 21 days with standard pre-medication (vitamin B12, folic acid, and dexamethasone). Results: 221 MPM p were evaluable for safety and 180 (113 chemonaïve; 67 pre-treated) for efficacy. Median age, 60 yrs (range: 25–89); 78.7% male; 73.3%, Karnofsky score ≥80. Response rate: 27% in the P group, 27.5% in the P+cis group and 30.4% in the P+Cb group, with a clinical benefit rate of 51.4%, 65.5% and 78.6%, respectively. Median time to progression (TTP): 6.9 months (m) in the P group and 8 m in the P+cis group. Median survival (MS): 14.1 m in the P group and 13.4 m in the P+cis group (figure). Neither TTP nor MS could be estimated in the P+Cb group due to high censoring rate. 1-year survival: 67.2% for the P group, 57.1% for the P+cis group, and 62.8% for the P+Cb group. Hematological toxicity was tolerable. Conclusions: Treatment with P plus a platinum resulted in improved survival in MPM compared to cis or Cb alone, with a manageable toxicity, supporting the findings of the phase III study. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Lilly Oncology