Pemetrexed Plus Cisplatin or Pemetrexed Plus Carboplatin for Chemonaïve Patients with Malignant Pleural Mesothelioma: Results of the International Expanded Access Program

doi:10.1097/JTO.0b013e31817c73d6

Journal of Thoracic Oncology

Volume 3, Issue 7, July 2008, Pages 756-763

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Introduction

Previously published results from a randomized phase III study of pemetrexed plus cisplatin in patients with malignant pleural mesothelioma (MPM) demonstrated a significant survival benefit and higher response rate compared with cisplatin. Although pemetrexed was under review by regulatory agencies, an International Expanded Access Program (EAP) provided more than 3000 mesothelioma patients with access to single-agent pemetrexed or pemetrexed in combination with cisplatin or carboplatin in 13 countries. This manuscript reports the safety and efficacy data from the nonrandomized open-label study in chemonaïve patients receiving pemetrexed plus platinum under the EAP.

Methods

Patients with histologically confirmed MPM, not amenable to curative surgery, received pemetrexed 500 mg/m² in combination with either cisplatin 75 mg/m² or carboplatin AUC 5, once every 21 days with standard premedication. Efficacy data were recorded at the end of study participation.

Results

A total of 1704 chemonaïve patients received pemetrexed plus cisplatin (n = 843) or pemetrexed plus carboplatin (n = 861) and were evaluated for safety. The efficacy evaluable population consisted of 745 patients in the pemetrexed plus cisplatin group and 752 patients in the pemetrexed plus carboplatin group for whom physician-reported tumor response was available. The pemetrexed plus cisplatin group demonstrated a response rate of 26.3% compared with 21.7% for the pemetrexed plus carboplatin group, with similar 1-year survival rates (63.1% versus 64.0%) and median time to progressive disease (7 months versus 6.9 months). The most common grade 3/4 hematologic toxicity was neutropenia in 23.9% of the pemetrexed plus cisplatin group and 36.1% of the pemetrexed plus carboplatin group.

Conclusion

This large EAP confirmed the activity of pemetrexed plus cisplatin and pemetrexed plus carboplatin in chemonaïve patients with MPM, demonstrating clinically similar time to progressive disease and 1-year survival rates.

Key Words

Cisplatin

Carboplatin

Expanded access program

Malignant pleural mesothelioma

Pemetrexed

Cited by (0)

Supported by Eli Lilly and Company, Indianapolis, IN, USA (H3E-MC-JMFL). These findings were presented in part at the 43rd American Society for Clinical Oncology Annual Meeting at Chicago, IL, June 1–5, 2007, and at the 12th World Conference on Lung Cancer at Seoul, South Korea, September 2–6, 2007.

Disclosure: Dr. Santoro, the organization has underwritten or paid me to speak to a professional or lay group. Dr. Stahel was paid honorarium and travel expenses to speak on the treatment of mesothelioma. Dr. Eberhardt filled the speakers bureau function for the organization and is a member of the advisory board at Lilly. Dr. Paz-Ares was paid honorarium and travel expenses to serve on the scientific advisory committee to Lilly. Dr. Liu is employed by Statprobe, Inc. and has consulted with Eli Lilly and Company. Dr. Ripoche is a full time Lilly employee.