Phase II Study of Pemetrexed Plus Carboplatin in Malignant Pleural Mesothelioma

• DOI: 10.1200/jco.2005.04.3190
• Publication Date: 2006-03-20T23:58:03Z
• Authors: Giovanni L. Ceresoli; Paolo A. Zucali; Adolfo G. Favaretto; Francesco Grossi; Paolo Bidoli; Guido Del Conte; Anna Ceribelli; Alessandra Bearz; Emanuela Morenghi; Raffaele Cavina; Maurizio Marangolo; Hector J. Soto Parra; Armando Santoro
• Keywords: Pemetrexed; Carboplatin; Regimen

Purpose This multicenter, phase II clinical study was conducted to evaluate the activity of combination pemetrexed and carboplatin in patients with malignant pleural mesothelioma (MPM). Patients Methods Chemotherapy-naive measurable disease adequate organ function, who were not eligible for curative surgery, received 500 mg/m 2 area under plasma concentration-time curve 5 mg/mL/min, administered intravenously every 21 days. All folic acid vitamin B 12 supplementation. Pemetrexed provided within Expanded Access Program. Results A total 102 enrolled. An objective response achieved 19 (two complete 17 partial responses), a rate 18.6% (95% CI, 11.6% 27.5%). Forty-eight (47.0%; 95% 37.1% 57.2%) had stable after treatment. Overall, 67 (65.7%) control 55.6% 74.8%). Median time progression 6.5 months; median overall survival 12.7 months. Compliance treatment excellent, relative dose-intensity 97% 98% carboplatin. Toxicity mild, grade 3 or 4 neutropenia occurring 9.7% cycles anemia 3.5% cycles. Nonhematologic toxicity negligible. Conclusion Treatment active well tolerated MPM. Disease rate, progression, similar results standard regimen cisplatin, suggesting that could be an alternative option these patients.