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Phase II Study of Pemetrexed Plus Carboplatin in Malignant Pleural Mesothelioma

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

From the Department of Medical Oncology and Hematology and Medical Statistics Unit, Istituto Clinico Humanitas Istituto di Ricovero e Cura a Carattere Scientifico, Rozzano; Department of Medical Oncology, Unit 2, National Cancer Institute, Milan; Department of Medical Oncology, University Hospital, Padua; Department of Medical Oncology, National Institute for Cancer Research, Genoa; Department of Medical Oncology, Azienda Ospedaliera, Trieste; Department of Medical Oncology, Unit A, Regina Elena Cancer Institute, Rome; Department of Medical Oncology, Unit A, National Cancer Institute, Aviano; and Department of Oncology and Hematology, Istituto Oncologico Romagnolo, Ravenna, Italy

Address reprint requests to Giovanni Luca Ceresoli, MD, Department of Medical Oncology and Hematology, Istituto Clinico Humanitas Istituto di Ricovero e Cura a Carattere Scientifico, Rozzano, Milan, Italy; e-mail: giovanni_luca.ceresoli{at}humanitas.it

PURPOSE: This multicenter, phase II clinical study was conducted to evaluate the activity of the combination of pemetrexed and carboplatin in patients with malignant pleural mesothelioma (MPM).

PATIENTS AND METHODS: Chemotherapy-naive patients with measurable disease and adequate organ function, who were not eligible for curative surgery, received pemetrexed 500 mg/m² and carboplatin area under the plasma concentration-time curve of 5 mg/mL/min, administered intravenously every 21 days. All patients received folic acid and vitamin B₁₂ supplementation. Pemetrexed was provided within the Expanded Access Program.

RESULTS: A total of 102 patients were enrolled. An objective response was achieved in 19 patients (two complete and 17 partial responses), for a response rate of 18.6% (95% CI, 11.6% to 27.5%). Forty-eight patients (47.0%; 95% CI, 37.1% to 57.2%) had stable disease after treatment. Overall, 67 patients (65.7%) achieved disease control (95% CI, 55.6% to 74.8%). Median time to progression was 6.5 months; median overall survival time was 12.7 months. Compliance to treatment was excellent, with a relative dose-intensity of 97% for pemetrexed and 98% for carboplatin. Toxicity was mild, with grade 3 or 4 neutropenia occurring in 9.7% of total cycles and grade 3 or 4 anemia occurring in 3.5% of total cycles. Nonhematologic toxicity was negligible.

CONCLUSION: Treatment with pemetrexed and carboplatin was active and well tolerated in patients with MPM. Disease control rate, time to disease progression, and overall survival were similar to the results achieved with the standard regimen of pemetrexed and cisplatin, suggesting that the carboplatin combination could be an alternative option for these patients.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005; and the 11th World Conference on Lung Cancer, Barcelona, Spain, July 3-6, 2005.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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