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Randomized Phase II Trial of Pemetrexed Combined With Either Cisplatin or Carboplatin in Untreated Extensive-Stage Small-Cell Lung Cancer

Mark A. Socinski, Charles Weissman, Lowell L. Hart, J. Thaddeus Beck, Janak K. Choksi, John P. Hanson, Diane Prager, Matthew J. Monberg, Zhishen Ye, Coleman K. Obasaju

From the Lineberger Comprehensive Cancer Center, Multidisciplinary Thoracic Oncology Program, University of North Carolina at Chapel Hill, Chapel Hill; Alamance Regional Medical Center, Burlington, NC; US Oncology, Latham, NY; Florida Cancer Specialists, Fort Meyers, FL; Highlands Oncology Group, Fayetteville, AR; St Luke's Medical Center, Milwaukee, WI; University of California Los Angeles Medical Center, Los Angeles, CA; and Eli Lilly & Company, Indianapolis, IN

Address reprint requests to Mark A. Socinski, MD, Associate Professor of Medicine, Multidisciplinary Thoracic Oncology Program, Lineberger Comprehensive Cancer Center, CB# 7305, University of North Carolina, Chapel Hill, NC 27599; e-mail: socinski{at}med.unc.edu

PURPOSE: Given the activity and tolerability of pemetrexed/platinum combinations in non–small-cell lung cancer, and the success of novel therapeutic strategies employed in recent extensive-stage small-cell lung cancer (ES-SCLC) trials, a randomized phase II trial was initiated to evaluate the use of cisplatin or carboplatin plus pemetrexed in previously untreated ES-SCLC.

PATIENTS AND METHODS: Patients were randomly assigned to receive pemetrexed 500 mg/m² plus cisplatin 75 mg/m² or pemetrexed plus carboplatin area under the concentration curve 5. Treatment was administered once every 21 days for a maximum of six cycles. All patients received folic acid, vitamin B₁₂, and steroid prophylaxis.

RESULTS: Between December 19, 2002, and May 17, 2004, 78 patients were enrolled onto this multicenter trial. Median age was 63 years (range, 46 to 82 years) for cisplatin/pemetrexed and 66 years (range, 47 to 75 years) for carboplatin/pemetrexed. Median survival time (MST) for cisplatin/pemetrexed was 7.6 months, with a 1-year survivorship of 33.4% and a response rate of 35% (95% CI, 20.6% to 51.7%). The MST for carboplatin/pemetrexed was 10.4 months, with a 1-year survivorship of 39.0% and a response rate of 39.5% (95% CI, 24.0 to 56.6). Median time to progression for cisplatin/pemetrexed was 4.9 months and for carboplatin/pemetrexed was 4.5 months. Median dose-intensity (actual/planned dose) was 98.94% for cisplatin and 99.95% for pemetrexed in the cisplatin/pemetrexed group and 93.21% for carboplatin and 98.50% for pemetrexed in the carboplatin/pemetrexed group. Grade 3/4 hematologic toxicities included neutropenia (15.8% v 20.0%) and thrombocytopenia (13.2% v 22.9%) in the cisplatin/pemetrexed and carboplatin/pemetrexed treatment groups, respectively.

CONCLUSION: Pemetrexed/platinum doublets had activity and appeared to be well-tolerated in first-line ES-SCLC.

Supported by Eli Lilly & Company.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, Orlando, FL, May 13-17, 2005.

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

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