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Randomized, Phase III Study of Weekly Paclitaxel in Combination With Carboplatin Versus Standard Every-3-Weeks Administration of Carboplatin and Paclitaxel for Patients With Previously Untreated Advanced Non–Small-Cell Lung Cancer

Chandra P. Belani, Suresh Ramalingam, Michael C. Perry, Renato V. LaRocca, David Rinaldi, Preston S. Gable, William J. Tester

From the Penn State Cancer Institute, Hershey; University of Pittsburgh Cancer Institute, Pittsburgh; Albert Einstein Medical Center, Philadelphia, PA; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; Kentuckiana Cancer Institute, Louisville, KY; Louisiana Oncology Associates, Lafayette, LA; and Naval Medical Center, San Diego, CA

Corresponding author: Chandra P. Belani, MD, Penn State Cancer Institute, H072, 500 University Drive, PO Box 850, Hershey, PA 77030; e-mail: cbelani{at}psu.edu

Purpose: To compare the efficacy and safety of weekly paclitaxel in combination with carboplatin administered every 4 weeks to the standard regimen of paclitaxel and carboplatin administered every 3 weeks for the treatment of patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods: Four hundred forty-four patients with previously untreated stage IIIB/IV NSCLC were randomly assigned to either arm 1 (n = 223), paclitaxel 100 mg/m² weekly for 3 of 4 weeks with carboplatin area under the curve (AUC) = 6 mg/mL · min on day 1 of each 4 week cycle, or arm 2 (n = 221), paclitaxel 225 mg/m² and carboplatin AUC = 6 on day 1 of each 3-week cycle. After four cycles of therapy, patients in both treatment arms were eligible to continue weekly paclitaxel (70 mg/m², 3 of 4 weeks) as maintenance therapy until unacceptable toxicity or disease progression.

Results: The objective response rate was 27.6% for arm 1 and 19.2% for arm 2. Median time to progression (TTP) was 18.4 and median survival (MS) was 38.6 weeks for arm 1. For arm 2, the median TTP and MS were 16.7 weeks and 42.9 weeks respectively. Grade 3/4 anemia was more common with arm 1, although grade 2/3 neuropathy and arthralgia were less common. The remainder of the toxicities were similar between the two arms.

Conclusion: All efficacy parameters were similar between the two treatment arms. The favorable nonhematologic toxicity profile of arm 1 makes this an alternative treatment option for patients with advanced NSCLC.

Supported in part by a grant from Bristol-Myers Squibb Company.

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

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

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