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Multicenter, Randomized Trial for Stage IIIB or IV Non–Small-Cell Lung Cancer Using Weekly Paclitaxel and Carboplatin Followed by Maintenance Weekly Paclitaxel or Observation

Chandra P. Belani, John Barstis, Michael C. Perry, Renato V. La Rocca, Sreenivasa R. Nattam, David Rinaldi, Ray Clark, Glenn M. Mills

From the University of Pittsburgh Cancer Institute, Pittsburgh, PA; University of California at Los Angeles Santa, Clarita Cancer Center, Valencia, CA; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; Kentuckiana Cancer Center, Louisville, KY; Fort Wayne Medical Oncology-Hematology, Fort Wayne, IN; Louisiana Oncology Associates, Lafayette; Louisiana State University Medical Center, Shreveport, LA; and Hematology and Oncology Associates, Jackson, MI.

Address reprint requests to Chandra P. Belani, MD, Professor of Medicine, Co-Director, Lung and Thoracic Cancer Program, University of Pittsburgh Cancer Institute, UPMC Cancer Pavilion, 5150 Centre Ave, Ste 570, Pittsburgh, PA 15232; email: belanicp{at}msx.upmc.edu.

Purpose: To explore the efficacy and safety of three regimens of weekly paclitaxel plus carboplatin as initial therapy and the feasibility of subsequent maintenance therapy versus observation in patients with advanced non–small-cell lung cancer (NSCLC).

Patients and Methods: Four hundred one patients were randomly assigned to one of the following arms: arm 1, paclitaxel 100 mg/m² weekly for 3 of 4 weeks with carboplatin (area under the curve [AUC] = 6) on day 1; arm 2, paclitaxel 100 mg/m² and carboplatin (AUC = 2) weekly for 3 of 4 weeks; or arm 3, paclitaxel 150 mg/m² cycle 1 and 100 mg/m² cycle 2 and carboplatin (AUC = 2) weekly for 6 of 8 weeks. Patients who responded (n = 130) at week 16 were randomly assigned to either weekly paclitaxel therapy (70 mg/m², 3 of 4 weeks; n = 65) or observation (n = 65).

Results: For the 390 assessable patients, the objective response rates observed with initial therapy were 32% for arm 1, 24% for arm 2, and 18% for arm 3. The median time to progression and median survival times were 30 and 49 weeks for arm 1, 21 and 31 weeks for arm 2, and 27 and 40 weeks for arm 3, respectively. The 1-year survival rates were 47% for arm 1, 31% for arm 2, and 41% for arm 3.

Conclusion: Arm 1, paclitaxel 100 mg/m² weekly for 3 of 4 weeks with carboplatin (AUC = 6) administered on day 1, demonstrates the most favorable therapeutic index in patients with advanced NSCLC.

Supported by a grant from Bristol-Myers Squibb Company, Princeton, NJ.

Previously presented at the Ninth Annual World Conference on Lung Cancer, Tokyo, Japan, September 11–15, 2000, and at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12–15, 2001.

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