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Journal of Clinical Oncology, Vol 23, No 1 (January 1), 2005: pp. 190-196
© 2005 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2005.07.172
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Single-Agent Versus Combination Chemotherapy in Advanced Non–Small-Cell Lung Cancer: The Cancer and Leukemia Group B (study 9730)

Rogerio C. Lilenbaum, James E. Herndon, II, Marcy A. List, Chris Desch, Dorothy M. Watson, Antonius A. Miller, Stephen L. Graziano, Michael C. Perry, Wayne Saville, Philippe Chahinian, Jane C. Weeks, Jimmie C. Holland, Mark R. Green

From the Mount Sinai Comprehensive Cancer Center, Miami Beach, FL; The Cancer and Leukemia Group B Statistical Center, Durham, NC; University of Chicago Cancer Research Center, Chicago, IL; Virginia Commonwealth University, Massey Cancer Center, Richmond, VA; Wake Forest University School of Medicine, Winston-Salem, NC; SUNY Upstate Medical University, Syracuse NY; University of Missouri/Ellis Fischel Cancer Center, Columbia, MO; University of California at San Diego, San Diego, CA; Mount Sinai School of Medicine and Memorial Sloan Kettering Cancer Center, New York, NY; The Dana Farber Cancer Institute, Boston, MA; Medical University of South Carolina, Charleston, SC

Address reprint requests to Rogerio C. Lilenbaum, MD, FACP, The Mount Sinai Comprehensive Cancer Center, 4306 Alton Rd, Miami Beach, FL 33140; e-mail: Rlilenba{at}salick.com

PURPOSE: We compared the efficacy of combination chemotherapy versus single-agent therapy in patients with advanced non–small-cell lung cancer.

PATIENTS AND METHODS: A total of 561 eligible patients were randomly assigned to receive paclitaxel alone or in combination with carboplatin.

RESULTS: The response rate was 17% in the paclitaxel arm and 30% in the carboplatin-paclitaxel arm (P < .0001). Median failure-free survival was 2.5 months in the paclitaxel arm and 4.6 months in the carboplatin-paclitaxel arm (P = .0002). Median survival times were 6.7 months (95% CI, 5.8 to 7.8) and 8.8 months (95% CI, 8.0 to 9.9), and 1-year survival rates were 32% (95% CI, 27% to 38%), and 37% (95% CI, 32% to 43%), respectively. The overall survival distributions were not statistically different: hazard ratio = 0.91 (95% CI, 0.77 to 1.17; P = .25). Hematological toxicity and nausea were more frequent in the combination arm, but febrile neutropenia and toxic deaths were equally low in both arms. There was no significant survival difference in elderly patients. Performance status 2 patients treated with combination chemotherapy had a better survival rate than those treated with single-agent therapy (P = .019).

CONCLUSION: Combination chemotherapy improves response rate and failure-free survival compared with single-agent therapy, but there was no statistically significant difference in the primary end point of overall survival. The results in elderly patients were similar to younger patients. Performance status 2 patients had a superior outcome when treated with combination chemotherapy.

The research for CALGB 9730 was supported, in part, by grants from the National Cancer Institute (CA31946) to the Cancer and Leukemia Group B (Richard L. Schilsky, Chairman). The contents of this manuscript are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute. This research was also partially supported by Bristol-Myers Squibb Company. This research also supported by CA45564, CA33601, CA41287, CA52784, CA03927, CA21060, CA12046, CA11789, CA04457, CA32291, CA77651, CA03927. Additional information appears in the Appendix.

Presented at the plenary Session, American Society of Clinical Oncology Group Meeting, Orlando, FL, May 2002.

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


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