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Randomized Phase II Trial of Docetaxel/Irinotecan and Gemcitabine/Irinotecan With or Without Celecoxib in the Second-Line Treatment of Non–Small-Cell Lung Cancer

Rogerio Lilenbaum, Mark A. Socinski, Nasser K. Altorki, Lowell L. Hart, Roger S. Keresztes, Subramanian Hariharan, Mark E. Morrison, Rana Fayyad, Phillip Bonomi

From the Mount Sinai Cancer Center, Miami Beach; Florida Cancer Specialists, Fort Myers, FL; Linberger Comprehensive Cancer Center, University of North Carolina, Chapel Hill, NC; Weill Medical College of Cornell University; Pfizer Oncology, New York, NY; and Rush-Presbyterian St Lukes Medical Center, Chicago, IL

Address reprint requests to Rogerio Lilenbaum, MD, Mount Sinai Cancer Center, 4306 Alton Rd, Miami Beach, FL 33140; e-mail: rlilenbaum{at}aptiumoncology.com

PURPOSE: Trials combining irinotecan/docetaxel and irinotecan/gemcitabine in second-line treatment of non–small-cell lung cancer (NSCLC) have yielded promising results. Preliminary data suggested that the selective cyclooxygenase -2 inhibitor celecoxib (CBX) might enhance efficacy of chemotherapeutic regimens. This multicenter, phase II, randomized trial investigated efficacy and safety of irinotecan and docetaxel and irinotecan and gemcitabine, with or without CBX, in second-line treatment of NSCLC.

PATIENTS AND METHODS: Patients 18 years or older were randomly assigned to receive irinotecan 60 mg/m² and docetaxel 35 mg/m², or irinotecan 100 mg/m² and gemcitabine 1,000 mg/m², with or without CBX 400 mg twice daily, for four cycles. Primary efficacy end points were median and 1-year survival probabilities. Patient-reported symptoms were assessed by the Lung Cancer Symptoms Scale (LCSS).

RESULTS: A total of 133 patients were assessable for efficacy and safety. Median survival time was 6.31 months for patients treated with CBX and 8.99 months for those treated with chemotherapy alone. One-year survival rates were 24% and 36% respectively. The overall toxicity rates and LCSS scores were similar between patients treated or not treated with CBX. Four deaths were considered possibly treatment related.

CONCLUSION: Survival results for the second-line regimens in this study were similar to results reported for single-agent therapy in this setting. CBX did not appear to enhance efficacy or improve patient-reported symptoms. The addition of high-dose CBX to second-line chemotherapy in NSCLC cannot be recommended.

Presented in abstract form at the 40th Annual Meeting of the American Society of Clinical Oncology, June 5-8, 2004, New Orleans, LA; and at the 10th and 11th World Conferences on Lung Cancer, August 10-14, 2003, Vancouver, British Columbia, Canada, and July 3-6, 2005, Barcelona, Spain, respectively.

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

R.L. and M.A.S. contributed equally to this manuscript.

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