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Phase III Randomized, Placebo-Controlled, Double-Blind Trial of Celecoxib in Addition to Standard Chemotherapy for
Martin J Edelman1, Xiaofei Wang1, Lydia Hodgson1
1Martin J. Edelman, University of Maryland Greenebaum Cancer Center, Baltimore, MD; Xiaofei Wang and Lydia Hodgson, Alliance Statistical and Data Center, Duke University; Thomas E. Stinchcombe, Duke University School of Medicine, Durham, NC; Richard T. Cheney, Roswell Park Cancer Institute, Buffalo; Ajeet Gajra, State University of New York Upstate Medical University, Syracuse, NY; Maria Q. Baggstrom, Washington University School of Medicine, St Louis, MO; Sachdev P. Thomas, Illinois Cancer Care, Peoria; Paula N. Friedman and Everett E. Vokes, University of Chicago; Olwen M. Hahn, Alliance Protocol Office, University of Chicago, Chicago, IL; Erin Bertino, The Ohio State University Medical Center, Columbus, OH; Karen L. Reckamp, City of Hope Comprehensive Cancer Center, Duarte, CA; Julian Molina, Mayo Clinic, Rochester; Jon Ritter, University of Minnesota, Minneapolis, MN; Joan H. Schiller, University of Texas Southwestern Medical Center, Dallas, TX; Kisha Mitchell-Richards, Yale University, New Haven, CT; and Ginger Milne, Vanderbilt University, Nashville, TN.
Abstract:
Purpose Tumor overexpression of cyclooxygenase-2 (COX-2) has been associated with worse outcome in non-small-cell lung cancer (NSCLC). In Cancer and Leukemia Group B (CALGB) 30203, we found that the selective COX-2 inhibitor celecoxib in addition to chemotherapy in advanced NSCLC improved progression-free and overall survival in patients with moderate to high COX-2 expression by immunohistochemistry (IHC). CALGB 30801 (Alliance) was designed to prospectively confirm that finding. Patients and Methods Patients with NSCLC (stage IIIB with pleural effusion or stage IV according to American Joint Committee on Cancer [sixth edition] criteria) were preregistered, and biopsy specimens were analyzed for COX-2 by IHC. Patients with COX-2 expression ≥ 2, performance status of 0 to 2, and normal organ function were eligible. Chemotherapy was determined by histology: carboplatin plus pemetrexed for nonsquamous NSCLC and carboplatin plus gemcitabine for squamous histology. Patients were randomly assigned to celecoxib (400 mg twice per day; arm A) or placebo (arm B). The primary objective was to demonstrate improvement in progression-free survival in patients with COX-2 index ≥ 4 with hazard ratio of 0.645 with approximately 85% power at two-sided significance level of .05. Results The study was halted for futility after 312 of the planned 322 patients with COX-2 index ≥ 2 were randomly assigned. There were no significant differences between the groups (hazard ratio, 1.046 for COX-2 ≥ 4). Subset analyses evaluating histology, chemotherapy regimen, and incremental COX-2 expression did not demonstrate any advantage for COX-2 inhibition. Elevation of baseline urinary metabolite of prostaglandin E2, indicating activation of the COX-2 pathway, was a negative prognostic factor. Values above the third quartile may have been a predictive factor. Conclusion COX-2 expression by IHC failed to select patients who could benefit from selective COX-2 inhibition. Urinary metabolite of prostaglandin E2 may be able to identify patients who could benefit from COX-2 inhibition.
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