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Vol. 76, No. 4, 2009
Issue release date: March 2009
Oncology 2009;76:254–261

Capecitabine and Celecoxib as Second-Line Treatment of Advanced Pancreatic and Biliary Tract Cancers

Pino M.S. · Milella M. · Gelibter A. · Sperduti I. · De Marco S. · Nuzzo C. · Bria E. · Carpanese L. · Ruggeri E.M. · Carlini P. · Cognetti F.
Departments of aMedical Oncology, bBiostatistics, and cDiagnostic and Interventional Radiology, Regina Elena National Cancer Institute, and dDepartment of Medical Oncology, San Camillo and Forlanini Hospitals, Rome, Italy

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Objective: An increasing number of patients with advanced pancreatic or biliary tract cancer who progress after a gemcitabine-containing regimen are candidates for further chemotherapy. We therefore evaluated a fully oral regimen of capecitabine and celecoxib (CapCel) as second-line treatment in these patients. Methods: Thirty-five patients with documented progressive disease after first-line treatment were enrolled. Capecitabine was administered at a dose of 1,000 mg/m2 b.i.d. for 2 consecutive weeks followed by 1 week of rest; celecoxib was given continuously at 200 mg b.i.d. Progression-free survival at 3 months was the primary study endpoint. Results: The CapCel combination was associated with an overall response rate of 9% and median survival duration of 19 weeks. Sixty percent of patients were free from progression 3 months after the start of treatment. Multivariate analysis identified a positive clinical benefit response and a decline in CA 19.9 serum levels >25% compared with baseline levels as independent predictors of prolonged survival. The treatment protocol was well tolerated with negligible hematological toxicity. The most common grade 3 non-hematological toxicities were hypertransaminasemia, diarrhea and asthenia. Conclusions: The CapCel combination is a safe treatment option with moderate activity in patients with pancreatic/biliary tract cancer after failure of a previous gemcitabine-containing regimen.

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