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

Pino M.S.a · Milella M.a · Gelibter A.a · Sperduti I.b · De Marco S.d · Nuzzo C.a · Bria E.a · Carpanese L.c · Ruggeri E.M.a · Carlini P.a · Cognetti F.a
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 Oncology 2009;76:254–261 (DOI:10.1159/000205388)


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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