Capecitabine and Celecoxib as Second-Line Treatment of Advanced Pancreatic and Biliary Tract CancersPino 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
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.
Michele Milella, MD
Department of Medical Oncology, Regina Elena National Cancer Institute
Via Elio Chianesi 53
IT–00144 Rome (Italy)
Tel. +39 06 5266 6919, Fax +39 06 5266 5637, E-Mail firstname.lastname@example.org
M.S. Pino and M. Milella contributed equally to this article.
Received: July 29, 2008
Accepted after revision: October 22, 2008
Published online: February 26, 2009
Number of Print Pages : 8
Number of Figures : 2, Number of Tables : 4, Number of References : 45
Oncology (International Journal of Cancer Research and Treatment)
Vol. 76, No. 4, Year 2009 (Cover Date: March 2009)
Journal Editor: Markman M. (Houston, Tex.)
ISSN: 0030-2414 (Print), eISSN: 1423-0232 (Online)
For additional information: http://www.karger.com/OCL