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Journal of Clinical Oncology, Vol 25, No 30 (October 20), 2007: pp. 4787-4792
© 2007 American Society of Clinical Oncology.
DOI: 10.1200/JCO.2007.11.8521

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Capecitabine Plus Erlotinib in Gemcitabine-Refractory Advanced Pancreatic Cancer

Matthew H. Kulke, Lawrence S. Blaszkowsky, David P. Ryan, Jeffrey W. Clark, Jeffrey A. Meyerhardt, Andrew X. Zhu, Peter C. Enzinger, Eunice L. Kwak, Alona Muzikansky, Colleen Lawrence, Charles S. Fuchs

From the Department of Medical Oncology, Dana-Farber Cancer Institute; Division of Hematology/Oncology, Massachusetts General Hospital; Department of Biostatistics, Massachusetts General Hospital; and the Channing Laboratory, Brigham and Women's Hospital, Boston MA

Address reprint requests to Matthew Kulke, MD, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; e-mail: Matthew_Kulke{at}dfci.harvard.edu

Purpose: The addition of either capecitabine or erlotinib to gemcitabine in the first-line treatment of advanced pancreatic cancer is associated with modest improvements in overall survival. We evaluated an oral regimen of capecitabine and erlotinib in patients with advanced pancreatic cancer who had experienced treatment failure with standard first-line therapy with gemcitabine.

Patients and Methods: Thirty patients with gemcitabine-refractory metastatic pancreatic cancer were treated with capecitabine, administered at a dose of 1,000 mg/m2 twice daily for 2 weeks, followed by a 1-week break. All patients also received erlotinib 150 mg daily. Patients were observed for evidence of response, toxicity, and survival. EGFR mutational status was assessed in available tumor blocks.

Results: Treatment with capecitabine and erlotinib in gemcitabine-refractory patients was associated with an overall objective radiologic response rate of 10% and a median survival duration of 6.5 months. In addition, 17% of the treated patients experienced decreases in tumor marker (CA 19-9) levels of more than 50% from baseline. Common toxicities included diarrhea, skin rash, fatigue, and hand-foot syndrome. EGFR mutations were detected in two of five available tumors; no association between treatment response and EGFR mutational status was evident.

Conclusion: The combination of capecitabine and erlotinib is active in patients with gemcitabine-refractory pancreatic cancer. This regimen may represent an acceptable treatment option in patients who experience treatment failure with standard first-line therapy with gemcitabine or for whom gemcitabine may not be an appropriate first-line treatment option.

Supported by Roche Inc.

Presented in part at the 41st Annual Meeting of the American Society of Clinical Oncology, May 13-17, 2005, Orlando, FL.

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


Related Correspondence

  • Second-Line Therapy in Gemcitabine-Pretreated Patients With Advanced Pancreatic Cancer
    Stefan Boeck and Volker Heinemann
    JCO 2008 26: 1178-1179 [Full Text]


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