Clinical Study

Oral Capecitabine in Gemcitabine-Pretreated Patients with Advanced Pancreatic Cancer
Stefan Boeck^a, Ralf Wilkowski^c, Christiane J. Bruns^b, Rolf D. Issels^{a, d}, Christoph Schulz^a, Nicolas Moosmann^a, Dorit Laessig^a, Michael Haas^a, Alexander Golf^e, Volker Heinemann^a

Departments of
^aInternal Medicine III, and
^bSurgery, Klinikum Grosshadern, Ludwig Maximilians University of Munich, Munich,
^cPractice for Radiooncology and Radiotherapy, Klinik Bad Trissl, Oberaudorf,
^dGSF, National Research Center for Environment and Health, Neuherberg, and
^eDepartment of Medicine I, Buergerhospital, Klinikum Stuttgart, Stuttgart, Germany

Address of Corresponding Author

Oncology 2007;73:221-227 (DOI: 10.1159/000127413)

  Key Words

• Capecitabine
• Chemotherapy
• Gemcitabine
• Pancreatic cancer

  Abstract

Objective: To date, no standard regimen for salvage chemotherapy after gemcitabine (Gem) failure has been defined for patients with advanced pancreatic cancer (PC). Oral capecitabine (Cap) has shown promising activity in first-line chemotherapy trials in PC patients. Methods: Within a prospective single-center study, Cap was offered to patients who had already received at least 1 previous treatment regimen containing full-dose Gem (as a single agent, as part of a combination chemotherapy regimen or sequentially within a chemoradiotherapy protocol). Cap was administered orally at a dose of 1,250 mg/m² twice daily for 14 days followed by 7 days of rest. Study endpoints were objective tumor response rate by imaging criteria (according to RECIST), carbohydrate antigen 19-9 (CA19-9) tumor marker response, time to progression, overall survival and toxicity. Results: A median of 3 treatment cycles (range 1-36) was given to 39 patients. After a median follow-up of 6.6 months, 27 patients were evaluable for response: no complete or partial responses were observed, but 15 patients (39%) had stable disease. A CA19-9 reduction of >20% after 2 cycles of Cap was documented in 6 patients (15%). Median time to progression was 2.3 months (range 0.5-45.1) and median overall survival (since start of Cap treatment) was 7.6 months (range 0.7-45.1). Predominant grade 2 and 3 toxicities (per patient analysis) were hand-foot syndrome 28% (13% grade 3); anemia 23%; leg edema 15%; diarrhea 13%; nausea/vomiting 10%, and leukocytopenia 10%. Conclusion: Single-agent Cap is a safe treatment option for Gem-pretreated patients with advanced PC. Further evaluation of Cap in controlled clinical trials of Gem-pretreated patients with advanced PC is recommended.

Copyright © 2008 S. Karger AG, Basel

  Author Contacts

Dr. Stefan Boeck, Department of Internal Medicine III, Klinikum Grosshadern Ludwig Maximilians University of Munich
Marchioninistrasse 15, DE-81377 Munich (Germany)
Tel. +49 89 7095 2208, Fax +49 89 7095 5256
E-Mail stefan.boeck@med.uni-muenchen.de

  Article Information

Received: October 3, 2007
Accepted after revision: October 9, 2007
Published online April 17, 2008
Number of Print Pages : 7
Number of Figures : 2, Number of Tables : 3, Number of References : 32