Oral Capecitabine in Gemcitabine-Pretreated Patients with Advanced Pancreatic CancerBoeck S. · Wilkowski R. · Bruns C.J. · Issels R.D. · Schulz C. · Moosmann N. · Laessig D. · Haas M. · Golf A. · Heinemann V.
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
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.
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
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
Oncology (International Journal of Cancer Research and Treatment)
Vol. 73, No. 3-4, Year 2007 (Cover Date: April 2008)
Journal Editor: Markman M. (Houston, Tex.)
ISSN: 0030–2414 (Print), eISSN: 1423–0232 (Online)
For additional information: http://www.karger.com/OCL