Oral capecitabine in gemcitabine-pretreated patients with advanced pancreatic cancer

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/m(2) 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
(C) 2008 S. Karger AG, Basel.