Abstract
4030 Background: Gemcitabine, oxaliplatin, and capecitabine are active agents in pancreatic cancer. This study was performed to define an optimal regimen for combination therapy. Methods: Between July 2002 and May 2004, 190 patients were recruited from 44 centres. Patients received 3-week regimens of either capecitabine 2 x 1000mg/m2 po d1–14 plus oxaliplatin 130mg/m2 iv d1 (CapOx) or capecitabine 2 x 825mg/m2 po d1–14 plus gemcitabine 1000mg/m2 iv d1+8 (CapGem) or gemcitabine 1000 mg/m2 iv d1+8 plus oxaliplatin 130 mg/m2 d8 (GemOx). Results: Patients in the CapOx, CapGem, and GemOx-arms were well balanced according to the strata Karnofsky Performance status (KPS >70% in 89% vs 92% vs 90%) and stage of disease (metastatic disease in 74% vs 76% vs 75%). Median age was 63 years (range 37–75). Patients received a median of 4 cycles of treatment. In a per patient analysis of CapOx vs CapGem vs GemOx, hematological grade 3–4 toxicity occurred in 6%, 16%, and 19%. Grade 3–4 neurosensoric toxicity was observed in 7%, 0% and 4%, while grade 2–3 hand-foot-syndrome was noted in 9%, 6%, and 2%, respectively. In October 2004, 141 patients were evaluable for response. The analysis of CapOx vs CapGem vs GemOx did not show any complete remission, while partial responses were obtained in 22%, 16%, and 13% of patients, and stable disease was documented in 33%, 45%, and 30% for a disease control rate of 55%, 61%, and 43%, respectively. Median PFS was 127 days, 143 days, and 91 days, while median overall survival was 243 days, 229 days, and 241 days, respectively (two-sided logrank test, p=0.6). Conclusions: The current interim evaluation of this trial indicates a comparable efficacy and tolerability for the investigated regimens CapOx, CapGem, and GemOx. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Sanofi-Synthelabo
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