Abstract
4108 Objective: To compare the efficacy and tolerability of three different combination regimens, CapOx, CapGem, and GemOx for treatment of advanced pancreatic cancer. Patients: Of 165 planned pts, 135 pts have been enrolled between June 2002 and December 2003 from 37 centres. Patients (pts) received 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 d 1+8 (CapGem) or or gemcitabine 1000 mg/m2 iv d1+8 plus oxaliplatin 130 mg/m2 d8 (GemOx). In all three treatment arms, cycles were repeated every 3 wks. Progression-free survival after 3 months was evaluated as a primary end-point. Results: At the interim analysis, 44, 45, and 46 pts had been included into the respective treatment arms. Median age was 63 yrs (range 40–74), 92% of pts presented with a KPS >70%, and 76% had metastatic disease. Stratification was performed with regard to KPS and stage of disease, and pts were accordingly well balanced between treatment groups. At the time of evaluation, 263 treatment cycles were evaluable for toxicity. Generally, hematotoxicity was low with regard to grade 3–4 anemia, leukopenia, and thrombopenia: 0%, 0%, 0% for CapOx, 18%, 0%, 0% for CapGem, and 0%, 5%, 15% for GemOx. Alopecia grade <2 occurred in 18%, 25%, and 32% of pts. Palmar-plantar erythrodysesthesia grade ≥ 2 was observed in 5% of patients each in the CapGem and the CapOx arm. Conclusion: At present time, all three treatment regimens CapOx, CapGem, and GemOx are comparably well tolerated and show a low profile of side effects. A comparative analysis of treatment efficacy will be presented at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Hoffmann La-Roche Roche Germany
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