Abstract
LBA4013 Background: Chemotherapy with Gemcitabine 1 g/m2 given on d 1, 8, 15 every four weeks is standard therapy in inoperable pancreatic cancer. The value of adjuvant therapy has not been clearly defined and no data on randomised trials with Gemcitabine in the adjuvant setting is available. Methods: This study was designed to evaluate the efficacy and toxicity of Gemcitabine in patients with resectable pancreatic cancer. Within 6 weeks after operation, patients were randomised to receive Gemcitabine or observation after stratification for positive or negative resection margins, nodal tumor involvement and tumor stage. Gemcitabine was administered at a dosage of 1g/m2 days 1, 8 and 15 every 4 weeks for 6 months. Patients in the observation arm received no specific postoperative treatment. Primary endpoint was disease free survival (DFS), secondary endpoints included overall survival (OS) and side effects in both groups. The study was powered to detect a significant difference with 90% probability at a significance level of 0.05. Results: Between 07/98 and 12/2004, 368 patients were randomised after a safety only interim analysis confirmed feasibility of adjuvant Gemcitabine therapy without excessive toxicity. At the meeting, data on time-to-event endpoints and toxicity data will be available and be presented. Conclusion: Will be made after final analysis of the results is completed. The results will be presented at the meeting. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Lilly Oncology Lilly Oncology
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