15095 Background: Pancreatoduodenectomy (PD) alone was considered a standard treatment for cancer of the pancreatic head for a long time before the recent advent of adjuvant chemotherapy (CTX). Since adjuvant chemotherapy cannot be applied to all patients (pts), and neoadjuvant chemoradiation is toxic, we initiated a prospective phase II trial in August 2001 to test the safety and outcome of neoadjuvant CTX without radiation for resectable pancreatic cancer. Methods: Pts with cytologically confirmed resectable ductal adenocarcinoma of the pancreatic head were eligible for this phase II trial. Staging and restaging examinations included chest and abdominal CT-scan, endoscopic ultrasound with cytology, PET/CT and diagnostic laparoscopy. CTX consisted of four treatments of gemcitabine (1000mg/m2) and cisplatin (50mg/m2) every two weeks, and PD was planned at week 8. CA 19–9, prealbumin serum levels, and quality of life (QLQ- 30) were also determined before and after CTX. The primary study end-point was resectability based on re-staging examinations. Follow-up CT- scans were performed every six months. Results: Thirty-one pts entered this trial. Of these, 27 completed CTX and restaging until analysis. At restaging two pts had peritoneal metastases resulting in a resectability rate of 93% (25/27). No grade IV, and 7 transient grade III toxicities occurred in five pts. Median progression-free and overall survival after diagnosis were 9.2 months (95% CI 7.7–10.8) and 26.5 months (95% CI 15.2–37.7), respectively, for resected pts. After CTX, CA 19–9 serum levels were decreased by 48% (p=0.01). Moreover, the overall quality of life was increased by 24% (p=0.02). Prealbumin serum levels were abnormal in 40% of the pts on study entry, and normal in all but 89% after CTX (p=0.02). Conclusions: Neoadjuvant gemcitabine/cisplatin over two months is well tolerated and does not jeopardize resectability of adenocarcinoma of the pancreatic head. It offers several advantages including patient selection for surgery, improvements in the nutritional status and quality of life. A randomized trial comparing adjuvant and neoadjuvant+adjuvant treatment is being planned. No significant financial relationships to disclose.
0199 The impact of adjuvant chemotherapy on quality of life in women with early breast cancer
