Phase II trial of 5-fluorouracil, adriamycin and cisplatin (FAP) followed by radiation and 5-fluorouracil in locally advanced pancreatic cancer.

A total of 19 patients (7 men, 12 women) with locally advanced pancreatic adenocarcinoma were treated with six cycles of FAP (5-fluorouracil, 300 mg/m2 i.v. on days 1-5; Adriamycin, 50 mg/m2 i.v. on day 1; cisplatin, 20 mg/m2 i.v. on days 1-5). Each course was repeated every 28 days. After six cycles, the treatment was followed by irradiation amounting to 4,000 cGy (split course) in combination with 5-FU (500 mg/m2) on days 1-3 of the two irradiation periods. The median age of our patients was 55 years (range, 40-64 years). The median WHO performance status was 1, with a range of 0-2. Three (16%) complete (CR) and six (31%) partial responses (PR) were observed, as were six cases of stable disease (SD) and four of progressive disease (PD). The median duration of response was 11 months, with a range of 4-24 months, and the median survival was 14 months (range, 5-27 + months). FAP toxicity was tolerated fairly poorly. The dose-limiting toxic effect was myelosuppression, with a mean WBC nadir of WHO grade 1.6 (range, 0-3) and a mean platelet count of WHO grade 1.1 (range, 0-4). Nausea and vomiting were not dose-limiting. Complete alopecia was seen in 14/19 patients. Neuropathy was mild (WHO grade 1) in seven and moderate (grade 2) in four. Irradiation in combination with 5-FU was generally well tolerated. Due to several reasons, only ten patients could be treated with all six cycles of FAP. We conclude that in future combined modality studies, irradiation should be given after three cycles of chemotherapy, and that combined modality treatment for locally advanced pancreatic cancer is feasible and warrants further testing.