Prospective randomized trial of 5-fluorouracil, doxorubicin, and mitomycin C for non-resectable pancreatic and biliary carcinoma: multicenter randomized trial.

BACKGROUND/AIMS: The efficacy of combination chemotherapy, which consists of fluorouracil, doxorubicin and mitomycin, was compared with that of palliative surgery-only in patients (control) having non-resectable pancreatic and biliary carcinomas in a multicenter randomized trial. METHODOLOGY: The patients were assigned to combination chemotherapy consisting of concomitant 5-fluorouracil 200mg/m 2 , doxorubicin 15mg/m 2 , and mitomycin 5mg/m 2 by intravenous administration. This combination chemotherapy was given concurrently as the initial dose within 1 week after palliative operation, and this regimen was repeated for at least 2 whole courses at 4-week intervals before the next course of therapy. Forty-two cases of this combination chemotherapy group and 41 of the control group were completely eligible for analysis. RESULTS: Regarding the overall 50% inhibition of tumor progression and that of gallbladder carcinoma, there were significantly better outcomes in the modified FAM therapy group. In this group, tumor reduction was achieved in 1 complete response (CR) and 2 partial response (PR) patients. With respect to the overall and differentiated survival times according to the tumor sites and the clinical efficacy, there was no difference between the groups. The most frequent adverse reactions were gastrointestinal manifestations such as anorexia, nausea, vomiting, and diarrhea; also noted was alopecia. CONCLUSIONS: Since this combination chemotherapy inhibited the tumor progression for significantly longer duration and, to a lesser extent, reduced the tumor size in non-resectable gallbladder carcinomas compared to a non-administrated chemotherapy group, this study will function as the basis for pursuing a more effective chemotherapy.