April 12, 1985

A Comparison of Three Chemotherapeutic Regimens in the Treatment of Advanced Pancreatic and Gastric CarcinomaFluorouracil vs Fluorouracil and Doxorubicin vs Fluorouracil, Doxorubicin, and Mitomycin

Author Affiliations

for the North Central Cancer Treatment Group
From the Illinois Oncology Research Association Community Clinical Oncology Program, Peoria (Dr Cullinan); the Mayo Clinic, Rochester, Minn (Drs Moertel, Fleming, and Rubin); the Duluth (Minn) Clinic CCOP (Dr Krook); the Fargo (ND) Clinic CCOP (Dr Everson); the St Cloud (Minn) Internists Ltd (Dr Windschitl); the Billings (Mont) Clinic (Dr Twito); the Sioux Falls (SD) Community Cancer Consortium CCOP (Drs Marschke and Barlow); the University of Nebraska Medical Center, Omaha (Dr Foley); and the Quain and Ramstad Clinic, Bismarck, ND (Dr Pfeifle).

JAMA. 1985;253(14):2061-2067. doi:10.1001/jama.1985.03350380077025

Three hundred five patients with advanced pancreatic and gastric carcinoma were randomly assigned to treatment with fluorouracil, fluorouracil plus doxorubicin (Adriamycin) (FA), or fluorouracil plus doxorubicin plus mitomycin (mitomycin C) (FAM). All regimens were equivalent with regard to patient survival. There is no reasonable likelihood that either the FA or FAM regimen could produce a meaningful survival advantage over fluorouracil alone. Interval to disease progression, objective response rates, and palliative effects (improved performance, body weight, or symptoms) were essentially equivalent among the three regimens. With regard to toxicity, the FAM regimen produced more anorexia, nausea, vomiting, leukopenia, thrombocytopenia, and cumulative bone marrow suppression. Fluorouracil alone produced more stomatitis and diarrhea. Because of a failure to produce improved survival or palliation, unrewarded toxicity, and excessive cost, neither the FA nor FAM regimen can be recommended for the treatment of advanced pancreatic or gastric cancer.

(JAMA 1985;253:2061-2067)