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Fluorouracil vs Fluorouracil and Doxorubicin vs Fluorouracil, Doxorubicin, and Mitomycin

Stephen A. Cullinan, MD; Charles G. Moertel, MD; Thomas R. Fleming, PhD; Joseph R. Rubin, MD; James E. Krook, MD; Lloyd K. Everson, MD; Harry E. Windschitl, MD; Donald I. Twito, MD; Robert F. Marschke, MD; John F. Foley, MD; Del M. Pfeifle, MD; John F. Barlow, MD

JAMA. 1985;253(14):2061-2067.

Abstract
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)

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).

Footnotes
Reprint requests to Illinois Oncology Research Association Community Clinical Oncology Program, 214 NE Glen Oak Ave, Suite 605, Peoria, IL 61603 (Dr Cullinan).

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