Adriamycin (NSC 123127) plus 5 fluorouracil (NSC 19893): a phase I study

Two new drug regimens capable of producing high response rates in breast cancer have been reported in the recent literature. This study, conducted in three member institutions of the Southwest Oncology Group (SWOG), was designed to determine the optimum dose of 5 FU and adriamycin in combination. Sixty three patients were entered in the study. Of the 61 patients evaluable for response to therapy, remissions occurred in 17. Responses occurred in carcinoma of breast, lung, head and neck, rectum, and esophagus. Since one of the primary objectives of this study was to develop a better protocol for breast cancer, the results of the 17 patients with this particular tumor were analyzed separately. There were 7 partial remissions, 2 complete remissions, and 8 nonresponders. The overall response rate for breast cancer was 53%.