Sixty‐two patients with metastatic breast cancer were treated randomly with either cyclophosphamide or 5‐fluorouracil. The patients were classified as haVing either an objective remission or a failure of treatment by accepted techniques. Eleven of 30 patients responded to 5‐fluorouracil, and 7 of 32 responded to cyclophosphamide. These differences are not significant. Subsequently, each patient was treated with the other agent, and 4 of 32 responded to 5‐fluorouracil, and 7 of 30 responded to cyclophosphamide. Thus, a total of 14 patients experienced clinical remissions of their disease with cyclophosphamide, and 15 had remissions with 5‐fluorouracil. Of the 18 patients responding to the first agent, 7 experienced objective regressions with the second agent, whereas only 4 of the 44 patients failing to respond to the first agent experienced objective remissions with the second agent. This difference was significant at p < 0.02. Factors such as menopausal age of patient, site of the dominant lesion, and response to prior hormonal therapy were of no value in predicting response to these two agents. Survival of the patients after the start of chemotherapy was 14.7 ± 10.2 months for patients responding to both agents, 10.5 ± 9.0 months for patients responding to the first agent only, 6.2 ± 12.8 months for patients responding to the second agent only, and 5.2 ± 4.5 months for patients responding to neither agent. Subjective improvement correlated well with objective improvement, but some patients failing to respond to therapy experienced temporary subjective improvement.
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Talley et al. (1965) studied this question.