Some doctors have questioned the benefit of chemotherapy treatment for women with stage II and III breast cancer over the age of 50 and recommend treatment with hormonal therapy utilizing tamoxifen as the initial first line treatment approach. In order to determine whether chemotherapy could provide additional benefit when added to tamoxifen chemotherapy, the National Cancer Institute sponsored a clinical study that evaluated chemotherapy plus tamoxifen to tamoxifen alone in women over 50 years of age with cancers responsive to tamoxifen therapy. Patients were treated with tamoxifen 20 mg a day for 5 years or chemotherapy with doxorubicin and cyclophosphamide, or melphalan and 5-fluorouracils plus tamoxifen.

The results of this clinical study enrolling 1,124 patients were originally reported 3 years from initiation of treatment and indicated that the time to cancer recurrence could be significantly reduced with the combination of chemotherapy and tamoxifen as compared to tamoxifen alone. Eighty-four percent of women treated with tamoxifen and chemotherapy were alive without evidence of cancer recurrence compared to only 67% of women treated with tamoxifen alone. The results of this clinical study have now been updated after 8 years of follow-up. Fifty-seven percent of patients treated with ACT (doxorubicin, cyclophosphamide, and tamoxifen ) were alive without evidence of cancer recurrence compared to only 45% of women treated with tamoxifen alone. Patients treated with chemotherapy plus tamoxifen were also more likely to survive. Sixty-eight percent of patients treated with chemotherapy plus tamoxifen compared to 63% of patients treated with tamoxifen alone were alive 8 years from initial treatment. (Journal of Clinical Oncology, Classic Papers and Current Comments, Vol 1, No 1, pp 71-84, 1996)

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