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Purpose   This study compared disease-free survival (DFS) obtained with two different regimens of adjuvant therapy in high-risk breast cancer.Methods   Women (who had performance status [PS] of 0 to 1) with operable, histologically confirmed, stage I to III adenocarcinoma of the breast were eligible. Patients had undergone primary surgery with no residual tumor. Treatments were as follows: arm 1 was doxorubicin 60 mg/m 2  plus cyclophosphamide 600 mg/m 2  every 3 weeks for four cycles followed by paclitaxel 175 mg/m 2  every 3 weeks for four cycles (ie, AC-P); and arm 2 was doxorubicin 50 mg/m 2  plus paclitaxel 200 mg/m 2  every 3 weeks for four cycles followed by paclitaxel 80 mg/m 2  weekly for 12 weeks.Results   Overall, 1,830 patients were enrolled and 1,801 were treated: arm 1 (n = 906; AC→P) and arm 2 (n = 895; AP-WP). Overall, patients had a PS of 0 (88%), had estrogen receptor and progesterone receptor–positive disease (52%), had one to three positive nodes (46%), and were postmenopausal (57%); the median age was 52 years. Currently, 1,640 patients (90%) are alive. The 6-year DFS was 79% to 80% in both groups. Disease relapse was the cause of death for 83 patients in arm 1 and in 66 patients of arm 2. Overall 6-year survival rates were 82% and 87% in arms 1 and 2, respectively. Reasons for patients being taken off study treatment included toxicity (13% in arm 1 v 20% in arm 2), progressive disease or recurrence (7% v 5%), and consent withdrawn (9% v 8%), respectively. The most frequent toxicities were hematologic, including neutropenia and leukopenia followed by neuropathy, myalgia, nausea, fatigue, headache, arthralgia, and vomiting.Conclusion   The results indicate that the AP-WP regimen is an equally effective and tolerable option for the adjuvant treatment of patients with high-risk breast cancer. The substitution of paclitaxel for cyclophosphamide results in comparable effectiveness of the regimen.

journal of clinical oncology

Phase III Multicenter Trial of Doxorubicin Plus Cyclophosphamide Followed by Paclitaxel Compared With Doxorubicin Plus Paclitaxel Followed by Weekly Paclitaxel As Adjuvant Therapy for Women With High-Risk Breast Cancer