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Breast Cancer Treatment (PDQ®): Treatment - Health Professional Information [NCI] - Stage I, II, IIIA, and Operable IIIC Breast Cancer

Table 6. Standard Adjuvant Chemotherapy Regimens for Stage I, II, IIIA, and Operable IIICHER2/neuNon-Overexpressing Breast Cancer continued...

A U.S. Intergroup study (CLB-9344) randomly assigned women with node-positive tumors to three dose levels of doxorubicin (60, 75, and 90 mg/m2) and a fixed dose of cyclophosphamide (600 mg/m2) every 3 weeks for four cycles. After AC chemotherapy, patients were randomly assigned for a second time to paclitaxel (175 mg/m2) every 3 weeks for four cycles versus no further therapy, and women with ER-positive tumors also received tamoxifen for 5 years. Although the dose-escalation of doxorubicin was not beneficial, the addition of paclitaxel resulted in statistically significant improvements in DFS (5%) and OS (3%).[172][Level of evidence: 1iiA] The results of a second trial, the NSABP-B-28 trial, have also been reported.[173] This trial randomly assigned 3,060 women with node-positive breast cancer to four cycles of postoperative AC or four cycles of AC followed by four cycles of paclitaxel. All women older than 50 years, and those younger than 50 years with receptor-positive disease, received tamoxifen. In this trial, DFS was significantly improved by the addition of paclitaxel (hazard ratio [HR], 0.83; 95% CI, 0.72–0.96; P = .006; 5-year DFS, 76% vs. 72%). The difference in OS was small (HR, 0.93), however, and not statistically significant (P = .46).[173][Level of evidence: 1iiA]

The regimen of 5-FU, doxorubicin, and cyclophosphamide (FAC) compared with docetaxel plus doxorubicin and cyclophosphamide (TAC) has been studied in 1,491 women with node-positive disease in the Breast Cancer International Research Group's (BCIRG-001) trial. Six cycles of either regimen were given as adjuvant postoperative therapy. A 75% DFS rate existed at 5 years in the TAC group, compared with a 68% survival in the FAC group (P = .001). TAC was associated with a 30% overall lower risk of death (5% absolute difference) than FAC (HR, .70; 98% CI, 0.53–0.91; P < .008). Anemia, neutropenia, febrile neutropenia, and infections were more common in the TAC group. No deaths were associated with infections in either group.[174,175][Level of evidence: 1iiA] (Refer to the PDQ summary on Fatigue for information on anemia.)

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