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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

    RegimenCycle Number and Duration (d)Cytoxan (mg/m²)5-FU (mg/m²)Doxorubicin (mg/m²)Paclitaxel/Docetaxel (mg/m²)
    AC = cyclophosphamide, doxorubicin; AC-T = cyclophosphamide, doxorubicin, taxol; CAF = cyclophosphamide, doxorubicin, fluorouracil; d = day; D = docetaxel; P = paclitaxel; T = taxol; TAC = docetaxel, doxorubicin and cyclophosphamide; TC = docetaxel and cyclophosphamide; 5-FU = fluorouracil.
    CAF [163]6 × 21500, IV d 1500, IV d 150, IV d 1 
    AC [166]4 × 21600, IV d 160, IV d 1 
    Dose-dense AC-T [179]4 (AC), 4 (T) ×14600, IV d 160, IV d 1P: 175, IV d 1
    TAC [193, 194]6 × 21500, IV d 150, IV d 1D: 75, IV d 1
    TC [195]4 x 21600, IV d 1 D: 75, IV d 1

    Adjuvant chemotherapy 1970s to 2000: Anthracycline-based regimens versus CMF

    The EBCTCG meta-analysis analyzed 11 trials that began in 1976 through 1989 in which women were randomized to receive regimens containing anthracyclines (e.g., doxorubicin or epirubicin) versus CMF alone. The EBCTCG overview analysis directly compared anthracycline-containing regimens (mostly 6 months of FEC or FAC) with CMF (either oral or IV) in approximately 14,000 women, 64% of whom were under 50 years.[85] Compared to CMF, anthracycline-based regimens were associated with a modest but statistically significant 11% proportional reduction in the annual risk of disease recurrence, and a 16% reduction in the annual risk of death. In each case, the absolute difference in outcomes between anthracycline-based and CMF-type chemotherapy was about 3% at 5 years and 4% at 10 years.[163][Level of evidence: 1iiA]

    The largest direct comparison of cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) (six cycles) versus CMF (six cycles) occurred in a U.S. Intergroup study (SWOG-8897), which was not included in the meta-analysis.[164] In this study, 2,691 patients were randomized to receive CAF or CMF with a second randomization to 5 years of tamoxifen versus no tamoxifen. Ten-year follow-up estimates indicated that CAF was not significantly better than CMF (P = .13) for the primary outcome of DFS (77% vs. 75%; HR, 1.09; 95% CI, 0.94–1.27). CAF had slightly better OS than CMF (85% vs. 82%, HR, 1.19 for CMF vs. CAF; 95% CI, 0.99–1.43), though values were statistically significant in the planned one-sided test (P = .03). Toxicity was greater with CAF and did not increase with tamoxifen. Overall, tamoxifen had no benefit (DFS, P = .16; OS, P = .37), but the tamoxifen effect differed by high-risk groups. For high-risk node-positive patients, tamoxifen was beneficial (DFS: HR, 1.32 for no tamoxifen vs. tamoxifen; 95% CI, 1.09–1.61; P = .003; OS: HR, 1.26; 95% CI, 0.99–1.61; P = .03) but not for high-risk node-negative patients (DFS: HR, 0.81 for no tamoxifen vs. tamoxifen; 95% CI, 0.64–1.03; OS: HR, 0.79; 95% CI, 0.60–1.05). The conclusion of this trial was that CAF did not improve DFS, compared with CMF; and, there was a slight effect on OS. Given greater toxicity, CAF cannot be concluded to be superior to CMF. Tamoxifen was effective in high-risk node-positive disease but not in high-risk node-negative disease.[164][Level of evidence: 1iiA]

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