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Table 5 Subgroup analysis by hormone receptor status of the benefit from taxane-containing adjuvant chemotherapy regimens

From: Recent advances in systemic therapy. Advances in adjuvant systemic chemotherapy of early breast cancer

     HR (95% CI) for DFS
Study Design Number of patients Stratification by hormone receptor status Hormone receptor positive Hormone receptor negative
CALGB 9344 [14, 65] AC × 4 versus AC × 4 → P × 4 3,121 No 0.88 (0.75–1.03)a 0.77 (0.64–0.88)
NSABP B-28 [15] AC × 4 versus AC × 4 → P × 4 3,060 Nob 0.77 (0.65–0.92), P = 0.004 0.90 (0.72–1.12), P = 0.33
GEICAM 9906 [16] FEC × 6 versus FEC × 4 → wP × 8 1,248 No 0.79 (0.54–1.15), P = 0.216 0.76 (0.51–1.12), P = 0.163
HE 10/97 [17, 42] E × 4 → CMF × 4 versus E × 3 → P × 3 → CMF × 3 (q2w) 604 Yes 0.90 (0.63–1.29) 0.69 (0.37–1.30)
E 2197 [38] AC × 4 versus AT × 4 2,952 Yes 0.99 (0.75–1.30), P = 0.96c 1.21 (0.92–1.59), P = 0.17c
USO 9735 [72] AC × 4 versus TC × 4 1,016 No 0.71 (0.47–1.08) 0.64 (0.38–1.04)
BIG 02-98 [25] A × 4 → CMF × 3 versus AC × 4 → CMF × 3 versus A × 3 → T × 3 → CMF × 3 versus AT × 4 → CMF × 3 2,887 No D versus control: 0.86 (0.71–1.03) Sequential D versus sequential control: 0.79 (0.61–1.05) D versus control: 0.89 (0.69–1.15) Sequential D versus sequential control: 0.80 (0.55–1.15)d
BCIRG 001 [20] FAC × 6 versus TAC × 6 1,491 No 0.72 (0.56–0.92) 0.69 (0.49–0.97)
PACS 01 [21] FEC × 6 versus FEC × 3 → T × 3 1,999 No 0.82 (0.63–1.07) 0.79 (0.57–1.11)
E 1199 [32] AC × 4 → P × 4 all q3w versus AC × 4 → P × 12w versus AC × 4 → D × 4 all q3w versus AC × 4 → D × 12w 4,950 Yes 1.31 (1.00–1.72), P = 0.05e 1.37 (0.98–1.93), P = 0.07e
  1. Subgroup analysis by hormone receptor status of the benefit from taxane-containing adjuvant chemotherapy regimens in different reported clinical trials (Modified from Martin and coworkers [67]). aDifferences in DFS were no longer significant after adjusting for multiple comparisons. bPatients aged 45 years with hormone receptor positive tumors and all patients who were 50 years or older regardless of hormone receptor status were given tamoxifen concomitantly with chemotherapy; tamoxifen use was a stratification factor. cHR of AT versus AC and HR>1 favors the taxane arm. dPatients with hormone receptor-negative disease exhibited the largest absolute improvement in 5-year DFS when the sequential docetaxel arm (A → D → CMF) was compared with the control arms; these group had a 7% or more absolute increase in 5-year DFS compared with either control arm or the concurrent docetaxel arm. eHR>1 favors the weekly paclitaxel arm. A, doxorubicin; C, cyclophosphamide; DFS, disease-free survival; E, epirubicin; F, 5-fluorouracil; T, docetaxel; w, week.