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

Breast Cancer Research

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

				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	No^b	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 = 0.96^c	1.21 (0.92–1.59), P = 0.17^c
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 = 0.05^e	1.37 (0.98–1.93), P = 0.07^e

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.

ISSN: 1465-542X