9, 0.71). In the subgroup of patients with tumor size > 2 cm (n = 2448), the
hazard ratio for OS was 0.67 (95% CI: 0.56, 0.80).
Table 9
Efficacy Results from Adjuvant Treatment of Breast Cancer(Studies NSABP B31, NCCTG N9831, HERA, and BCIRG006)
DFS
events
DFS Hazard
ratio
(95% CI)
p-value
Deaths
(OS events)
OS Hazard ratio
p-value
Studies NSABP B31 and NCCTG N9831*
AC→TH
(n = 1872)†
(n = 2031)‡
133† 0.48†,§
(0.39, 0.59)
p< 0.0001⁋
289‡ 0.64‡,§
(0.55, 0.74)
p< 0.0001⁋
AC→T
(n = 1880)†
(n = 2032)‡
261† 418‡
HERA#
Chemo→
Intravenous trastuzumab
(n = 1693)
127 0.54
(0.44, 0.67)
p< 0.0001Ϸ
31 0.75
p = NSß
Chemo→
Observation
(n = 1693)
219 40
BCIRG006à
TCH
(n = 1075)
134 0.67
(0.54 – 0.84)
p=0.0006⁋,è
56
AC→TH
(n = 1074)
121 0.60
(0.48 – 0.76)
p< 0.0001⁋,à
49
AC→T
(n = 1073)
180 80
CI = confidence interval. *
Studies NSABP B31 and NCCTG N9831 regimens: doxorubicin and cyclophosphamidefollowed by paclitaxel (AC→T) or paclitaxel plus intravenous trastuzumab (AC→TH). † Efficacy eva luable population, for the primary DFS analysis, following a median follow-upof 2.0 years in the AC→TH arm.
‡ Efficacy eva luable population, for the final OS analysis, following 707 deaths (8.3 years of
median follow-up in the AC→TH arm).
Hazard ratio estimated by Cox regression stratified by clinical trial, intended paclitaxelschedule, number of positive nodes, and hormone receptor status. stratified log-rank test. # At definitive DFS analysis with median duration of follow-up of 12.6 months in the oneyearintravenous trastuzumab treatment arm. log-rank test.
ß NS = non-significant.
à BCIRG006 regimens: doxorubicin and cyclophosphamide followed by docetaxel (AC→T)or docetaxel plus intravenous trastuzumab (AC→TH); docetaxel and carboplatin plus
intravenous trastuzumab (TCH). è A two-sided alpha level of 0.025 for each comparison.
Figure 1
Duration of Disease-Free Survival in Patients with Adjuvant Treatment of Breast Cancer(Studies NSABP B31 and NCCTG N9831)
Figure 2
Duration of Overall Survival in Patients with Adjuvant Treatment of Breast Cancer(Studies NSABP B31 and NCCTG N9831)
Figure 3
Duration of Disease-Free Survival in Patients withAdjuvant Treatment of Breast Cancer (BCIRG006)Exploratory analyses of DFS as a function of HER2 overexpression or gene amplification were conducted forpatients in Study NCCTG N9831 and HERA, where central laboratory testing data were available. The resultsare shown in Table 10. The number of events in Study NCCTG N9831 was small with the exception of theIHC 3+/FISH+ subgroup, which constituted 81% of those with data. Definitive conclusions cannot be drawnregarding efficacy within other subgroups due to the small number of events. The number of events in HERAwas adequate to demonstrate significant effects on DFS in the IHC 3+/FISH unknown and the FISH+/IHCunknown subgroups.
Table 10
Treatment Outcomes in Study NCCTG N9831and HERA as aFunction of HER2 Overexpression or Amplification
Study NCCTG N9831 HERA*
HER2 Ass |
