Table 2.
PFS in the ITT population and selected subgroups
Median PFS, monthsa | HR (95 % CI)b | P valuec | P value (interaction)d | ||
---|---|---|---|---|---|
Eribulin | Control | ||||
Overall population | 4.0 | 3.4 | 0.90 (0.81, 0.997) | 0.046 | |
HER2 status | |||||
Positive | 4.0 | 4.7 | 1.02 (0.78, 1.34) | 0.865 | 0.185 |
Negative | 3.7 | 3.0 | 0.84 (0.74, 0.95) | 0.006 | |
HER2 negative/hormone receptor positive | 4.2 | 3.4 | 0.87 (0.75, 1.02) | 0.084 | |
ER status | |||||
Positive | 4.2 | 3.7 | 0.86 (0.74, 0.99) | 0.040 | 0.527 |
Negative | 3.0 | 2.9 | 0.89 (0.75, 1.06) | 0.212 | |
Triple negative | 2.8 | 2.6 | 0.78 (0.63, 0.96) | 0.018 | 0.117 |
Non-triple negative | 4.2 | 3.8 | 0.926 (0.82, 1.04) | 0.21 | |
Number of organs involved | |||||
≤2 | 4.2 | 4.2 | 0.92 (0.79, 1.07) | 0.290 | 0.468 |
>2 | 3.7 | 2.8 | 0.86 (0.74, 0.99) | 0.043 | |
Visceral disease | |||||
Yes | 3.8 | 3.3 | 0.94 (0.84, 1.05) | 0.274 | |
No | 4.7 | 4.3 | 0.75 (0.56, 1.02) | 0.065 | |
Taxane refractory | |||||
Yes | 3.5 | 2.8 | 0.90 (0.77, 1.05) | 0.176 | |
No | 4.3 | 4.0 | 0.87 (0.75, 1.01) | 0.079 |
ER estrogen receptor, CI confidence interval, HER2 human epidermal growth factor receptor 2, HR hazard ratio, ITT intent-to-treat, PFS progression-free survival, PR progesterone receptor
aBased on curve adjusted by study
bCox proportional hazards stratified by geographic region, prior capecitabine use and study (overall population additionally stratified by HER2 status; HER2-negative population additionally stratified by triple-negative status)
cBased on stratified log-rank test
dInteraction P values (Cox model) are given for subgroups for which significant differences were apparent