Table 2.
Summary of Efficacy End Points of Ixabepilone Plus Capecitabine Combination
| Efficacy End Point | Ixabepilone Plus Capecitabine | Capecitabine |
|---|---|---|
| Overall survival (randomized patients) | ||
| No. of patients | 609 | 612 |
| OS, months | ||
| Median | 16.4 | 15.6 |
| 95% CI | 14.9 to 17.9 | 13.9 to 17.0 |
| No. of events | 430 | 450 |
| Hazard ratio | 0.90 | |
| 95% CI | 0.78 to 1.03 | |
| Stratified log-rank P | .1162 | |
| OS Adjusted Cox regression | 0.85* | |
| 95% CI | 0.75 to 0.98 | |
| P | .0231 | |
| PFS (measurable disease patients) | ||
| No. of patients | 480 | 480 |
| PFS | ||
| Median, months | 6.2 | 4.4 |
| 95% CI | 5.59 to 6.77 | 4.14 to 5.42 |
| Hazard ratio | 0.79 | |
| 95% CI | 0.69 to 0.90 | |
| Stratified log-rank P | .0005 | |
| ORR (response-evaluable patients) | ||
| No. of patients | 462 | 462 |
| Objective response rate, % | 43.3 | 28.8 |
| 95% CI | 38.7 to 47.9 | 24.7 to 33.2 |
| Odds ratio | 1.89 | |
| 95% CI | 1.44 to 2.50 | |
| Cochran-Mantel-Haenszel P | < .0001 | |
| Complete response | ||
| No. | 16 | 11 |
| % | 3 | 2 |
| Partial response | ||
| No. | 184 | 122 |
| % | 40 | 26 |
| Progressive disease | ||
| No. | 57 | 111 |
| % | 12 | 24 |
| Not determined | ||
| No. | 35 | 36 |
| % | 8 | 8 |
| Stable disease | ||
| No. | 170 | 182 |
| % | 37 | 39 |
| Month 6 stable disease rate | 15 | 15 |
| 95% CI | 11.8 to 18.5 | 11.4 to 18.0 |
Abbreviations: OS, overall survival; PFS, progression-free survival; ORR, objective response rate.
*
Adjusted for age, Karnofsky performance status, number of organ sites, estrogen receptor status, hepatic impairment, time from diagnosis, and visceral disease, which were all prespecified in the study protocol.