Table 2. Overall Survival, Progression-free Survival, and Response Rates in the Intention-to-Treat Population.
| Efficacy Variable | nab-Paclitaxel plus Gemcitabine (N = 431) |
Gemcitabine Alone (N = 430) |
Hazard Ratio or Response-Rate Ratio (95% CI)* |
P Value |
|---|---|---|---|---|
| Overall survival | ||||
| Median overall survival — mo (95% CI) | 8.5 (7.9–9.5) | 6.7 (6.0–7.2) | 0.72 (0.62–0.83) | <0.001 |
| Survival rate — % (95% CI) | ||||
| 6 mo | 67 (62–71) | 55 (50–60) | <0.001 | |
| 12 mo | 35 (30–39) | 22 (18–27) | <0.001 | |
| 18 mo | 16 (12–20) | 9 (6–12) | 0.008 | |
| 24 mo | 9 (6–13) | 4 (2–7) | 0.02 | |
| Progression-free survival | ||||
| Median progression-free survival — mo (95% CI) | 5.5 (4.5–5.9) | 3.7 (3.6–4.0) | 0.69 (0.58–0.82) | <0.001 |
| Rate of progression-free survival — % (95% CI) | ||||
| 6 mo | 44 (39–50) | 25 (20–30) | ||
| 12 mo | 16 (12–21) | 9 (5–14) | ||
| Response | ||||
| Rate of objective response | ||||
| Independent review | ||||
| No. of patients with a response | 99 | 31 | 3.19 (2.18–4.66) | <0.001 |
| % (95% CI) | 23 (19–27) | 7 (5–10) | ||
| Investigator review | ||||
| No. of patients with a response | 126 | 33 | 3.81 (2.66–5.46) | <0.001 |
| % (95% CI) | 29 (25–34) | 8 (5–11) | ||
| Rate of disease control† | ||||
| No. of patients | 206 | 141 | 1.46 (1.23–1.72) | <0.001 |
| % (95% CI) | 48 (43–53) | 33 (28–37) | ||
| Best response according to independent review — no. (%) |
||||
| Complete response | 1 (<1) | 0 | ||
| Partial response | 98 (23) | 31 (7) | ||
| Stable disease | 118 (27) | 122 (28) | ||
| Progressive disease | 86 (20) | 110 (26) | ||
| Could not be evaluated‡ | 128 (30) | 167 (39) |
The hazard ratio for death is provided for overall survival, and the hazard ratio for progression or death is provided for progression-free survival, with a hazard ratio of less than 1 favoring the nab-paclitaxel–gemcitabine group. The response-rate ratios are provided for the response rates, with a response-rate ratio of more than 1 favoring the nab-paclitaxel–gemcitabine group. The 95% confidence interval for response-rate ratios was calculated according to the asymptotic 95% confidence interval of the relative risk in the nab-paclitaxel–gemcitabine group, as compared with the gemcitabine group.
Disease control included confirmed complete response, confirmed partial response, and stable disease for 16 weeks or more.
Included are 72 patients (17%) in the nab-paclitaxel–gemcitabine group and 87 (20%) in the gemcitabine group who did not have an assessment after the baseline visit.