Efficacy variable | Patients treated to PD | Patients treated to AEs | ||||
---|---|---|---|---|---|---|
nab-P + Gem (n = 224) | Gem (n = 233) | nab-P + Gem (n = 98) | Gem (n = 58) | nab-P + Gem (n = 431) | Gem (n = 430) | |
Overall survival, median, months | 9.8 | 7.5 | 7.7 | 6.0 | 8.7 | 6.6 |
Hazard ratio (95 % CI) | 0.69 (0.56–0.84) | 0.87 (0.60–1.27) | 0.72 (0.62–0.83) | |||
P value | <0.001 | 0.466 | <0.001 | |||
Progression-free survival, median, months | 6.0 | 3.8 | 5.5 | 5.0 | 5.5 | 3.7 |
Hazard ratio (95 % CI) | 0.62 (0.50–0.79) | 0.63 (0.40–1.01) | 0.69 (0.58–0.82) | |||
P value | <0.001 | 0.053 | <0.001 | |||
Overall response rate, % | 27 | 9 | 19 | 10 | 23 | 7 |
Complete response | <1 | 0 | 0 | 0 | <1 | 0 |
Partial response | 26 | 9 | 19 | 10 | 23 | 7 |
Stable disease | 33 | 35 | 30 | 34 | 27 | 28 |
Response rate ratio (95 % CI) | 3.12 (1.95–5.00) | 1.87 (0.79–4.42) | 3.19 (2.18–4.66) | |||
P value | <0.001 | 0.137 | <0.001 | |||
Disease control ratea | 57 | 40 | 43b | 42c | 48 | 33 |
Disease control rate ratio (95 % CI) | 1.42 (1.17–1.72) | 1.03 (0.71–1.49) | 1.46 (1.23–1.72) | |||
P value | <0.001 | 0.896 | <0.001 |