TABLE III.
Outcome
|
Regimen
|
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
Group | Type |
(A) Nab-paclitaxel and carboplatin
|
(B) Paclitaxel
a
and carboplatin
|
|||||||
(n) | (%) | 95% ci | (n) | (%) | 95% ci | hr or rrr | 95% ci b | p Valuec | ||
Intention-to-treat12 | 521 | 531 | ||||||||
Median os (months) | 12.1 | 10.8 to 12.9 | 11.2 | 10.3 to 12.6 | 0.922 | 0.797 to 1.066 | ns | |||
Overall response | 170 | 33 | 28.6 to 36.7 | 132 | 25 | 21.2 to 28.5 | 1.313 | 1.082 to 1.593 | 0.005 | |
Complete response | 0 | 1 | <1 | |||||||
Partial response | 170 | 33 | 131 | 25 | ||||||
Stable diseased | 104 | 20 | 128 | 24 | ||||||
Progressive disease | 83 | 16 | 84 | 16 | ||||||
Squamous subset62 | 229 | 221 | ||||||||
Median os (months) | 10.7 | 9.4 to 12.5 | 9.5 | 8.6 to 11.6 | 0.890 | 0.719 to 1.101 | ns | |||
Overall response | 94 | 41 | 34.7 to 47.4 | 54 | 24 | 18.8 to 30.1 | 1.680 | 1.271 to 2.221 | <0.001 | |
Nonsquamous subset62 | 292 | 310 | ||||||||
Median os (months) | 13.1 | nr | 13.0 | nr | 0.950 | nr | nr | |||
Overall response | 76 | 26 | 21.0 to 31.1 | 78 | 25 | 20.3 to 30.0 | 1.034 | 0.788 to 1.358 | ns | |
Age ≥70 subset63 | 74 | 82 | ||||||||
Median os (months) | 19.9 | 12.7 to 22.3 | 10.4 | 8.6 to 13.6 | 0.583 | 0.388 to 0.875 | 0.009 | |||
Overall response | 25 | 34 | 23.0 to 44.6 | 20 | 24 | 15.1 to 33.7 | 1.385 | nr | ns | |
Age <70 subset63 | 447 | 449 | ||||||||
Median os (months) | 11.4 | 10.3 to 12.6 | 11.3 | 10.3 to 12.9 | 0.999 | 0.855 to 1.167 | ns | |||
Overall response | 145 | 32 | 28.1 to 36.8 | 112 | 25 | 20.9 to 28.9 | 1.300 | NR | 0.013 |
Solvent-based.
Calculated for rrrs according to the asymptotic 95% ci of the relative risk of regimen A to regimen B.
By chi-square test.
Defined as 16 weeks or more.
ci = confidence interval; hr = hazard ratio; rrr = response rate ratio; os = overall survival; ns = nonsignificant; nr = not reported.