Table 2.
Investigator-assessed best tumor response a
| |
Arm I: Axitinib (Continuous) + Pem/Cis |
Arm II: Axitinib (Modified) + Pem/Cis |
Arm III: Pem/Cis Alone |
|---|---|---|---|
| n = 55 b | n = 58 | n = 57 b | |
| Best overall response, n (%) |
|
|
|
| CR |
0 |
0 |
0 |
| PR |
25 (45.5) |
23 (39.7) |
15 (26.3) |
| SD (≥8 weeks) |
18 (32.7) |
19 (32.8) |
22 (38.6) |
| PD |
4 (7.3) |
7 (12.1) |
8 (14.0) |
| Not assessed |
0 |
1 (1.7) |
1 (1.8) |
| Indeterminatec |
7 (12.7) |
8 (13.8) |
9 (15.8) |
| Overall confirmed ORR, n (%) |
25 (45.5) |
23 (39.7) |
15 (26.3) |
| 95% CI |
32.0–59.4 |
27.0–53.4 |
15.5–39.7 |
| Treatment comparison, risk ratiod (95% CI) vs. arm III |
1.75 |
1.51 |
– |
| (1.05–2.94) |
(0.87–2.63) |
– |
|
| Pe | 0.01 | 0.07 | – |
Abbreviations: Pem/Cis Pemetrexed/cisplatin, CR Complete response, PR Partial response, SD Stable disease, PD Progressive disease, ORR Objective response rate, CI Confidence interval.
aBased on data cutoff date of March 11, 2011.
bOne patient in arm I and two patients in arm III had no measureable disease at baseline.
cPatients who did not have evaluable baseline scan or no post-randomization scan or those who had stable disease for <8 weeks.
dCalculated based on a normal distribution.
eOne-sided Cochran-Mantel-Haenszel test stratified by Eastern Cooperative Oncology Group performance status and gender.