Table 2. Efficacy by duration of prior therapy.
|
Prior sunitinib |
Prior cytokines |
|||
|---|---|---|---|---|
| <9.7 mo | ⩾9.7 mo | <6.5 mo | ⩾6.5 mo | |
|
Axitinib arm | ||||
| Patients,a
n |
96 |
96 |
66 |
60 |
| mPFS, mo (95% CI) |
6.4 (4.6–8.3) |
6.6 (5.2–8.3) |
8.6 (6.5–13.8) |
15.7 (12.2–22.1) |
| HRb (95% CI) | 0.998 (0.726–1.371) | 1.966 (1.265–3.058) | ||
| P-valuec |
0.996 |
0.002 |
||
| mOS, mo (95% CI) |
11.7 (9.3–15.2) |
18.1 (14.8–23.0) |
26.3 (18.8–31.6) |
NE (28.0–NE) |
| HRb (95% CI) | 1.242 (0.879–1.754) | 1.983 (1.115–3.525) | ||
| P-valuec |
0.220 |
0.017 |
||
|
Sorafenib arm | ||||
| Patients,d
n |
95 |
99 |
59 |
66 |
| mPFS, mo (95% CI) |
3.5 (1.9–4.7) |
4.5 (3.0–6.5) |
6.7 (5.6–9.5) |
8.4 (7.2–10.2) |
| HRb (95% CI) | 1.146 (0.824–1.593) | 1.118 (0.747–1.675) | ||
| P-valuec |
0.431 |
0.580 |
||
| mOS, mo (95% CI) |
14.9 (10.5–18.0) |
19.0 (15.0–23.9) |
23.1 (17.3–31.9) |
34.5 (27.8–34.5) |
| HRb (95% CI) | 1.517 (1.073–2.416) | 1.930 (1.133–3.289) | ||
| P-valuec | 0.018 | 0.014 | ||
Abbreviations: CI=confidence interval; HR=hazard ratio; mo=months; mOS=median overall survival; mPFS=median progression-free survival; NE=not estimable.
a
Two patients were missing duration of prior sunitinib because of protocol deviation.
b
Assuming proportional hazards model, a HR<1 indicates a reduction in favour of <median; a HR>1 indicates a reduction in favour of ⩾median.
c
P-value based on two-sided unstratified log-rank test and not adjusted for multiplicity.
d
One patient who received prior sunitinib was excluded from analysis because of missing start date.