|
Inlyta 1 mg 3mg, 5 mg & 7mg film-coated tablets(十三)
|
ORR b,e % (95% CI)
|
11.3 (7.2, 16.7)
|
7.7 (4.4, 12.4)
|
1.48f (0.79, 2.75)
|
NS
|
|
Prior cytokine treatment
|
N = 126
|
N = 125
|
|
|
|
Median PFS a,b in months (95% CI)
|
12.0 (10.1, 13.9)
|
6.6 (6.4, 8.3)
|
0.52 (0.38, 0.72)
|
< 0.0001h
|
|
Median OS d in months (95% CI)
|
29.4 (24.5, NE)
|
27.8 (23.1, 34.5)
|
0.81 (0.56, 1.19)
|
NS
|
|
ORR b,e % (95% CI)
|
32.5 (24.5, 41.5)
|
13.6 (8.1, 20.9)
|
2.39f (1.43-3.99)
|
0.0002i
|
cacy results
CI=Confidence interval, HR=Hazard ratio (axitinib/sorafenib); ITT: Intent-to-treat; NE: not estimable; NS: not statistically significant; ORR: Objective response rate; OS: Overall survival; PFS: Progression-free survival.
a Time from randomization to progression or death due to any cause, whichever occurs first. Cutoff date: 03 June 2011.
b Assessed by independent radiology review according to RECIST.
c One-sided p-value from a log-rank test of treatment stratified by ECOG performance status and prior therapy.
d Cutoff date: 01 November 2011.
e Cutoff date: 31 August 2010.
f Risk ratio is used for ORR. A risk ratio > 1 indicated a higher likelihood of responding in the axitinib arm; a risk ratio < 1 indicated a higher likelihood of responding in the sorafenib arm.
g One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status and prior therapy.
h One-sided p-value from a log-rank test of treatment stratified by ECOG performance status.
i One-sided p-value from Cochran-Mantel-Haenszel test of treatment stratified by ECOG performance status.
Figure 1. Kaplan-Meier curve of progression-free survival by independent assessment for the overall population
Figure 2. Kaplan-Meier curve of progression-free survival by independent assessment for the prior sunitinib subgroup
Figure 3. Kaplan-Meier curve of progression-free survival by independent assessment for the prior cytokine subgroup
Paediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with axitinib in all subsets of the paediatric population for treatment of kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) (see section 4.2 for information on paediatric use).
5.2 Pharmacokinetic properties
After oral administration of axitinib tablets, the mean absolute bioavailability is 58% compared to intravenous administration. The plasma half life of axitinib ranges from 2.5 to 6.1 hours. Dosing of axitinib at 5 mg twice daily resulted in less than two-fold accumulation compared to administration of a single dose. Based on the short half-life of axitinib, steady state is expected within 2 to 3 days of the initial dose.
Absorption and dist |
