Abstract
Background
In a randomized phase III trial in treatment-naive patients with metastatic renal
cell carcinoma (RCC), axitinib versus sorafenib yielded numerically longer progression-free
survival (median, 10.1 vs. 6.5 months; hazard ratio [HR], 0.77; 1-sided P = .038) and significantly higher objective response rate (32% vs. 15%; 1-sided P = .0006). In this article, we report overall survival (OS) and updated safety results.
Patients and Methods
Previously untreated patients with metastatic RCC (n = 288), stratified according
to Eastern Cooperative Oncology Group performance status (ECOG PS; 0 vs. 1), were
randomized 2:1 to receive axitinib 5 mg twice per day (b.i.d.; n = 192) or sorafenib
400 mg b.i.d. (n = 96).
Results
Median OS (95% confidence interval [CI]) was 21.7 months (18.0-31.7) with axitinib
versus 23.3 months (18.1-33.2) with sorafenib (stratified HR, 0.995; 95% CI, 0.731-1.356;
1-sided P = .4883). Among patients with ECOG PS of 0, median OS was numerically longer with
axitinib than with sorafenib (41.2 vs. 31.9 months; HR, 0.811, 1-sided P = .1748), whereas among patients with ECOG PS 1, median OS was shorter with axitinib
than with sorafenib (14.2 vs. 19.8 months; HR, 1.203; 1-sided; P = .7973). Incidence and severity of common adverse events were consistent with previous
reports.
Conclusion
OS was similar between axitinib and sorafenib in treatment-naive patients with metastatic
RCC, and no new safety signals emerged.
Keywords
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Article info
Publication history
Published online: May 27, 2016
Accepted:
May 18,
2016
Received in revised form:
April 27,
2016
Received:
February 17,
2016
Footnotes
ClinicalTrials.gov NCT00920816.
Identification
Copyright
© 2016 Elsevier Inc. All rights reserved.
