Is Axitinib Still a Valid Option for mRCC in the Second-Line Setting? Prognostic Factor Analyses From the AXIS Trial

Area of Science:

• Oncology
• Clinical Trials
• Medical Treatments

Background:

• The AXIS trial investigated axitinib versus sorafenib in metastatic renal-cell carcinoma (mRCC) patients previously treated with sunitinib.
• Post hoc analyses were conducted to identify patient subgroups that might derive greater benefit from axitinib.

Purpose of the Study:

• To evaluate the efficacy of axitinib compared to sorafenib in specific subgroups of mRCC patients.
• To identify prognostic factors associated with improved progression-free survival (PFS) and overall survival (OS) in the second-line setting.

Main Methods:

• The study involved a post hoc analysis of the phase 3 AXIS trial (NCT00678392).
• Univariate and multivariate analyses identified prognostic factors for PFS and OS.
• PFS and OS were assessed in subgroups defined by non-bulky disease, favorable/intermediate risk, and absence of bone or liver metastases.

Main Results:

• In patients with favorable prognostic factors (n=86), axitinib demonstrated significantly longer PFS versus sorafenib (HR=0.476, P=.0126).
• Overall survival (OS) was similar between axitinib and sorafenib across all subgroups (HR=0.902, P=.7661).
• Generally, longer PFS was observed with axitinib versus sorafenib across subgroups, with similar OS.

Conclusions:

• Axitinib is a suitable second-line treatment option for patients with mRCC, including various subgroups.
• A significant reduction in PFS event risk was observed with axitinib compared to sorafenib in selected patient subgroups.