PHASE III AXIS TRIAL OF AXITINIB VERSUS SORAFENIB IN PATIENTS WITH METASTATIC RENAL CELL CARCINOMA: ASIAN SUBGROUP ANALYSIS

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Abstract

Background

Axitinib is a potent and selective second-generation inhibitor of vascular endothelial growth factor receptors 1–3. In the phase III AXIS study in second-line metastatic renal cell carcinoma (mRCC), axitinib demonstrated significant improvement in progression-free survival (PFS) compared with sorafenib (median PFS, 6.7 versus 4.7 months; hazard ratio [HR] 0.665; one-sided P < 0.0001). We investigated efficacy and safety in Asian patients enrolled in the AXIS study.

Methods

Eligible patients had clear-cell mRCC; progressive disease per RECIST after one prior systemic first-line therapy; and Eastern Cooperative Oncology Group performance status (PS) of 0 or 1. Patients were stratified by PS and prior therapy, then randomized 1:1 to receive axitinib or sorafenib. Tumour imaging was assessed by an independent review committee.

Results

Of the 723 enrolled patients, 158 were Asian (axitinib arm: n = 77; sorafenib arm: n = 81). Of the Asian patients, 74% were male, median age was 61 years, and 59% had PS = 0; prior therapies were 54% cytokine-, 41% sunitinib-, 4% bevacizumab-, and 1% temsirolimus-based regimens. Median PFS in the Asian patients was 10.3 months in the axitinib arm and 4.7 months in the sorafenib arm (HR 0.578; 95% confidence interval, 0.362–0.924; one-sided P = 0.0096). The objective response rate (ORR) was 31.2% versus 7.4% (one-sided P = 0.0003) in the Asian patients receiving axitinib and sorafenib, respectively. Common adverse events (AEs) in the Asian patients receiving axitinib were hypertension (53%), diarrhoea (53%), hand-foot syndrome (47%), fatigue (45%), decreased appetite (36%), dysphonia (36%), and hypothyroidism (31%). Common AEs in the Asian patients receiving sorafenib were hand-foot syndrome (70%), diarrhoea (46%), hypertension (34%), and alopecia (30%).

Conclusions

Axitinib is effective and well tolerated in the Asian patients with mRCC. Consistent with global phase III trial results, PFS and ORR were higher with axitinib versus sorafenib in the Asian patients.

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