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08-12-2013 | Article

Axitinib shows ‘clinical activity and acceptable safety profile’ in phase III trial


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medwireNews: Axitinib has demonstrated clinical activity in a phase III clinical trial comparing it with sorafenib as first-line treatment for metastatic renal cell carcinoma (mRCC), although it offered no advantage in increasing progression-free survival.

Lead author Thomas Hutson (Baylor Sammons Cancer Center, Dallas, Texas) and colleagues write that, “although median progression-free survival was numerically longer with axitinib than with sorafenib, the difference was not significant.”

A total of288 patients were recruited to the study from 13 countries. Of these, 192 were randomly assigned to receive axitinib (5 mg twice daily), although three patients did not receive treatment, and 96 to receive sorafenib (400 mg twice daily). Patients had not received previous systemic therapy for mRCC and had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

The researchers report in The Lancet Oncology that median progression-free survival was 10.1 months in patients given axitinib and 6.5 months in those given sorafenib, a nonsignificant difference. However, an independent review committee of radiologists, who were masked to which treatment group patients were in, judged that more patients had an objective response with axitinib then sorafenib (32 vs 16%).

In a related comment, Nadia Yousaf and James Larkin, from the Royal Marsden Hospital in London, UK, also point out that the study showed a significant increase in progression-free survival with axitinib among patients with an ECOG performance status of 0, at 13.7 versus 6.6 months with sorafenib , but not among those with a status of 1. This, they say, is in line with axitinib being one of the more potent and selective vascular endothelial growth factor receptor inhibitors.

Serious adverse events were reported in 34% of patients receiving axitinib, and 25% of patients receiving sorafenib. The most frequent all-grade all-causality adverse events seen with axitinib were diarrhea, hypertension, weight decrease and fatigue; with sorafenib they were diarrhea, palmar–plantar erythrodysesthesia, and hypertension. One patient in the axitinib group died of treatment-related cardiac arrest.

Quality of life was similar in both patient groups and was maintained until the end of treatment, when most patients discontinued because of disease progression.

“Although there was no significant difference between patient groups’ progression-free survival, axitinib showed clinical activity and an acceptable safety profile as first-line therapy for patients with treatment-naïve metastatic renal-cell carcinoma,” Hutson and colleagues conclude.

medwireNews ( is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013

By Afsaneh Gray, medwireNews Reporter