Axitinib viable for Japanese RCC patients
medwireNews: Axitinib offers a new, targeted, second-line therapy option for Japanese patients with advanced renal cell carcinoma (RCC), subgroup analysis shows.
"With disparities in efficacy and toxicities reported for some anti-cancer agents in different ethnic populations, it is critical to evaluate new anti-cancer agents in different ethnic populations in order to optimize their clinical benefits while minimizing potential toxicities," note Takeshi Ueda (Chiba Cancer Center, Japan) and colleagues.
They did just that for a subgroup of Japanese patients participating in the global randomized phase III AXIS trial of axitinib versus sorafenib following failure of one prior systemic therapy for metastatic RCC. In the case of Japanese patients, this was primarily cytokine therapy.
In all, 25 of 361 and 29 of 362 patients randomly assigned to receive axitinib and sorafenib, respectively, were Japanese.
As in the overall study population, Japanese patients treated with axitinib had a significantly longer progression-free survival (PFS), as assessed by an independent review committee, at 12.1 months, compared with 4.9 months for patients taking sorafenib.
A decrease in target lesions of at least 30% was seen in 15 (60%) patients treated with axitinib versus two (7%) patients treated with sorafenib, and objective response rate was significantly higher in the axitinib group than the sorafenib group, at 52.0% versus 3.4%.
"Importantly, results demonstrated that the PFS advantage of axitinib over sorafenib was maintained in Japanese patients when time to symptom deterioration was included with the overall efficacy assessment, consistent with the overall population and indicated that axitinib provides extended symptom and disease control for these patients," the researchers point out in the Japanese Journal of Clinical Oncology.
Axitinib was generally well tolerated by the patients, and the safety profile was comparable to that for the general population, except for hypertension, dysphonia, hand-foot syndrome, hypothyroidism, and stomatitis occurring more frequently in Japanese patients.
These events were effectively managed with antihypertensive and thyroid medications and/or axitinib dose reduction or interruption.
"Thus, axitinib provides a new targeted therapy option for Japanese patients with advanced RCC following prior systemic therapy," the team concludes.
medwireNews (www.medwirenews.com) is an independent clinical news service provided by Springer Healthcare Limited. © Springer Healthcare Ltd; 2013
By Lucy Piper, Senior medwireNews Reporter