Clinical efficacy and tolerance of sunitinib in the treatment of advanced renal cell carcinoma / 中华泌尿外科杂志

ABSTRACT

Objective To evaluate the clinical efficacy and side effects of sunitinib in the treatment of advanced renal cell carcinoma. Methods Forty-five patients with advanced renal cell carcinoma and an average age of 48.6 yrs were treated with sunitinib. Among the study group, 25 were male and 20 were female. In group one, patients received sunitinib treatment in repeated six week cycles consisting of four weeks of sunitinib 50 mg daily followed by two weeks off treatment (schedule 4/2). In group two, a single daily dose of sunitinib 37.5 mg was administrated to 20 patients without off treatment. A CT scan was used to evaluate the treatment efficacy after each cycle and the side effects were recorded accordingly. Results Clinical efficacy could be evaluated in 40 patients. Of these, two achieved complete response, eight achieved partial response, 27 were stable and the remaining eight experienced disease progression with four patients dying during the study period. The side effects of sunitinib in group one and in group two included hypertension 32% (8/25) and 10% (2/20), P=0.02; liver function impairment 32% (8/25) and 20% (4/20), P=0.011; hand-foot skin reaction 68% (17/25) and 60% (12/20), respectively. The incidence of major side effects of sunitinib were different in Chinese patients than from what had been previously reported in studies conducted in US and Europe. Generally, most of the sunitinib side effects were easy to manage. Conclusions There weredifferences between the two groups of Chinese patients treated with different sunitinib protocols. The protocol of sunitinib 37.5mg daily without off-treatment was better than the protocol of sunitinib 50mg daily (schedule 4/2) in regard to liver function impairment and hypertension.