Interim safety results from the all cases post-marketing study (PMS) of sunitinib in 1,027 Japanese patients with renal cell carcinoma (RCC) or gastrointestinal stromal tumor (GIST).

e15133 Background: In Japan, sunitinib malate (SUTENT) was approved in April 2008 for unresectable or metastatic RCC and GIST. As recommended by the Japanese Ministry of Health Labor and Welfare guidance, we conducted an all-cases PMS to further evaluate the safety of sunitinib following its approval in Japan to supplement the information already available for this agent. We report here interim safety results from the PMS for sunitinib in 1,027 Japanese patients (773 patients with RCC and 254 patients with GIST). Methods: All 1,027 patients were examined for eligibility and registered for this study before initial treatment with sunitinib. Patients were followed for up to 1.5 years. We used descriptive statistics and logistic regression analyses to determine the incidences of adverse events (AEs) and the impact of related factors. Results: The incidence of all-grade AEs reported was 95.6% (982/1,027 patients). The most frequent grade 3/4 AEs (MedDRA) included: platelet count decrease (32.7%), white blood ...