Essential efficacy and safety profiles of everolimus in Japanese patients with metastatic renal cell carcinoma.

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e15140 Background: Although the efficacy of sorafenib and sunitinib was similar in Asian and non-Asian patients with metastatic renal cell carcinoma (mRCC), large differences have been shown in the incidence of adverse events (AEs) in these populations. Due to limited data obtained from the RECORD-1 global study thus far (only 15 patients enrolled in the everolimus group), there is no strong evidence to support the efficacy and safety of everolimus in Japanese patients. Moreover, the incidence of interstitial lung diseases (ILD) in the temsirolimus Asian phase-II study was significantly higher as compared to Western phase-III data. Therefore, it is very important to establish the AE profile of everolimus in the Japanese population. Methods: The target patient population consisted of patients with advanced renal cell carcinoma who had been treated with everolimus since January 2010. Data on efficacy, PFS and response rate and safety were collected and demographic factors that could be correlated with efficacy and safety were carefully investigated. Data will be up-dated until May 2011, when the final data from approximately 150 cases will be shown. Results: Demographic data from 87 evaluable patients is as follows: mean age of 62 years; male to female ratio of 78:22; PS of 0 in 73%, 1 in 14%, 2-4 in 13%; histological diagnosis of clear cell carcinoma in 79%. Prior treatments were cytokines in 52%, sunitinib in 72%, and sorafenib in 60%. The reasons for discontinuation of prior therapy were progression (73%), adverse events (25%), and others (2%). Efficacy was demonstrated with a median PFS of 2.8 months and RR of PR7%/SD47%/PD20%. The incidence of adverse events (all grades) was 85% and discontinuation due to AEs was 30 %. Major AEs were stomatitis (45%), thrombocytopenia (25%), and anemia (24%).Serious adverse events (Grades 3-4) were anemia (9%), thrombocytopenia (6%), hyperglycemia (5%), and ILD (5%). Onset of adverse events was less than 28 days after starting the administration of everolimus. Conclusions: These findings suggest that everolimus was shown to be associated with relatively serious adverse events in Japanese patients and further up-date is necessary to provide an Asian AE profile of everolimus.