MP69-10 ASSESSMENT OF EFFICACY, SAFETY AND QUALITY OF LIFE OF 110 PATIENTS TREATED WITH SUNITINIB AS FIRST-LINE THERAPY FOR METASTATIC RENAL CELL CARCINOMA: EXPERIENCE IN REAL WORLD CLINICAL PRACTICE IN JAPAN

Abstract

You have accessJournal of UrologyKidney Cancer: Advanced II1 Apr 2015MP69-10 ASSESSMENT OF EFFICACY, SAFETY AND QUALITY OF LIFE OF 110 PATIENTS TREATED WITH SUNITINIB AS FIRST-LINE THERAPY FOR METASTATIC RENAL CELL CARCINOMA: EXPERIENCE IN REAL WORLD CLINICAL PRACTICE IN JAPAN Ken-ichi Harada, Hideaki Miyake, and Masato Fujisawa Ken-ichi HaradaKen-ichi Harada More articles by this author , Hideaki MiyakeHideaki Miyake More articles by this author , and Masato FujisawaMasato Fujisawa More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2514AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Sunitinib, an orally available inhibitor of multiple tyrosine kinases, is regarded as having one of the strongest antitumor activities against metastatic renal cell carcinoma (mRCC); however, there have been no studies including a comparatively large number of Japanese patients treated with sunitinib as first-line therapy for mRCC. The objective of this study was to comprehensively evaluate the clinical outcomes of 110 consecutive Japanese patients who received at least two cycles of sunitinib as first-line therapy for mRCC in a routine clinical setting. METHODS This was conducted as a retrospective study reviewing clinicopathological data from a total of 110 consecutive Japanese patients with mRCC who were treated with sunitinib as first-line therapy between September 2008 and October 2013 in a routine clinical setting at our institution. RESULTS Initially, 50 mg of sunitinib was administered once daily on a 4-weeks-on, followed by 2-weeks-off dosing schedule; however, dose modification was required in 102 patients, and the relative dose-intensity was 62.6% throughout this series. As the best responses to sunitinib, 2, 28, 65 and 15 were judged to show a complete response, partial response, stable disease and progressive disease, respectively. The median progression-free survival (PFS) and overall survival (OS) following the treatment with sunitinib was 7.8 and 33.2 months, respectively. Multivariate analyses of several factors identified the following independent predictors of PFS and OS: Memorial Sloan-Kettering Cancer Center (MSKCC) classification and C-reactive protein (CRP) level for PFS and liver metastasis, MSKCC classification and CRP level for OS. The common adverse events related to sunitinib corresponding to grade 3 ≤ were thrombocytopenia in 59, leukopenia in 23, fatigue in 22, hand-foot syndrome in 15 and hypertension in 12. Quality of life (QOL) analysis using SF-36 revealed no significant differences in any scale scores between surveys performed before and 3 months after the treatment with sunitinib. CONCLUSIONS Collectively, these findings suggest that the introduction of sunitinib as a first-line agent can lead to favorable disease control with acceptable tolerability, resulting in improved prognosis of Japanese mRCC patients without the impairment of QOL. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e870 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Ken-ichi Harada More articles by this author Hideaki Miyake More articles by this author Masato Fujisawa More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...