title: Treatment outcomes of sorafenib for first line or cytokinerefractory advanced renal cell carcinoma in Japanese patients.
abstract: The objective of the present study was to document the treatment efficacy and safety of sorafenib in Japanese patients with advanced renal cell carcinoma (RCC). A retrospective analysis of 50 consecutive patients with metastatic RCC between January 2005 and December 2009 was carried out. Patients received sorafenib after failed cytokine therapy or first-line sorafenib treatment. All received 400 mg of sorafenib orally twice daily. Five of 14 patients with bone metastases were also given bisphosphonates. Tumor response was evaluated every 1-2 months according to the Response Evaluation Criteria in Solid Tumors. Adverse events (AE) were evaluated at each visit during and after treatment, and were recorded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events version 3.0. Dose modification of sorafenib was permitted if grade 3 or 4 AE occurred. Treatment continued until disease progression or treatment intolerance occurred. Partial response, and stable disease as best objective responses were observed in 11 (22%) and 23 (46%) patients, respectively. Median progression-free survival was 7.3 months and median overall survival was 11.9 months. All patients experienced AE and one or more grade 3/4 AE occurred in 43 of 50 (86%) patients. Although it requires close monitoring, sorafenib treatment seemed to be effective in the present study population.
authors.affiliation: Division of Urology, Chiba Cancer Center, Chuo-ku, Chiba, Japan. urolccc@yahoo.co.jp
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ueda
authors.forename: Yusuke
authors.initials: Y
authors.lastname: Imamura
authors.forename: Atsushi
authors.initials: A
authors.lastname: Komaru
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukasawa
authors.forename: Tomokazu
authors.initials: T
authors.lastname: Sazuka
authors.forename: Takahito
authors.initials: T
authors.lastname: Suyama
authors.forename: Yukio
authors.initials: Y
authors.lastname: Naya
authors.forename: Naoki
authors.initials: N
authors.lastname: Nihei
authors.forename: Tomohiko
authors.initials: T
authors.lastname: Ichikawa
authors.forename: Masayuki
authors.initials: M
authors.lastname: Maruoka
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001557:Benzenesulfonates / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D016207:Cytokines / Q000627:therapeutic use; D018450:Disease Progression; D005260:Female; D006801:Humans; D007564:Japan; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D001557:Benzenesulfonates; D016207:Cytokines; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib