title: A phase II study of sunitinib in Japanese patients with metastatic renal cell carcinoma: insights into the treatment, efficacy and safety.
abstract: OBJECTIVE
  This study aims to assess the efficacy and safety of sunitinib in Japanese patients with metastatic renal cell carcinoma (RCC).
  
  
  METHODS
  Fifty-one Japanese patients with prior nephrectomy, 25 treatment-naive patients (first-line group) and 26 cytokine-refractory patients (pretreated group) were enrolled in this phase II trial. Patients received sunitinib 50 mg orally, once daily, in repeated 6-week cycles (4 weeks on treatment, 2 weeks off). The primary endpoint was RECIST-defined objective response rate (ORR) with tumour assessments every 6 weeks via computed tomography or magnetic resonance imaging. Toxicity was assessed regularly. In the primary efficacy analysis of the intent-to-treat (ITT) population, ORR and 95% confidence interval were calculated based on independent review. Secondary time-to-event endpoints, such as progression-free survival (PFS), were estimated using the Kaplan-Meier method.
  
  
  RESULTS
  In the ITT population, ORR was 48.0% in the first-line group (after a median 4 cycles), 46.2% in the pretreated group (5 cycles) and 47.1% overall, with median times to tumour response of 7.1, 10.7 and 10.0 weeks, respectively. Median PFS was 46.0, 33.6 and 46.0 weeks, respectively. The most common treatment-related grade 3/4 adverse events and laboratory abnormalities were fatigue (20%), hand-foot syndrome (14%) and hypertension (12%), decreased platelet count (55%), decreased neutrophil count (51%), increased lipase (39%) and decreased lymphocyte count (33%).
  
  
  CONCLUSIONS
  In Japanese patients with RCC, sunitinib is consistently effective and tolerable with similar risk/benefit as that in Western patients, though there was a trend toward greater antitumour efficacy and higher incidence of haematological adverse events in Japanese patients.
authors.affiliation: Department of Urology, University of Tsukuba, Graduate School of Comprehensive Human Sciences, Tsukuba 305-8576, Japan.
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.forename: Takeshi
authors.initials: T
authors.lastname: Yuasa
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Fujimoto
authors.forename: Masashi
authors.initials: M
authors.lastname: Niwakawa
authors.forename: Soichi
authors.initials: S
authors.lastname: Mugiya
authors.forename: Tsuneharu
authors.initials: T
authors.lastname: Miki
authors.forename: Norio
authors.initials: N
authors.lastname: Nonomura
authors.forename: Masayuki
authors.initials: M
authors.lastname: Takahashi
authors.forename: Yoshihiro
authors.initials: Y
authors.lastname: Hasegawa
authors.forename: Naoki
authors.initials: N
authors.lastname: Agata
authors.forename: Brett
authors.initials: B
authors.lastname: Houk
authors.forename: Seiji
authors.initials: S
authors.lastname: Naito
authors.forename: Hideyuki
authors.initials: H
authors.lastname: Akaza
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D006801:Humans; D007211:Indoles / Q000627:therapeutic use*; D007564:Japan; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008207:Lymphatic Metastasis; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D011379:Prognosis; D011758:Pyrroles / Q000627:therapeutic use*; D012449:Safety; D000077210:Sunitinib; D015996:Survival Rate; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib