title: Feasibly of axitinib as first-line therapy for advanced or metastatic renal cell carcinoma: a single-institution experience in Japan.
abstract: BACKGROUND
  Clinical benefit of axitinib as a first line agent to treat patients with metastatic renal cell carcinoma (mRCC), or locally advanced renal cell carcinoma (RCC) have not been clearly demonstrated. The aim of this study was to evaluate the efficacy and safety of axitinib as first-line therapy in Japanese patients with locally advanced RCC or mRCC.
  
  
  METHODS
  In this retrospective study, we focused on eighteen patients who underwent first-line therapy with axitinib between May 2012 and May 2014 at Hirosaki University. Axitinib was orally administered at a dose of 10 mg daily. Progression-free survival (PFS) was the primary endpoint, while secondary endpoints included overall response rate (ORR) and adverse events (AEs).
  
  
  RESULTS
  All patients had histologically proven clear cell RCC. The median duration of the administration of axitinib was 10.8 months. According to the response evaluation criteria for solid tumors, five patients (27.8%) achieved a partial response and nine (50%) had stable disease. The 1-year PFS rate was 84.4%, and the median PFS was 20.4 months (95% confidence interval, 17.5 - 21.7). No serious AEs were reported during the study, and there were no toxicity-related deaths.
  
  
  CONCLUSIONS
  In the current study, axitinib showed acceptable oncological outcomes and favorable safety profile as first-line therapy for locally advanced RCC or mRCC in treatment-naïve Japanese patients. Thus, first-line therapy with axitinib may provide a feasible option for treatment of advanced RCC or mRCC patients.
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. goodwin@cc.hirosaki-u.ac.jp.
authors.forename: Takuya
authors.initials: T
authors.lastname: Koie
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. coyama@cc.hirosaki-u.ac.jp.
authors.forename: Chikara
authors.initials: C
authors.lastname: Ohyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. uroyone@cc.hirosaki-u.ac.jp.
authors.forename: Takahiro
authors.initials: T
authors.lastname: Yoneyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. ha-yama@cc.hirosaki-u.ac.jp.
authors.forename: Hayato
authors.initials: H
authors.lastname: Yamamoto
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tsushi.imai@gmail.com.
authors.forename: Atsushi
authors.initials: A
authors.lastname: Imai
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. shingorilla2@gmail.com.
authors.forename: Shingo
authors.initials: S
authors.lastname: Hatakeyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. y-hashi@cc.hirosaki-u.ac.jp.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Hashimoto
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tohruyon@cc.hirosaki-u.ac.jp.
authors.forename: Tohru
authors.initials: T
authors.lastname: Yoneyama
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. tobisawa@cc.hirosaki-u.ac.jp.
authors.forename: Yuki
authors.initials: Y
authors.lastname: Tobisawa
authors.affiliation: Department of Urology, Hirosaki University Graduate School of Medicine, 5 Zaifucho, Hirosaki, 036-8562, Japan. moribio@cc.hirosaki-u.ac.jp.
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Mori
mesh_terms: D000368:Aged; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007191:Indazoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D008297:Male; D008875:Middle Aged; D009392:Nephrectomy; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D007093:Imidazoles; D007191:Indazoles; D047428:Protein Kinase Inhibitors; D000077784:Axitinib