title: The best objective response of target lesions and the incidence of treatment-related hypertension are associated with the survival of patients with metastatic renal cell carcinoma treated with sunitinib: a Japanese retrospective study.
abstract: BACKGROUND
  The aim of this study is to investigate the prognostic relevance of the best objective response of metastatic target lesions during sunitinib treatment in patients with metastatic renal cell carcinoma.
  
  
  METHODS
  Radiographic analysis of the best objective response according to the Response Evaluation Criteria in Solid Tumors was assessed in 50 patients. Clinicopathological characteristics including the Heng risk classification and sunitinib-related adverse reactions were compared among four patient subgroups [complete response or partial response (CR/PR), stable disease (SD), progressive disease (PD), and those without treatment evaluation (NE)]. Kaplan-Meier and Cox proportional regression analyses of progression-free survival and overall survival were performed to identify prognostic variables.
  
  
  RESULTS
  The best objective response was CR/PR in 12 (24 %) patients, SD in 22 (44 %), PD in 6 (12 %), and NE in 10 (20 %). The incidence of hypertension and hypothyroidism was associated with a better objective response. Progression-free survival was 15.0, 9.2, 6.8, and 2.2 months in the CR/PR, SD, PD, and NE groups, respectively (P = 0.0004, log-rank test), while the corresponding median overall survival was 59.7, 24.2, 17.1, and 18.1 months, respectively (P = 0.007). Multivariate analysis revealed that hazard ratios for risk of death of the SD, PD, and NE groups were 4.51 (P = 0.06), 7.93 (P = 0.02), and 4.88 (P = 0.04), respectively, as compared to the CR/PR group.
  
  
  CONCLUSIONS
  Our findings suggested that the best objective response of target lesions was a prognostic marker for both progression-free survival and overall survival in sunitinib treatment. Furthermore, the incidence of sunitinib-induced hypertension was associated with a longer progression-free survival.
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. makitomiyake@yahoo.co.jp.
authors: Makito
authors: M
authors: Miyake
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. masaomikuwada@gmail.com.
authors: Masaomi
authors: M
authors: Kuwada
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. horimaus@gmail.com.
authors: Shunta
authors: S
authors: Hori
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. tigers.yosuke@gmail.com.
authors: Yosuke
authors: Y
authors: Morizawa
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. takuro.birds.nest@gmail.com.|Department of Pathology, Nara Medical University, Nara, Japan. takuro.birds.nest@gmail.com.
authors: Yoshihiro
authors: Y
authors: Tatsumi
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. sanai@naramed-u.ac.jp.
authors: Satoshi
authors: S
authors: Anai
authors: Department of Urology, Tane General Hospital, Osaka, Japan. yukinari46@nyc.odn.ne.jp.
authors: Yukinari
authors: Y
authors: Hosokawa
authors: Department of Urology, Tane General Hospital, Osaka, Japan. uro@tane.or.jp.
authors: Yoshiki
authors: Y
authors: Hayashi
authors: Department of Urology, Matsuzaka Chuo General Hospital, Mie, Japan. tomioka515@yahoo.co.jp.
authors: Atsushi
authors: A
authors: Tomioka
authors: Department of Urology, Matsuzaka Chuo General Hospital, Mie, Japan. t-otani@mch.miekosei.or.jp.
authors: Takeshi
authors: T
authors: Otani
authors: Department of Urology, Yamato Takada Municipal Hospital, Nara, Japan. maccoi41@yahoo.co.jp.
authors: Kenji
authors: K
authors: Otsuka
authors: Department of Urology, Yamato Takada Municipal Hospital, Nara, Japan. nakagawa@ym-hp.yamatotakada.nara.jp.
authors: Yoshinori
authors: Y
authors: Nakagawa
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. unnkoderu@hotmail.com.|Department of Urology, Nara Prefecture General Medical Center, Nara, Japan. unnkoderu@hotmail.com.
authors: Yasushi
authors: Y
authors: Nakai
authors: Department of Urology, Nara Prefecture General Medical Center, Nara, Japan. urodept@m3.kcn.ne.jp.
authors: Shoji
authors: S
authors: Samma
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. sendo@naramed-u.ac.jp.
authors: Nobumichi
authors: N
authors: Tanaka
authors: Department of Urology, Nara Medical University, 840 Shijo-cho, Nara, 634-8522, Japan. kiyokun@naramed-u.ac.jp.
authors: Kiyohide
authors: K
authors: Fujimoto
mesh_terms: D000368:Aged; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000556:secondary*; D003710:Demography; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D006973:Hypertension / Q000139:chemically induced* / Q000453:epidemiology*; D015994:Incidence; D007211:Indoles / Q000009:adverse effects* / Q000627:therapeutic use*; D007564:Japan / Q000453:epidemiology; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D015999:Multivariate Analysis; D016016:Proportional Hazards Models; D011758:Pyrroles / Q000009:adverse effects* / Q000627:therapeutic use*; D012189:Retrospective Studies; D000077210:Sunitinib; D016896:Treatment Outcome
chemical_list: D007211:Indoles; D011758:Pyrroles; D000077210:Sunitinib