title: Clinical efficacy and prognostic factors of tumor progression in Japanese patients with advanced renal cell carcinoma treated with sorafenib.
abstract: OBJECTIVE
  Result of clinical trial for registration purpose is often difficult to generalize because of its limited population in number and inclusion criteria.
  
  
  METHODS
  To understand the efficacy of sorafenib under daily medical practice, we retrospectively investigated therapeutic outcomes of 175 Japanese patients with advanced renal cell carcinoma treated with sorafenib at 15 centers.
  
  
  RESULTS
  The objective response rate and disease control rate were 15.4 and 77.1%, respectively, being similar to those in the Phase II study in Japanese patients (19.4 and 73.6 months). Any tumor shrinkage was observed with 53% of patients, while tumor control without growth was in 61%. Lung lesions were more sensitive to sorafenib than other lesions, in terms of any tumor shrinkage (54%) and the extent of maximal shrinkage, while tumor control was better in lymph node metastases (77%) than in lung (69%). Liver was worse in any tumor shrinkage (35%), tumor control (55%) and the extent of tumor growth. Slightly, shorter median overall survival of 21.1 months compared with Phase II clinical trial (25.3 months) is likely to be attributable to different patient population, because median overall survival was improved to 26.4 months when the population was matched to that in Phase II trial. Univariate and multivariate analyses identified prognostic factors for worse overall survival, including intermediate and poor Memorial Sloan-Kettering Cancer Center risk, Eastern Cooperative Oncology Group performance status ≥1, the presence of non-clear cell component and the presence of liver metastasis.
  
  
  CONCLUSIONS
  In conclusion, the present study confirmed the efficacy of sorafenib in the real-world setting on advanced renal cell carcinoma.
authors.affiliation: Department of Urology, Tokyo Women's Medical University, Tokyo tkondo@kc.twmu.ac.jp.
authors.forename: Tsunenori
authors.initials: T
authors.lastname: Kondo
authors.affiliation: Department of Urology, Tokyo Women's Medical University Medical Center East, Tokyo.
authors.forename: Hayakazu
authors.initials: H
authors.lastname: Nakazawa
authors.affiliation: Department of Urology, Keio University School of Medicine, Tokyo.
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Oya
authors.affiliation: Department of Urology, Nippon Medical School, Tokyo.
authors.forename: Go
authors.initials: G
authors.lastname: Kimura
authors.affiliation: Department of Urology, Tokyo Medical and Dental University Graduate School, Tokyo.
authors.forename: Yasuhisa
authors.initials: Y
authors.lastname: Fujii
authors.affiliation: Department of Urology, JR Tokyo General Hospital, Tokyo.
authors.forename: Takashi
authors.initials: T
authors.lastname: Hatano
authors.affiliation: Department of Urology, Nihon University School of Medicine, Tokyo.
authors.forename: Nozomu
authors.initials: N
authors.lastname: Kawata
authors.affiliation: Department of Urology, Tokyo University, Tokyo.
authors.forename: Haruki
authors.initials: H
authors.lastname: Kume
authors.affiliation: Department of Urology, Showa University Koto Toyosu Hospital, Tokyo.
authors.forename: Masashi
authors.initials: M
authors.lastname: Morita
authors.affiliation: Department of Urology, Toho University School of Medicine, Tokyo.
authors.forename: Koichi
authors.initials: K
authors.lastname: Nakajima
authors.affiliation: Department of Urology, Tokyo Medical University, Tokyo.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Ohno
authors.affiliation: Department of Urology, Kyorin University, Tokyo.
authors.forename: Takatsugu
authors.initials: T
authors.lastname: Okegawa
authors.affiliation: Department of Medical Oncology, Cancer Institute Hospital, Tokyo.
authors.forename: Shunji
authors.initials: S
authors.lastname: Takahashi
authors.affiliation: Department of Urology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Yoshiaki
authors.initials: Y
authors.lastname: Wakumoto
authors.affiliation: Department of Urology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
authors.forename: Shigeo
authors.initials: S
authors.lastname: Horie
authors.forename: Raizo
authors.initials: R
authors.lastname: Yamaguchi
authors.forename: Kazutaka
authors.initials: K
authors.lastname: Saito
authors.forename: Masaya
authors.initials: M
authors.lastname: Murakami
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000970:Antineoplastic Agents / Q000008:administration & dosage*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000473:pathology; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives*; D010671:Phenylurea Compounds / Q000008:administration & dosage*; D012189:Retrospective Studies; D000077157:Sorafenib; D016896:Treatment Outcome
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D009536:Niacinamide; D000077157:Sorafenib
keywords: carcinoma; metastasis; neoplasm; prognosis; real-world practice; renal cell; sorafenib