title: Overall survival of first-line axitinib in metastatic renal cell carcinoma: Japanese subgroup analysis from phase II study.
abstract: Subgroup analyses of a randomized global phase II study of axitinib showed objective response rate of 66% and median progression-free survival of 27.6 months in treatment-naïve Japanese patients with metastatic renal cell carcinoma (RCC). This analysis evaluated overall survival (OS) and safety in 44 Japanese patients and compared the results with 169 non-Japanese patients. In addition, baseline characteristics for predictive factors that may influence OS in first-line metastatic RCC were explored in all patients using a Cox proportional hazard model. With median follow-up of 33 months, fewer than half (16 of 44) of the Japanese patients had died and median OS was not reached (95% confidence interval [CI], 38.8 months-not estimable), whereas 107 of 169 (63%) non-Japanese patients had died and median OS was 33.9 months (95% CI, 28.9-42.7). Estimated 1-year, 2-year and 3-year survival probability (95% CI) was 86.4% (76.2-96.5), 75.0% (62.2-87.8) and 68.2% (54.4-81.9), respectively, in Japanese patients, and was higher than that in non-Japanese patients (75.1% [68.4-81.8], 62.1% [54.5-69.7] and 47.2% [39.3-55.1], respectively). The updated safety analysis did not reveal any new adverse events of concern among Japanese or non-Japanese patients. The multivariate analysis identified that lower baseline Eastern Cooperative Oncology Group performance status, lower baseline tumor burden, and longer time from histopathological diagnosis to treatment were significant positive predictors of OS. The current analysis confirmed the clinical activity of axitinib in treatment-naïve Japanese patients with metastatic RCC, with an acceptable toxicity profile.
authors.affiliation: Department of Urology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Mototsugu
authors.identifier: http://orcid.org/0000-0002-2048-4263
authors.initials: M
authors.lastname: Oya
authors.affiliation: Department of Urology, Yamagata University Faculty of Medicine, Yamagata, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.affiliation: Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Fukasawa
authors.affiliation: Department of Urology, Hokkaido University Graduate School of Medicine, Hokkaido, Japan.
authors.forename: Nobuo
authors.initials: N
authors.lastname: Shinohara
authors.affiliation: Department of Urology, Akita University School of Medicine, Akita, Japan.
authors.forename: Tomonori
authors.initials: T
authors.lastname: Habuchi
authors.affiliation: Department of Solid Tumor Oncology, Cleveland Clinic, Taussig Cancer Institute, Cleveland, Ohio, USA.
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.affiliation: Pfizer Japan, Tokyo, Japan.
authors.forename: Yosuke
authors.initials: Y
authors.lastname: Fujii
authors.affiliation: Pfizer Japan, Tokyo, Japan.
authors.forename: Yoichi
authors.initials: Y
authors.lastname: Kamei
authors.affiliation: Pfizer Japan, Tokyo, Japan.
authors.forename: Yoshiko
authors.initials: Y
authors.lastname: Umeyama
authors.affiliation: Pfizer Oncology, San Diego, California, USA.
authors.forename: Angel H
authors.initials: AH
authors.lastname: Bair
authors.affiliation: Department of Urology, Kindai University Faculty of Medicine, Osaka, Japan.
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000401:mortality*; D018572:Disease-Free Survival; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007191:Indazoles / Q000627:therapeutic use*; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000401:mortality*; D008297:Male; D008875:Middle Aged; D016016:Proportional Hazards Models; D047428:Protein Kinase Inhibitors / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D007093:Imidazoles; D007191:Indazoles; D047428:Protein Kinase Inhibitors; D000077784:Axitinib
keywords: Antiangiogenic agent; Japanese; axitinib; clinical trial phase II; renal cell carcinoma