title: Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma.
abstract: In a randomized phase II trial in metastatic renal cell carcinoma (mRCC), objective response rate was significantly higher with axitinib versus placebo titration (54% vs. 34%; 1-sided P = .019).
  
  
  
  Treatment-naive patients with mRCC (n = 213) received axitinib 5 mg twice per day (b.i.d.) for 4 weeks. Patients meeting dose titration criteria were randomized to receive axitinib 5 mg b.i.d. with axitinib or placebo titration (n = 56 each); 91 patients ineligible for randomization continued axitinib 5 mg b.i.d.; 10 discontinued before randomization.
  
  
  
  Median overall survival (95% confidence interval [CI]) was 42.7 months (24.7-not estimable) with axitinib titration versus 30.4 months (23.7-45.0) with placebo titration (stratified hazard ratio, 0.785; 95% CI, 0.485-1.272; 1-sided P = .162), and 41.6 months (95% CI, 33.0-not estimable) in nonrandomized patients. Safety data were consistent with previous reports.
  
  
  
  Median overall survival was numerically longer in patients with first-line mRCC who received axitinib versus placebo titration. No new safety signal was observed after long-term axitinib treatment in first-line mRCC.
authors.affiliation: Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH. Electronic address: rinib2@ccf.org.
authors.forename: Brian I
authors.initials: BI
authors.lastname: Rini
authors.affiliation: Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
authors.forename: Yoshihiko
authors.initials: Y
authors.lastname: Tomita
authors.affiliation: Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
authors.forename: Bohuslav
authors.initials: B
authors.lastname: Melichar
authors.affiliation: Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Ueda
authors.affiliation: Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
authors.forename: Viktor
authors.initials: V
authors.lastname: Grünwald
authors.affiliation: H. Lee Moffitt Cancer Center, Tampa, FL.
authors.forename: Mayer N
authors.initials: MN
authors.lastname: Fishman
authors.affiliation: Department of Urology, Kinki University Faculty of Medicine, Osaka, Japan.
authors.forename: Hirotsugu
authors.initials: H
authors.lastname: Uemura
authors.affiliation: Department of Urology, Keio University School of Medicine, Tokyo, Japan.
authors.forename: Mototsugu
authors.initials: M
authors.lastname: Oya
authors.affiliation: Pfizer Oncology, San Diego, CA.
authors.forename: Angel H
authors.initials: AH
authors.lastname: Bair
authors.affiliation: Pfizer Oncology, San Diego, CA.
authors.forename: Glen I
authors.initials: GI
authors.lastname: Andrews
authors.affiliation: Pfizer Oncology, San Diego, CA.
authors.forename: Brad
authors.initials: B
authors.lastname: Rosbrook
authors.affiliation: The University of Texas M.D. Anderson Cancer Center, Houston, TX.
authors.forename: Eric
authors.initials: E
authors.lastname: Jonasch
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000627:therapeutic use; D000077784:Axitinib; D002292:Carcinoma, Renal Cell / Q000188:drug therapy*; D018572:Disease-Free Survival; D004309:Double Bind Interaction; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D007191:Indazoles / Q000008:administration & dosage* / Q000627:therapeutic use; D007680:Kidney Neoplasms / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016019:Survival Analysis; D016896:Treatment Outcome
chemical_list: D020533:Angiogenesis Inhibitors; D007093:Imidazoles; D007191:Indazoles; D000077784:Axitinib
keywords: First-line treatment; Kidney cancer; Phase II; VEGFR inhibitor; mRCC