Overall Survival Analysis From a Randomized Phase II Study of Axitinib With or Without Dose Titration in First-Line Metastatic Renal Cell Carcinoma

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.

Clinical genitourinary cancer. 2016 Apr 22 [Epub ahead of print]

Brian I Rini, Yoshihiko Tomita, Bohuslav Melichar, Takeshi Ueda, Viktor Grünwald, Mayer N Fishman, Hirotsugu Uemura, Mototsugu Oya, Angel H Bair, Glen I Andrews, Brad Rosbrook, Eric Jonasch

Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH. Electronic address: ., Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan., Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic., Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan., Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany., H. Lee Moffitt Cancer Center, Tampa, FL., Department of Urology, Kinki University Faculty of Medicine, Osaka, Japan., Department of Urology, Keio University School of Medicine, Tokyo, Japan., Pfizer Oncology, San Diego, CA., Pfizer Oncology, San Diego, CA., Pfizer Oncology, San Diego, CA., The University of Texas M.D. Anderson Cancer Center, Houston, TX.