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Clin Genitourin Cancer. 2016 Dec;14(6):499-503. doi: 10.1016/j.clgc.2016.04.005. Epub 2016 Apr 22.

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

Author information

1
Department of Hematology and Oncology, Cleveland Clinic Taussig Cancer Institute, Cleveland, OH. Electronic address: rinib2@ccf.org.
2
Department of Urology, Department of Molecular Oncology, Niigata University Graduate School of Medical and Dental Sciences, Niigata, Japan.
3
Palacky University Medical School and Teaching Hospital, Olomouc, Czech Republic.
4
Prostate Center and Division of Urology, Chiba Cancer Center, Chiba, Japan.
5
Department of Hematology, Hemostasis, Oncology, and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany.
6
H. Lee Moffitt Cancer Center, Tampa, FL.
7
Department of Urology, Kinki University Faculty of Medicine, Osaka, Japan.
8
Department of Urology, Keio University School of Medicine, Tokyo, Japan.
9
Pfizer Oncology, San Diego, CA.
10
The University of Texas M.D. Anderson Cancer Center, Houston, TX.

Abstract

BACKGROUND:

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).

PATIENTS AND METHODS:

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.

RESULTS:

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.

CONCLUSION:

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.

KEYWORDS:

First-line treatment; Kidney cancer; Phase II; VEGFR inhibitor; mRCC

PMID:
27236772
DOI:
10.1016/j.clgc.2016.04.005
[Indexed for MEDLINE]

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