Abstract
Randomized, double-blind phase III study of pazopanib versus placebo in patients with metastatic renal cell carcinoma who have no evidence of disease following metastasectomy: A trial of the ECOG-ACRIN cancer research group (E2810)
Journal of clinical oncology, Vol.37(15_suppl), pp.4502-4502
05/20/2019
DOI: 10.1200/JCO.2019.37.15_suppl.4502
Abstract
Abstract only
4502
Background: Patients with no evidence of disease (NED) after metastasectomy for metastatic renal cell carcinoma (mRCC) are at high risk of recurrence, but no systemic therapy has been shown to benefit this population. Pazopanib is an inhibitor of VEGFR and other kinases that improves progression-free survival in patients with measurable RCC metastatic disease. We performed a randomized, double-blind, placebo-controlled multicenter study to test the hypothesis that pazopanib would improve disease-free survival in patients with mRCC rendered NED after metastasectomy Methods: Patients with NED following metastasectomy were randomized 1:1 to receive pazopanib starting at 800 mg daily vs. placebo for 52 weeks. Patients were stratified by 1 vs. > 1 site of resected disease, and by disease-free interval ≤ vs. > 1 year. Clinical assessment for toxicity and patient-reported outcomes were performed every 4 weeks, and restaging scans every 12 weeks. The study was designed to observe a 42% improvement in disease-free survival (DFS) from 25% to 45% at 3 years. Results: From August 2012 to July 2017, 129 patients were enrolled. The study was unblinded after 83 DFS events had been observed (92% information). The median follow-up from randomization was 30 months (range 0.4 – 66.5 months). The study did not meet the primary endpoint: hazard ratio (95% CI) for DFS was 0.85 (0.55, 1.31) p= 0.47 in favor of pazopanib. At the time of unblinding, 22/129 (17%) of subjects had died. The HR for overall survival (OS) was 2.65 (1.02, 6.9) in favor of placebo ( p= 0.05). Patient-reported outcomes and laboratory correlates will be reported separately. Conclusions: 52 weeks of pazopanib did not improve DFS compared to blinded placebo in patients with mRCC who were NED after metastasectomy. There was a trend toward worse overall survival with pazopanib. Clinical trial information: NCT01575548.
Details
- Title: Subtitle
- Randomized, double-blind phase III study of pazopanib versus placebo in patients with metastatic renal cell carcinoma who have no evidence of disease following metastasectomy: A trial of the ECOG-ACRIN cancer research group (E2810)
- Creators
- Leonard Joseph Appleman - UPMC Hillman Cancer CenterManeka Puligandla - Dana-Farber Cancer InstituteSumanta K. Pal - City Of Hope National Medical CenterWayne Harris - Emory UniversityNeeraj Agarwal - University of UtahBrian Addis Costello - Mayo Clinic in ArizonaChristopher W. Ryan - Oregon Health & Science UniversityMichael Pins - University of Illinois ChicagoJill Kolesar - University of Wisconsin Carbone Cancer CenterDaniel A. Vaena - University of IowaRahul Atul Parikh - The University of Kansas Cancer CenterMehmood Hashmi - University of KansasJanice P. Dutcher - Cancer Research FoundationRobert S. DiPaola - University of KentuckyNaomi B. Haas - Penn Center for AIDS ResearchMichael Anthony Carducci - Sidney Kimmel Comprehensive Cancer Center
- Resource Type
- Abstract
- Publication Details
- Journal of clinical oncology, Vol.37(15_suppl), pp.4502-4502
- DOI
- 10.1200/JCO.2019.37.15_suppl.4502
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Publisher
- AMER SOC CLINICAL ONCOLOGY
- Language
- English
- Date published
- 05/20/2019
- Academic Unit
- Pharmacy; Pharmaceutical Sciences and Experimental Therapeutics
- Record Identifier
- 9984695793102771
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