SAN FRANCISCO, CA USA (UroToday.com) - Presented by Rana R. McKay, MD at the 2014 Genitourinary Cancers Symposium - January 30 - February 1, 2014 - San Francisco Marriott Marquis - San Francisco, California USA
Dana-Farber Cancer Institute, Boston, MA USA
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Abstract:
Background: Increasing evidence suggests that angiotensin II modulates angiogenesis and tumorigenesis. In this study, we utilized a clinical trials database to evaluate the role of ASIs (angiotensin-converting enzyme inhibitors and angiotension-receptor blockers) on survival outcomes in patients with mRCC.
Methods: We conducted an analysis of patients with mRCC treated from 2003-2013 on phase III (NCT00083889, NCT00065468, NCT00678392, NCT00474786, NCT00631371, NCT00920816) and II clinical trials (NCT00054886, NCT00077974, NCT00267748, NCT00338884, NCT00137423, NCT00835978). We evaluated patients treated with ASIs at baseline or within the first 30 days of study. Statistical analyses were performed using Cox regression and the Kaplan-Meier method.
Results: We identified 4,736 patients treated with sunitinib (n=1,059), sorafenib (n=772), axitinib (n=896), temsirolimus (TEM) (n=457), TEM + interferon-alfa (IFN-α) (n=208), bevacizumab (BEV) + TEM (n=393), BEV + IFN-α (n=391), or IFN-α (n=560). Most patients were < 65 years of age (69%), male (71%), with clear-cell histology (89%) and prior nephrectomy (70%). With regard to International mRCC Database Consortium risk groups, 14%, 42%, and 24% had favorable, intermediate, and poor-risk disease, respectively. 1383 (29%) patients received treatment with an ASI. Baseline hypertension was present in 84% of ASI users and 33% of ASI non-users. ASI use was associated with improved progression-free survival (PFS) and overall survival (OS) when compared to patients who did not receive an ASI. This association was retained in multivariable analysis adjusted for age, gender, presence of bone metastases, and risk groups.
Conclusions: This is the largest retrospective study to date evaluating the role of ASIs on outcomes in cancer patients. In this analysis, we demonstrate that concomitant use of ASIs may improve survival outcomes in patients with mRCC treated in the era of targeted therapy.
Author(s): Rana R. McKay, Gustavo Enrique Rodriguez, Xun Lin, Ronit Simantov, Toni K. Choueiri; Dana-Farber Cancer Institute, Boston, MA; Ernst Mario School of Pharmacy, Rutgers University, Piscataway, NJ; Pfizer Oncology, San Diego, CA; Pfizer Oncology, New York, NY