Abstract:
BACKGROUND:Sunitinib malate, a targeted tyrosine kinase inhibitor, is standard of care for metastatic renal cell carcinoma (mRCC) and serves as the active comparator in several ongoing mRCC clinical trials. In this analysis we report benchmarks for clinical outcomes on the basis of International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) risk groups for patients treated with sunitinib for mRCC in a first-line setting. MATERIALS AND METHODS:A retrospective analysis was performed on data from sunitinib-treated patients (n = 375) in the pivotal phase III trial of sunitinib versus interferon-α as first-line treatment for mRCC. Objective response rates (ORRs) were determined from independently reviewed radiologic assessments. The Kaplan-Meier method was used to estimate median progression-free survival (PFS) and median overall survival (OS) according to patient risk group. RESULTS:Median PFS (95% confidence interval [CI]) was 14.1 (13.4-17.1), 10.7 (10.5-12.5), 2.4 (1.1-4.7), and 10.6 (8.1-10.9) months in sunitinib-treated patients in the IMDC favorable (n = 134), intermediate (n = 205), poor (n = 34), and intermediate + poor (n = 239) risk groups, respectively. Median OS (95% CI) was 23.0 (19.8-27.8), 5.1 (4.3-9.9), and 20.3 (16.8-23.0) months in sunitinib-treated patients in IMDC intermediate, poor, and intermediate + poor risk groups, respectively, and was not reached in the favorable risk group (>50% of patients were alive at data cutoff). ORRs (95% CI) was 53.0% (44.2%-61.7%), 33.7% (27.2%-40.6%), 11.8% (3.3%-27.5%), and 30.5% (24.8%-36.8%) in sunitinib-treated patients in IMDC favorable, intermediate, poor, and intermediate + poor risk groups, respectively. CONCLUSION:Results of this retrospective analysis show differences in patient outcomes for PFS, OS, and ORR on the basis of IMDC prognostic risk group assignment for patients with mRCC.
journal_name
Clin Genitourin Cancerjournal_title
Clinical genitourinary cancerauthors
Rini BI,Hutson TE,Figlin RA,Lechuga MJ,Valota O,Serfass L,Rosbrook B,Motzer RJdoi
10.1016/j.clgc.2018.04.005subject
Has Abstractpub_date
2018-08-01 00:00:00pages
298-304issue
4eissn
1558-7673issn
1938-0682pii
S1558-7673(18)30136-8journal_volume
16pub_type
杂志文章,多中心研究,随机对照试验abstract::Systemic treatment of men with metastatic prostate cancer is rapidly evolving. Androgen deprivation therapy remains the first-line treatment for advanced disease and the backbone of sequential strategies. For patients with extensive metastatic disease the addition of docetaxel markedly improves survival. In case patie...
journal_title:Clinical genitourinary cancer
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