PI-LBA06 VA CSP#553 CHEMOTHERAPY AFTER PROSTATECTOMY (CAP) FOR HIGH RISK PROSTATE CARCINOMA: A PHASE III RANDOMIZED STUDY

Abstract

You have accessJournal of UrologyPlenary I - Tuesday1 Apr 2016PI-LBA06 VA CSP#553 CHEMOTHERAPY AFTER PROSTATECTOMY (CAP) FOR HIGH RISK PROSTATE CARCINOMA: A PHASE III RANDOMIZED STUDY Daniel Lin, Mark Garzotto, William Aronson, Joseph Basler, Thomas Beer, Mary Brophy, Kevin Kelly, Kelvin Lee, Ying Lu, Vivian Markle, Valerie McGuire, Unimye Nseyo, Robert Ringer, Steven Savage, Mei-Chiung Shih, Patricia Sinnott, Edward Uchio, Yajie Wang, Claire Yang, and Bruce Montgomery Daniel LinDaniel Lin More articles by this author , Mark GarzottoMark Garzotto More articles by this author , William AronsonWilliam Aronson More articles by this author , Joseph BaslerJoseph Basler More articles by this author , Thomas BeerThomas Beer More articles by this author , Mary BrophyMary Brophy More articles by this author , Kevin KellyKevin Kelly More articles by this author , Kelvin LeeKelvin Lee More articles by this author , Ying LuYing Lu More articles by this author , Vivian MarkleVivian Markle More articles by this author , Valerie McGuireValerie McGuire More articles by this author , Unimye NseyoUnimye Nseyo More articles by this author , Robert RingerRobert Ringer More articles by this author , Steven SavageSteven Savage More articles by this author , Mei-Chiung ShihMei-Chiung Shih More articles by this author , Patricia SinnottPatricia Sinnott More articles by this author , Edward UchioEdward Uchio More articles by this author , Yajie WangYajie Wang More articles by this author , Claire YangClaire Yang More articles by this author , and Bruce MontgomeryBruce Montgomery More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2016.03.129AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES The VA Cooperative Studies Group Study #553 was designed to prospectively evaluate the efficacy of early adjuvant chemotherapy added to the standard of care (SOC) for patients with prostate cancer who are potentially cured by radical prostatectomy but who are at high risk for relapse based on clinical and pathologic parameters. METHODS Patients at high risk for relapse after prostatectomy were randomized in 1:1 ratio to the SOC group of observation or to the chemotherapy group with docetaxel and prednisone administered every 3 weeks for 18 weeks. Randomization was stratified for PSA, Gleason score, tumor stage and the presence of positive margins, within each site. The primary endpoint was progression-free survival. Secondary endpoints included overall, prostate cancer-specific, and metastasis-free survival and time to initiation of androgen deprivation. Time to event data were compared using a log-rank test in the ITT analysis. Proportional hazards regression were used to calculate estimates of hazard ratio, adjusting for stratifying variables and incorporating site via a gamma frailty. RESULTS A total of 297 patients randomized between July 2006 and October 2011 were included in the analysis (157 randomized to SOC and 140 to chemotherapy). The median follow-up was 62.4 months (range 0.2 to 104.3 months). For the primary endpoint, the two groups did not statistically differ in progression-free survival (median time to progression 55.5 months in chemotherapy group, 45.6 months in SOC group; logrank test p=0.26; adjusted hazard ratio (HR) 0.82; 95% confidence interval (CI) 0.60-1.14). Subgroup analyses showed benefit in progression-free survival for patients with tumor stage ≥T3b (HR 0.58, 95% CI 0.34-0.98, logrank test p=0.041) and for African Americans (HR 0.54, 95% CI 0.29-1.01, p=0.054). The secondary endpoint analyses are hampered by low event rates for all secondary endpoints. The most common adverse events ≥Grade 3 related or possibly related to chemotherapy included neutropenia in 40%, hyperglycemia in 18%, and fatigue in 5%, with febrile neutropenia in 1.4%. CONCLUSIONS Adjuvant chemotherapy in high-risk prostate cancer using docetaxel and prednisone was well tolerated and did not lead to statistically significant improvement in progression-free survival for the ITT population as a whole. Subgroup analyses suggest potential benefit for patients with higher risk pathology (≥pT3b) and African-American ancestry, supporting ongoing and planned trials of systemic chemotherapy for hormone-sensitive prostate cancer. © 2016FiguresReferencesRelatedDetails Volume 195Issue 4SApril 2016Page: e1071 Advertisement Copyright & Permissions© 2016MetricsAuthor Information Daniel Lin More articles by this author Mark Garzotto More articles by this author William Aronson More articles by this author Joseph Basler More articles by this author Thomas Beer More articles by this author Mary Brophy More articles by this author Kevin Kelly More articles by this author Kelvin Lee More articles by this author Ying Lu More articles by this author Vivian Markle More articles by this author Valerie McGuire More articles by this author Unimye Nseyo More articles by this author Robert Ringer More articles by this author Steven Savage More articles by this author Mei-Chiung Shih More articles by this author Patricia Sinnott More articles by this author Edward Uchio More articles by this author Yajie Wang More articles by this author Claire Yang More articles by this author Bruce Montgomery More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...