Abstract | BACKGROUND: The Veterans Affairs Cooperative Studies Program study #553 was designed to evaluate the efficacy of adjuvant chemotherapy added to the standard of care (SOC) for patients who are at high risk for relapse after prostatectomy. OBJECTIVE: DESIGN, SETTING, AND PARTICIPANTS: OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: RESULTS AND LIMITATIONS: A total of 298 of the planned 636 patients were randomized. The median follow-up was 59.1 mo (0.2-103.7 mo). For the primary endpoint, the two groups did not statistically differ in PFS (median 55.5 mo in the chemotherapy group and 42.2 mo in the SOC group; test adjusted for site via gamma frailty p=0.21; adjusted hazard ratio [HR] 0.80; 95% confidence interval [CI] 0.58-1.11; p=0.18). Prespecified subgroup analyses showed benefit in PFS for patients with tumor stage ≥T3b (HR 0.54, 95% CI 0.32-0.92; p=0.022) and patients with Gleason score ≤7 (HR 0.65, 95% CI 0.43-0.99; p=0.046). Secondary endpoint analyses are hampered by low event rates. The most common adverse events (≥grade 3 related or possibly related to chemotherapy) included neutropenia (43%), hyperglycemia (20%), and fatigue (5%), with febrile neutropenia in 2%. CONCLUSIONS:
Adjuvant chemotherapy in high-risk prostate cancer using docetaxel and prednisone did not lead to statistically significant improvement in PFS for the intention-to-treat population as a whole. The analysis was challenged by lower power due to accrual limitation. Subgroup analyses suggest potential benefit for patients with Gleason grade ≤7 and stage≥pT3b (ClinicalTrials.gov number NCT00132301). PATIENT SUMMARY:
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Authors | Daniel W Lin, Mei-Chiung Shih, William Aronson, Joseph Basler, Tomasz M Beer, Mary Brophy, Matthew Cooperberg, Mark Garzotto, W Kevin Kelly, Kelvin Lee, Valerie McGuire, Yajie Wang, Ying Lu, Vivian Markle, Unyime Nseyo, Robert Ringer, Stephen J Savage, Patricia Sinnott, Edward Uchio, Claire C Yang, R Bruce Montgomery |
Journal | European urology
(Eur Urol)
Vol. 77
Issue 5
Pg. 563-572
(05 2020)
ISSN: 1873-7560 [Electronic] Switzerland |
PMID | 31924316
(Publication Type: Clinical Trial, Phase III, Journal Article, Randomized Controlled Trial, Research Support, U.S. Gov't, Non-P.H.S.)
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Copyright | Copyright © 2020 European Association of Urology. Published by Elsevier B.V. All rights reserved. |
Topics |
- Aged
- Aged, 80 and over
- Chemotherapy, Adjuvant
- Humans
- Male
- Middle Aged
- Progression-Free Survival
- Prostatectomy
- Prostatic Neoplasms
(drug therapy, surgery)
- Risk Assessment
- United States
- United States Department of Veterans Affairs
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