Abstract | BACKGROUND: OBJECTIVE: We assessed the association of PSA levels at 3 (PSA-3mo) and 7 (PSA-7mo) mo with overall survival (OS) in patients with mHSPC treated with ADT combined with either bicalutamide or orteronel in the S1216 phase 3 clinical trial. DESIGN, SETTING, AND PARTICIPANTS: PSA responses to treatment of patients in the S1216 trial were categorized as: complete response (CR) if PSA was ≤0.2 ng/ml, partial response if PSA was >0.2 and ≤4 ng/ml, and no response (NR) if PSA was >4 ng/ml. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A Cox analysis (adjusted for treatment arm and three stratification factors: performance status, severity of disease, and early vs late induction) was used for OS association. While PSA-7mo association was a prespecified objective, PSA-3mo association was also evaluated. RESULTS AND LIMITATIONS: A total of 1251 and 1231 patients from the S1216 study were evaluable for PSA-3mo and PSA-7mo, respectively. A PSA-7mo CR was associated with improved OS compared with NR (HR: 0.20; p < 0.0001). A PSA-3mo CR showed a similar association to NR (HR: 0.34; p < 0.0001). The association of a PSA response with survival did not differ by treatment arm at either time point. CONCLUSIONS: The PSA-3mo and PSA-7mo responses were strongly associated with OS; taken with other emerging prognostic biomarkers, these markers may allow for early identification of patients at the highest risk of death, aid with counseling in clinical practice, and permit design of future clinical trials targeting these patients. PATIENT SUMMARY:
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Authors | Mamta Parikh, Catherine Tangen, Maha H A Hussain, Shilpa Gupta, Sam Callis, Yeonjung Jo, Andrea Harzstark, Channing J Paller, Saby George, Matthew R Zibelman, Heather H Cheng, Benjamin L Maughan, Jingsong Zhang, Russell K Pachynski, Alan H Bryce, Daniel W Lin, David I Quinn, Seth P Lerner, Ian M Thompson, Tanya B Dorff, Primo N Lara, Neeraj Agarwal |
Journal | European urology oncology
(Eur Urol Oncol)
(Mar 23 2024)
ISSN: 2588-9311 [Electronic] Netherlands |
PMID | 38523017
(Publication Type: Journal Article)
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Copyright | Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved. |