Prostate-specific antigen value at 3 & 7 months (PSA-3mo, PSA-7mo) and overall survival (OS) in metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation (ADT) with or without orteronel (SWOG S1216).
Year: 2023
Type: conference-abstract
Abstract: 5074 Background: Analysis of phase 3 studies of patients (pts) with mHSPC in the era of ADT, including in combination with docetaxel and/or androgen receptor axis targeted therapies have established PSA-7mo as a key prognostic marker. Our objective was to evaluate the association between PSA-3mo, PSA 7-mo and OS measured in the phase 3 S1216 trial in mHSPC comparing ADT + orteronel (treatment arm) vs ADT + bicalutamide (control arm) [NCT01809691]. Methods: Pts enrolled in the S1216 trial with available PSA-3mo & PSA-7mo were included in this analysis. PSA responses were defined as complete response (CR) if PSA ≤ 0.2 ng/mL, partial response (PR) for PSA >0.2 and ≤ 4ng/mL, and no response (NR) as PSA >4 ng/mL at month 3 or 7. Landmark OS was measured and Cox regression model applied adjusting for stratification (performance status, extent of disease, early vs late start of treatment, treatment arm). Results: 1251 pts were alive and evaluable for PSA-3mo and 1231 pts were evaluable at 7 mo, out of a total of 1279 pts. The median age was 67 (range: 43-92), 10% of patients were black, 96% had a Zubrod performance status of 0-1. Median PSA at baseline was 29 ng/ml (range: 2-6710). Of pts on treatment vs.control arm, PSA-3mo CR, PR, and NR occurred in 52% vs 35%; 31% vs 42%, and 17% vs 23%, respectively. Of pts on treatment vs control arm, PSA-7mo CR, PR, and NR occurred in 61% vs 46%, 20% vs 26%, and 19% vs 29%, respectively. CR or PR at either timepoint led to significantly better outcomes than those with NR. No interaction between treatment arm and PSA response was observed in terms of OS. Conclusions: PSA-3mo and PSA-7mo are strong prognostic markers for pts with mHSPC. More pts on ADT with orteronel achieved CR at 3 and 7 mo. In addition to its use in counseling patients in the clinic, PSA-3mo and PSA-7mo may be used as parameters for designing future trials in pts with mHSPC, utilizing the next generation of intensification or de-intensification treatment regimens. Clinical trial information: NCT01809691 . [Table: see text]
Source: Journal of Clinical Oncology
Authors: Mamta Parikh, Catherine Tangen, Maha H. A. Hussain, Shilpa Gupta, Yeonjung Jo, Andrea Harzstark, Channing Judith Paller, Saby George, Matthew R. Zibelman, Heather H. Cheng, Benjamin L. Maughan, Jingsong Zhang, Russell Kent Pachynski, Alan Haruo Bryce, Daniel W. Lin, David I. Quinn, Ian M Thompson, Tanya B. Dorff, Primo N Lara, Neeraj Agarwal
Institutions: UC Davis Comprehensive Cancer Center, Fred Hutch Cancer Center, Northwestern University, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Cleveland Clinic, Huntsman Cancer Institute, Kaiser Permanente, Kaiser Permanente San Francisco Medical Center, Johns Hopkins University, Sidney Kimmel Comprehensive Cancer Center, Roswell Park Comprehensive Cancer Center, Fox Chase Cancer Center, University of Utah, Moffitt Cancer Center, Washington University in St. Louis, Mayo Clinic Hospital, University of Washington Medical Center, USC Norris Comprehensive Cancer Center, Children's Hospital of San Antonio, City Of Hope National Medical Center, City of Hope
Language: English
Subfield: Pulmonary and Respiratory Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
Funder: National Institutes of Health
OpenAlex ID: W4379281781