Early Prostate-Specific Antigen Response by 6 Months Is Predictive of Treatment Effect in Metastatic Hormone Sensitive Prostate Cancer: An Exploratory Analysis of the TITAN Trial.

Autor: Roy S; Department of Radiation Oncology, Rush University Medical Center, Chicago, Illinois., Sun Y; Case Western Reserve University, Cleveland, Ohio., Chi KN; BC Cancer and Vancouver Prostate Centre, Vancouver, British Columbia, Canada., Ong M; The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, Ontario, Canada., Malone S; The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, Ontario, Canada., Wallis CJD; Department of Urology, Mount Sinai Hospital, University Health Network, University of Toronto, Toronto, Ontario, Canada., Kishan AU; Department of Radiation Oncology, University of California Los Angeles, Los Angeles, California., Malone J; The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, Ontario, Canada., Swami U; Department of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., Gebrael G; Department of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., Brown JR; University Hospitals, Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio., Jia AY; University Hospitals, Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio., Morgan SC; The Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, Ontario, Canada., Saad F; Department of Surgery, Centre hospitalier de l'Université de Montréal, Montreal, Quebec, Canada., Chowdhury S; Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute, London, United Kingdom., Agarwal N; Department of Medical Oncology, Huntsman Cancer Institute, University of Utah, Salt Lake City, Utah., Spratt DE; University Hospitals, Seidman Cancer Center, Case Western Reserve University, Cleveland, Ohio.
Jazyk: angličtina
Zdroj: The Journal of urology [J Urol] 2024 Nov; Vol. 212 (5), pp. 672-681. Date of Electronic Publication: 2024 Jul 26.
DOI: 10.1097/JU.0000000000004158
Abstrakt: Purpose: Early PSA response has been found to be prognostic of outcomes in metastatic hormone sensitive prostate cancer. We performed a secondary analysis of the TITAN trial to determine if early PSA response was predictive of treatment efficacy in metastatic hormone sensitive prostate cancer patients.
Materials and Methods: Early PSA response was defined as achieving a PSA level of ≤ 0.2 ng/mL by 6 months of random assignment. A Cox proportional hazard model was constructed in a landmark population with an interaction term between the treatment and early PSA response to determine differential treatment effect on overall survival (OS). We applied multivariable Cox proportional hazard regression model with time to early PSA response fitted with restricted cubic spline to determine the association of time to early PSA response with OS.
Results: Approximately 24% (124/524) of patients in the androgen deprivation therapy (ADT) alone group and 61% (321/524) in the apalutamide group had PSA response ≤ 0.2 ng/mL by 6 months. Longer time to early PSA response was associated with significantly superior OS in the apalutamide group. There was a significant difference in treatment effect from apalutamide on OS ( P = .03 for interaction) among 6-month PSA responders (HR: 0.66; 95% CI: 0.44-1.00) vs nonresponders (HR: 1.14; 95% CI: 0.89-1.46). This difference in treatment effect was not statistically significant at 3 months ( P = .17 for interaction). Among 6-month PSA responders, 3-year confounder-adjusted OS was 84% (80%-88%) for the apalutamide group and 74% (66%-82%) for the ADT alone group. Among nonresponders, 3-year adjusted OS for the 2 treatment arms were 58% (52%-65%) and 56% (51%-60%), respectively.
Conclusions: Early PSA response by 6 months was a predictor of treatment efficacy from ADT plus apalutamide on OS. Longer time to early PSA response was associated with superior OS in the apalutamide arm.
Databáze: MEDLINE