Prostate-specific Antigen at 3 Months as a Predictor of Radiologic Progression-free Survival in Metastatic Hormone-sensitive Prostate Cancer Treated with Apalutamide: Analysis of 633 Patients in a Real-world Database
Year: 2024
Type: article
Study design: Observational Study
Abstract: Background and objective: The depth of the prostate-specific antigen (PSA) decline after androgen receptor pathway inhibitor (ARPI) treatment combined with androgen deprivation therapy for patients with metastatic hormone-sensitive prostate cancer (mHSPC) may affect prognosis. The primary objective in our study was the correlation between the PSA response at 3 mo and radiologic progression-free survival (rPFS) at 24 mo. Three groups were defined according to the PSA decline: complete response (PSA ≤0.02 ng/ml), partial response (PSA >0.02 and ≤0.2 ng/ml), and incomplete response (PSA >0.2 ng/ml). Secondary objectives were correlation between the PSA response at 3 mo and overall survival, and the development of a model predicting complete PSA response. Methods: We conducted a retrospective multicenter study of patients with mHSPC treated with apalutamide from May 2018 to September 2023 registered in the Real-World Evidence APA registry across 20 centers. Key findings and limitations: We included 633 patients with mHSPC. The median age at diagnosis was 68 yr (interquartile range [IQR] 63-75) and median PSA was 16 ng/ml (IQR 7.5-64). Some 63% of the short had low-volume disease, 51% had de novo disease, 48% had recurrent disease. At 3 mo, 27% had a complete response, 42% a partial response, and 31% an incomplete response, with corresponding rRFS rates at 24 mo of 92%, 86%, and 63%. According to the predictive model, a complete PSA response at 3 mo was associated with the use of next-generation imaging and PSA <50 ng/ml at diagnosis. Study limitations include heterogeneity among the groups and variations in data quality and assessment methods. Conclusions and clinical implications: Patients with a complete PSA response after 3 mo of apalutamide treatment face a very low risk of progression within 2 yr. Conversely, nearly 50% of patients with an incomplete PSA response will experience disease progression. Patient summary: For patients with metastatic prostate cancer that is still responsive to hormone therapy, a complete response after treatment with a drug called apalutamide is associated with a very low risk of progression within 2 years. However, nearly half of patients with an incomplete response to apalutamide will experience progression of their cancer.
Source: European Urology Open Science
Authors: Mario Hassi Roman, Kinga Mate, Pedro De Pablos-Rodriguez, Álvaro Zamora Horcajada, Ana Guijarro Cascales, Ángeles Sanchís Bonet, Antoni Vilaseca, Darío Vázquez-Martul Pazos, Estefanía Linares Espinós, Jesús Muñoz Rodríguez, José Manuel de la Morena Gallego, José Ramón Alemán, Juan Gómez Rivas, Luigi Formisano, Maria J. Juan Fita, Marc Costa Planells, Mario Domínguez Esteban, Meritxell Pérez Márquez, Miguel García Sanz, Nagore García Expósito, Natalia Picola, Pol Servian Vives, Raquel Sopeña Sutil, Miguel A. Climent Durán, Miguel Ramírez Backhaus
Institutions: Hospital Dipreca, Péterfy Sándor Utcai Kórház-Rendelőintézet és Baleseti Központ, Fundación Instituto Valenciano de Oncología, Complejo Asistencial Universitario de Palencia, Hospital Universitario Fundación Alcorcón, Hospital Clínic de Barcelona, Complexo Hospitalario Universitario A Coruña, Hospital Universitario La Paz, Corporació Sanitària Parc Taulí, Hospital Universitario Infanta Sofía, Hospital Universitari de Tortosa Verge de la Cinta, Hospital Clínico San Carlos, Federico II University Hospital, University of Naples Federico II, Vall d'Hebron Hospital Universitari, Marqués de Valdecilla University Hospital, Consorci Sanitari de Terrassa, Hospital Universitario de León, Bellvitge University Hospital, Hospital Universitari Germans Trias i Pujol, Hospital Universitario 12 De Octubre
Language: English
Subfield: Cancer Research
Domain: Life Sciences
Open Access status: gold
Estimated APC paid: $1,800
OpenAlex ID: W4403480179