Apalutamide for prostate cancer: multicentre and multidisciplinary real-world study of 227 patients

Abstract

Apalutamide; Metastatic hormone-sensitive prostate cancer; Prostate cancer

Apalutamida; Cáncer de próstata metastásico sensible a hormonas; Cáncer de prostata

Apalutamida; Càncer de pròstata metastàtic sensible a les hormones; Càncer de pròstata

Objective: To evaluate the efficacy and safety of apalutamide prostate cancer compared to the pivotal trials patients and to identify the first subsequent therapy in a real-world setting. Methods: The study is prospective and observational based on real-world evidence, performed by different medical disciplines and eight academics centres around Barcelona, Spain. It included all patients with metastatic hormone-sensitive prostate cancer (mHSPC) and high-risk non-metastatic castration-resistant prostate cancer (nmCRPC) treated with apalutamide from June 2018 to December 2022. Results: Of 227 patients treated with apalutamide, 10% had ECOG-PS 2, and 41% were diagnosed with new-generation imaging. In the mHSPC group (209 patients), 75 years was the median age, 53% had synchronous metastases, and 22% were M1a. In the nmCRPC (18 patients), 82 years was the median age, and 81% ≤6 months had PSA doubling time. Patients achieved PSA90 in 92% of mHSPC and 50% of nmCRPC and PSA ≤0.2 in 71% of mHSPC and 39% of nmCRPC. Treatment-related adverse events occurred in 40.1% of mHSPC and 44.4% of nmCRPC. After discontinuation of apalutamide due to disease progression, 54.5% in mHSPC and 75% in nmCRPC started chemotherapy, while after discontinuation because of adverse events, 73.3% in mHSPC and 100% in nmCRPC continued with other hormonal-therapies.

This study did not receive funding. Julián Córdoba and Meritxell Pérez have received sponsorship from Janssen for medical congresses and symposiums. Alejo Rodriguez- Vida, Jesús Muñoz Rodriguez, Antonio Alcaraz and Antoni Vilaseca have received honoraria from Janssen for advisory board meetings, symposiums and travel ex-penses. The other authors declare no conflict of interest. Approval of the research protocol by an Institutional Reviewer Board: HCB/2019/0919.