2026-04-17T02:20:14Zhttps://recercat.cat/oai/request

oai:recercat.cat:11351/83562024-12-13T10:57:44Zcom_2072_378070com_2072_378040col_2072_378092

Radium-223 for patients with metastatic castration-resistant prostate cancer with asymptomatic bone metastases progressing on first-line abiraterone acetate or enzalutamide: A single-arm phase II trial Carles Galceran, Joan Mellado, Begoña Méndez-Vidal, María J. Vázquez, Sergio Gonzalez-del-Alba, Aranzazu Morales Barrera, Rafael Alonso-Gordoa, Teresa Pròstata - Càncer - Tractament Antiandrògens - Ús terapèutic Avaluació de resultats (Assistència sanitària) DISEASES::Neoplasms::Neoplasms by Site::Urogenital Neoplasms::Genital Neoplasms, Male::Prostatic Neoplasms::Prostatic Neoplasms, Castration-Resistant Other subheadings::Other subheadings::Other subheadings::/drug therapy CHEMICALS AND DRUGS::Hormones, Hormone Substitutes, and Hormone Antagonists::Hormone Antagonists::Androgen Antagonists ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT::Diagnosis::Prognosis::Treatment Outcome ENFERMEDADES::neoplasias::neoplasias por localización::neoplasias urogenitales::neoplasias de los genitales masculinos::neoplasias de la próstata::neoplasias prostáticas resistentes a la castración Otros calificadores::Otros calificadores::Otros calificadores::/farmacoterapia COMPUESTOS QUÍMICOS Y DROGAS::hormonas, sustitutos de hormonas y antagonistas de hormonas::antagonistas de hormonas::antagonistas de andrógenos TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS::diagnóstico::pronóstico::resultado del tratamiento Bone metastases; Metastatic castration-resistant prostate cancer Metástasis óseas; Cáncer de próstata metastásico resistente a la castración Metàstasis òssies; Càncer de pròstata resistent a la castració metastàtic Purpose The paper aims to evaluate the efficacy and safety of 223Ra in patients who progressed after first-line androgen deprivation therapy. Patients and methods EXCAAPE (NCT03002220) was a multicentre, single-arm, open-label, non-controlled phase IIa trial in 52 patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases who have progressed on abiraterone acetate or enzalutamide, up to six doses of 223Ra (55 kBq/kg of body weight per month). The primary end-point was radiographic progression-free survival (rPFS). Secondary end-points included rPFS based on androgen receptor splice variant 7 (AR-V7) expression in circulating tumour cells (CTCs), overall survival, and safety. Results Median rPFS was 5.5 months (95% CI 5.3–5.5). Median rPFS of patients with AR-V7(−) CTCs was longer than that of patients with AR-V7(+) CTCs (5.5 versus 2.2 months, respectively; P = 0.056). Median overall survival was 14.8 months (95% CI 11.2–not reached) and was significantly greater for AR-V7(−) patients than for AR-V7(+) patients (14.8 months versus 3.5 months, respectively; P < 0.01). 223Ra was well tolerated; anaemia and thrombocytopenia were the most common grade 3/4 adverse events (5.8% and 11.5%, respectively). Conclusions 223Ra seems to be a reasonable treatment for patients with metastatic castration-resistant prostate cancer and asymptomatic bone metastases progressing on novel hormonal therapy and had an acceptable safety profile. The study was conceived and designed by Joan Carles in collaboration with Medica Scientia Innovation Research (MEDSIR). MEDSIR, as legal sponsor of the study, is responsible for compliance with all clinical and regulatory procedures and adherence to the study protocol. MEDSIR had a role in study design, collection, management, analysis, and interpretation of the data and writing of the report. Bayer Inc. funded the study and provided 223Ra. The funder of the study had no role in data collection, management, data analysis, data interpretation, writing of the report, or decision to submit the manuscript for publication. All authors had full access to the data used to prepare the manuscript and participated in writing, editing, and/or critically reviewing the manuscript. The manuscript was written with editorial support from a medical writer, funded by MEDSIR. The corresponding author had final responsibility for the decision to submit for publication. 2023-11-08T10:18:40Z 2023-11-08T10:18:40Z 2023-11-08T10:18:40Z 2022-10-27T07:21:52Z 2022-10-27T07:21:52Z 2022-09 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion http://hdl.handle.net/11351/8356 European Journal of Cancer;173 https://doi.org/10.1016/j.ejca.2022.06.057 Attribution-NonCommercial-NoDerivatives 4.0 International http://creativecommons.org/licenses/by-nc-nd/4.0/ info:eu-repo/semantics/openAccess Elsevier Scientia