Darolutamide in Spanish patients with nonmetastatic castration-resistant prostate cancer: ARAMIS subgroup analysis.

Aim: Darolutamide significantly prolonged metastasis-free survival (MFS) versus placebo in the Phase III ARAMIS study. We analyzed outcomes in Spanish participants in ARAMIS. Patients & methods: Patients with high-risk nonmetastatic castration-resistant prostate cancer were randomized 2:1 to darolutamide 600 mg twice daily or placebo, plus androgen-deprivation therapy.

The primary end point was MFS. Descriptive statistics are reported for this post hoc analysis. Results: In Spanish participants, darolutamide (n = 75) prolonged MFS versus placebo (n = 42): hazard ratio 0.345, 95% confidence interval 0.175-0.681. The incidence and type of treatment-emergent adverse events were comparable between treatment arms. Conclusion: For Spanish participants in ARAMIS, efficacy outcomes favored darolutamide versus placebo, with a similar safety profile, consistent with the overall ARAMIS population. Clinical Trials Registration: NCT02200614 (ClinicalTrials.gov).

Reduced risk of cancer spreading in Spanish patients with nonmetastatic castration-resistant prostate cancer treated with darolutamide in the global ARAMIS study Darolutamide is an oral treatment for a type of prostate cancer that has stopped responding to other treatments and is at risk of spreading to other parts of the body (termed “nonmetastatic castration-resistant prostate cancer” or “nmCRPC”). In the international ARAMIS study, patients treated with darolutamide lived longer without their cancer spreading than patients who were given placebo (sugar) pills. We wanted to know whether Spanish patients in ARAMIS had similar characteristics and treatment outcomes to other patients in the study. We found that the 75 Spanish patients who were treated with darolutamide had a significantly lower risk of their cancer spreading than the 42 Spanish patients who received placebo. The two groups of Spanish patients had similar side effects.

Future oncology (London, England). 2023 May 24 [Epub ahead of print]

Joan Carles, Rafael A Medina-Lopez, Javier Puente, Álvaro Gómez-Ferrer, Javier Casas Nebra, María Isabel Sáez Medina, Maria J Ribal, Alfredo Rodríguez Antolín, José Luís Álvarez-Ossorio, José Francisco Suárez Novo, Cristina Moretones Agut, Shankar Srinivasan, Jorge Ortiz, Karim Fizazi

Vall d'Hebron Institute of Oncology, Hospital Universitari Vall d'Hebron, Barcelona, Spain., Urology Department, Vírgen del Rocío University Hospital, Seville, Spain., Medical Oncology Department, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria del Hospital Clínico San Carlos (IdISSC), CIBERONC, Madrid, Spain., Instituto Valenciano de Oncologia, Valencia, Spain., Hospital Universitario Lucus Augusti, Lugo, Spain., UGCI of Medical Oncology, Hospitales Regional & Universitario Virgen de la Victoria, IBIMA, UMA, Malaga, Spain., Uro-Oncology Unit, Hospital Clinic, University of Barcelona, Barcelona, Spain., Hospital Universitario 12 de Octubre, Madrid, Spain., Department of Urology, Puerta del Mar University Hospital, Cádiz, Spain., Hospital Universitari de Bellvitge, l'Hospitalet de Llobregat, Spain., Bayer Hispania, SL, Sant Joan Despí, Spain., Bayer HealthCare, Whippany, NJ 07981, USA., Institut Gustave Roussy, University of Paris-Saclay, Villejuif, France.