Darolutamide Maintenance in Patients With Metastatic Castration-Resistant Prostate Cancer With Nonprogressive Disease After Taxane Treatment (SAKK 08/16).

Autor:	Gillessen S; EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.; Faculty of Biomedical Sciences, USI, Lugano, Switzerland., Procopio G; Fondazione Istituto Nazionale dei Tumori, Milano, Italy., Hayoz S; Competence Center of SAKK, Bern, Switzerland., Kremer E; Competence Center of SAKK, Bern, Switzerland., Schwitter M; Division of Oncology/Hematology, Kantonsspital Graubünden, Chur, Switzerland., Caffo O; Presidio Ospedaliero Santa Chiara, Trento, Italy., Lorente D; Consorci Hospitalari Provincial de Castellón, Castellón de la Plana, Spain., Pedrazzini A; Fondazione Oncologia Lago Maggiore, Locarno, Switzerland., Roubaud G; Institut Bergonié, Bordeaux, France., Nenan S; Unicancer, Département de la recherche et développement, Groupe d'étude des tumeurs urogénitales (GETUG), Paris, France., Omlin A; Department of Hematology and Oncology, Kantonsspital St Gallen, St Gallen, Switzerland.; Onkozentrum Zürich Seefeld, Zürich, Switzerland., Buttigliero C; Department of Oncology, University of Torino, S. Luigi Hospital, Orbassano (Torino), Italy., Delgado Mingorance JI; Hospital Infanta Cristina, Badajoz, Spain., González-Del-Alba A; Department of Medical Oncology, Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain., Delgado MT; Hospital Universitario San Cecilio, Granada, Spain., Nole F; Istituto Europeo di Oncologia (IEO), Milano, Italy., Turco F; EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.; Department of Oncology, University of Torino, S. Luigi Hospital, Orbassano (Torino), Italy., Pereira Mestre R; EOC-Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland., Ribi K; Competence Center of SAKK, Bern, Switzerland.; IBCSG Coordinating Office, Bern, Switzerland., Cathomas R; Division of Oncology/Hematology, Kantonsspital Graubünden, Chur, Switzerland.
Jazyk:	angličtina
Zdroj:	Journal of clinical oncology : official journal of the American Society of Clinical Oncology [J Clin Oncol] 2023 Jul 10; Vol. 41 (20), pp. 3608-3615. Date of Electronic Publication: 2023 Feb 08.
DOI:	10.1200/JCO.22.01726
Abstrakt:	Purpose: To assess the efficacy and safety of darolutamide maintenance after successful taxane chemotherapy in patients with metastatic castration-resistant prostate cancer (mCRPC). Patients and Methods: Swiss Group for Clinical Cancer Research (SAKK) 08/16 is a randomized phase II study. Patients with mCRPC who received prior androgen-receptor pathway inhibitors (ARPIs) and subsequently had nonprogressive disease on a taxane were randomly assigned to darolutamide 600 mg twice a day or placebo twice a day. The primary end point was radiographic progression-free survival (rPFS) at 12 weeks. Secondary end points were rPFS, event-free survival, overall survival (OS), prostate-specific antigen (PSA) 50% response rate, and adverse events. Results: Overall, 92 patients were recruited by 26 centers. Prior taxane was docetaxel in 93% and cabazitaxel in 7%. Prior ARPI was abiraterone in 60%, enzalutamide in 31%, and both in 9%. rPFS at 12 weeks was significantly improved with darolutamide (64.7% v 52.2%; P = .127). Median rPFS on darolutamide was 5.5 versus 4.5 months on placebo (hazard ratio [HR], 0.54 [95% CI, 0.32 to 0.91]; P = .017), and median event-free survival was 5.4 versus 2.9 months (HR, 0.46 [95% CI, 0.29 to 0.73]; P = .001). PSA 50% response rate was improved (22% v 4%; P = .014). Median OS for darolutamide was 24 versus 21.3 months for placebo (HR, 0.62 [95% CI, 0.3 to 1.26]; P = .181). Treatment-related adverse events were similar in both arms. Conclusion: SAKK 08/16 met its primary end point, showing that switch maintenance with darolutamide after prior taxane chemotherapy and at least one ARPI resulted in a statistically significant but clinically modest rPFS prolongation with good tolerability. The median OS with darolutamide maintenance appears promising. Should these findings be confirmed in a larger trial, maintenance treatment could be a novel strategy in managing patients with mCRPC, especially those who responded well to prior ARPI.
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu