医学
醋酸阿比特龙酯
前列腺癌
临床终点
泌尿科
内科学
相伴的
危险系数
随机对照试验
前列腺
强的松
放射治疗
肿瘤科
雄激素剥夺疗法
胃肠病学
癌症
置信区间
作者
Giulio Francolini,Andrea Gaetano Allegra,Beatrice Detti,Vanessa Di Cataldo,Saverio Caini,Alessio Bruni,Gianluca Ingrosso,Rolando Maria D’Angelillo,A.R. Alitto,Matteo Augugliaro,Luca Triggiani,Silvana Parisi,Gaetano Facchini,Marco Banini,Gabriele Simontacchi,Isacco Desideri,Icro Meattini,Richard K. Valicenti,Lorenzo Livi,Giulia Marvaso
摘要
PURPOSE ARTO (ClinicalTrials.gov identifier: NCT03449719 ) is a multicenter, phase II randomized clinical trial testing the benefit of adding stereotactic body radiation therapy (SBRT) to abiraterone acetate and prednisone (AAP) in patients with oligometastatic castrate-resistant prostate cancer (CRPC). MATERIALS AND METHODS All patients were affected by oligometastatic CRPC as defined as three or less nonvisceral metastatic lesions. Patients were randomly assigned 1:1 to receive either AAP alone (control arm) or AAP with concomitant SBRT to all the sites of disease (experimental arm). Primary end point was the rate of biochemical response (BR), defined as a prostate-specific antigen (PSA) decrease ≥50% from baseline measured at 6 months from treatment start. Complete BR (CBR), defined as PSA < 0.2 ng/mL at 6 months from treatment, and progression-free survival (PFS) were secondary end points. RESULTS One hundred and fifty-seven patients were enrolled between January 2019 and September 2022. BR was detected in 79.6% of patients (92% v 68.3% in the experimental v control arm, respectively), with an odds ratio (OR) of 5.34 (95% CI, 2.05 to 13.88; P = .001) in favor of the experimental arm. CBR was detected in 38.8% of patients (56% v 23.2% in the experimental v control arm, respectively), with an OR of 4.22 (95% CI, 2.12 to 8.38; P < .001). SBRT yielded a significant PFS improvement, with a hazard ratio for progression of 0.35 (95% CI, 0.21 to 0.57; P < .001) in the experimental versus control arm. CONCLUSION The trial reached its primary end point of biochemical control and PFS, suggesting a clinical advantage for SBRT in addition to first-line AAP treatment in patients with metastatic castration-resistant prostate cancer.
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