Randomized, Open-Label Phase 2 Study of Apalutamide plus Androgen Deprivation Therapy versus Apalutamide Monotherapy versus Androgen Deprivation Monotherapy in Patients with Biochemically Recurrent Prostate Cancer.

IF 2.3 Q3 ONCOLOGY Prostate Cancer Pub Date : 2022-01-01 DOI:10.1155/2022/5454727
Rahul Aggarwal, Joshi J Alumkal, Russell Z Szmulewitz, Celestia S Higano, Alan H Bryce, Angela Lopez-Gitlitz, Sharon A McCarthy, Branko Miladinovic, Kelly McQuarrie, Shibu Thomas, Ke Zhang, Eric J Small
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Abstract

Purpose: This randomized phase 2 study sought to assess the treatment effect of a finite duration of apalutamide with and without androgen deprivation therapy (ADT) in biochemically recurrent prostate cancer (BCR PC). Materials and Methods. Patients with BCR PC after primary definitive therapy and prostate-specific antigen (PSA) doubling time ≤12 months were randomized to open-label apalutamide (240 mg/d) alone, apalutamide plus ADT, or ADT alone (1 : 1:1 ratio) for 12 months followed by a 12-month observation period (NCT01790126). Mean changes from baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) at 12 months (primary endpoint) and other prespecified assessments of health-related quality of life (HRQoL), PSA nadir, time to PSA progression, time to testosterone recovery, recovered testosterone >150 ng/dL without PSA progression at 24 months, and molecular markers were evaluated.

Results: In 90 enrolled patients (apalutamide plus ADT (n = 31), apalutamide (n = 29), ADT (n = 30)), FACT-P at 12 months was not significantly different between apalutamide, ADT and apalutamide, and ADT groups. Addition of apalutamide to ADT prolonged time to PSA progression but this change did not reach statistical significance (hazard ratio (HR): 0.56, 95% confidence interval (CI): 0.23-1.36, P=0.196); time to testosterone recovery was similar in the ADT-containing groups. In apalutamide plus ADT, apalutamide, and ADT groups, 37.9%, 37.0%, and 19.2% of patients, respectively, had testosterone >150 ng/dL at 24 months without confirmed PSA progression. Of the few biomarkers expressed in blood, EPHA3 was significantly associated with shorter time to PSA progression (P=0.02) in the overall population.

Conclusions: HRQoL was similar in patients treated with apalutamide alone, ADT alone, or their combination, although apalutamide plus ADT did not demonstrate statistically significant noninferiority in change from baseline in overall HRQoL. The aggregated efficacy and safety outcomes support further evaluation of apalutamide plus ADT in BCR PC.

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阿帕鲁胺加雄激素剥夺治疗与阿帕鲁胺单药治疗与雄激素剥夺单药治疗在生化复发前列腺癌患者中的随机、开放标签2期研究
目的:这项随机2期研究旨在评估阿帕鲁胺联合或不联合雄激素剥夺治疗(ADT)对生化复发性前列腺癌(BCR PC)的治疗效果。材料与方法。原发性确诊治疗后,前列腺特异性抗原(PSA)翻倍时间≤12个月的BCR PC患者,随机分为单独使用开放标签阿帕鲁胺(240 mg/d)、阿帕鲁胺加ADT或单独使用ADT(1:1比例)治疗12个月,然后进行12个月的观察(NCT01790126)。12个月(主要终点)时癌症治疗-前列腺功能评估(FACT-P)和其他预先规定的健康相关生活质量(HRQoL)、PSA最低点、PSA进展时间、睾酮恢复时间、24个月时恢复睾酮>150 ng/dL且PSA无进展的平均变化,以及分子标记物进行评估。结果:90例入选患者(阿帕鲁胺加ADT (n = 31),阿帕鲁胺加ADT (n = 29), ADT (n = 30)), 12个月时的FACT-P在阿帕鲁胺、ADT加阿帕鲁胺组和ADT组之间无显著差异。在ADT中加入阿帕鲁胺延长了PSA进展的时间,但这种变化没有达到统计学意义(风险比(HR): 0.56, 95%可信区间(CI): 0.23-1.36, P=0.196);睾酮恢复时间与adt组相似。在阿帕鲁胺加ADT、阿帕鲁胺和ADT组中,分别有37.9%、37.0%和19.2%的患者在24个月时睾酮>150 ng/dL,未确诊PSA进展。在血液中表达的少数生物标志物中,EPHA3与总体人群中较短的PSA进展时间显著相关(P=0.02)。结论:单独使用阿帕鲁胺、单独使用ADT或联合使用阿帕鲁胺治疗的患者的HRQoL相似,尽管阿帕鲁胺加ADT在总体HRQoL的基线变化方面没有统计学意义上的显着非劣效性。综合疗效和安全性结果支持进一步评估阿帕鲁胺加ADT治疗BCR PC。
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来源期刊
Prostate Cancer
Prostate Cancer ONCOLOGY-
CiteScore
2.70
自引率
0.00%
发文量
9
审稿时长
13 weeks
期刊介绍: Prostate Cancer is a peer-reviewed, Open Access journal that provides a multidisciplinary platform for scientists, surgeons, oncologists and clinicians working on prostate cancer. The journal publishes original research articles, review articles, and clinical studies related to the diagnosis, surgery, radiotherapy, drug discovery and medical management of the disease.
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