Tumor regression after neoadjuvant hormonal therapy in high risk prostate cancer: pathological outcomes from a randomized phase II trial.

IF 2.8 2区 医学 Q2 UROLOGY & NEPHROLOGY
Leonardo Cardili, Diogo Assed Bastos, Eder Nisi Ilario, Marina Alessandra Pereira, Giuliano Bettoni Guglielmetti, Maurício Cordeiro, José Pontes, Rafael Ferreira Coelho, William Carlos Nahas, Katia Ramos Moreira Leite
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Abstract

Purpose: High-risk localized prostate cancer (HRLPC) commonly progresses to metastatic disease after local treatment. Neoadjuvant androgen deprivation therapy (nADT) before radical prostatectomy (RP) has recently been suggested to improve early oncological outcomes in HRLPC. We aimed to perform an exploratory analysis of the pathological outcomes from a prospective trial testing nADT before RP.

Methods: Prospective, single-centered, phase II, randomized trial performed between October 2018 and July 2021. Random assignment (1:1) for nADT modalities: goserelin (10.8 mg) plus abiraterone acetate (1000 mg/d) plus prednisone (5 mg/d), with or without apalutamide (240 mg/d) for 12 weeks, followed by RP (within 30 days) and extended lymph node dissection. Baseline clinical and pathological variables were assessed in needle biopsies before nADT. Tumor regression was histologically evaluated in surgical specimens using the residual cancer burden index (RCB).

Results: Sixty-two patients reached the surgical phase. Good response (RCB ≤ 0.25 cm³) was achieved in 14 patients (22.5%). Overall stage migration rate between baseline status (MRI before nADT) and final status (after surgery) was 27.4%. Late stage detection (high tumor burden, perineural invasion) and altered PTEN/ERG immunostatus showed significant association with poor response in univariate analysis. Higher baseline tumor burden was the only independent factor related to poor response in multivariate analysis.

Conclusions: There are subgroups of patients, such as those with low baseline cancer burden and PTEN/ERG wild-type status, more likely to achieve good response with nADT. In the case of long term oncological benefit to be proven, nADT might be an additional therapeutic resource for these patients.

高危前列腺癌新辅助激素治疗后的肿瘤消退:一项随机 II 期试验的病理结果。
目的:高危局部前列腺癌(HRLPC)通常在局部治疗后发展为转移性疾病。最近有人提出,在根治性前列腺切除术(RP)前进行新辅助雄激素剥夺治疗(nADT)可改善HRLPC的早期肿瘤预后。我们的目的是对一项前瞻性试验的病理结果进行探索性分析,该试验测试了前列腺癌根治术前的 nADT:2018年10月至2021年7月期间进行的前瞻性、单一中心、II期随机试验。随机分配(1:1)nADT模式:戈舍瑞林(10.8毫克)加醋酸阿比特龙(1000毫克/天)加泼尼松(5毫克/天),加或不加阿帕鲁胺(240毫克/天),持续12周,然后进行RP(30天内)和扩大淋巴结清扫。在进行 nADT 之前,对针刺活检的临床和病理基线变量进行了评估。采用残留癌负担指数(RCB)对手术标本中的肿瘤消退情况进行组织学评估:结果:62 例患者进入手术阶段。结果:62 名患者进入了手术阶段,其中 14 名患者(22.5%)获得了良好反应(RCB ≤ 0.25 cm³)。基线状态(nADT前的磁共振成像)与最终状态(手术后)之间的总体分期迁移率为27.4%。在单变量分析中,晚期发现(高肿瘤负荷、神经周围侵犯)和PTEN/ERG免疫状态改变与不良反应有显著相关性。在多变量分析中,较高的基线肿瘤负荷是唯一与不良反应相关的独立因素:结论:有一些亚组患者,如基线肿瘤负荷低和PTEN/ERG野生型状态的患者,更有可能通过nADT获得良好反应。在长期肿瘤学获益有待证实的情况下,nADT 可能会成为这些患者的额外治疗资源。
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来源期刊
World Journal of Urology
World Journal of Urology 医学-泌尿学与肾脏学
CiteScore
6.80
自引率
8.80%
发文量
317
审稿时长
4-8 weeks
期刊介绍: The WORLD JOURNAL OF UROLOGY conveys regularly the essential results of urological research and their practical and clinical relevance to a broad audience of urologists in research and clinical practice. In order to guarantee a balanced program, articles are published to reflect the developments in all fields of urology on an internationally advanced level. Each issue treats a main topic in review articles of invited international experts. Free papers are unrelated articles to the main topic.
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