Do Indian men have similar oncological outcomes with abiraterone plus androgen deprivation therapy in the setting of metastatic hormone-sensitive prostate cancer? A prospective observational study

IF 17.7 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-07-01 DOI:10.4103/iju.iju_459_23
S. Mandal, Vivek Tarigopula, S. Kumaraswamy, M. Das, Sambit Tripathy, Kalandi Barik, P. Nayak
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Abstract

Combination of abiraterone with androgen deprivation therapy (ADT) has better survival outcomes than ADT alone in metastatic Hormone-sensitive prostate cancer (mHSPC) in the Western population. In this prospective (Clinical Trials Registry-India [CTRI] registered) observational study, we present the comparative oncological outcomes of ADT alone and ADT + abiraterone in Indian patients, which is not available currently. This study (CTRI-number-CTRI/2020/07/026545) included newly diagnosed mHSPC patients from January 2020 to June 2023 in a tertiary care hospital, urology department. Patients fulfilling inclusion criteria were advised ADT with abiraterone (A + ADT), and those not affording received ADT monotherapy (ADT). The primary endpoint was overall survival (OS). Secondary outcomes included prostate-specific antigen (PSA) decline >90%, radiographic progression-free survival (rPFS), and PSA progression-free survival (pPFS). Out of 278 patients with mHSPC, 163 patients were excluded and 115 were analyzed (ADT = 40 vs. A + ADT = 75). After a median follow-up of 20.3 months, 11 of 40 (27.5%) in ADT-only arm and 15 of 75 (20%) in ADT + abiraterone arm had died (Hazard-ratio of death 0.72; 95% confidence interval 0.68–0.88; P < 0.001). A PSA decline of >90% was seen in 85% in the ADT alone group and 93.3% in the ADT + abiraterone group. Significantly better outcomes of the ADT + abiraterone were seen in the secondary endpoints of rPFS (P < 0.001) and pPFS (P < 0.001). The OS benefit was 28% reduction in risk of death in our study versus 37% and 38% in STAMPEDE and LATITUDE, respectively. pPFS and rPFS were also poorer in Indian subsets. Abiraterone with ADT improves OS, PSA response, rPFS, and pPFS in the Indian population akin to the Western data but with poorer OS, rPFS, and PSA progression-free survival on comparison.
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对于转移性激素敏感性前列腺癌患者,阿比特龙加雄激素剥夺疗法对印度男性的肿瘤治疗效果相似吗?前瞻性观察研究
在西方人群中,对于转移性激素敏感性前列腺癌(mHSPC)患者,阿比特龙与雄激素剥夺疗法(ADT)的联合治疗比单独使用 ADT 有更好的生存效果。在这项前瞻性(注册于印度临床试验注册中心 [CTRI])观察性研究中,我们对印度患者进行了单纯 ADT 和 ADT + 阿比特龙的肿瘤治疗效果比较,目前尚无相关数据。 这项研究(CTRI 编号-CTRI/2020/07/026545)纳入了一家三级医院泌尿科在 2020 年 1 月至 2023 年 6 月期间新诊断出的 mHSPC 患者。符合纳入标准的患者被建议接受阿比特龙联合 ADT(A+ADT)治疗,无法负担的患者则接受 ADT 单药治疗(ADT)。主要终点是总生存期(OS)。次要结局包括前列腺特异性抗原(PSA)下降>90%、放射学无进展生存期(rPFS)和PSA无进展生存期(pPFS)。 在278名mHSPC患者中,163名患者被排除在外,115名患者接受了分析(ADT = 40 vs. A + ADT = 75)。中位随访20.3个月后,纯ADT组40例患者中有11例(27.5%)死亡,ADT+阿比特龙组75例患者中有15例(20%)死亡(死亡危险比为0.72;95%置信区间为0.68-0.88;P<0.001)。单纯ADT组中有85%的患者PSA下降>90%,ADT+阿比特龙组中有93.3%的患者PSA下降>90%。在次要终点rPFS(P<0.001)和pPFS(P<0.001)中,ADT+阿比特龙组的疗效显著更好。在我们的研究中,OS的获益是死亡风险降低28%,而在STAMPEDE和LATITUDE中分别为37%和38%。 阿比特龙联合ADT可改善印度人群的OS、PSA反应、rPFS和pPFS,这与西方的数据相似,但OS、rPFS和PSA无进展生存期较差。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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