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TALAPRO-2 研究结果的简明报告:他拉唑帕尼联合恩扎卢胺对比安慰剂联合恩扎卢胺用于晚期前列腺癌患者。

Plain language summary of the results from the TALAPRO-2 study: Talazoparib plus enzalutamide versus placebo plus enzalutamide for patients with advanced prostate cancer.

机构信息

Huntsman Cancer Institute (NCI-CCC), University of Utah, Salt Lake City, UT, USA.

Peter MacCallum Cancer Centre, Melbourne, Victoria, Australia.

出版信息

Future Oncol. 2024;20(29):2123-2135. doi: 10.1080/14796694.2024.2362108. Epub 2024 Jul 12.

DOI:10.1080/14796694.2024.2362108
PMID:38995237
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11524199/
Abstract

WHAT IS THIS SUMMARY ABOUT?: This summary describes the results from the TALAPRO-2 research study (also known as a clinical trial). The TALAPRO-2 study tested the combination of two medicines called talazoparib plus enzalutamide. This combination of medicines was used as the first treatment for adult patients with metastatic castration-resistant prostate cancer. The combination of talazoparib plus enzalutamide was compared with a placebo plus enzalutamide.

WHAT IS METASTATIC CASTRATION-RESISTANT PROSTATE CANCER?: Metastatic castration-resistant prostate cancer is a type of cancer that starts in the prostate and has spread to other parts of the body. Castration-resistant means that the cancer continues to grow even when testosterone levels in the blood are reduced to very low levels. Taking medicines to lower testosterone levels in the blood is a standard treatment for men with advanced prostate cancer.

WHAT ARE THE AIMS OF THE TALAPRO-2 TRIAL?: TALAPRO-2 looked at if combining talazoparib plus enzalutamide would increase the length of time patients lived before their cancer got worse or they died compared with a placebo plus enzalutamide. Researchers looked at how treatment affected the size and number of tumors and the length of time before patients needed to change to a new cancer medicine. Researchers also looked at any side effects patients had during the study.

WHAT ARE THE KEY TAKEAWAYS?: A total of 805 patients with metastatic castration-resistant prostate cancer took part in the study. Compared with patients who took a placebo plus enzalutamide, the group of patients who took talazoparib plus enzalutamide had a 37% reduced risk of their cancer getting worse or dying. Some patients had tumors that at the start of the study could be measured with scans. Sixty-two percent of patients who took talazoparib plus enzalutamide had their tumors decrease or shrink to the point that they could no longer be seen on scans versus 44% of patients who took a placebo plus enzalutamide. Patients who took talazoparib plus enzalutamide were more likely to have a longer time before they needed to change to a new cancer medicine. The most common side effects of talazoparib plus enzalutamide were low levels of red blood cells (66% of patients) and neutrophils (36% of patients), and excessive tiredness or exhaustion (34% of patients). NCT03395197 (TALAPRO-2) (ClinicalTrials.gov).

摘要

这段文本描述了 TALAPRO-2 研究(也称为临床试验)的结果。TALAPRO-2 研究测试了两种药物——他拉唑帕利加恩扎卢胺的联合用药。这种联合用药被用作转移性去势抵抗性前列腺癌成年患者的一线治疗药物。他拉唑帕利加恩扎卢胺与安慰剂加恩扎卢胺进行了比较。

转移性去势抵抗性前列腺癌是一种起始于前列腺并已扩散到身体其他部位的癌症。去势抵抗意味着即使血液中的睾酮水平降低到非常低的水平,癌症仍会继续生长。服用降低血液中睾酮水平的药物是晚期前列腺癌男性的标准治疗方法。

TALAPRO-2 研究旨在观察他拉唑帕利加恩扎卢胺联合用药是否能延长患者的无进展生存期,即癌症恶化或死亡的时间,与安慰剂加恩扎卢胺相比。研究人员观察了治疗对肿瘤大小和数量的影响,以及患者需要改用新的癌症药物之前的时间。研究人员还观察了患者在研究期间的任何副作用。

共有 805 名转移性去势抵抗性前列腺癌患者参加了这项研究。与服用安慰剂加恩扎卢胺的患者相比,服用他拉唑帕利加恩扎卢胺的患者癌症恶化或死亡的风险降低了 37%。一些患者在研究开始时可以通过扫描测量肿瘤。服用他拉唑帕利加恩扎卢胺的患者中有 62%的肿瘤缩小或消失,以至于在扫描上无法看到,而服用安慰剂加恩扎卢胺的患者中有 44%。服用他拉唑帕利加恩扎卢胺的患者需要改用新的癌症药物的时间更长。他拉唑帕利加恩扎卢胺最常见的副作用是红细胞计数降低(66%的患者)和中性粒细胞计数降低(36%的患者)以及过度疲劳或乏力(34%的患者)。NCT03395197(TALAPRO-2)(ClinicalTrials.gov)。