[177Lu]Lu-PSMA-617与多西他赛在化疗中的比较——转移性Castion-Ristant前列腺癌癌症:2期随机对照试验的最终生存分析。

IF 9.1 1区 医学 Q1 RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING Journal of Nuclear Medicine Pub Date : 2023-11-01 Epub Date: 2023-09-14 DOI:10.2967/jnumed.123.266141
Swayamjeet Satapathy, Bhagwant Rai Mittal, Ashwani Sood, Chandan Krushna Das, Ravimohan Suryanarayan Mavuduru, Shikha Goyal, Jaya Shukla, Shrawan Kumar Singh
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引用次数: 0

摘要

前列腺特异性膜抗原(PSMA)抑制剂[177Lu]Lu-PSMA-617先前已被证明在化疗幼稚的转移性去势抵抗性前列腺癌症患者中实现生化反应方面不劣于多烯紫杉醇。在此,我们报告了一项2期随机对照试验的总生存率(OS)的最终分析。方法:将40例化疗幼稚、PSMA阳性转移性去势耐药前列腺癌症患者随机分为[177Lu]Lu-PSMA-617(n=20)或多西他赛(n=20。35名患者按照方案接受了治疗。使用Kaplan-Meier曲线和Cox回归模型进行生存分析。结果:平均随访时间为33.4 在意向治疗分析中,[177Lu]Lu-PSMA-617和多西他赛组的中位OS为15.0 mo(95%置信区间,9.5-20.5 mo)和15.0 mo(95%置信区间,8.1-21.9 mo)(P=0.905)。在按方案分析中,中位OS为19.0 mo(95%置信区间,12.3-25.7 mo)与15.0 mo(95%置信区间,8.1-21.9 mo)(P=0.712)。在所分析的亚组中,两组之间的OS没有观察到显著差异。结论:在化疗前早期给予[177Lu]Lu-PSMA-617的长期疗效与多西他赛相当。
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[177Lu]Lu-PSMA-617 Versus Docetaxel in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Final Survival Analysis of a Phase 2 Randomized, Controlled Trial.

The prostate-specific membrane antigen (PSMA) inhibitor [177Lu]Lu-PSMA-617 has been previously demonstrated to be noninferior to docetaxel in achieving a biochemical response in chemotherapy-naïve metastatic castration-resistant prostate cancer patients. Here, we report the final analysis of overall survival (OS) for a phase 2 randomized, controlled trial. Methods: Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [177Lu]Lu-PSMA-617 (n = 20) or docetaxel (n = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan-Meier curves and the Cox regression model. Results: The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [177Lu]Lu-PSMA-617 and docetaxel arms was 15.0 mo (95% CI, 9.5-20.5 mo) and 15.0 mo (95% CI, 8.1-21.9 mo), respectively (P = 0.905). In per-protocol analysis, the median OS was 19.0 mo (95% CI, 12.3-25.7 mo) versus 15.0 mo (95% CI, 8.1-21.9 mo), respectively (P = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. Conclusion: Long-term outcomes with [177Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.

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来源期刊
Journal of Nuclear Medicine
Journal of Nuclear Medicine 医学-核医学
CiteScore
13.00
自引率
8.60%
发文量
340
审稿时长
1 months
期刊介绍: The Journal of Nuclear Medicine (JNM), self-published by the Society of Nuclear Medicine and Molecular Imaging (SNMMI), provides readers worldwide with clinical and basic science investigations, continuing education articles, reviews, employment opportunities, and updates on practice and research. In the 2022 Journal Citation Reports (released in June 2023), JNM ranked sixth in impact among 203 medical journals worldwide in the radiology, nuclear medicine, and medical imaging category.
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