{"title":"[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。","authors":"Swayamjeet Satapathy, Bhagwant Rai Mittal, Ashwani Sood, Chandan Krushna Das, Ravimohan Suryanarayan Mavuduru, Shikha Goyal, Jaya Shukla, Shrawan Kumar Singh","doi":"10.2967/jnumed.123.266141","DOIUrl":null,"url":null,"abstract":"<p><p>The prostate-specific membrane antigen (PSMA) inhibitor [<sup>177</sup>Lu]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. <b>Methods:</b> Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [<sup>177</sup>Lu]Lu-PSMA-617 (<i>n</i> = 20) or docetaxel (<i>n</i> = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan-Meier curves and the Cox regression model. <b>Results:</b> The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [<sup>177</sup>Lu]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 (<i>P</i> = 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 (<i>P</i> = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. <b>Conclusion:</b> Long-term outcomes with [<sup>177</sup>Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.</p>","PeriodicalId":16758,"journal":{"name":"Journal of Nuclear Medicine","volume":" ","pages":"1726-1729"},"PeriodicalIF":9.1000,"publicationDate":"2023-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"[<sup>177</sup>Lu]Lu-PSMA-617 Versus Docetaxel in Chemotherapy-Naïve Metastatic Castration-Resistant Prostate Cancer: Final Survival Analysis of a Phase 2 Randomized, Controlled Trial.\",\"authors\":\"Swayamjeet Satapathy, Bhagwant Rai Mittal, Ashwani Sood, Chandan Krushna Das, Ravimohan Suryanarayan Mavuduru, Shikha Goyal, Jaya Shukla, Shrawan Kumar Singh\",\"doi\":\"10.2967/jnumed.123.266141\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>The prostate-specific membrane antigen (PSMA) inhibitor [<sup>177</sup>Lu]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. <b>Methods:</b> Forty chemotherapy-naïve, PSMA-positive metastatic castration-resistant prostate cancer patients were randomly assigned to [<sup>177</sup>Lu]Lu-PSMA-617 (<i>n</i> = 20) or docetaxel (<i>n</i> = 20). Thirty-five patients received treatment per the protocol. Survival analysis was done using Kaplan-Meier curves and the Cox regression model. <b>Results:</b> The mean follow-up duration was 33.4 mo. In intention-to-treat analysis, the median OS for the [<sup>177</sup>Lu]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 (<i>P</i> = 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 (<i>P</i> = 0.712). No significant difference in OS was observed between the 2 arms across the analyzed subgroups. <b>Conclusion:</b> Long-term outcomes with [<sup>177</sup>Lu]Lu-PSMA-617 administered earlier in the prechemotherapy setting are comparable to those with docetaxel.</p>\",\"PeriodicalId\":16758,\"journal\":{\"name\":\"Journal of Nuclear Medicine\",\"volume\":\" \",\"pages\":\"1726-1729\"},\"PeriodicalIF\":9.1000,\"publicationDate\":\"2023-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Nuclear Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2967/jnumed.123.266141\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2023/9/14 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Nuclear Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2967/jnumed.123.266141","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2023/9/14 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
[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.
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.