Giulia Giannini , Mona Kafka , Hannes Neuwirt , Nastasiia Artamonova , Gianpaolo di Santo , Irene Virgolini , Robert Dotzauer , Emil Deiss , Pia Paffenholz , Axel Heidenreich , Sazan Rasul , Igor Tsaur , Steffen Rausch , Holger Einspieler , Christian la Fougère , Nils F. Trautwein , Fabio Zattoni , Matteo Sepulcri , Isabel Heidegger
{"title":"223Radium 治疗后 177Lu-PSMA 治疗的安全性和有效性：多国真实世界回顾性分析","authors":"Giulia Giannini , Mona Kafka , Hannes Neuwirt , Nastasiia Artamonova , Gianpaolo di Santo , Irene Virgolini , Robert Dotzauer , Emil Deiss , Pia Paffenholz , Axel Heidenreich , Sazan Rasul , Igor Tsaur , Steffen Rausch , Holger Einspieler , Christian la Fougère , Nils F. Trautwein , Fabio Zattoni , Matteo Sepulcri , Isabel Heidegger","doi":"10.1016/j.clgc.2024.102260","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div><sup>177</sup>Lu PSMA therapy is increasingly used for metastatic castration-resistant prostate cancer (mCRPC) treatment. However, data on its efficacy and safety in patients previously treated with <sup>223</sup>Ra remain limited.</div></div><div><h3>Methods</h3><div>This retrospective, multicenter study evaluated 233 mCRPC patients treated with <sup>177</sup>Lu PSMA at 5 European centers. The cohort included 27 patients previously treated with <sup>223</sup>Ra and 206 Radium-naive patients. Statistical analyses, including Chi-squared, Mann-Whitney U tests, and multivariate logistic regression, were used to assess response and mortality. Predictors of response and mortality were identified using multivariate models.</div></div><div><h3>Results</h3><div>Patients who experienced a longer interval between castration resistance and the initiation of <sup>177</sup>Lu PSMA therapy demonstrated better responses (median 17 months in responders vs. 8.5 months in progressors, <em>P</em> = .001). Platelet counts were significantly lower in the progressive group compared to the responsive group (<em>P</em> = .01). Multivariate regression confirmed lower platelet levels as a predictor of poor response (<em>P</em> = .029). The overall response rate to <sup>177</sup>Lu PSMA was 54%, similar between the <sup>223</sup>Ra-pretreated and Radium-naive groups. However, mortality was significantly higher in the <sup>223</sup>Ra-pretreated group (86%) compared to the Radium-naive group (51%, <em>P</em> = .003). ECOG performance status (<em>P</em> = .004) and ALP levels (<em>P</em> = .030) were significant predictors of mortality, while CRP showed a trend towards significance (<em>P</em> = .064). Tolerability of <sup>177</sup>Lu PSMA was comparable to the safety profile reported in the literature, with 44% of <sup>223</sup>Ra-pretreated patients experiencing AEs and 22% experiencing severe AEs (Grade ≥ 3).</div></div><div><h3>Conclusions</h3><div><sup>177</sup>Lu PSMA therapy is effective and well-tolerated in mCRPC patients pretreated with <sup>223</sup>Ra. However, higher mortality was observed in the <sup>223</sup>Ra-pretreated group. ECOG PS, ALP, and platelet counts were significant predictors of response and mortality, and a longer interval between therapies was associated with better outcomes. These findings underscore the importance of treatment sequencing and monitoring prognostic markers.</div></div>","PeriodicalId":10380,"journal":{"name":"Clinical genitourinary cancer","volume":"23 1","pages":"Article 102260"},"PeriodicalIF":2.3000,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Safety and Efficacy of 177Lu-PSMA Therapy Following 223Radium Treatment: A Retrospective Multinational Real-World Analysis\",\"authors\":\"Giulia Giannini , Mona Kafka , Hannes Neuwirt , Nastasiia Artamonova , Gianpaolo di Santo , Irene Virgolini , Robert Dotzauer , Emil Deiss , Pia Paffenholz , Axel Heidenreich , Sazan Rasul , Igor Tsaur , Steffen Rausch , Holger Einspieler , Christian la Fougère , Nils F. Trautwein , Fabio Zattoni , Matteo Sepulcri , Isabel Heidegger\",\"doi\":\"10.1016/j.clgc.2024.102260\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div><sup>177</sup>Lu PSMA therapy is increasingly used for metastatic castration-resistant prostate cancer (mCRPC) treatment. However, data on its efficacy and safety in patients previously treated with <sup>223</sup>Ra remain limited.</div></div><div><h3>Methods</h3><div>This retrospective, multicenter study evaluated 233 mCRPC patients treated with <sup>177</sup>Lu PSMA at 5 European centers. The cohort included 27 patients previously treated with <sup>223</sup>Ra and 206 Radium-naive patients. Statistical analyses, including Chi-squared, Mann-Whitney U tests, and multivariate logistic regression, were used to assess response and mortality. Predictors of response and mortality were identified using multivariate models.</div></div><div><h3>Results</h3><div>Patients who experienced a longer interval between castration resistance and the initiation of <sup>177</sup>Lu PSMA therapy demonstrated better responses (median 17 months in responders vs. 8.5 months in progressors, <em>P</em> = .001). Platelet counts were significantly lower in the progressive group compared to the responsive group (<em>P</em> = .01). Multivariate regression confirmed lower platelet levels as a predictor of poor response (<em>P</em> = .029). The overall response rate to <sup>177</sup>Lu PSMA was 54%, similar between the <sup>223</sup>Ra-pretreated and Radium-naive groups. However, mortality was significantly higher in the <sup>223</sup>Ra-pretreated group (86%) compared to the Radium-naive group (51%, <em>P</em> = .003). ECOG performance status (<em>P</em> = .004) and ALP levels (<em>P</em> = .030) were significant predictors of mortality, while CRP showed a trend towards significance (<em>P</em> = .064). Tolerability of <sup>177</sup>Lu PSMA was comparable to the safety profile reported in the literature, with 44% of <sup>223</sup>Ra-pretreated patients experiencing AEs and 22% experiencing severe AEs (Grade ≥ 3).</div></div><div><h3>Conclusions</h3><div><sup>177</sup>Lu PSMA therapy is effective and well-tolerated in mCRPC patients pretreated with <sup>223</sup>Ra. However, higher mortality was observed in the <sup>223</sup>Ra-pretreated group. ECOG PS, ALP, and platelet counts were significant predictors of response and mortality, and a longer interval between therapies was associated with better outcomes. These findings underscore the importance of treatment sequencing and monitoring prognostic markers.</div></div>\",\"PeriodicalId\":10380,\"journal\":{\"name\":\"Clinical genitourinary cancer\",\"volume\":\"23 1\",\"pages\":\"Article 102260\"},\"PeriodicalIF\":2.3000,\"publicationDate\":\"2024-11-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Clinical genitourinary cancer\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1558767324002301\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical genitourinary cancer","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1558767324002301","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"ONCOLOGY","Score":null,"Total":0}
Safety and Efficacy of 177Lu-PSMA Therapy Following 223Radium Treatment: A Retrospective Multinational Real-World Analysis
Background
177Lu PSMA therapy is increasingly used for metastatic castration-resistant prostate cancer (mCRPC) treatment. However, data on its efficacy and safety in patients previously treated with 223Ra remain limited.
Methods
This retrospective, multicenter study evaluated 233 mCRPC patients treated with 177Lu PSMA at 5 European centers. The cohort included 27 patients previously treated with 223Ra and 206 Radium-naive patients. Statistical analyses, including Chi-squared, Mann-Whitney U tests, and multivariate logistic regression, were used to assess response and mortality. Predictors of response and mortality were identified using multivariate models.
Results
Patients who experienced a longer interval between castration resistance and the initiation of 177Lu PSMA therapy demonstrated better responses (median 17 months in responders vs. 8.5 months in progressors, P = .001). Platelet counts were significantly lower in the progressive group compared to the responsive group (P = .01). Multivariate regression confirmed lower platelet levels as a predictor of poor response (P = .029). The overall response rate to 177Lu PSMA was 54%, similar between the 223Ra-pretreated and Radium-naive groups. However, mortality was significantly higher in the 223Ra-pretreated group (86%) compared to the Radium-naive group (51%, P = .003). ECOG performance status (P = .004) and ALP levels (P = .030) were significant predictors of mortality, while CRP showed a trend towards significance (P = .064). Tolerability of 177Lu PSMA was comparable to the safety profile reported in the literature, with 44% of 223Ra-pretreated patients experiencing AEs and 22% experiencing severe AEs (Grade ≥ 3).
Conclusions
177Lu PSMA therapy is effective and well-tolerated in mCRPC patients pretreated with 223Ra. However, higher mortality was observed in the 223Ra-pretreated group. ECOG PS, ALP, and platelet counts were significant predictors of response and mortality, and a longer interval between therapies was associated with better outcomes. These findings underscore the importance of treatment sequencing and monitoring prognostic markers.
期刊介绍：
Clinical Genitourinary Cancer is a peer-reviewed journal that publishes original articles describing various aspects of clinical and translational research in genitourinary cancers. Clinical Genitourinary Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of genitourinary cancers. The main emphasis is on recent scientific developments in all areas related to genitourinary malignancies. Specific areas of interest include clinical research and mechanistic approaches; drug sensitivity and resistance; gene and antisense therapy; pathology, markers, and prognostic indicators; chemoprevention strategies; multimodality therapy; and integration of various approaches.
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