Kambiz Rahbar, Markus Essler, Matthias Eiber, Christian la Fougère, Vikas Prasad, Wolfgang P Fendler, Philipp Rassek, Ergela Hasa, Helmut Dittmann, Ralph A Bundschuh, Kim M Pabst, Milena Kurtinecz, Anja Schmall, Frank Verholen, Oliver Sartor
{"title":"177Lu-前列腺特异性膜抗原治疗转移性Castion-耐药前列腺癌症和既往223Ra患者(RALU研究)。","authors":"Kambiz Rahbar, Markus Essler, Matthias Eiber, Christian la Fougère, Vikas Prasad, Wolfgang P Fendler, Philipp Rassek, Ergela Hasa, Helmut Dittmann, Ralph A Bundschuh, Kim M Pabst, Milena Kurtinecz, Anja Schmall, Frank Verholen, Oliver Sartor","doi":"10.2967/jnumed.123.266125","DOIUrl":null,"url":null,"abstract":"<p><p><sup>223</sup>Ra-dichloride (<sup>223</sup>Ra) and <sup>177</sup>Lu-prostate-specific membrane antigen (PSMA) are approved treatments for metastatic castration-resistant prostate cancer (mCRPC). The safety and effectiveness of sequential use of <sup>223</sup>Ra and <sup>177</sup>Lu-PSMA in patients with mCRPC are not well described. This study aimed to evaluate <sup>177</sup>Lu-PSMA safety and efficacy in patients with mCRPC previously treated with <sup>223</sup>Ra. <b>Methods:</b> The radium→lutetium (RALU) study was a multicenter, retrospective, medical chart review. Participants had received at least 1 <sup>223</sup>Ra dose and, in any subsequent therapy line, at least 1 <sup>177</sup>Lu-PSMA dose. Primary endpoints included the incidence of adverse events (AEs), serious AEs, grade 3-4 hematologic AEs, and abnormal laboratory values. Secondary endpoints included overall survival, time to next treatment/death, and change from baseline in serum prostate-specific antigen and alkaline phosphatase levels. <b>Results:</b> Data were from 133 patients. Before <sup>177</sup>Lu-PSMA therapy, 56% (75/133) of patients received at least 4 life-prolonging therapies; all patients received <sup>223</sup>Ra (73% received 5-6 injections). Overall, 27% (36/133) of patients received at least 5 <sup>177</sup>Lu-PSMA infusions. Any-grade treatment-emergent AEs were reported in 79% (105/133) of patients and serious AEs in 30% (40/133). The most frequent grade 3-4 laboratory abnormalities were anemia (30%, 40/133) and thrombocytopenia (13%, 17/133). Median overall survival was 13.2 mo (95% CI, 10.5-15.6 mo) from the start of <sup>177</sup>Lu-PSMA. <b>Conclusion:</b> In this real-world setting, <sup>223</sup>Ra followed by <sup>177</sup>Lu-PSMA therapy in heavily pretreated patients with mCRPC was clinically feasible, with no indication of impairment of <sup>177</sup>Lu-PSMA safety or effectiveness.</p>","PeriodicalId":16758,"journal":{"name":"Journal of Nuclear Medicine","volume":null,"pages":null},"PeriodicalIF":9.1000,"publicationDate":"2023-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690117/pdf/","citationCount":"0","resultStr":"{\"title\":\"<sup>177</sup>Lu-Prostate-Specific Membrane Antigen Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer and Prior <sup>223</sup>Ra (RALU Study).\",\"authors\":\"Kambiz Rahbar, Markus Essler, Matthias Eiber, Christian la Fougère, Vikas Prasad, Wolfgang P Fendler, Philipp Rassek, Ergela Hasa, Helmut Dittmann, Ralph A Bundschuh, Kim M Pabst, Milena Kurtinecz, Anja Schmall, Frank Verholen, Oliver Sartor\",\"doi\":\"10.2967/jnumed.123.266125\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p><sup>223</sup>Ra-dichloride (<sup>223</sup>Ra) and <sup>177</sup>Lu-prostate-specific membrane antigen (PSMA) are approved treatments for metastatic castration-resistant prostate cancer (mCRPC). The safety and effectiveness of sequential use of <sup>223</sup>Ra and <sup>177</sup>Lu-PSMA in patients with mCRPC are not well described. This study aimed to evaluate <sup>177</sup>Lu-PSMA safety and efficacy in patients with mCRPC previously treated with <sup>223</sup>Ra. <b>Methods:</b> The radium→lutetium (RALU) study was a multicenter, retrospective, medical chart review. Participants had received at least 1 <sup>223</sup>Ra dose and, in any subsequent therapy line, at least 1 <sup>177</sup>Lu-PSMA dose. Primary endpoints included the incidence of adverse events (AEs), serious AEs, grade 3-4 hematologic AEs, and abnormal laboratory values. Secondary endpoints included overall survival, time to next treatment/death, and change from baseline in serum prostate-specific antigen and alkaline phosphatase levels. <b>Results:</b> Data were from 133 patients. Before <sup>177</sup>Lu-PSMA therapy, 56% (75/133) of patients received at least 4 life-prolonging therapies; all patients received <sup>223</sup>Ra (73% received 5-6 injections). Overall, 27% (36/133) of patients received at least 5 <sup>177</sup>Lu-PSMA infusions. Any-grade treatment-emergent AEs were reported in 79% (105/133) of patients and serious AEs in 30% (40/133). The most frequent grade 3-4 laboratory abnormalities were anemia (30%, 40/133) and thrombocytopenia (13%, 17/133). Median overall survival was 13.2 mo (95% CI, 10.5-15.6 mo) from the start of <sup>177</sup>Lu-PSMA. <b>Conclusion:</b> In this real-world setting, <sup>223</sup>Ra followed by <sup>177</sup>Lu-PSMA therapy in heavily pretreated patients with mCRPC was clinically feasible, with no indication of impairment of <sup>177</sup>Lu-PSMA safety or effectiveness.</p>\",\"PeriodicalId\":16758,\"journal\":{\"name\":\"Journal of Nuclear Medicine\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":9.1000,\"publicationDate\":\"2023-12-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10690117/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Nuclear Medicine\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2967/jnumed.123.266125\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"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.123.266125","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"RADIOLOGY, NUCLEAR MEDICINE & MEDICAL IMAGING","Score":null,"Total":0}
177Lu-Prostate-Specific Membrane Antigen Therapy in Patients with Metastatic Castration-Resistant Prostate Cancer and Prior 223Ra (RALU Study).
223Ra-dichloride (223Ra) and 177Lu-prostate-specific membrane antigen (PSMA) are approved treatments for metastatic castration-resistant prostate cancer (mCRPC). The safety and effectiveness of sequential use of 223Ra and 177Lu-PSMA in patients with mCRPC are not well described. This study aimed to evaluate 177Lu-PSMA safety and efficacy in patients with mCRPC previously treated with 223Ra. Methods: The radium→lutetium (RALU) study was a multicenter, retrospective, medical chart review. Participants had received at least 1 223Ra dose and, in any subsequent therapy line, at least 1 177Lu-PSMA dose. Primary endpoints included the incidence of adverse events (AEs), serious AEs, grade 3-4 hematologic AEs, and abnormal laboratory values. Secondary endpoints included overall survival, time to next treatment/death, and change from baseline in serum prostate-specific antigen and alkaline phosphatase levels. Results: Data were from 133 patients. Before 177Lu-PSMA therapy, 56% (75/133) of patients received at least 4 life-prolonging therapies; all patients received 223Ra (73% received 5-6 injections). Overall, 27% (36/133) of patients received at least 5 177Lu-PSMA infusions. Any-grade treatment-emergent AEs were reported in 79% (105/133) of patients and serious AEs in 30% (40/133). The most frequent grade 3-4 laboratory abnormalities were anemia (30%, 40/133) and thrombocytopenia (13%, 17/133). Median overall survival was 13.2 mo (95% CI, 10.5-15.6 mo) from the start of 177Lu-PSMA. Conclusion: In this real-world setting, 223Ra followed by 177Lu-PSMA therapy in heavily pretreated patients with mCRPC was clinically feasible, with no indication of impairment of 177Lu-PSMA safety or effectiveness.
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.