Kambiz Rahbar1, Hojjat Ahmadzadehfar2, Clemens Kratochwil3, Uwe Haberkorn3, Michael Schäfers4, Markus Essler2, Richard P Baum5, Harshad R Kulkarni5, Matthias Schmidt6, Alexander Drzezga6, Peter Bartenstein7, Andreas Pfestroff8, Markus Luster8, Ulf Lützen9, Marlies Marx9, Vikas Prasad10, Winfried Brenner10, Alexander Heinzel11, Felix M Mottaghy11, Juri Ruf12, Philipp Tobias Meyer12, Martin Heuschkel13, Maria Eveslage14, Martin Bögemann15, Wolfgang Peter Fendler7, Bernd Joachim Krause13,16. 1. Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany rahbar@uni-muenster.de. 2. Department of Nuclear Medicine, University Hospital Bonn, Bonn, Germany. 3. Department of Nuclear Medicine, University of Heidelberg, Heidelberg, Germany. 4. Department of Nuclear Medicine, University Hospital Muenster, Muenster, Germany. 5. Theranostics Center for Molecular Radiotherapy and Molecular Imaging, Zentralklinik, Bad Berka, Bad Berka, Germany. 6. Department of Nuclear Medicine, University of Cologne, Cologne, Germany. 7. Department of Nuclear Medicine, Ludwig-Maximilians-University Munich, Munich, Germany. 8. Department of Nuclear Medicine, University of Marburg, Marburg, Germany. 9. Department of Nuclear Medicine, University of Schleswig-Holstein, Campus Kiel, Kiel, Germany. 10. Department of Nuclear Medicine, Charite, University Hospital Berlin, Berlin, Germany. 11. Department of Nuclear Medicine, University Hospital Aachen, Aachen, Germany. 12. Department of Nuclear Medicine, University of Freiburg, Freiburg, Germany. 13. Department of Nuclear Medicine, University of Rostock, Rostock, Germany. 14. Institute of Biostatistics and Clinical Research, University of Muenster, Muenster, Germany. 15. Department of Urology, University Hospital Muenster, Muenster, Germany; and. 16. German Society of Nuclear Medicine Göttingen, Göttingen, Germany.
Abstract
177Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). Initiated by the German Society of Nuclear Medicine, a retrospective multicenter data analysis was started in 2015 to evaluate efficacy and safety of 177Lu-PSMA-617 in a large cohort of patients. METHODS: One hundred forty-five patients (median age, 73 y; range, 43-88 y) with mCRPC were treated with 177Lu-PSMA-617 in 12 therapy centers between February 2014 and July 2015 with 1-4 therapy cycles and an activity range of 2-8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (version 4.0) on the basis of serial blood tests and the attending physician's report. The primary endpoint for efficacy was biochemical response as defined by a prostate-specific antigen decline ≥ 50% from baseline to at least 2 wk after the start of RLT. RESULTS: A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response in 99 patients as well as data for physician-reported and laboratory-based toxicity in 145 and 121 patients, respectively, were available. The median follow-up was 16 wk (range, 2-30 wk). Nineteen patients died during the observation period. Grade 3-4 hematotoxicity occurred in 18 patients: 10%, 4%, and 3% of the patients experienced anemia, thrombocytopenia, and leukopenia, respectively. Xerostomia occurred in 8%. The overall biochemical response rate was 45% after all therapy cycles, whereas 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and the presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response. CONCLUSION: The present retrospective multicenter study of 177Lu-PSMA-617 RLT demonstrates favorable safety and high efficacy exceeding those of other third-line systemic therapies in mCRPC patients. Future phase II/III studies are warranted to elucidate the survival benefit of this new therapy in patients with mCRPC.
177Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castration-resistant prostate cancer (mCRPC). Initiated by the German Society of Nuclear Medicine, a retrospective multicenter data analysis was started in 2015 to evaluate efficacy and safety of 177Lu-PSMA-617 in a large cohort of patients. METHODS: One hundred forty-five patients (median age, 73 y; range, 43-88 y) with mCRPC were treated with 177Lu-PSMA-617 in 12 therapy centers between February 2014 and July 2015 with 1-4 therapy cycles and an activity range of 2-8 GBq per cycle. Toxicity was categorized by the common toxicity criteria for adverse events (version 4.0) on the basis of serial blood tests and the attending physician's report. The primary endpoint for efficacy was biochemical response as defined by a prostate-specific antigen decline ≥ 50% from baseline to at least 2 wk after the start of RLT. RESULTS: A total of 248 therapy cycles were performed in 145 patients. Data for biochemical response in 99 patients as well as data for physician-reported and laboratory-based toxicity in 145 and 121 patients, respectively, were available. The median follow-up was 16 wk (range, 2-30 wk). Nineteen patients died during the observation period. Grade 3-4 hematotoxicity occurred in 18 patients: 10%, 4%, and 3% of the patients experienced anemia, thrombocytopenia, and leukopenia, respectively. Xerostomia occurred in 8%. The overall biochemical response rate was 45% after all therapy cycles, whereas 40% of patients already responded after a single cycle. Elevated alkaline phosphatase and the presence of visceral metastases were negative predictors and the total number of therapy cycles positive predictors of biochemical response. CONCLUSION: The present retrospective multicenter study of 177Lu-PSMA-617 RLT demonstrates favorable safety and high efficacy exceeding those of other third-line systemic therapies in mCRPC patients. Future phase II/III studies are warranted to elucidate the survival benefit of this new therapy in patients with mCRPC.
Authors: Simona Malaspina; Ugo De Giorgi; Jukka Kemppainen; Angelo Del Sole; Giovanni Paganelli Journal: Radiol Med Date: 2018-08-16 Impact factor: 3.469
Authors: Hian Liang Huang; Aaron Kian Ti Tong; Sue Ping Thang; Sean Xuexian Yan; Winnie Wing Chuen Lam; Kelvin Siu Hoong Loke; Charlene Yu Lin Tang; Lenith Tai Jit Cheng; Gideon Su Kai Ooi; Han Chung Low; Butch Maulion Magsombol; Wei Ying Tham; Charles Xian Yang Goh; Colin Jingxian Tan; Yiu Ming Khor; Sumbul Zaheer; Pushan Bharadwaj; Wanying Xie; David Chee Eng Ng Journal: Nucl Med Mol Imaging Date: 2019-01-25