Rahbar, Kambiz ORCID: 0000-0002-4591-4055, Ahmadzadehfar, Hojjat, Kratochwil, Clemens, Haberkorn, Uwe, Schaefers, Michael, Essler, Markus, Baum, Richard P., Kulkarni, Harshad R., Schmidt, Matthias, Drzezga, Alexander, Bartenstein, Peter, Pfestroff, Andreas, Luster, Markus, Luetzen, Ulf, Marx, Marlies, Prasad, Vikas ORCID: 0000-0003-2010-4117, Brenner, Winfried, Heinzel, Alexander ORCID: 0000-0002-2430-4557, Mottaghy, Felix M., Ruf, Juri, Meyer, Philipp Tobias, Heuschkel, Martin, Eveslage, Maria ORCID: 0000-0002-8802-1134, Boegemann, Martin, Fendler, Wolfgang Peter and Krause, Bernd Joachim (2017). German Multicenter Study Investigating Lu-177-PSMA-617 Radioligand Therapy in Advanced Prostate Cancer Patients. J. Nucl. Med., 58 (1). S. 85 - 91. RESTON: SOC NUCLEAR MEDICINE INC. ISSN 1535-5667

Full text not available from this repository.

Abstract

Lu-177-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 Lu-177-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 Lu-177-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 Lu-177-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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Rahbar, KambizUNSPECIFIEDorcid.org/0000-0002-4591-4055UNSPECIFIED
Ahmadzadehfar, HojjatUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kratochwil, ClemensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haberkorn, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefers, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Essler, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baum, Richard P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kulkarni, Harshad R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schmidt, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Drzezga, AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bartenstein, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Pfestroff, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luster, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Luetzen, UlfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Marx, MarliesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Prasad, VikasUNSPECIFIEDorcid.org/0000-0003-2010-4117UNSPECIFIED
Brenner, WinfriedUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinzel, AlexanderUNSPECIFIEDorcid.org/0000-0002-2430-4557UNSPECIFIED
Mottaghy, Felix M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ruf, JuriUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meyer, Philipp TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heuschkel, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eveslage, MariaUNSPECIFIEDorcid.org/0000-0002-8802-1134UNSPECIFIED
Boegemann, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fendler, Wolfgang PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krause, Bernd JoachimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-243640
DOI: 10.2967/jnumed.116.183194
Journal or Publication Title: J. Nucl. Med.
Volume: 58
Number: 1
Page Range: S. 85 - 91
Date: 2017
Publisher: SOC NUCLEAR MEDICINE INC
Place of Publication: RESTON
ISSN: 1535-5667
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
GA-68-PSMA LIGAND; CLINICAL-TRIALS; PSMA; ENZALUTAMIDE; ABIRATERONE; STATISTICS; DOCETAXEL; PET/CTMultiple languages
Radiology, Nuclear Medicine & Medical ImagingMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/24364

Downloads

Downloads per month over past year

Altmetric

Export

Actions (login required)

View Item View Item