TY - JOUR
T1 - German multicenter study investigating 177Lu-PSMA-617 Radioligand therapy in advanced prostate cancer patients
AU - Rahbar, Kambiz
AU - Ahmadzadehfar, Hojjat
AU - Kratochwil, Clemens
AU - Haberkorn, Uwe
AU - Schafers, Michael
AU - Essler, Markus
AU - Baum, Richard P.
AU - Kulkarni, Harshad R.
AU - Schmidt, Matthias
AU - Drzezga, Alexander
AU - Bartenstein, Peter
AU - Pfestroff, Andreas
AU - Luster, Markus
AU - Lutzen, Ulf
AU - Marx, Marlies
AU - Prasad, Vikas
AU - Brenner, Winfried
AU - Heinzel, Alexander
AU - Mottaghy, Felix M.
AU - Ruf, Juri
AU - Meyer, Philipp Tobias
AU - Heuschkel, Martin
AU - Eveslage, Maria
AU - Bögemann, Martin
AU - Fendler, Wolfgang Peter
AU - Krause, Bernd Joachim
N1 - Publisher Copyright:
© COPYRIGHT 2017 by the Society of Nuclear Medicine and Molecular Imaging.
PY - 2017/1/1
Y1 - 2017/1/1
N2 - 177Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castrationresistant 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.
AB - 177Lu-labeled PSMA-617 is a promising new therapeutic agent for radioligand therapy (RLT) of patients with metastatic castrationresistant 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.
KW - MCRPC
KW - Prostate cancer
KW - PSMA-617
KW - Radioligand therapy
UR - http://www.scopus.com/inward/record.url?scp=85009062605&partnerID=8YFLogxK
U2 - 10.2967/jnumed.116.183194
DO - 10.2967/jnumed.116.183194
M3 - Article
C2 - 27765862
AN - SCOPUS:85009062605
SN - 0161-5505
VL - 58
SP - 85
EP - 90
JO - Journal of Nuclear Medicine
JF - Journal of Nuclear Medicine
IS - 1
ER -