Re: Lutetium-177-PSMA-617 for Metastatic Castration-Resistant Prostate Cancer

Autor: Scott T. Tagawa, Vision Investigators, Oliver Sartor, Bernd J. Krause, Alison Armour, Chandler H Park, Michael J. Morris, Euloge Kpamegan, Ken Herrmann, Luke T. Nordquist, Ghassan El-Haddad, Johann S. de Bono, Kambiz Rahbar, Richard A. Messmann, Nitin Vaishampayan, Michelle DeSilvio, Wendy J Pérez-Contreras, Tomasz M. Beer, Germo Gericke, Karim Fizazi, Kim N. Chi
Rok vydání: 2021
Předmět:
Male
Oncology
medicine.medical_specialty
Urology
Medizin
chemistry.chemical_element
Lutetium
030204 cardiovascular system & hematology
Castration resistant
urologic and male genital diseases
Article
law.invention
Heterocyclic Compounds
1-Ring
03 medical and health sciences
Prostate cancer
0302 clinical medicine
Text mining
Randomized controlled trial
law
Internal medicine
medicine
Humans
Combined Modality Therapy
030212 general & internal medicine
Survival analysis
Aged
Aged
80 and over
Radioisotopes
medicine.diagnostic_test
business.industry
Prostate
Dipeptides
General Medicine
Middle Aged
Prostate-Specific Antigen
medicine.disease
Survival Analysis
Clinical trial
Prostatic Neoplasms
Castration-Resistant
chemistry
Positron emission tomography
Positron-Emission Tomography
Kallikreins
business
Zdroj: N Engl J Med
ISSN: 0302-2838
DOI: 10.1016/j.eururo.2021.07.006
Popis: BACKGROUND: Metastatic castration-resistant prostate cancer remains fatal despite recent advances. Prostate-specific membrane antigen (PSMA) is highly expressed in metastatic castration-resistant prostate cancer. Lutetium-177 ((177)Lu)–PSMA-617 is a radioligand therapy that delivers beta-particle radiation to PSMA-expressing cells and the surrounding microenvironment. METHODS: We conducted an international, open-label, phase 3 trial evaluating (177)Lu-PSMA-617 in patients who had metastatic castration-resistant prostate cancer previously treated with at least one androgen-receptor–pathway inhibitor and one or two taxane regimens and who had PSMA-positive gallium-68 ((68)Ga)–labeled PSMA-11 positron-emission tomographic–computed tomographic scans. Patients were randomly assigned in a 2:1 ratio to receive either (177)Lu-PSMA-617 (7.4 GBq every 6 weeks for four to six cycles) plus protocol-permitted standard care or standard care alone. Protocol-permitted standard care excluded chemotherapy, immunotherapy, radium-223 ((223)Ra), and investigational drugs. The alternate primary end points were imaging-based progression-free survival and overall survival, which were powered for hazard ratios of 0.67 and 0.73, respectively. Key secondary end points were objective response, disease control, and time to symptomatic skeletal events. Adverse events during treatment were those occurring no more than 30 days after the last dose and before subsequent anticancer treatment. RESULTS: From June 2018 to mid-October 2019, a total of 831 of 1179 screened patients underwent randomization. The baseline characteristics of the patients were balanced between the groups. The median follow-up was 20.9 months. (177)Lu-PSMA-617 plus standard care significantly prolonged, as compared with standard care, both imaging-based progression-free survival (median, 8.7 vs. 3.4 months; hazard ratio for progression or death, 0.40; 99.2% confidence interval [CI], 0.29 to 0.57; P
Databáze: OpenAIRE
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