177 Lu-PSMA-617 radioligand therapy of metastatic castration-resistant prostate cancer: Initial 254-patient results from a prospective registry (REALITY Study).

Autor: Khreish F; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Ghazal Z; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Marlowe RJ; Spencer-Fontayne Corporation, Jersey City, NJ, USA., Rosar F; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Sabet A; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Maus S; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Linxweiler J; Department of Urology, Saarland University, Homburg, Germany., Bartholomä M; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany., Ezziddin S; Department of Nuclear Medicine, Saarland University, Kirrberger Str. Geb. 50, 66421, Homburg, Germany. samer.ezziddin@uks.eu.
Jazyk: angličtina
Zdroj: European journal of nuclear medicine and molecular imaging [Eur J Nucl Med Mol Imaging] 2022 Feb; Vol. 49 (3), pp. 1075-1085. Date of Electronic Publication: 2021 Sep 07.
DOI: 10.1007/s00259-021-05525-7
Abstrakt: Purpose: Preliminary data from retrospective analyses and recent data from large randomized controlled trials suggest safety and efficacy of radioligand therapy (RLT) targeting prostate-specific membrane antigen (PSMA) in men with metastatic castration-resistant prostate cancer (mCRPC). Limited data on this modality have been published regarding large samples treated in everyday practice.
Methods: We analyzed prospectively collected registry data regarding lutetium-177 ( 177 Lu)-PSMA-617 RLT of 254 consecutive men with mCRPC seen in everyday academic practice. Since 177 Lu-PSMA-617 was experimental salvage treatment following failure of individually appropriate conventional therapies, patients were generally elderly and heavily pretreated (median age 70 years; prior taxanes 74.0%, 188/254), with late-end-stage disease (visceral metastasis in 32.7%, 83/254). Primary endpoints were response to RLT, defined by changes from baseline serum prostate-specific antigen (PSA) concentration, PSA progression-free survival (PSA-PFS), and overall survival (OS), estimated with Kaplan-Meier statistics, and caregiver-reported and patient-reported safety. Unless noted, median (minimum-maximum) values are given.
Results: Patients received 3 (1-13) 177 Lu-PSMA-617 activities (6.5 [2.5-11.6] GBq/cycle) every 5.7 (3.0-11.0) weeks. Best response was ≥ 50% PSA reduction in 52.0% of patients (132/254). PSA-PFS was 5.5 (95% confidence interval [95%CI] 4.4-6.6) months and OS, 14.5 (95%CI 11.5-17.5) months. In multivariable Cox proportional-hazards modeling, response to the initial ≤ 2 RLT administrations was the strongest significant prognosticator related to OS (hazard ratio 3.7 [95%CI 2.5-5.5], p < 0.001). No RLT-related deaths or treatment discontinuations occurred; the most frequent RLT-related Grade 3/4 adverse events were anemia (18/254 patients, 7.1%), thrombocytopenia (11/254, 4.3%), and lymphopenia (7/254, 2.8%). RLT-related xerostomia, all grade 1/2, was noted in 53/254 (20.9%).
Conclusions: In a large, prospectively observed "real-world" cohort with late-stage/end-stage mCRPC and conventional treatment failure, 177 Lu-PSMA-617 RLT was effective, safe, and well-tolerated. Early biochemical disease control by such therapy was associated with better OS. Prospective study earlier in the disease course may be warranted.
(© 2021. The Author(s).)
Databáze: MEDLINE
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