Safety and Efficacy of Extended Therapy with [ 177 Lu]Lu-PSMA: A German Multicenter Study.

Autor:	Seifert R; Department of Nuclear Medicine, University Hospital Essen, Essen, Germany.; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, University Hospital Bern, Bern, Switzerland.; Department of Nuclear Medicine, University Hospital Münster, Münster, Germany., Telli T; Department of Nuclear Medicine, University Hospital Essen, Essen, Germany.; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany., Lapa C; German Cancer Consortium, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany., Desaulniers M; Department of Nuclear Medicine, University Hospital Essen, Essen, Germany.; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany., Hekimsoy T; German Cancer Consortium, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.; Bavarian Cancer Research Center, Erlangen, Germany., Weber WA; German Cancer Consortium, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.; Bavarian Cancer Research Center, Erlangen, Germany., Pfob C; German Cancer Consortium, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, Faculty of Medicine, University of Augsburg, Augsburg, Germany., Hadaschik B; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany.; Department of Urology, University Hospital Essen, Essen, Germany; and., Bögemann M; West German Cancer, University Hospital Essen, Essen, Germany.; Department of Urology, University Hospital Münster, Münster, Germany., Schäfers M; West German Cancer, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, University Hospital Münster, Münster, Germany., Herrmann K; Department of Nuclear Medicine, University Hospital Essen, Essen, Germany.; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany., Rahbar K; West German Cancer, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, University Hospital Münster, Münster, Germany., Eiber M; German Cancer Consortium, University Hospital Essen, Essen, Germany.; Department of Nuclear Medicine, Klinikum Rechts der Isar, Technical University Munich, Munich, Germany.; Bavarian Cancer Research Center, Erlangen, Germany., Fendler WP; Department of Nuclear Medicine, University Hospital Essen, Essen, Germany; wolfgang.fendler@uk-essen.de.; German Cancer Consortium, University Hospital Essen, Essen, Germany.; West German Cancer, University Hospital Essen, Essen, Germany.
Jazyk:	angličtina
Zdroj:	Journal of nuclear medicine : official publication, Society of Nuclear Medicine [J Nucl Med] 2024 Jun 03; Vol. 65 (6), pp. 909-916. Date of Electronic Publication: 2024 Jun 03.
DOI:	10.2967/jnumed.123.267321
Abstrakt:	Prospective results have demonstrated favorable safety and efficacy of [ 177 Lu]Lu-PSMA radiopharmaceutical therapy for up to 6 cycles in men with metastatic castration-resistant prostate cancer. However, no systematic data are available outlining the feasibility of extended therapy beyond 6 cycles. We aim to evaluate the safety and efficacy of extended [ 177 Lu]Lu-PSMA radiopharmaceutical therapy in patients who have received more than 6 cycles. Methods: In total, 111 patients were included in this multicenter retrospective analysis. Based on individual decisions, patients underwent uninterrupted continuation of therapy (continuous treatment) or reexposure after a therapy break (rechallenge treatment) between 2014 and 2023. Overall survival, 50% prostate-specific antigen (PSA) decline (measured 8-12 wk after treatment initiation or rechallenge), PSMA PET response, and grades per Common Terminology Criteria for Adverse Events were assessed. χ 2 tests, multivariable Cox regression analysis, and log-rank tests were applied for statistical analyses. Results: Patients received extended treatment with [ 177 Lu]Lu-PSMA, either as a continuous treatment (43/111, 38.7%) or as a rechallenge (68/111, 61.3%) treatment, with median cumulative doses of 57.4 or 60.8 GBq, respectively. Overall survival from the initiation of [ 177 Lu]Lu-PSMA was 31.3, 23.2, and 40.2 mo for the entire cohort, the continuous treatment group, and the rechallenge treatment group, respectively. The initial 50% PSA decline was significantly higher in the retreated group than in the continuous group (57/63 [90.4%] vs. 26/42 [61.9%]; P = 0.006). A 50% PSA decline was observed in 23 of 62 patients (37.1%) after the first rechallenge. The rate of grades 3-4 toxicity was comparable between continuous and rechallenge treatments (anemia, 7/43 [16.3%] vs. 13/68 [19.1%)], P = 0.6; leukocytopenia, 1/43 [2.3%] vs. 2/67 [3.0%], P = 0.3; thrombocytopenia, 3/43 [7.0%] vs. 3/68 [4.4%], P = 0.3; renal, 2/43 [4.7%] vs. 5/68 [7.4%], P = 0.2). Conclusion: Extended therapy with [ 177 Lu]Lu-PSMA is safe and has not been associated with increased grades 3-4 toxicity. Patient candidates for extended treatment experienced a favorable median survival of 31.3 mo from the first administration. Response under [ 177 Lu]Lu-PSMA rechallenge demonstrated preserved efficacy of [ 177 Lu]Lu-PSMA after a treatment break. (© 2024 by the Society of Nuclear Medicine and Molecular Imaging.)
Databáze:	MEDLINE
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