177Lu-PSMA vs. cabazitaxel in patients with castration-resistant prostate cancer: Real-world efficacy and safety data from the ARON-3 study

Mandel, Philipp;Groener, Daniel;Follacchio, Giulia;Ürün, Yüksel;Bögemann, Martin;et.al.
(2025) European Journal of Cancer — Vol. 229, p. 115789 (2025)

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Authors
  • Mandel, Philipp
    Author
  • Groener, Danielorcid-logo
    Author
  • Follacchio, Giulia
    Author
  • Ürün, Yükselorcid-logo
    Author
  • Author
  • Bögemann, Martin
    Author
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Abstract
Background: Radioligand therapy with [ 177 Lu]Lutetium-177-PSMA-617 (177 Lu-PSMA) was recently introduced in clinical practice in the US, Latin America and in most European countries for progressive, metastatic castration-resistant prostate cancer (mCRPC). However, multicenter real-world data on cancer-control outcomes are scant. Methods: Real-word data from the ARON-3 collaboration in progressive mCRPC patients treated with 177 Lu-PSMA vs. cabazitaxel were collected. A retrospective analysis was performed, including overall survival (OS), progression free survival (PFS), time to treatment failure (TTF) and PSA50/90 rates. Results: Data from 285 (50.1 %) patients receiving 177 Lu-PSMA vs. 283 (49.9 %) cabazitaxel after one or two lines of ARPI and Docetaxel were analyzed. PSA50 and PSA90 rates were higher, and TTF and OS were significantly longer in 177 Lu-PSMA patients, even after multivariable adjustment (p ≤ 0.01). This effect held true for most subgroups such as age < 70 and ≥ 70 years, ECOG 0-1, distant lymph nodes and one vs. two lines of prior ARPI. Incidence of grade 3-4 adverse events were comparable between both treatments (37 % vs. 43 % for 177 Lu-PSMA vs. cabazitaxel cohort p = 0.5) but differed according to the type of adverse events. Sensitivity analyses with cross-over adjustment showed similar effects. Conclusions: Analyzing the currently largest real-world cohort comparing 177 Lu-PSMA vs. cabazitaxel, we provided robust information of 177 Lu-PSMA being at least equally effective or possibly even superior to cabazitaxel regarding cancer-control outcomes with reasonable side effects.
Affiliations
  • Goethe University Frankfurt, University Hospital, Frankfurt am Main, GermanyDepartment of Urology
  • University Hospital Hamburg-Eppendorf, Hamburg, GermanyMartini-Klinik Prostate Cancer Center
  • Macerata Hospital, AST, Macerata 62100, ItalyNuclear Medicine Unit
  • Ankara University Medical Faculty, Ankara, TurkeyMedical Oncology
  • Mexico City, MexicoInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
  • Koç University Hospital, Istanbul, TurkeyDepartment of Medical Oncology
  • University Hospital Bonn (UKB), Bonn, GermanyDepartment of Urology
  • Sociedad de Oncología y Hematología del Cesar, Valledupar, ColombiaClinical Oncology
  • NHS Foundation Trust, London, UKRoyal Marsden NHS Foundation Trust
  • Santa Maria delle Grazie Hospital, Napoli, Pozzuoli ASL NA2 NORD, ItalyOncology Operative Unit
  • Markey Cancer Center, University of Kentucky, Lexington, KY, USADivision of Medical Oncology, Department of Internal Medicine
  • University of Foggia, Policlinico Riuniti, Foggia, ItalyUnit of Medical Oncology and Biomolecular Therapy, Department of Medical and Surgical Sciences
  • Buenos Aires, ArgentinaInstituto de Oncologia Angel H. Roffo
  • IRCCS European Institute of Oncology, Milan, ItalyDivision of Cancer Prevention and Genetics
  • Institutd’ Investigaci´ o Biom` edica Sant Pau, Hospital de La Santa Creu I Sant Pau, Barcelona, SpainDepartment of Medical Oncology
  • University Hospital Münster, Münster, Germany; West German Cancer Center, Münster, GermanyDepartment of Urology
  • University of Florence, Viale Pieraccini 6, Florence 50139, ItalyDepartment of Health Sciences, Section of Clinical Pharmacology and Oncology
  • Ochsner Medical Center, New Orleans, LA, USADepartment of Internal Medicine, Hematology/Oncology
  • Livorno Hospital, Azienda Toscana Nord Ovest, Livorno 57124, ItalyMedical Oncology Unit
  • Universidad El Bosque, Bogota, ColombiaInternal Medicine
  • Azienda Ospedaliero-Universitaria Pisana, Pisa, ItalyMedical Oncology
  • Tawam Hospital, Al Ain, United Arab EmiratesMedical Oncology
  • IRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, ItalyMedical Oncology
  • Hospital Universitario Ram´ on y Cajal, Madrid, SpainMedical Oncology Department
  • Newcastle University, Newcastle upon Tyne, UKTranslational and Clinical Research Institute, Centre for Cancer
  • Hospital Sírio-Libanes, Sao Paulo, BrazilDepartment of Medical Oncology
  • Cincinnati, OH, USACincinnati Cancer Advisors
  • LACOG, Porto Alegre, BrazilLatin American Cooperative Oncology Group
  • Brasília, DF, BrazilHospital Sírio-Libanes
  • Sao Paulo, SP, BrazilHospital Israelita Albert Einstein
  • University of Bologna, Bologna, ItalyDepartment of Medical and Surgical Sciences (DIMEC)
  • Clinic for Radiology and Nuclear Medicine, Frankfurt am Main, GermanyGoethe University Frankfurt, University Hospital, Department of Nuclear Medicine
  • Macerata Hospital, Macerata, ItalyMedical Oncology Unit

Citations

Mandel, P., Groener, D., Follacchio, G., Ürün, Y., Bourlon, M., Sabet, A., Grünwald, F., Tural, D., Büttner, T., Kopp, R., Taha, T., Chun, F., Facchini, G., Myint, Z., Seront, E., Conteduca, V., Quiroga, M., Aurilio, G., Palacios, G., & Bögemann, M. (2025). 177Lu-PSMA vs. cabazitaxel in patients with castration-resistant prostate cancer: Real-world efficacy and safety data from the ARON-3 study. European Journal of Cancer, 229, 115789. https://doi.org/10.1016/j.ejca.2025.115789 (Original work published 2025)