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Observational Study
. 2025 Jul 1;25(1):1119.
doi: 10.1186/s12885-025-14294-7.

Final analysis of ArtemisR, a European real-world retrospective study of apalutamide for the treatment of patients with metastatic hormone-sensitive prostate cancer

Martin Boegemann  1 , Mostefa Bennamoun  2 , Louis Marie Dourthe  3 , Juan Antonio Encarnacion  4 , Axel Hegele  5   6 , Eva Hellmis  7 , Igor Latorzeff  8 , Wolfgang Leicht  9 , Julián Oñate-Celdrán  10 , Antonio Rosino-Sánchez  11 , Krystelle Hanna  12 , Joana Lencart  13 , Martin Lukac  14 , Claudio A Schioppa  15 , Suzy Van Sanden  15 , Gero Kramer  16
Affiliations
Observational Study

Final analysis of ArtemisR, a European real-world retrospective study of apalutamide for the treatment of patients with metastatic hormone-sensitive prostate cancer

Martin Boegemann et al. BMC Cancer. .

Abstract

Background: We examined real-world outcomes of patients with metastatic hormone-sensitive prostate cancer (mHSPC) treated with apalutamide plus androgen deprivation therapy (ADT). The current study, reflecting real-life practice, included specific subpopulations not evaluated in the pivotal phase III TITAN study: patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy.

Methods: ArtemisR is the first European multi-country observational study to retrospectively collect data from medical records of patients with mHSPC treated with apalutamide plus ADT in routine clinical practice. Response rates of patients with 50% and 90% decrease in PSA level (PSA50 and PSA90) compared with baseline and undetectable PSA (uPSA, < 0.2 ng/mL) were reported. Time to PSA response, time to metastatic castration-resistant prostate cancer (mCRPC), proportion of apalutamide discontinuation, and survival at 12 months were also examined using the Kaplan-Meier method.

Results: The analysis included 242 patients from Germany, France, Spain, and Austria; median age was 71 years. Median follow-up was 25.5 months from treatment initiation. Within 12 months of apalutamide initiation, 96% of patients achieved PSA50, 82% achieved PSA90, and 61% achieved uPSA. The median times to PSA50, PSA90, and uPSA were 1.08 months (95% confidence interval [CI]: 0.99-1.28), 1.94 months (95% CI: 1.54-2.27), and 3.48 months (95% CI: 2.92-5.68), respectively. At 12 months after treatment initiation, 94% of patients were alive, 91% had not progressed to mCRPC, and 81% remained on apalutamide plus ADT. Patients diagnosed with novel imaging, patients with M1a disease only, and patients treated with concomitant radiotherapy also showed deep and fast PSA responses (PSA90 and uPSA) with apalutamide plus ADT. Apalutamide-related adverse events (AEs) were reported in 90 patients (37%), and six patients (2.5%) discontinued apalutamide due to AEs. No new safety signals were detected.

Conclusions: The ArtemisR European multi-centre study examined the efficacy and safety of apalutamide plus ADT for patients with mHSPC, further validating the deep and fast PSA response associated with this treatment regimen. These real-world outcomes were additionally observed in a more diverse patient population than that included in the pivotal TITAN study.

Keywords: Apalutamide; Metastatic hormone-sensitive prostate cancer; Prostate-specific antigen.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by Independent Ethics Committees (IECs)/Institutional Review Boards (IRBs) at each participating institution, including Vienna General Hospital (Allgemeines Krankenhaus Wien) IRB/IEC; Ethics Committee of the Medical Association of Westphalia-Lippe and the Medical Faculty of the Westphalian Wilhelms University of Münster (Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster); Ethics Committee at the Hesse State Medical Association (Ethikkommission bei der Landesärztekammer Hessen); Hospital of the Brothers of Mercy Vienna (Krankenhaus Barmherzige Brüder Wien); Clinical Research Ethic Committee ​​León Health Area (Comité Ético de Investigación Clínica [CEIC] Area de Salud de León); Clinical Research Ethic Committee of the José María Morales Meseguer General University Hospital (CEIC del Hospital General Universitario José María Morales Meseguer); Clinical Research Ethic Committee of the Virgen de la Arrixaca Hospital (CEIC del Hospital Virgen de la Arrixaca); and Ethics and Scientific Committee for Research, Studies and Evaluations in the Field of Health (Comite ethique et scientifique pour les recherches, les etudes et les evaluations dans le domaine de la sante [CESREES]). The need for informed consent was waived by Ethics Committee of the Medical Association of Westphalia-Lippe and the Medical Faculty of the Westphalian Wilhelms University of Münster (Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster) and many other IECs/IRBs at each participating institution whose names are mentioned above. The study was conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Good Clinical Practice guidelines, and applicable regulatory requirements. An informed consent form waiver or opt-out letter process, as applicable, has been followed based on country- and site-specific requirements. Consent for publication: Not applicable. Competing interests: M. Boegemann: Employment: Janssen; Honoraria: Advanced Accelerator Applications, Amgen, Astellas Pharma, AstraZeneca, Bayer/Vital, Bristol Myers Squibb, Eisai, EUSA Pharma, Ipsen, Janssen-Cilag, Merck, MSD, Novartis, Pfizer, Roche, Sanofi/Aventis; Consulting or Advisory Role: Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Ipsen, Janssen-Cilag, Merck, MSD, Novartis, Roche, Sanofi; Research Funding: Ipsen (Inst); Janssen-Cilag; Travel, Accommodation, Expenses: Amgen, Bayer, BMS GmbH & Co. KG, Janssen-Cilag. M. Bennamoun: Financial Interests, Invited Speaker: Janssen, AstraZeneca, Ipsen, Astellas. L.M. Dourthe: Honoraria: Janssen, Ipsen, Bayer, Pfizer. J.A. Encarnacion: Nothing to declare. A. Hegele: Advisor/Honoraria/Scientific lecture: Astra Zeneca, APOGEPHA, Pfizer, BMS, Ipsen, Janssen, Merck, MSD, Dr. Pfleger. E. Hellmis: Advisor/Honoraria: Accord Healthcare, APOGEPHA, Astellas, AstraZeneca, Bayer Vital, BMS, Eisai, Hexal, Ipsen, Janssen, Merck, MSD, Novartis, Pfizer, Recordati, Roche, Takeda. I. Latorzeff: Advisor/Honoraria: Astellas, Bayer, BioProtect, Boston Scientific, Janssen, Ipsen. W. Leicht: Nothing to declare. J. Oñate-Celdrán: Astellas, Bayer, Ipsen, GSK, Janssen, Recordati. A. Rosino-Sánchez: Advisor/Honoraria: AstraZeneca – MSD, Astellas, Bayer, GP Pharm, Ipsen, Janssen, Recordati. K. Hanna: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. J. Lencart: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. M. Lukac: Employee: Parexel International S.R.O. On Behalf of Janssen Pharmaceutica LLC, a Johnson & Johnson Company. C.A. Schioppa: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. S. Van Sanden: Full-time Employee: Janssen Pharmaceutica LLC; Shareholder: Johnson & Johnson. G. Kramer: Honoraria or Consultation fee: Accord Healthcare, Astella, AstraZeneca, Bayer, Ferring, Ipsen, Janssen, MSD, Novartis, Pfizer, Takeda.

Figures

Fig. 1
Fig. 1
Patients achieving PSA50 and PSA90 responses (A) and uPSA response (B) for specific time periods. PSA response was categorised by decreases in PSA levels of 50% (PSA50) or 90% (PSA90) versus baseline. Patients with PSA levels ≥ 0.2 ng/mL at baseline who achieved PSA levels < 0.2 ng/mL were classified as having uPSA. N is the number of evaluable patients (with both baseline and ≥ 1 PSA measurement) per time period. Abbreviations: PSA, prostate-specific antigen; PSA50, 50% decrease in PSA level; PSA90, 90% decrease in PSA level; uPSA, undetectable PSA
Fig. 2
Fig. 2
Time to PSA50 response (A), PSA90 response (B), and uPSA (C)a. Abbreviation: CI, confidence interval. a PSA response was defined as a decrease in PSA level from baseline of 50% (PSA50) or 90% (PSA90), or to < 0.2 ng/mL (uPSA), recorded during follow-up until the earliest between subsequent therapy and 3 months after treatment with apalutamide end. A response after switching to another therapy, or > 3 months after stopping apalutamide treatment was not counted
Fig. 3
Fig. 3
Multivariable analysis of time to PSA90 (A) and uPSA (B)a. Abbreviations: CI, confidence interval; HR, hazard ratio; PSA, prostate-specific antigen; PSA90, 90% decrease in PSA level; uPSA, undetectable prostate-specific antigen. a HR > 1 indicates faster response, with respect to the reference category for each variable
Fig. 4
Fig. 4
Time to mCRPC (A) and overall survival (B) among patients treated with apalutamide. Abbreviations: CI, confidence interval; mCRPC, metastatic castration-resistant prostate cancer; NE, not evaluable; NR, not reported
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References

    1. Bray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024;74(3):229–63. 10.3322/caac.21834. - PubMed
    1. US National Cancer Institute. Cancer Stat Facts: Prostate Cancer. 2024. Available from: https://seer.cancer.gov/statfacts/html/prost.html. Accessed August 2024.
    1. Parker C, Castro E, Fizazi K, Heidenreich A, Ost P, Procopio G, et al. ESMO Guidelines Committee. Prostate cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020;31(9):1119–34. 10.1016/j.annonc.2020.06.011. - PubMed
    1. Fizazi K, Gillessen S. Updated treatment recommendations for prostate cancer from the ESMO Clinical Practice Guideline considering treatment intensification and use of novel systemic agents. Ann Oncol. 2023;34(6):557–63. 10.1016/j.annonc.2023.02.015. - PubMed
    1. Cornford P, van den Bergh RCN, Briers E, Van Den Broeck T, Brunckhorst O, Darraugh J, et al. EAU-EANM-ESTRO-ESUR-ISUP-SIOG Guidelines on Prostate Cancer-2024 Update. Part I: Screening, Diagnosis, and Local Treatment with Curative Intent. Eur Urol. 2024;86(2):148–63. 10.1016/j.eururo.2024.03.027. - PubMed

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