Clinical impact of volume of disease and time of metastatic disease presentation on patients receiving enzalutamide or abiraterone acetate plus prednisone as first-line therapy for metastatic castration-resistant prostate cancer.

Abiraterone acetate Androgen receptor pathway inhibitors Enzalutamide Metachronous metastases Metastatic castration-resistant prostate cancer Prognostic factor Synchronous metastases Volume of disease

Journal

Journal of translational medicine
ISSN: 1479-5876
Titre abrégé: J Transl Med
Pays: England
ID NLM: 101190741

Informations de publication

Date de publication:
03 02 2023
Historique:
received: 03 11 2022
accepted: 28 12 2022
entrez: 4 2 2023
pubmed: 5 2 2023
medline: 8 2 2023
Statut: epublish

Résumé

Metastatic castration-resistant prostate cancer remains a challenging condition to treat. Among the available therapeutic options, the androgen receptor signaling inhibitors abiraterone acetate plus prednisone (AA) and enzalutamide (Enza), are currently the most used first-line therapies in clinical practice. However, validated clinical indicators of prognosis in this setting are still lacking. In this study, we aimed to evaluate a prognostic model based on the time of metastatic disease presentation (after prior local therapy [PLT] or de-novo [DN]) and disease burden (low volume [LV] or high-volume [HV]) at AA/Enza onset for mCRPC patients receiving either AA or Enza as first-line. A cohort of consecutive patients who started AA or Enza as first-line treatment for mCRPC between January 1st, 2015, and April 1st, 2019 was identified from the clinical and electronic registries of the 9 American and European participating centers. Patients were classified into 4 cohorts by the time of metastatic disease presentation (PLT or DN) and volume of disease (LV or HV; per the E3805 trial, HV was defined as the presence of visceral metastases and/or at least 4 bone metastases of which at least 1 out the axial/pelvic skeleton) at AA/Enza onset. The endpoint was overall survival defined as the time from AA or Enza initiation, respectively, to death from any cause or censored at the last follow-up visit, whichever occurred first. Of the 417 eligible patients identified, 157 (37.6%) had LV/PLT, 87 (20.9%) LV/DN, 64 (15.3%) HV/PLT, and 109 (26.1%) HV/DN. LV cohorts showed improved median overall survival (59.0 months; 95% CI, 51.0-66.9 months) vs. HV cohorts (27.5 months; 95% CI, 22.8-32.2 months; P = 0.0001), regardless of the time of metastatic presentation. In multivariate analysis, HV cohorts were confirmed associated with worse prognosis compared to those with LV (HV/PLT, HR = 1.87; p = 0.029; HV/DN, HR = 2.19; P = 0.002). Our analysis suggests that the volume of disease could be a prognostic factor for patients starting AA or Enza as first-line treatment for metastatic castration-resistant prostate cancer, pending prospective clinical trial validation.

Sections du résumé

BACKGROUND
Metastatic castration-resistant prostate cancer remains a challenging condition to treat. Among the available therapeutic options, the androgen receptor signaling inhibitors abiraterone acetate plus prednisone (AA) and enzalutamide (Enza), are currently the most used first-line therapies in clinical practice. However, validated clinical indicators of prognosis in this setting are still lacking. In this study, we aimed to evaluate a prognostic model based on the time of metastatic disease presentation (after prior local therapy [PLT] or de-novo [DN]) and disease burden (low volume [LV] or high-volume [HV]) at AA/Enza onset for mCRPC patients receiving either AA or Enza as first-line.
METHODS
A cohort of consecutive patients who started AA or Enza as first-line treatment for mCRPC between January 1st, 2015, and April 1st, 2019 was identified from the clinical and electronic registries of the 9 American and European participating centers. Patients were classified into 4 cohorts by the time of metastatic disease presentation (PLT or DN) and volume of disease (LV or HV; per the E3805 trial, HV was defined as the presence of visceral metastases and/or at least 4 bone metastases of which at least 1 out the axial/pelvic skeleton) at AA/Enza onset. The endpoint was overall survival defined as the time from AA or Enza initiation, respectively, to death from any cause or censored at the last follow-up visit, whichever occurred first.
RESULTS
Of the 417 eligible patients identified, 157 (37.6%) had LV/PLT, 87 (20.9%) LV/DN, 64 (15.3%) HV/PLT, and 109 (26.1%) HV/DN. LV cohorts showed improved median overall survival (59.0 months; 95% CI, 51.0-66.9 months) vs. HV cohorts (27.5 months; 95% CI, 22.8-32.2 months; P = 0.0001), regardless of the time of metastatic presentation. In multivariate analysis, HV cohorts were confirmed associated with worse prognosis compared to those with LV (HV/PLT, HR = 1.87; p = 0.029; HV/DN, HR = 2.19; P = 0.002).
CONCLUSION
Our analysis suggests that the volume of disease could be a prognostic factor for patients starting AA or Enza as first-line treatment for metastatic castration-resistant prostate cancer, pending prospective clinical trial validation.

Identifiants

pubmed: 36737752
doi: 10.1186/s12967-022-03861-2
pii: 10.1186/s12967-022-03861-2
pmc: PMC9896712
doi:

Substances chimiques

Abiraterone Acetate EM5OCB9YJ6
Prednisone VB0R961HZT
enzalutamide 93T0T9GKNU
Nitriles 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

75

Informations de copyright

© 2023. The Author(s).

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Auteurs

Pier Vitale Nuzzo (PV)

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA.

Filippo Pederzoli (F)

Department of Pathology and Laboratory Medicine, Weill Cornell Medicine, New York, NY, USA.

Calogero Saieva (C)

Cancer Risk Factors and Lifestyle Epidemiology Unit-ISPRO, Florence, Italy.

Elisa Zanardi (E)

Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Giuseppe Fotia (G)

Medical Oncology Department, Fondazione IRCCS Istituto Nazionale Tumori, Milan, Italy.

Andrea Malgeri (A)

Division of Medical Oncology, Policlinico Universitario Campus Bio-Medico, Rome, Italy.

Sabrina Rossetti (S)

Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.

Loana Valenca Bueno (L)

Instituto D'Or de Pesquisa e Ensino, Salvador, State of Bahia, Brazil.
Hospital São Rafael, Salvador, State of Bahia, Brazil.

Livia Maria Q S Andrade (LMQS)

Instituto D'Or de Pesquisa e Ensino, Salvador, State of Bahia, Brazil.
Hospital São Rafael, Salvador, State of Bahia, Brazil.

Anna Patrikidou (A)

Department of Medical Oncology, Gustave Roussy Institute, Villejuif, France.

Ricardo Pereira Mestre (RP)

Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.

Mikol Modesti (M)

Istituto Oncologico della Svizzera Italiana, Bellinzona, Switzerland.

Sandro Pignata (S)

Department of Urology and Gynecology, Istituto Nazionale Tumori IRCCS Fondazione G. Pascale, Naples, Italy.

Giuseppe Procopio (G)

Oncology Unit, ASST Cremona, Cremona, CR, Italy.

Giuseppe Fornarini (G)

Medical Oncology Unit 1, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.

Ugo De Giorgi (U)

Department of Medical Oncology, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST), Meldola, Italy.

Antonio Russo (A)

Department of Surgical, Oncological, and Oral Sciences, Section of Medical Oncology, University of Palermo, Palermo, Italy.

Edoardo Francini (E)

Department of Experimental and Clinical Medicine, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. edoardo.francini@unifi.it.

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Classifications MeSH