Title | 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. |
Publication Type | Journal Article |
Year of Publication | 2023 |
Authors | Nuzzo PVitale, Pederzoli F, Saieva C, Zanardi E, Fotia G, Malgeri A, Rossetti S, Bueno LValenca, Andrade LMaria QS, Patrikidou A, Mestre RPereira, Modesti M, Pignata S, Procopio G, Fornarini G, De Giorgi U, Russo A, Francini E |
Corporate Authors | SPARTACUSS Investigators |
Journal | J Transl Med |
Volume | 21 |
Issue | 1 |
Pagination | 75 |
Date Published | 2023 Feb 03 |
ISSN | 1479-5876 |
Keywords | Abiraterone Acetate, Antineoplastic Combined Chemotherapy Protocols, Humans, Male, Nitriles, Prednisone, Prospective Studies, Prostatic Neoplasms, Castration-Resistant, Treatment Outcome |
Abstract | 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. |
DOI | 10.1186/s12967-022-03861-2 |
Alternate Journal | J Transl Med |
PubMed ID | 36737752 |
PubMed Central ID | PMC9896712 |
Grant List | P50 CA211024 / CA / NCI NIH HHS / United States |
Related Faculty:
Pier Nuzzo, Ph.D.