Real-World Safety and Efficacy Outcomes with Abiraterone Acetate Plus Prednisone or Prednisolone as the First- or Second-Line Treatment for Metastatic Castration-Resistant Prostate Cancer: Data from the Prostate Cancer Registry.
Journal
Targeted oncology
ISSN: 1776-260X
Titre abrégé: Target Oncol
Pays: France
ID NLM: 101270595
Informations de publication
Date de publication:
05 2021
05 2021
Historique:
accepted:
06
03
2021
pubmed:
8
4
2021
medline:
1
12
2021
entrez:
7
4
2021
Statut:
ppublish
Résumé
Despite standard-of-care androgen-deprivation therapy and an increasing number of treatment options, the mortality rate for prostate cancer remains high. Progress to metastatic castration-resistant prostate cancer (mCRPC) necessitates additional treatments. Abiraterone acetate plus prednisone or prednisolone (AAP) prolongs survival in chemotherapy-naive and docetaxel-experienced patients. To evaluate the real-world safety and efficacy of AAP as first-line and second-line [post-docetaxel only (AAP-PD)] treatment in patients with mCRPC. The Prostate Cancer Registry (PCR) was a prospective, international, observational study of patients with mCRPC in routine clinical practice. Men aged ≥ 18 years with confirmed mCRPC were included. Baseline characteristics, safety (treatment-emergent adverse events, treatment-emergent severe adverse events), and efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed. At baseline, patients who received first-line AAP (n = 754) were generally older than patients who received AAP-PD (n = 354); median age was 76 years and 70 years, respectively. However, the rate of visceral metastasis was higher in the AAP-PD cohort than in the AAP cohort (17.7% vs. 9.6%, respectively). Demographics and disease characteristics of patients with baseline cardiovascular disease were similar to those of the overall registry population. Efficacy outcomes were similar for all patients, regardless of the line of AAP therapy. For first-line AAP and AAP-PD, respectively, the median PFS was 8.9 and 5.8 months for all patients and 9.1 and 6.0 months for patients with cardiovascular comorbidities; median OS was 27.1 and 23.4 months for all patients, and 27.4 and 23.1 months for patients with cardiovascular comorbidities. There were no unexpected adverse events in any patient subgroup. These real-world data complement the findings from randomized controlled trials, indicating that first- and second-line AAP is well tolerated and effective in patients with mCRPC, including those with underlying CV comorbidities. NCT02236637, registered 8 September 2014.
Sections du résumé
BACKGROUND
Despite standard-of-care androgen-deprivation therapy and an increasing number of treatment options, the mortality rate for prostate cancer remains high. Progress to metastatic castration-resistant prostate cancer (mCRPC) necessitates additional treatments. Abiraterone acetate plus prednisone or prednisolone (AAP) prolongs survival in chemotherapy-naive and docetaxel-experienced patients.
OBJECTIVE
To evaluate the real-world safety and efficacy of AAP as first-line and second-line [post-docetaxel only (AAP-PD)] treatment in patients with mCRPC.
PATIENTS AND METHODS
The Prostate Cancer Registry (PCR) was a prospective, international, observational study of patients with mCRPC in routine clinical practice. Men aged ≥ 18 years with confirmed mCRPC were included. Baseline characteristics, safety (treatment-emergent adverse events, treatment-emergent severe adverse events), and efficacy [progression-free survival (PFS) and overall survival (OS)] were analyzed.
RESULTS
At baseline, patients who received first-line AAP (n = 754) were generally older than patients who received AAP-PD (n = 354); median age was 76 years and 70 years, respectively. However, the rate of visceral metastasis was higher in the AAP-PD cohort than in the AAP cohort (17.7% vs. 9.6%, respectively). Demographics and disease characteristics of patients with baseline cardiovascular disease were similar to those of the overall registry population. Efficacy outcomes were similar for all patients, regardless of the line of AAP therapy. For first-line AAP and AAP-PD, respectively, the median PFS was 8.9 and 5.8 months for all patients and 9.1 and 6.0 months for patients with cardiovascular comorbidities; median OS was 27.1 and 23.4 months for all patients, and 27.4 and 23.1 months for patients with cardiovascular comorbidities. There were no unexpected adverse events in any patient subgroup.
CONCLUSIONS
These real-world data complement the findings from randomized controlled trials, indicating that first- and second-line AAP is well tolerated and effective in patients with mCRPC, including those with underlying CV comorbidities.
TRIAL REGISTRATION NUMBER
NCT02236637, registered 8 September 2014.
Identifiants
pubmed: 33826036
doi: 10.1007/s11523-021-00807-4
pii: 10.1007/s11523-021-00807-4
pmc: PMC8105236
doi:
Substances chimiques
Abiraterone Acetate
EM5OCB9YJ6
Prednisone
VB0R961HZT
Banques de données
ClinicalTrials.gov
['NCT02236637']
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
357-367Références
World Health Organization. GLOBOCAN 2018: all cancers. https://gco.iarc.fr/today/data/factsheets/cancers/39-All-cancers-fact-sheet.pdf . Accessed 17 May 2019.
Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018;68:394–424. https://doi.org/10.3322/caac.21492 .
doi: 10.3322/caac.21492
pubmed: 30207593
World Health Organization. GLOBOCAN 2020 (Europe): all cancers. https://gco.iarc.fr/today/data/factsheets/populations/908-europe-fact-sheets.pdf . Accessed 10 July 2020.
Basch E, Loblaw DA, Oliver TK, Carducci M, Chen RC, Frame JN, et al. Systemic therapy in men with metastatic castration-resistant prostate cancer: American Society of Clinical Oncology and Cancer Care Ontario clinical practice guideline. J Clin Oncol. 2014;32:3436–48. https://doi.org/10.1200/JCO.2013.54.8404 .
doi: 10.1200/JCO.2013.54.8404
pubmed: 25199761
pmcid: 4876355
Beer TM, Armstrong AJ, Rathkopf DE, Loriot Y, Sternberg CN, Higano CS, et al. Enzalutamide in metastatic prostate cancer before chemotherapy. N Engl J Med. 2014;371:424–33. https://doi.org/10.1056/NEJMoa1405095 .
doi: 10.1056/NEJMoa1405095
pubmed: 24881730
pmcid: 4418931
de Bono JS, Oudard S, Ozguroglu M, Hansen S, Machiels JP, Kocak I, et al. Prednisone plus cabazitaxel or mitoxantrone for metastatic castration-resistant prostate cancer progressing after docetaxel treatment: a randomised open-label trial. Lancet. 2010;376:1147–54. https://doi.org/10.1016/S0140-6736(10)61389-X .
doi: 10.1016/S0140-6736(10)61389-X
pubmed: 20888992
Parker C, Nilsson S, Heinrich D, Helle SI, O’Sullivan JM, Fossa SD, et al. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013;369:213–23. https://doi.org/10.1056/NEJMoa1213755 .
doi: 10.1056/NEJMoa1213755
pubmed: 23863050
Ryan CJ, Smith MR, Fizazi K, Saad F, Mulders PF, Sternberg CN, et al. Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study. Lancet Oncol. 2015;16:152–60. https://doi.org/10.1016/S1470-2045(14)71205-7 .
doi: 10.1016/S1470-2045(14)71205-7
pubmed: 25601341
Tannock IF, de Wit R, Berry WR, Horti J, Pluzanska A, Chi KN, et al. Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer. N Engl J Med. 2004;351:1502–12. https://doi.org/10.1056/NEJMoa040720 .
doi: 10.1056/NEJMoa040720
pubmed: 15470213
de Bono JS, Logothetis CJ, Molina A, Fizazi K, North S, Chu L, et al. Abiraterone and increased survival in metastatic prostate cancer. N Engl J Med. 2011;364:1995–2005. https://doi.org/10.1056/NEJMoa1014618 .
doi: 10.1056/NEJMoa1014618
pubmed: 21612468
pmcid: 3471149
Jin S, Pazdur R, Sridhara R. Re-evaluating eligibility criteria for oncology clinical trials: analysis of investigational New Drug Applications in 2015. J Clin Oncol. 2017;35:3745–52. https://doi.org/10.1200/JCO.2017.73.4186 .
doi: 10.1200/JCO.2017.73.4186
pubmed: 28968168
pmcid: 5692723
Templeton AJ, Booth CM, Tannock IF. Informing patients about expected outcomes: the efficacy-effectiveness gap. J Clin Oncol. 2020;38:1651–4. https://doi.org/10.1200/JCO.19.02035 .
doi: 10.1200/JCO.19.02035
pubmed: 32160103
Pathak S, Thekkekara R, Yadav U, Ahmed AT, Yim B, Lad TE, et al. Efficacy of upfront docetaxel with androgen deprivation therapy for castration-sensitive metastatic prostate cancer among minority patients. Am J Ther. 2020. https://doi.org/10.1097/mjt.0000000000001085 .
doi: 10.1097/mjt.0000000000001085
pubmed: 32384317
Gyawali B, Parsad D, Feinberg BA, Nabhan C. Real-world evidence and randomized studies in the precision oncology era: the right balance. JCO Precis Oncol. 2017. https://doi.org/10.1200/po.17.00132 .
doi: 10.1200/po.17.00132
Kim HS, Lee S, Kim JH. Real-world evidence versus randomized controlled trial: clinical research based on electronic medical records. J Korean Med Sci. 2018;33:e213. https://doi.org/10.3346/jkms.2018.33.e213 .
doi: 10.3346/jkms.2018.33.e213
pubmed: 30127705
pmcid: 6097073
Chowdhury S, Bjartell A, Lumen N, Maroto P, Paiss T, Gomez-Veiga F, et al. Real-world outcomes in first-line treatment of metastatic castration-resistant prostate cancer: the Prostate Cancer Registry. Target Oncol. 2020;15:301–15. https://doi.org/10.1007/s11523-020-00720-2 .
doi: 10.1007/s11523-020-00720-2
pubmed: 32500294
pmcid: 7283204
Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, et al. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013;368:138–48. https://doi.org/10.1056/NEJMoa1209096 .
doi: 10.1056/NEJMoa1209096
pubmed: 23228172