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
Bjartell, Anders (Lund University. Department of Translational Medicine, Medical Faculty)
Lumen, Nicolaas (Universitair Ziekenhuis Gent)
Maroto Rey, Pablo (Institut d'Investigació Biomèdica Sant Pau)
Paiss, Thomas (Urologie team Ulm, Ulm, Germany)
Gomez-Veiga, Francisco (Instituto de Investigación Biomédica de Salamanca)
Birtle, Alison (Royal Preston Hospital)
Kramer, Gero (Medical University of Vienna. Department of Urology)
Kalinka, Ewa (Polish Mother's Memorial Hospital, Research Institute. Clinic of Oncology)
Spaëth, Dominique (Centre d'Oncologie de Gentilly, Nancy, France)
Feyerabend, Susan (Studienpraxis Urologie, Nürtingen, Germany)
Matveev, Vsevolod (N.N. Blokhin National Cancer Research Center)
Lefresne, Florence (Janssen Pharmaceutica N.V.. EMEA Oncology)
Lukac, Martin (Parexel International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V)
Wapenaar, Robert (Janssen-Cilag B.V., Breda, The Netherlands)
Costa, Luis (Universidade de Lisboa. Oncology Division, Faculdade de Medicina, Hospital de Santa Maria, Instituto de Medicina Molecular)
Chowdhury, Simon (Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute)
Universitat Autònoma de Barcelona

Fecha:	2021
Resumen:	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. The online version contains supplementary material available at 10. 1007/s11523-021-00807-4.
Derechos:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Lengua:	Anglès
Documento:	Article ; recerca ; Versió publicada
Publicado en:	Targeted Oncology, Vol. 16 (april 2021) , p. 357-367, ISSN 1776-260X

DOI: 10.1007/s11523-021-00807-4
PMID: 33826036

11 p, 832.5 KB

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