-
Je něco špatně v tomto záznamu ?
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
A. Bjartell, N. Lumen, P. Maroto, T. Paiss, F. Gomez-Veiga, A. Birtle, G. Kramer, E. Kalinka, D. Spaëth, S. Feyerabend, V. Matveev, F. Lefresne, M. Lukac, R. Wapenaar, L. Costa, S. Chowdhury
Jazyk angličtina Země Francie
Typ dokumentu časopisecké články, práce podpořená grantem
NLK
ProQuest Central
od 2006-01-01 do Před 1 rokem
Medline Complete (EBSCOhost)
od 2006-01-01 do Před 1 rokem
Nursing & Allied Health Database (ProQuest)
od 2006-01-01 do Před 1 rokem
Health & Medicine (ProQuest)
od 2006-01-01 do Před 1 rokem
Family Health Database (ProQuest)
od 2006-01-01 do Před 1 rokem
- MeSH
- abirateron farmakologie terapeutické užití MeSH
- lidé MeSH
- nádory prostaty rezistentní na kastraci farmakoterapie MeSH
- prednison farmakologie terapeutické užití MeSH
- registrace MeSH
- senioři MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
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.
Centre d'Oncologie de Gentilly Nancy France
Clinic of Oncology Polish Mother's Memorial Hospital Research Institute Lodz Poland
Department of Translational Medicine Medical Faculty Lund University Malmö Sweden
Department of Urology Ghent University Hospital Ghent Belgium
Department of Urology Medical University of Vienna Vienna Austria
Department of Urology Skåne University Hospital Malmö Jan Waldenströms gata 5 SE 205 02 Malmö Sweden
EMEA Oncology Janssen Pharmaceutica N 5 Beerse Belgium
Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute London UK
Janssen Cilag B 5 Breda The Netherlands
N N Blokhin National Cancer Research Center Moscow Russia
Parexel International Czech Republic s r o on behalf of Janssen Pharmaceutica N 5 Beerse Belgium
Royal Preston Hospital Preston UK
Citace poskytuje Crossref.org
- 000
- 00000naa a2200000 a 4500
- 001
- bmc22004428
- 003
- CZ-PrNML
- 005
- 20220127145246.0
- 007
- ta
- 008
- 220113s2021 fr f 000 0|eng||
- 009
- AR
- 024 7_
- $a 10.1007/s11523-021-00807-4 $2 doi
- 035 __
- $a (PubMed)33826036
- 040 __
- $a ABA008 $b cze $d ABA008 $e AACR2
- 041 0_
- $a eng
- 044 __
- $a fr
- 100 1_
- $a Bjartell, Anders $u Department of Urology, Skåne University Hospital Malmö, Jan Waldenströms gata 5, SE 205 02, Malmö, Sweden. anders.bjartell@med.lu.se $u Department of Translational Medicine, Medical Faculty, Lund University, Malmö, Sweden. anders.bjartell@med.lu.se
- 245 10
- $a 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 / $c A. Bjartell, N. Lumen, P. Maroto, T. Paiss, F. Gomez-Veiga, A. Birtle, G. Kramer, E. Kalinka, D. Spaëth, S. Feyerabend, V. Matveev, F. Lefresne, M. Lukac, R. Wapenaar, L. Costa, S. Chowdhury
- 520 9_
- $a 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.
- 650 _2
- $a abirateron $x farmakologie $x terapeutické užití $7 D000069501
- 650 _2
- $a senioři $7 D000368
- 650 _2
- $a lidé $7 D006801
- 650 _2
- $a mužské pohlaví $7 D008297
- 650 _2
- $a prednison $x farmakologie $x terapeutické užití $7 D011241
- 650 _2
- $a nádory prostaty rezistentní na kastraci $x farmakoterapie $7 D064129
- 650 _2
- $a registrace $7 D012042
- 655 _2
- $a časopisecké články $7 D016428
- 655 _2
- $a práce podpořená grantem $7 D013485
- 700 1_
- $a Lumen, Nicolaas $u Department of Urology, Ghent University Hospital, Ghent, Belgium
- 700 1_
- $a Maroto, Pablo $u Department of Medical Oncology, Hospital de la Santa Creu i Sant Pau, Autonomous University of Barcelona, Barcelona, Spain
- 700 1_
- $a Paiss, Thomas $u Urologie team Ulm, Ulm, Germany
- 700 1_
- $a Gomez-Veiga, Francisco $u Urology Department and Kidney Transplant Unit, Translational Research Group of Urology GITUR-IBSAL, Salamanca University Hospital, Salamanca, Spain
- 700 1_
- $a Birtle, Alison $u Royal Preston Hospital, Preston, UK
- 700 1_
- $a Kramer, Gero $u Department of Urology, Medical University of Vienna, Vienna, Austria
- 700 1_
- $a Kalinka, Ewa $u Clinic of Oncology, Polish Mother's Memorial Hospital, Research Institute, Lodz, Poland
- 700 1_
- $a Spaëth, Dominique $u Centre d'Oncologie de Gentilly, Nancy, France
- 700 1_
- $a Feyerabend, Susan $u Studienpraxis Urologie, Nürtingen, Germany
- 700 1_
- $a Matveev, Vsevolod $u N.N. Blokhin National Cancer Research Center, Moscow, Russia
- 700 1_
- $a Lefresne, Florence $u EMEA Oncology, Janssen Pharmaceutica N.V., Beerse, Belgium
- 700 1_
- $a Lukac, Martin $u Parexel International Czech Republic s.r.o, on behalf of Janssen Pharmaceutica N.V., Beerse, Belgium
- 700 1_
- $a Wapenaar, Robert $u Janssen-Cilag B.V., Breda, The Netherlands
- 700 1_
- $a Costa, Luis $u Oncology Division, Faculdade de Medicina, Hospital de Santa Maria, Instituto de Medicina Molecular, Universidade de Lisboa, Lisbon, Portugal
- 700 1_
- $a Chowdhury, Simon $u Guy's and St Thomas' NHS Foundation Trust and Sarah Cannon Research Institute, London, UK
- 773 0_
- $w MED00189571 $t Targeted oncology $x 1776-260X $g Roč. 16, č. 3 (2021), s. 357-367
- 856 41
- $u https://pubmed.ncbi.nlm.nih.gov/33826036 $y Pubmed
- 910 __
- $a ABA008 $b sig $c sign $y p $z 0
- 990 __
- $a 20220113 $b ABA008
- 991 __
- $a 20220127145242 $b ABA008
- 999 __
- $a ok $b bmc $g 1751793 $s 1155577
- BAS __
- $a 3
- BAS __
- $a PreBMC
- BMC __
- $a 2021 $b 16 $c 3 $d 357-367 $e 20210407 $i 1776-260X $m Targeted oncology $n Target Oncol $x MED00189571
- LZP __
- $a Pubmed-20220113