Pertuzumab retreatment for HER2-positive advanced breast cancer: A randomized, open-label phase III study (PRECIOUS).
HER2-positive
advanced breast cancer
heavily pretreated
pertuzumab
trastuzumab
Journal
Cancer science
ISSN: 1349-7006
Titre abrégé: Cancer Sci
Pays: England
ID NLM: 101168776
Informations de publication
Date de publication:
Sep 2022
Sep 2022
Historique:
revised:
25
05
2022
received:
16
03
2022
accepted:
16
06
2022
pubmed:
28
6
2022
medline:
14
9
2022
entrez:
27
6
2022
Statut:
ppublish
Résumé
No standard options existed for human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer that progresses after second-line trastuzumab emtansine therapy before 2020. The purpose of this study was to examine the efficacy of pertuzumab retreatment after disease progression following pertuzumab-containing therapy for HER2-positive locally advanced or metastatic breast cancer for the first time. This randomized, open-label, multicenter phase III trial was undertaken in 93 sites in Japan. Eligible patients with HER2-positive breast cancer who had received pertuzumab, trastuzumab, and chemotherapy as first- and/or second-line therapy were randomly assigned (1:1) to: (i) pertuzumab, trastuzumab, and physician's choice chemotherapy (PTC), or (ii) trastuzumab and physician's choice chemotherapy (TC). The primary end-point was investigator-assessed progression-free survival (PFS). Between August 1, 2015 and December 31, 2018, 219 patients were randomized to PTC (n = 110) or TC (n = 109). Median follow-up was 14.2 months (interquartile range, 9.0-22.2), and median PFS was 5.3 months (95% confidence interval [CI], 4.0-6.6) with PTC and 4.2 months (95% CI, 3.2-4.8) with TC (stratified hazard ratio 0.76 [95% CI upper limit 0.967]; p = 0.022). Progression-free survival was improved by adding pertuzumab in all prespecified subgroups. The PTC arm showed a trend towards better overall survival and duration of response, but similar objective response and health-related quality of life. The incidence of treatment-related adverse events was similar between groups except for diarrhea. Pertuzumab retreatment contributes to disease control for HER2-positive locally advanced or metastatic breast cancer previously treated with pertuzumab-containing regimens.
Identifiants
pubmed: 35754298
doi: 10.1111/cas.15474
pmc: PMC9459345
doi:
Substances chimiques
Antibodies, Monoclonal, Humanized
0
Receptor, ErbB-2
EC 2.7.10.1
pertuzumab
K16AIQ8CTM
Trastuzumab
P188ANX8CK
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
3169-3179Subventions
Organisme : Chugai Pharmaceutical Co., Ltd.
Informations de copyright
© 2022 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
Références
N Engl J Med. 2020 Feb 13;382(7):610-621
pubmed: 31825192
Eur J Cancer. 2011 Oct;47(15):2273-81
pubmed: 21741829
J Clin Oncol. 2009 Apr 20;27(12):1999-2006
pubmed: 19289619
Breast. 2017 Oct;35:78-84
pubmed: 28662406
J Clin Oncol. 2017 Jan 10;35(2):141-148
pubmed: 28056202
Cancer Cell. 2004 Apr;5(4):317-28
pubmed: 15093539
Exp Cell Res. 2003 Mar 10;284(1):54-65
pubmed: 12648465
Mol Cell Biol. 1996 Oct;16(10):5276-87
pubmed: 8816440
N Engl J Med. 2017 Jul 13;377(2):122-131
pubmed: 28581356
Lancet Oncol. 2012 Jan;13(1):25-32
pubmed: 22153890
Cancer Res. 2009 Dec 15;69(24):9330-6
pubmed: 19934333
Lancet Oncol. 2017 Jun;18(6):732-742
pubmed: 28526536
J Oncol Pract. 2018 Aug;14(8):501-504
pubmed: 29989839
Breast Cancer. 2016 May;23(3):329-42
pubmed: 26910609
Cancer Sci. 2022 Sep;113(9):3169-3179
pubmed: 35754298
Cancer Res. 2008 Jul 15;68(14):5878-87
pubmed: 18632642
J Clin Oncol. 2017 Sep 10;35(26):3030-3038
pubmed: 28437161
Ann Oncol. 2019 May 1;30(5):766-773
pubmed: 30796821
Lancet Oncol. 2014 Jun;15(7):689-99
pubmed: 24793816
J Clin Oncol. 1997 Mar;15(3):974-86
pubmed: 9060536
Cancer Cell. 2009 May 5;15(5):429-40
pubmed: 19411071
Ann Oncol. 2013 Sep;24(9):2278-84
pubmed: 23704196
JAMA Netw Open. 2019 Nov 1;2(11):e1916211
pubmed: 31774522
Eur J Cancer. 2016 Jul;62:132-7
pubmed: 27189322
Breast Cancer Res. 2016 Dec 13;18(1):126
pubmed: 27955684
N Engl J Med. 2019 Feb 14;380(7):617-628
pubmed: 30516102
N Engl J Med. 2012 Jan 12;366(2):109-19
pubmed: 22149875
JAMA Oncol. 2021 Apr 01;7(4):573-584
pubmed: 33480963
Cancer Res. 2004 Apr 1;64(7):2343-6
pubmed: 15059883
N Engl J Med. 2012 Nov 8;367(19):1783-91
pubmed: 23020162
J Clin Oncol. 2015 Feb 10;33(5):442-7
pubmed: 25547504
Cancer Chemother Pharmacol. 2020 Nov;86(5):641-654
pubmed: 32997196
N Engl J Med. 2020 Feb 13;382(7):597-609
pubmed: 31825569
J Clin Epidemiol. 2004 Sep;57(9):898-910
pubmed: 15504633
Ann Oncol. 2013 Oct;24(10):2630-2635
pubmed: 23868905