Fulvestrant with or without anti-HER2 therapy in patients in a postmenopausal hormonal state and with ER-positive HER2-positive advanced or metastatic breast cancer: A subgroup analysis of data from the Safari study (JBCRG-C06).
HER2-positive advanced or metastatic breast cancer
fulvestrant
real-world evidence
time to chemotherapy
Journal
Cancer medicine
ISSN: 2045-7634
Titre abrégé: Cancer Med
Pays: United States
ID NLM: 101595310
Informations de publication
Date de publication:
09 2023
09 2023
Historique:
revised:
03
07
2023
received:
01
05
2023
accepted:
19
07
2023
medline:
28
9
2023
pubmed:
1
8
2023
entrez:
1
8
2023
Statut:
ppublish
Résumé
The role of endocrine therapy in the treatment of patients in a postmenopausal hormonal state and with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer (AMBC) is unclear. We analyzed the data from 94 patients with ER-positive HER2-positive AMBC enrolled in the Safari study (UMIN000015168), a retrospective cohort study of 1072 ER-positive AMBC patients in a postmenopausal hormonal state who received fulvestrant 500 mg (F500): (1) to compare time to treatment failure (TTF) and overall survival (OS) by treatment group, and TTF by treatment line; (2) in patients who received endocrine therapy (including F500) or anti-HER2 therapy as initial systemic therapy before chemotherapy, to investigate relations between TTF for the first-line therapy or time to chemotherapy (TTC) and OS; (3) to investigate factors associated with OS. The TTF was longer in the patients treated with F500 as first- or second-line therapy (n = 20) than in those who received later-line F500 therapy (n = 74) (6.6 vs. 3.7 months; HR, 1.98; p = 0.014). In the 59 patients who received endocrine therapy or anti-HER2 therapy as initial systemic therapy before chemotherapy, those with TTC ≥3 years had longer median OS than those with TTC <3 years (10.5 vs. 5.9 years; HR, 0.32; p = 0.001). Longer TTC was associated with prolonged OS. In patients with ER-positive HER2-positive AMBC enrolled in the Safari study, TTF was longer in patients who received F500 as first- or second-line therapy. In patients who received chemotherapy-free initial systemic therapy, the prolonged OS in those with TTC ≥3 years suggests that this value may be a helpful cut-off for indicating clinical outcomes.
Sections du résumé
BACKGROUND
The role of endocrine therapy in the treatment of patients in a postmenopausal hormonal state and with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced or metastatic breast cancer (AMBC) is unclear.
METHODS
We analyzed the data from 94 patients with ER-positive HER2-positive AMBC enrolled in the Safari study (UMIN000015168), a retrospective cohort study of 1072 ER-positive AMBC patients in a postmenopausal hormonal state who received fulvestrant 500 mg (F500): (1) to compare time to treatment failure (TTF) and overall survival (OS) by treatment group, and TTF by treatment line; (2) in patients who received endocrine therapy (including F500) or anti-HER2 therapy as initial systemic therapy before chemotherapy, to investigate relations between TTF for the first-line therapy or time to chemotherapy (TTC) and OS; (3) to investigate factors associated with OS.
RESULTS
The TTF was longer in the patients treated with F500 as first- or second-line therapy (n = 20) than in those who received later-line F500 therapy (n = 74) (6.6 vs. 3.7 months; HR, 1.98; p = 0.014). In the 59 patients who received endocrine therapy or anti-HER2 therapy as initial systemic therapy before chemotherapy, those with TTC ≥3 years had longer median OS than those with TTC <3 years (10.5 vs. 5.9 years; HR, 0.32; p = 0.001). Longer TTC was associated with prolonged OS.
CONCLUSIONS
In patients with ER-positive HER2-positive AMBC enrolled in the Safari study, TTF was longer in patients who received F500 as first- or second-line therapy. In patients who received chemotherapy-free initial systemic therapy, the prolonged OS in those with TTC ≥3 years suggests that this value may be a helpful cut-off for indicating clinical outcomes.
Identifiants
pubmed: 37525895
doi: 10.1002/cam4.6390
pmc: PMC10523974
doi:
Substances chimiques
Fulvestrant
22X328QOC4
Receptor, ErbB-2
EC 2.7.10.1
Types de publication
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
17718-17730Informations de copyright
© 2023 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Références
Lancet. 2017 Dec 17;388(10063):2997-3005
pubmed: 27908454
JAMA Oncol. 2020 Jan 01;6(1):116-124
pubmed: 31563959
N Engl J Med. 1998 Oct 1;339(14):974-84
pubmed: 9753714
Ann Oncol. 2021 Aug;32(8):1015-1024
pubmed: 34102253
Cancer Med. 2023 Sep;12(17):17718-17730
pubmed: 37525895
J Clin Oncol. 2009 Nov 20;27(33):5529-37
pubmed: 19786670
JCO Oncol Pract. 2021 Oct;17(10):594-604
pubmed: 34077236
Curr Med Res Opin. 2018 Jan;34(1):49-54
pubmed: 29095648
Clin Cancer Res. 2022 Aug 15;28(16):3433-3442
pubmed: 35552673
Breast Cancer Res Treat. 2021 Nov;190(1):103-109
pubmed: 34453206
J Clin Oncol. 2009 Nov 20;27(33):5538-46
pubmed: 19786658
J Clin Oncol. 2010 Jun 1;28(16):2784-95
pubmed: 20404251
Breast Cancer. 2020 May;27(3):322-331
pubmed: 32240526
Ann Oncol. 2010 Jun;21(6):1246-1253
pubmed: 19875750
Breast Cancer Res Treat. 2017 Jun;163(3):545-554
pubmed: 28337663
Lancet Oncol. 2020 Apr;21(4):519-530
pubmed: 32171426
J Clin Oncol. 2018 Oct 1;36(28):2826-2835
pubmed: 30106636
N Engl J Med. 2022 Mar 10;386(10):942-950
pubmed: 35263519
J Clin Oncol. 2013 Nov 1;31(31):3997-4013
pubmed: 24101045
Breast Cancer. 2020 May;27(3):389-398
pubmed: 31811519
Lancet Oncol. 2013 May;14(6):461-71
pubmed: 23602601
N Engl J Med. 2017 Jul 13;377(2):122-131
pubmed: 28581356
Ann Oncol. 2020 Dec;31(12):1623-1649
pubmed: 32979513
N Engl J Med. 2019 Feb 14;380(7):617-628
pubmed: 30516102
Ann Oncol. 2011 May;22(5):1000-1010
pubmed: 20966181
J Clin Oncol. 2015 Nov 10;33(32):3781-7
pubmed: 26371134
Jpn J Clin Oncol. 2022 May 31;52(6):545-553
pubmed: 35296894