Challenging Endocrine Sensitivity of Hormone Receptor-Positive/HER2-Negative Advanced Breast Cancer with the Combination of Eribulin and Endocrine Therapy: The REVERT Study.
endocrine resistance
eribulin
luminal breast cancer
Journal
Cancers
ISSN: 2072-6694
Titre abrégé: Cancers (Basel)
Pays: Switzerland
ID NLM: 101526829
Informations de publication
Date de publication:
29 Nov 2022
29 Nov 2022
Historique:
received:
08
11
2022
revised:
22
11
2022
accepted:
23
11
2022
entrez:
11
12
2022
pubmed:
12
12
2022
medline:
12
12
2022
Statut:
epublish
Résumé
Luminal advanced breast cancer (ABC) patients eventually progress on endocrine therapy. REVERT aimed to explore whether eribulin could restore endocrine sensitivity in a randomized, non-comparative phase II trial. Aromatase inhibitor (AI)-resistant patients with luminal ABC were randomized 1:1 to receive eribulin +/- AI. Patients were stratified by prior cyclin-dependent kinases 4/6 inhibitor (CDK4/6i) treatment. The primary endpoint was an investigator-assessed overall response rate (ORR) according to RECIST version 1.1 in the eribulin + AI arm. An interim analysis was planned with 11 evaluable patients according to a two-stage Simon design. Twenty-two patients were enrolled (15 eribulin + AI arm; 7 eribulin arm). The trial was terminated early in March 2021, with eight (36.4%) patients still on treatment. ORR was 26.7% in the eribulin + AI arm (95% CI, 7.8-55.1%; Eribulin + AI does not seem to improve outcomes compared with eribulin monotherapy in patients with AI-resistant luminal ABC. This chemo-endocrine approach deserves further investigation after progression to CDK4/6i-based therapy.
Sections du résumé
BACKGROUND
BACKGROUND
Luminal advanced breast cancer (ABC) patients eventually progress on endocrine therapy. REVERT aimed to explore whether eribulin could restore endocrine sensitivity in a randomized, non-comparative phase II trial.
METHODS
METHODS
Aromatase inhibitor (AI)-resistant patients with luminal ABC were randomized 1:1 to receive eribulin +/- AI. Patients were stratified by prior cyclin-dependent kinases 4/6 inhibitor (CDK4/6i) treatment. The primary endpoint was an investigator-assessed overall response rate (ORR) according to RECIST version 1.1 in the eribulin + AI arm. An interim analysis was planned with 11 evaluable patients according to a two-stage Simon design.
RESULTS
RESULTS
Twenty-two patients were enrolled (15 eribulin + AI arm; 7 eribulin arm). The trial was terminated early in March 2021, with eight (36.4%) patients still on treatment. ORR was 26.7% in the eribulin + AI arm (95% CI, 7.8-55.1%;
CONCLUSION
CONCLUSIONS
Eribulin + AI does not seem to improve outcomes compared with eribulin monotherapy in patients with AI-resistant luminal ABC. This chemo-endocrine approach deserves further investigation after progression to CDK4/6i-based therapy.
Identifiants
pubmed: 36497361
pii: cancers14235880
doi: 10.3390/cancers14235880
pmc: PMC9737152
pii:
doi:
Types de publication
Journal Article
Langues
eng
Références
Mol Cancer Ther. 2005 Jul;4(7):1086-95
pubmed: 16020666
Br J Cancer. 2014 Mar 18;110(6):1497-505
pubmed: 24569463
Lancet Oncol. 2021 Apr;22(4):489-498
pubmed: 33794206
Cancers (Basel). 2021 Nov 11;13(22):
pubmed: 34830800
Lancet. 2011 Mar 12;377(9769):914-23
pubmed: 21376385
Breast Cancer Res Treat. 2014 Dec;148(3):553-61
pubmed: 25381136
J Clin Oncol. 2000 Nov 15;18(22):3758-67
pubmed: 11078488
J Clin Oncol. 2015 Feb 20;33(6):594-601
pubmed: 25605862
Clin Cancer Res. 2022 Aug 2;28(15):3256-3267
pubmed: 35583555
Clin Cancer Res. 2015 Jun 1;21(11):2445-52
pubmed: 25838395
Anticancer Res. 2020 Dec;40(12):6699-6712
pubmed: 33288563
Lancet. 2020 Mar 7;395(10226):817-827
pubmed: 32145796
Future Oncol. 2019 Dec;15(34):3935-3944
pubmed: 31660764
Future Oncol. 2019 Oct;15(28):3209-3218
pubmed: 31426673
BMC Cancer. 2011 Sep 28;11:417
pubmed: 21955753
J Clin Oncol. 2003 Jun 1;21(11):2101-9
pubmed: 12775735
Cancer Sci. 2014 Oct;105(10):1334-42
pubmed: 25060424
NPJ Breast Cancer. 2021 Nov 25;7(1):145
pubmed: 34824288