A multicenter phase II trial of anti-EGFR-immunoliposomes loaded with doxorubicin in patients with advanced triple negative breast cancer.
Journal
Scientific reports
ISSN: 2045-2322
Titre abrégé: Sci Rep
Pays: England
ID NLM: 101563288
Informations de publication
Date de publication:
06 03 2023
06 03 2023
Historique:
received:
04
10
2022
accepted:
03
03
2023
entrez:
6
3
2023
pubmed:
7
3
2023
medline:
9
3
2023
Statut:
epublish
Résumé
Advanced triple negative breast cancer (TNBC) is an aggressive, but initially chemo-sensitive disease. The prognosis is poor and more than three quarters of patients experience progression 12 months after the initiation of conventional first-line chemotherapy. Approximately two thirds of TNBC express epidermal growth factor receptor 1 (EGFR). We have developed an anti-EGFR targeted nanocontainer drug by inserting anti-EGFR antibody fragments into the membrane of pegylated liposomes (anti-EGFR-ILs-dox). The payload consists of doxorubicin, a standard drug for TNBC. In a first-in-human phase I trial in 26 patients with various advanced solid malignancies, anti-EGFR-ILs-dox has shown little toxicity and encouraging efficacy. In this single-arm phase II trial, we assessed the efficacy of anti-EGFR-ILs-dox as first-line therapy in patients with advanced, EGFR + TNBC. The primary endpoint was progression-free survival at 12 months (PFS12m). Secondary endpoints included overall response rate (ORR), duration of response (DOR), time to progression (TTP), overall survival (OS) and adverse events (AEs). 48 patients received anti-EGFR-ILs-dox 50 mg/m
Identifiants
pubmed: 36879012
doi: 10.1038/s41598-023-30950-z
pii: 10.1038/s41598-023-30950-z
pmc: PMC9988854
doi:
Substances chimiques
Liposomes
0
ErbB Receptors
EC 2.7.10.1
Doxorubicin
80168379AG
Banques de données
ClinicalTrials.gov
['NCT02833766']
Types de publication
Clinical Trial, Phase II
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
3705Informations de copyright
© 2023. The Author(s).
Références
Neuro Oncol. 2020 May 15;22(5):684-693
pubmed: 31747009
Oncology. 2012;82(4):218-27
pubmed: 22508241
Lancet. 2020 Dec 5;396(10265):1817-1828
pubmed: 33278935
Anticancer Res. 2007 May-Jun;27(3A):1285-94
pubmed: 17593621
N Engl J Med. 2022 Mar 24;386(12):1143-1154
pubmed: 35320644
Clin Cancer Res. 2007 Aug 1;13(15 Pt 1):4429-34
pubmed: 17671126
Onco Targets Ther. 2019 Sep 20;12:7749-7756
pubmed: 31571924
N Engl J Med. 2010 Nov 11;363(20):1938-48
pubmed: 21067385
ESMO Open. 2022 Feb;7(1):100365
pubmed: 34998092
Cancer Treat Rev. 2008 Aug;34(5):391-406
pubmed: 18358614
Cancer Res. 2005 Dec 15;65(24):11631-8
pubmed: 16357174
Int J Pharm. 2015 Apr 30;484(1-2):8-15
pubmed: 25701632
Int J Nanomedicine. 2007;2(3):345-52
pubmed: 18019833
N Engl J Med. 2021 Apr 22;384(16):1529-1541
pubmed: 33882206
N Engl J Med. 2018 Nov 29;379(22):2108-2121
pubmed: 30345906
J Clin Oncol. 2012 Jul 20;30(21):2615-23
pubmed: 22665533
N Engl J Med. 2022 Jul 21;387(3):217-226
pubmed: 35857659
Lancet Oncol. 2012 Dec;13(12):1234-41
pubmed: 23153506
Cancer Sci. 2021 Dec;112(12):5020-5033
pubmed: 34609773
CA Cancer J Clin. 2018 Nov;68(6):394-424
pubmed: 30207593
J Drug Target. 2012 Jun;20(5):422-32
pubmed: 22519893
J Clin Oncol. 2008 Mar 10;26(8):1275-81
pubmed: 18250347