Pilot study of bevacizumab in combination with docetaxel and cyclophosphamide as adjuvant treatment for patients with early stage HER-2 negative breast cancer, including analysis of candidate circulating markers of cardiac toxicity: ICORG 08-10 trial.
bevacizumab
breast cancer
cardiotoxicity biomarker
docetaxel/cyclophosphamide
Journal
Therapeutic advances in medical oncology
ISSN: 1758-8340
Titre abrégé: Ther Adv Med Oncol
Pays: England
ID NLM: 101510808
Informations de publication
Date de publication:
2019
2019
Historique:
received:
14
08
2018
accepted:
29
05
2019
entrez:
7
8
2019
pubmed:
7
8
2019
medline:
7
8
2019
Statut:
epublish
Résumé
Combining bevacizumab and chemotherapy produced superior response rates compared with chemotherapy alone in metastatic breast cancer. As bevacizumab may cause hypertension (HTN) and increase the risk of cardiac failure, we performed a pilot study to evaluate the feasibility and toxicity of a non-anthracycline-containing combination of docetaxel with cyclophosphamide and bevacizumab in early stage breast cancer patients. Treatment consisted of four 3-weekly cycles of docetaxel and cyclophosphamide (75/600 mg/m A total of 106 patients were accrued in nine sites. Median follow up was 65 months (1-72 months). Seventeen protocol-defined relapse events were observed, accounting for an overall disease-free survival (DFS) rate of 84%. The DFS rates for hormone receptor positive (HR+) and triple-negative (TN) patients were 95% We observed a low relapse rate in node-positive, HR+ patients; however, results in TN breast cancer were less encouraging. Given the negative results of three large phase III trials, it is unlikely that this approach will be investigated further. ClinicalTrials.gov Identifier: NCT00911716.
Sections du résumé
BACKGROUND
BACKGROUND
Combining bevacizumab and chemotherapy produced superior response rates compared with chemotherapy alone in metastatic breast cancer. As bevacizumab may cause hypertension (HTN) and increase the risk of cardiac failure, we performed a pilot study to evaluate the feasibility and toxicity of a non-anthracycline-containing combination of docetaxel with cyclophosphamide and bevacizumab in early stage breast cancer patients.
METHODS
METHODS
Treatment consisted of four 3-weekly cycles of docetaxel and cyclophosphamide (75/600 mg/m
RESULTS
RESULTS
A total of 106 patients were accrued in nine sites. Median follow up was 65 months (1-72 months). Seventeen protocol-defined relapse events were observed, accounting for an overall disease-free survival (DFS) rate of 84%. The DFS rates for hormone receptor positive (HR+) and triple-negative (TN) patients were 95%
CONCLUSIONS
CONCLUSIONS
We observed a low relapse rate in node-positive, HR+ patients; however, results in TN breast cancer were less encouraging. Given the negative results of three large phase III trials, it is unlikely that this approach will be investigated further.
TRIAL REGISTRATION
BACKGROUND
ClinicalTrials.gov Identifier: NCT00911716.
Identifiants
pubmed: 31384312
doi: 10.1177/1758835919864236
pii: 10.1177_1758835919864236
pmc: PMC6657121
doi:
Banques de données
ClinicalTrials.gov
['NCT00911716']
Types de publication
Journal Article
Langues
eng
Pagination
1758835919864236Déclaration de conflit d'intérêts
Conflict of interest statement: The authors declare that there is no conflict of interest.
Références
J Clin Oncol. 2001 Feb 15;19(4):1207-25
pubmed: 11181687
J Clin Oncol. 2002 Mar 1;20(5):1215-21
pubmed: 11870163
Tumori. 2002 Nov-Dec;88(6):527-9
pubmed: 12597151
Invest Ophthalmol Vis Sci. 2008 Oct;49(10):4523-7
pubmed: 18441313
Chin Med J (Engl). 2010 Apr 5;123(7):901-6
pubmed: 20497685
Cancer Treat Rev. 2011 Jun;37(4):300-11
pubmed: 21126826
Ren Fail. 2011;33(3):291-7
pubmed: 21401353
Ann Oncol. 2012 Feb;23(2):331-7
pubmed: 21821545
Ann Oncol. 2012 Dec;23(12):3104-10
pubmed: 22851407
Cancer Res. 2013 Jan 15;73(2):539-49
pubmed: 23108136
J Clin Oncol. 2013 Mar 20;31(9):1219-30
pubmed: 23401453
Ann Oncol. 2013 Nov;24(11):2773-80
pubmed: 23894038
Lancet Oncol. 2013 Sep;14(10):933-42
pubmed: 23932548
J Am Coll Cardiol. 2014 Mar 4;63(8):809-16
pubmed: 24291281
Invest New Drugs. 2014 Dec;32(6):1285-94
pubmed: 24894652
Target Oncol. 2015 Jun;10(2):189-98
pubmed: 25185646
Int J Mol Sci. 2014 Dec 11;15(12):23024-41
pubmed: 25514409
Clin Chem. 2015 Sep;61(9):1164-72
pubmed: 26220066
Memo. 2017;10(4):194-201
pubmed: 29250196
J Clin Oncol. 2018 Jul 10;36(20):2052-2060
pubmed: 29792754
J Clin Oncol. 2018 Sep 1;36(25):2621-2629
pubmed: 30040523
Nat Commun. 2018 Oct 5;9(1):4112
pubmed: 30291241
Nat Med. 1995 Feb;1(2):149-53
pubmed: 7585012
J Immunol. 1998 Feb 1;160(3):1224-32
pubmed: 9570538