Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancer With Serum VEGF as Primary Endpoint: The NEOZOL Study.

Details

Serval ID
serval:BIB_110C7F879038
Type
Article: article from journal or magazin.
Collection
Publications
Title
Comparative Study of Neoadjuvant Chemotherapy With and Without Zometa for Management of Locally Advanced Breast Cancer With Serum VEGF as Primary Endpoint: The NEOZOL Study.
Journal
Clinical breast cancer
Author(s)
Lelièvre L., Clézardin P., Magaud L., Roche L., Tubiana-Mathieu N., Tigaud J.D., Topart D., Raban N., Mouret-Reynier M.A., Mathevet P.
ISSN
1938-0666 (Electronic)
ISSN-L
1526-8209
Publication state
Published
Issued date
12/2018
Peer-reviewed
Oui
Volume
18
Number
6
Pages
e1311-e1321
Language
english
Notes
Publication types: Clinical Trial, Phase II ; Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
Neoadjuvant chemotherapy has become the treatment of choice for locally advanced breast cancer. Zoledronic acid (ZA) is a bisphosphonate initially used in the treatment of bone metastases because of its antibone resorption effect. Antitumor effects of ZA, including the inhibition of cell adhesion to mineralized bone or the antiangiogenic effect, have been demonstrated. However, the clinical significance of these effects remains to be determined.
We undertook a multicenter open-label randomized trial to analyze the value of adding ZA to neoadjuvant chemotherapy for TNM clinical stage T2/T3 breast cancer. The primary endpoint was the evolution of serum VEGF.
The data from 24 patients were included in the ZA group and 26 in the control group. The evolution of serum VEGF was slightly in favor of ZA at 5.5 months (-0.7% vs. +7.5%), without reaching statistical significance (P = .52). The secondary endpoints were the breast conservation rate (higher with ZA; 83.3% vs. 65.4%; P = NS), pathologic complete response (no effect), and circulating tumor cells (odds ratio, 0.68 in favor of ZA; 95% confidence interval, 0.02-24.36). No cases of jaw necrosis or severe renal failure were observed in either group.
ZA is an antitumor drug of interest because of its multiple effects on tumor biology. Larger trials with longer follow-up that include additional endpoints such as relapse and survival rates would be of interest.
Keywords
Adult, Aged, Antineoplastic Combined Chemotherapy Protocols/therapeutic use, Biomarkers, Tumor/blood, Bone Density Conservation Agents/therapeutic use, Bone Neoplasms/blood, Bone Neoplasms/drug therapy, Bone Neoplasms/secondary, Breast Neoplasms/blood, Breast Neoplasms/drug therapy, Breast Neoplasms/pathology, Carcinoma, Ductal, Breast/blood, Carcinoma, Ductal, Breast/drug therapy, Carcinoma, Ductal, Breast/secondary, Carcinoma, Lobular/blood, Carcinoma, Lobular/drug therapy, Carcinoma, Lobular/secondary, Drug Therapy, Combination, Female, Follow-Up Studies, Humans, Middle Aged, Neoadjuvant Therapy/mortality, Prognosis, Prospective Studies, Survival Rate, Vascular Endothelial Growth Factor A/blood, Young Adult, Zoledronic Acid/therapeutic use, Breast cancer, Locally advanced breast cancer, Neoadjuvant treatment, Vascular endothelial growth factor, Zoledronic acid
Pubmed
Web of science
Create date
20/08/2018 14:19
Last modification date
18/09/2019 6:10
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