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Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer : ARTemis Trial

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Earl, H. M., Hiller, Louise, Dunn, Janet A., Blenkinsop, C., Grybowicz, L., Vallier, A.-L., Gounaris, I., Abraham, J. E., Hughes-Davies, L., McAdam, K. et al.
(2017) Disease-free and overall survival at 3.5 years for neoadjuvant bevacizumab added to docetaxel followed by fluorouracil, epirubicin and cyclophosphamide, for women with HER2 negative early breast cancer : ARTemis Trial. Annals of Oncology, 28 (8). pp. 1817-1824. doi:10.1093/annonc/mdx173

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Official URL: http://dx.doi.org/10.1093/annonc/mdx173

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Abstract

Background:
The ARTemis trial previously reported that addition of neoadjuvant bevacizumab (Bev) to docetaxel (D) followed by fluorouracil, epirubicin and cyclophosphamide (D-FEC) in HER2 negative breast cancer improved the pathological complete response (pCR) rate. We present disease-free survival (DFS) and overall survival (OS) with central pathology review.

Patients and methods:
Patients were randomized to 3 cycles of D followed by 3 cycles of FEC (D-FEC), ±4 cycles of Bev (Bev + D-FEC). DFS and OS were analyzed by treatment and by central pathology reviewed pCR and Residual Cancer Burden (RCB) class.

Results:
A total of 800 patients were randomized [median follow-up 3.5 years (IQR 3.2–4.4)]. DFS and OS were similar across treatment arms [DFS hazard ratio (HR)=1.18 (95% CI 0.89–1.57), P = 0.25; OS HR = 1.26 (95% CI 0.90–1.76), P = 0.19). Both local pathology report review and central histopathology review confirmed a significant improvement in DFS and OS for patients who achieved a pCR [DFS HR = 0.38 (95% CI 0.23–0.63), P < 0.001; OS HR = 0.43 (95% CI 0.24–0.75), P = 0.003]. However, significant heterogeneity was observed (P = 0.02); larger improvements in DFS were obtained with a pCR achieved with D-FEC than a pCR achieved with Bev + D-FEC. As RCB class increased, significantly worse DFS and OS was observed (P for trend <0.0001), which effect was most marked in the ER negative group.

Conclusions:
The addition of short course neoadjuvant Bev to standard chemotherapy did not demonstrate a DFS or OS benefit. Achieving a pCR with D-FEC is associated with improved DFS and OS but not when pCR is achieved with Bev + D-FEC. At the present time therefore, Bev is not recommended in early breast cancer.

Item Type: Journal Article
Subjects: R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Divisions: Faculty of Medicine > Warwick Medical School > Health Sciences > Clinical Trials Unit
Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
Library of Congress Subject Headings (LCSH): Breast -- Cancer -- Chemotherapy, Clinical trials, Bevacizumab, Antineoplastic agents
Journal or Publication Title: Annals of Oncology
Publisher: Oxford University Press
ISSN: 0923-7534
Official Date: 1 August 2017
Dates:
DateEvent
1 August 2017Published
27 April 2017Available
3 April 2017Accepted
Volume: 28
Number: 8
Page Range: pp. 1817-1824
DOI: 10.1093/annonc/mdx173
Status: Peer Reviewed
Publication Status: Published
Access rights to Published version: Open Access
RIOXX Funder/Project Grant:
Project/Grant IDRIOXX Funder NameFunder ID
CRUK/08/037Cancer Research UKhttp://dx.doi.org/10.13039/501100000289
UNSPECIFIEDRochehttp://dx.doi.org/10.13039/100004337
UNSPECIFIEDSanofihttp://dx.doi.org/10.13039/100004339
Contributors:
ContributionNameContributor ID
Research GroupARTemis Investigators Group, UNSPECIFIED

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