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

H. M. Earl, L Hiller, J Dunn, C Blenkinsop, L Grybowicz, A-L Vallier, I Gounaris, J Abraham, L Hughes-Davies, K McAdam, S Chan, R Ahmad, T Hickish, D Rea, C. Caldas, J M S Bartlett, D A Cameron, E Provenzano, J Thomas, R L HaywardARTemis Investigators Group

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Abstract

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

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

Results: 800 patients were randomised (median follow-up 3·5 yrs (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 category 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 (ClinicalTrials.gov number NCT01093235).

ClinicalTrials.gov: (NCT 01093235).

Original languageEnglish
JournalAnnals of Oncology
DOIs
Publication statusPublished - 27 Apr 2017

Keywords

  • Journal Article
  • ARTemis
  • breast cancer
  • bevacizumab
  • neoadjuvant chemotherapy

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