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Clinical Trial
. 2014 Nov 25;111(11):2051-7.
doi: 10.1038/bjc.2014.504. Epub 2014 Sep 30.

Selecting first-line bevacizumab-containing therapy for advanced breast cancer: TURANDOT risk factor analyses

T Brodowicz  1 , I Lang  2 , Z Kahan  3 , R Greil  4 , S Beslija  5 , S M Stemmer  6 , B Kaufman  7 , L Petruzelka  8 , A Eniu  9 , R Anghel  10 , K Koynov  11 , D Vrbanec  12 , T Pienkowski  13 , B Melichar  14 , S Spanik  15 , S Ahlers  16 , D Messinger  16 , M J Inbar  17 , C Zielinski  1
Affiliations
Clinical Trial

Selecting first-line bevacizumab-containing therapy for advanced breast cancer: TURANDOT risk factor analyses

T Brodowicz et al. Br J Cancer. .

Abstract

Background: The randomised phase III TURANDOT trial compared first-line bevacizumab-paclitaxel (BEV-PAC) vs bevacizumab-capecitabine (BEV-CAP) in HER2-negative locally recurrent/metastatic breast cancer (LR/mBC). The interim analysis revealed no difference in overall survival (OS; primary end point) between treatment arms; however, progression-free survival (PFS) and objective response rate were significantly superior with BEV-PAC. We sought to identify patient populations that may be most appropriately treated with one or other regimen.

Methods: Patients with HER2-negative LR/mBC who had received no prior chemotherapy for advanced disease were randomised to either BEV-PAC (bevacizumab 10 mg kg(-1) days 1 and 15 plus paclitaxel 90 mg m(-2) days 1, 8 and 15 q4w) or BEV-CAP (bevacizumab 15 mg kg(-1) day 1 plus capecitabine 1000 mg m(-2) bid days 1-14 q3w). The study population was categorised into three cohorts: triple-negative breast cancer (TNBC), high-risk hormone receptor-positive (HR+) and low-risk HR+. High- and low-risk HR+ were defined, respectively, as having ⩾2 vs ⩽1 of the following four risk factors: disease-free interval ⩽24 months; visceral metastases; prior (neo)adjuvant anthracycline and/or taxane; and metastases in ⩾3 organs.

Results: The treatment effect on OS differed between cohorts. Non-significant OS trends favoured BEV-PAC in the TNBC cohort and BEV-CAP in the low-risk HR+ cohort. In all three cohorts, there was a non-significant PFS trend favouring BEV-PAC. Grade ⩾3 adverse events were consistently less common with BEV-CAP.

Conclusions: A simple risk factor index may help in selecting bevacizumab-containing regimens, balancing outcome, safety profile and patient preference. Final OS results are expected in 2015 (ClinicalTrials.gov NCT00600340).

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Figures

Figure 1
Figure 1
Overall survival (primary end point) according to risk category and treatment arm. Abbreviations: BEV–CAP=bevacizumab–capecitabine; BEV–PAC=bevacizumab–paclitaxel; HR+=hormone-receptor positive; TNBC=triple-negative breast cancer.
Figure 2
Figure 2
Progression-free survival (secondary end point) according to risk category and treatment arm. Abbreviations: BEV–CAP=bevacizumab–capecitabine; BEV–PAC=bevacizumab–paclitaxel; HR+=hormone-receptor positive; TNBC=triple-negative breast cancer.
See this image and copyright information in PMC

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