TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00) : a randomised phase 3 trial
Bonnefoi, Herve ...
Background: TP53 has a crucial role in the DNA damage response. We therefore tested the hypothesis that taxanes confer a greater advantage than do anthracyclines on breast cancers with mutated TP53 ...than in those with wild-type TP53. Methods: In an open-label, phase 3 study, women (age <71 years) with locally advanced, inflammatory, or large operable breast cancers were randomly assigned in a 1:1 ratio to either a standard anthracycline regimen (six cycles of intravenous fluorouracil 500 mg/m^(2), epirubicin 100 mg/m^(2), and cyclophosphamide 500 mg/m^(2) every 21 days šFEC100đ, or fluorouracil 600 mg/m^(2), epirubicin 75 mg/m^(2), cyclophosphamide 900 mg/m^(2) štailored FECđ starting on day 1 and then every 21 days) or a taxane-based regimen (three cycles of docetaxel 100 mg/m^(2), intravenously infused over 1 h on day 1 every 21 days, followed by three cycles of intravenous epirubicin 90 mg/m^(2) and docetaxel 75 mg/m^(2) on day 1 every 21days šT-ETđ) at 42 centres in Europe. Randomisation was by use of a minimisation method that stratified patients by institution and initial tumourstage. The primary endpoint was progression-free survival (PFS) according to TP53 status. Analysis was by intention to treat. This is the final analysis of this trial. The study is registered with ClinicalTrials.gov,number NCT00017095. Findings: 928 patients were enrolled inthe FEC group and 928 in the T-ET group. TP53 status was not assessable for 183 (20%) patients in the FEC group and 204 (22%) patients in the T-ET group mainly because of low tumour-cell content in the biopsy. 361 primary endpoint events were recorded in the FEC group and 314 in the T-ET group. In patients with TP53-mutated tumours, 5-year PFS was 59 5% (95% CI 53 4-65 1) in the T-ETgroup (n=326) and 55 3% (49 2-60 9) in the FEC group (n=318; hazard ratio 0 84, 98% CI 0 63-1 14; p=0 17). (Abstract truncated at 2000 characters)
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