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Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial.
Ellis, Paul A Barrett-Lee, P J Johnson, Lindsay Cameron, David O'Reilly, Susan Verrill, Mark W Smith, Ian Yarnold, John Coleman, Robert E
Ellis, Paul A
Barrett-Lee, P J
Johnson, Lindsay
Cameron, David
O'Reilly, Susan
Verrill, Mark W
Smith, Ian
Yarnold, John
Coleman, Robert E
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Abstract
BACKGROUND: Incorporation of a taxane as adjuvant treatment for early breast cancer offers potential for further improvement of anthracycline-based treatment. The UK TACT study (CRUK01/001) investigated whether sequential docetaxel after anthracycline chemotherapy would improve patient outcome compared with standard chemotherapy of similar duration. METHODS: In this multicentre, open-label, phase III, randomised controlled trial, 4162 women (aged >18 years) with node-positive or high-risk node-negative operable early breast cancer were randomly assigned by computer-generated permuted block randomisation to receive FEC (fluorouracil 600 mg/m(2), epirubicin 60 mg/m(2), cyclophosphamide 600 mg/m(2) at 3-weekly intervals) for four cycles followed by docetaxel (100 mg/m(2) at 3-weekly intervals) for four cycles (n=2073) or control (n=2089). For the control regimen, centres chose either FEC for eight cycles (n=1265) or epirubicin (100 mg/m(2) at 3-weekly intervals) for four cycles followed by CMF (cyclophosphamide 600 mg/m(2), methotrexate 40 mg/m(2), and fluorouracil 600 mg/m(2) at 4-weekly intervals) for four cycles (n=824). The primary endpoint was disease-free survival. Analysis was by intention to treat (ITT). This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN79718493. FINDINGS: All randomised patients were included in the ITT population. With a median follow-up of 62 months, disease-free survival events were seen in 517 of 2073 patients in the experimental group compared with 539 of 2089 controls (hazard ratio [HR] 0.95, 95% CI 0.85-1.08; p=0.44). 75.6% (95% CI 73.7-77.5) of patients in the experimental group and 74.3% (72.3-76.2) of controls were alive and disease-free at 5 years. The proportion of patients who reported any acute grade 3 or 4 adverse event was significantly greater in the experimental group than in the control group (p<0.0001); the most frequent events were neutropenia (937 events vs 797 events), leucopenia (507 vs 362), and lethargy (456 vs 272). INTERPRETATION: This study did not show any overall gain from the addition of docetaxel to standard anthracycline chemotherapy. Exploration of predictive biomarker-defined subgroups might have the potential to better target the use of taxane-based therapy. FUNDING: Cancer Research UK (CRUK 01/001), Sanofi-Aventis, Pfizer, and Roche.
Authors
Ellis, Paul A
Barrett-Lee, P J
Johnson, Lindsay
Cameron, David
Wardley, Andrew M
O'Reilly, Susan
Verrill, Mark W
Smith, Ian
Yarnold, John
Coleman, Robert E
Earl, Helena
Canney, Peter A
Twelves, Chris
Poole, Christopher
Bloomfield, David
Hopwood, Penelope
Johnston, Stephen
Dowsett, Mitch
Bartlett, John M S
Ellis, Ian
Peckitt, Clare
Hall, Emma
Bliss, Judith M
Barrett-Lee, P J
Johnson, Lindsay
Cameron, David
Wardley, Andrew M
O'Reilly, Susan
Verrill, Mark W
Smith, Ian
Yarnold, John
Coleman, Robert E
Earl, Helena
Canney, Peter A
Twelves, Chris
Poole, Christopher
Bloomfield, David
Hopwood, Penelope
Johnston, Stephen
Dowsett, Mitch
Bartlett, John M S
Ellis, Ian
Peckitt, Clare
Hall, Emma
Bliss, Judith M
Description
Date
2009-05-16
Publisher
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Keywords
Breast Cancer
Oestrogen Receptors
Oestrogen Receptors
Type
Article
Citation
Sequential docetaxel as adjuvant chemotherapy for early breast cancer (TACT): an open-label, phase III, randomised controlled trial. 2009, 373 (9676):1681-92 Lancet