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Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial

Ford, Hugo; Marshall, Andrea; Bridgewater, John A.; Janowitz, Tobias; Coxon, Fareeda; Wadsley, Jonathan; Mansoor, Wasat; Fyfe, David; Madhusudan, Srinivasan; Middleton, Gary; Swinson, Daniel; Falk, Stephen; Chau, Ian; Cunningham, David; Kareclas, Paula; Cook, Natalie; Blazeby, Jane M.; Dunn, Janet A.

Authors

Hugo Ford

Andrea Marshall

John A. Bridgewater

Tobias Janowitz

Fareeda Coxon

Jonathan Wadsley

Wasat Mansoor

David Fyfe

Gary Middleton

Daniel Swinson

Stephen Falk

Ian Chau

David Cunningham

Paula Kareclas

Natalie Cook

Jane M. Blazeby

Janet A. Dunn



Abstract

BACKGROUND: Second-line chemotherapy for patients with oesophagogastric adenocarcinoma refractory to platinum and fluoropyrimidines has not shown benefits in health-related quality of life (HRQoL). We assessed whether the addition of docetaxel to active symptom control alone can improve survival and HRQoL for patients.

METHODS: For this open-labelled, multicentre trial, we recruited patients aged 18 years or older from 30 UK centres. Patients were eligible if they had an advanced, histologically confirmed adenocarcinoma of the oesophagus, oesophagogastric junction, or stomach that had progressed on or within 6 months of treatment with a platinum-fluoropyrimidine combination. Patients could have an Eastern Cooperative Oncology Group performance status of 0-2. We randomly assigned patients using a central, computerised minimisation procedure to receive docetaxel plus active symptom control, or active symptom control alone (1:1; stratified by disease status, disease site, duration of response to previous chemotherapy, and performance status). Docetaxel was given at a dose of 75 mg/m(2) by intravenous infusion every 3 weeks for up to six cycles. The primary endpoint was overall survival, analysed by intention to treat. This is the report of the planned final analysis. This study is an International Standardised Randomised Controlled Trial, number ISRCTN13366390.

FINDINGS: Between April 21, 2008, and April 26, 2012, we recruited 168 patients, allocating 84 to each treatment group. After a median follow-up of 12 months [IQR 10-21]) and 161 (96%) deaths (80 in the docetaxel group, 81 in the active symptom control group), median overall survival in the docetaxel group was 5.2 months (95% CI 4.1-5.9) versus 3.6 months (3.3-4.4) in the active symptom control group (hazard ratio 0.67, 95% CI 0.49-0.92; p=0.01). Docetaxel was associated with higher incidence of grade 3-4 neutropenia (12 [15%] patients vs no patients), infection (15 [19%] patients vs two [3%] patients), and febrile neutropenia (six [7%] patients vs no patients). Patients receiving docetaxel reported less pain (p=0.0008) and less nausea and vomiting (p=0.02) and constipation (p=0.02). Global HRQoL was similar between the groups (p=0.53). Disease specific HRQoL measures also showed benefits for docetaxel in reducing dysphagia (p=0.02) and abdominal pain (p=0.01).

INTERPRETATION: Our findings suggest that docetaxel can be recommended as an appropriate second-line treatment for patients with oesophagogastric adenocarcinoma that is refractory to treatment with platinum and fluoropyrimidine.

Journal Article Type Article
Publication Date Jan 20, 2014
Journal Lancet Oncology
Print ISSN 1470-2045
Electronic ISSN 1474-5488
Publisher Elsevier
Peer Reviewed Peer Reviewed
Volume 15
Issue 1
APA6 Citation Ford, H., Marshall, A., Bridgewater, J. A., Janowitz, T., Coxon, F., Wadsley, J., …Dunn, J. A. (2014). Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial. Lancet Oncology, 15(1), https://doi.org/10.1016/S1470-2045%2813%2970549-7
DOI https://doi.org/10.1016/S1470-2045%2813%2970549-7
Publisher URL http://www.sciencedirect.com/science/article/pii/S1470204513705497
Copyright Statement Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0

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Copyright Statement
Copyright information regarding this work can be found at the following address: http://creativecommons.org/licenses/by/4.0





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