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Docetaxel versus active symptom control for refractory oesophagogastric adenocarcinoma (COUGAR-02): an open-label, phase 3 randomised controlled trial - 31/12/13

Doi : 10.1016/S1470-2045(13)70549-7 
Hugo E R Ford, DrMD a, , Andrea Marshall, PhD b, John A Bridgewater, PhD c, Tobias Janowitz, PhD a, Fareeda Y Coxon, MRCP d, Jonathan Wadsley, FRCR e, Wasat Mansoor, PhD f, David Fyfe, MD g, Srinivasan Madhusudan, FRCP h, Gary W Middleton, ProfMD i, Daniel Swinson, MD j, Stephen Falk, MD k, Ian Chau, MD l, David Cunningham, ProfMD l, Paula Kareclas, PhD a, Natalie Cook, PhD a, Jane M Blazeby, ProfMD m, , Janet A Dunn, ProfPhD b,

on behalf of the COUGAR-02 Investigators

a Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK 
b Warwick Clinical Trials Unit, Coventry, UK 
c University College London Cancer Institute, Huntley Street, London, UK 
d Newcastle General Hospital, Newcastle, UK 
e Weston Park Hospital, Sheffield, UK 
f Christie Hospital, Manchester, UK 
g Lancaster Royal Infirmary, Lancaster, UK 
h Queens Medical Centre, Nottingham, UK 
i Royal Surrey County Hospital, Guildford, UK 
j St James’ University Hospital, Leeds, UK 
k Bristol Haematology and Oncology Centre, Bristol, UK 
l Royal Marsden Hospital, Sutton, UK 
m University of Bristol, Bristol, UK 

* Correspondence to: Dr Hugo E R Ford, Box 193, Addenbrooke’s Hospital, Hills Rd, Cambridge CB2 0QQ, UK

Summary

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/m2 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.

Funding

Cancer Research UK.

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© 2014  Ford et al. Open Access article distributed under the terms of CC BY. Publié par Elsevier Masson SAS. Tous droits réservés.
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P. 78-86 - janvier 2014 Retour au numéro
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