Cougar-02: A randomized phase III study of docetaxel versus active symptom control in advanced esophagogastric adenocarcinoma.

Cancers of the Esophagus and Stomach
Session Type and Session Title: 
General Poster Session A: Cancers of the Esophagus and Stomach
Oral Abstract Session: Cancers of the Esophagus and Stomach (eQ&A)
Abstract Number: 
J Clin Oncol 31, 2013 (suppl 4; abstr LBA4)
Hugo Ford, Andrea Marshall, Jonathan Wadsley, Fareeda Y. Coxon, Wasat Mansoor, John A. Bridgewater, Srinivasan Madhusudan, Stephen Falk, Gary William Middleton, Daniel Swinson, Ian Chau, Joyce Thompson, Jane M. Blazeby, David Cunningham, Paula Kareclas, Janet A. Dunn, National Cancer Research Institute, Upper GI Clinical Studies Group; Addenbrooke's Hospital, NIHR Cambridge Biomedical Research Centre, Cambridge, United Kingdom; Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom; Department of Clinical Oncology, Weston Park Hospital, Sheffield, United Kingdom; Northern Centre for Cancer Care, Newcastle upon Tyne, United Kingdom; Christie Hospital NHS Foundation Trust, Manchester, United Kingdom; University College London, London, United Kingdom; School of Molecular Medical Sciences, Nottingham University Hospitals, Nottingham, United Kingdom; Bristol Oncology, Bristol, United Kingdom; Royal Surrey County Hospital, Guildford, United Kingdom; St. James's Hospital, Leeds, United Kingdom; The Royal Marsden Hospital, Sutton, United Kingdom; Birmingham Heartlands Hospital, Birmingham, United Kingdom; University of Bristol, Bristol, United Kingdom; The Royal Marsden Hospital NHS Foundation Trust, London and Surrey, United Kingdom; Cambridge Cancer Trials Centre, Cambridge, United Kingdom

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Abstract Disclosures


Background: Survival in patients who relapse after first-line chemotherapy for advanced esophagogastric adenocarcinoma (OGC) is poor though recently randomized trials have suggested a small survival benefit for second-line chemotherapy with taxanes or irinotecan. There is very little data on quality of life or survival, particularly in patients who progress shortly after first-line therapy. Methods: COUGAR-02 was a multicenter open-label, randomized controlled phase III trial for patients with locally advanced or metastatic OGC of performance status (PS) 0-2 who had progressed within 6 months of previous platinum/fluoropyrimidine (PF) chemotherapy (CT). Patients were randomized (1:1) to receive either docetaxel 75mg/m2every 3 weeks for up to 6 cycles or active symptom control (ASC), which could include any treatment thought by the treating clinician to be appropriate for the management of symptoms including radiotherapy, steroids and supportive medications. The primary endpoint was overall survival. Secondary endpoints were response rate, toxicity, health related quality of life (HRQL) and healthcare resource use. Results: Between April 2008 and April 2012, 168 patients were recruited (84 patients in each arm). Median age was 65 years (range 28-84), 81% were male. PS at randomisation was 0 for 27%, 1 for 57% and 2 for 15%. Site of disease was stomach in 46%, esophagogastric junction in 34% and esophagus in 20%. 86% had metastatic disease. 43% progressed during previous CT, 28% progressed within 3 months of end of previous CT and 29% progressed between 3 and 6 months. 19 (23%) patients completed 6 CT cycles (median 3 cycles per patient). The main reasons for not completing treatment were progression and toxicity. Docetaxel significantly improved overall survival over ASC alone (median 5.2 months (95% CI 4.1-5.9 months) for docetaxel; 3.6 months (95% CI 3.3-4.4 months) for ASC, HR=0.67 (95% CI 0.49-0.92); p=0.01). 7% had a partial response and 46% had stable disease after CT. 21% on docetaxel had grade 4 toxicity. Conclusions: The addition of docetaxel to ASC significantly improved overall survival. Docetaxel can be considered a standard of care in this setting. Clinical trial information: 13366390.