Cougar-02: A randomized phase III study of docetaxel versus active symptom control in patients with relapsed esophago-gastric adenocarcinoma.

Gastrointestinal (Noncolorectal) Cancer
Session Type and Session Title: 
Oral Abstract Session, Gastrointestinal (Noncolorectal) Cancer
Abstract Number: 
J Clin Oncol 31, 2013 (suppl; abstr 4023)
Natalie Cook, Andrea Marshall, Jane M. Blazeby, John A. Bridgewater, Jonathan Wadsley, Fareeda Y. Coxon, Wasat Mansoor, Srinivasan Madhusudan, Stephen Falk, Gary William Middleton, Daniel Swinson, Ian Chau, Joyce Thompson, David Cunningham, Paula Kareclas, Janet A. Dunn, Hugo Ford; Cambridge University Hospitals NHS Founsation Trust, Cambridge, United Kingdom; Warwick Clinical Trials Unit, University of Warwick, Coventry, United Kingdom; University of Bristol, Bristol, United Kingdom; University College London Cancer Institute, London, United Kingdom; Weston Park Hospital, Sheffield, United Kingdom; Northern Centre for Cancer Care, Newcastle Upon Tyne, United Kingdom; Christie Hospital NHS Foundation Trust, Manchester, United Kingdom; School of Molecular Medical Sciences, Nottingham University Hospitals, Nottingham, United Kingdom; Bristol Haematology and Oncology Centre, Bristol, United Kingdom; St Lukes Cancer Centre, Guildford, United Kingdom; St. James's Hospital, Leeds, United Kingdom; The Royal Marsden NHS Foundation Trust, London, United Kingdom; Birmingham Heart of England Foundation Trust, Birmingham, United Kingdom; The Royal Marsden Hospital NHS Foundation Trust, London, United Kingdom; Cambridge Cancer Trials Centre, University of Cambridge, Cambridge, United Kingdom; Cambridge University Hospitals NHS Foundation Trust, Cambridge, United Kingdom

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Abstract Disclosures


Background: Survival in patients who relapse after first-line chemotherapy (CT) for advanced esophago-gastric adenocarcinoma (EGC) is poor though recently randomised trials (RCT) have suggested a small benefit for second line chemotherapy with taxanes or irinotecan. There is very little data on health related quality of life (HRQL) or overall survival (OS), particularly in patients who progress shortly after first-line therapy. Methods: COUGAR-02 was a multicentre open-label, phase III RCT for patients with locally advanced or metastatic EGC of performance status (PS) 0-2 who had progressed within 6 months of previous platinum/fluoropyrimidine CT. Patients were randomised (1:1) to receive either docetaxel 75mg/m2every 3 weeks for up to 6 cycles or active symptom control (ASC). The primary endpoint was OS. The secondary endpoint of HRQL, assessed using EORTC QLQ-C30 and QLQ-ST022, was analysed using standardised area under a curve and compared using Wilcoxon rank sum test. Sensitivity analysis adjusting for dropouts due to death were performed using quality adjusted survival. Results: 168 patients (84 patients in each arm) were recruited between April 2008 and April 2012. Median age was 65 years (range 28-84); 81% were males. PS at randomisation was 0 for 27%, 1 for 57% and 2 for 15%. 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. Median number of cycles of docetaxel was 3. 23% completed 6 cycles. Docetaxel was well tolerated and resulted in a significantly improved OS over ASC alone (HR=0.67 (95% CI 0.49-0.92); p=0.01). Objective response rate was 7%. For QLQ-C30, patients on docetaxel arm reported significantly less pain (p=0.0008) and trend for less nausea and vomiting (p=0.02) and constipation (p=0.02) than those on ASC arm. Similar global HRQL seen (p=0.53).For QLQ-ST022, trend seen for less dysphagia (p=0.02) and pain symptoms (p=0.01) for patients on docetaxel arm than ASC Conclusions: Docetaxel provided a significant OS benefit over ASC with improvements in symptom scores and no loss in overall HRQL. Docetaxel can be considered a standard of care in this setting. Clinical trial information: NCT00978549.