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Session: Gastrointestinal (Noncolorectal) Cancer

Type: Oral Abstract Session

Time: Sunday June 4, 8:00 AM to 11:00 AM

Location: Hall D2

Adjuvant capecitabine for biliary tract cancer: The BILCAP randomized study.

Hepatobiliary Cancer

Gastrointestinal (Noncolorectal) Cancer

2017 ASCO Annual Meeting

Abstract No:

J Clin Oncol 35, 2017 (suppl; abstr 4006)

Author(s): John Neil Primrose, Richard Fox, Daniel H. Palmer, Raj Prasad, Darius Mirza, David Alan Anthoney, Philippa Corrie, Stephen Falk, Harpreet Singh Wasan, Paul J. Ross, Lucy R. Wall, Jonathan Wadsley, T.R. Jeffry Evans, Deborah Stocken, Raaj Praseedom, David Cunningham, O James Garden, Clive Stubbs, Juan W. Valle, John A. Bridgewater; University of Southampton, Southampton, United Kingdom; University of Birmingham, Birmingham, United Kingdom; Department of Molecular and Clinical Cancer Medicine, University of Liverpool and Clatterbridge Cancer Centre, Liverpool, United Kingdom; Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; Birmingham Queen Elizabeth Hospital, Birmingham, United Kingdom; CRUK Clinical Cancer Centre, Leeds, United Kingdom; Cambridge Cancer Trials Centre, Cambridge, United Kingdom; Bristol Haematology and Oncology Centre, Bristol, United Kingdom; Hammersmith Hospital, Imperial College London, London, United Kingdom; Guy's Hospital, London, United Kingdom; Western General Hospital, Edinburgh, United Kingdom; Weston Park Hospital, Sheffield, United Kingdom; University of Glasgow, Beatson West of Scotland Cancer Centre, Glasgow, United Kingdom; Newcastle University, Newcastle-upon-Tyne, United Kingdom; Cambridge University Hospitals, Cambridge, United Kingdom; Royal Marsden Hospital, Surrey, United Kingdom; The University of Edinburgh, Edinburgh, United Kingdom; Cancer Research UK Clinical Trials Unit, University of Birmingham, Birmingham, United Kingdom; Department of Medical Oncology, The Christie NHS Foundation Trust, Manchester, United Kingdom; University College London Cancer Institute, London, United Kingdom

Abstract Disclosures


Background: Despite improvements in multidisciplinary management, BTC has a poor outcome. Approximately 20% of cases are suitable for surgical resection with a 5 year survival of < 10%. BILCAP aimed to determine whether capecitabine (Cape) improves overall survival (OS) compared to observation (Obs) following radical surgery. Methods: Patients with completely-resected cholangiocarcinoma (CCA) or gallbladder cancer (including liver and pancreatic resection, as appropriate), with adequate biliary drainage, no ongoing infection, adequate renal, haematological and liver function, and ECOG PS ≤2, were randomized 1:1 to Cape (1250 mg/m2 D1-14 every 21 days, for 8 cycles) or Obs. Randomization was minimized on tumor site, resection status, ECOG PS and surgical center. The primary outcome was OS in the intention to treat (ITT) population. 410 patients were needed to detect a hazard ratio (HR) of 0.69 (2-sided α = 0.05 and 80% power). HR was estimated by Cox survival model with adjustment for the minimization factors. Primary analysis performed with at least 24 months (m) follow-up. Results: 447 participants were randomized to Cape (n = 223) or Obs (n = 224) from 44 UK sites between 2006-2014. Median age was 63y (IQR 55, 69) and 201 (45%), 232 (52%), and 14 (3%) patients were ECOG PS 0, 1 and 2 respectively. Primary site: 84 (19%) intrahepatic, 128 (28%) hilar, 156 (35%) extrahepatic CCA and 79 (18%) muscle-invasive gallbladder cancers. Resection margins: R0 in 279 (62%) and R1 in 168 (38%); 207 (46%) were node-negative. Follow up was at least 36m in > 80% of surviving patients. By ITT analysis (n = 447), median OS was 51m (95%CI 35, 59) for Cape and 36m (95%CI 30, 45) for Obs, HR 0.80 (95%CI 0.63, 1.04; p = 0.097). Sensitivity analyses with adjustment for nodal status, grade of disease and gender indicated HR 0.71 (95%CI 0.55, 0.92 p < 0.01). In the per-protocol analysis (Cape n = 210, Obs n = 220) median OS was 53m (95%CI 40, NR) for Cape and 36m (95%CI 30, 44) for Obs, HR 0.75 (95%CI 0.58, 0.97; p = 0.028). Median RFS (ITT) was 25m (95%CI 19, 37) for Cape and 18m (95%CI 13, 28) for Obs. Grade 3-4 toxicity was less than anticipated. Conclusions: Cape improves OS in BTC when used as adjuvant and should become standard of care. Clinical trial information: ISRCTN72785446.

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