2019 ASCO Annual Meeting!
Session: Gastrointestinal (Noncolorectal) Cancer
Type: Oral Abstract Session
Time: Sunday June 2, 9:45 AM to 12:45 PM
Location: Arie Crown Theater
ABC-06 | A randomised phase III, multi-centre, open-label study of Active Symptom Control (ASC) alone or ASC with oxaliplatin / 5-FU chemotherapy (ASC+mFOLFOX) for patients (pts) with locally advanced / metastatic biliary tract cancers (ABC) previously-treated with cisplatin/gemcitabine (CisGem) chemotherapy.
Gastrointestinal (Noncolorectal) Cancer
2019 ASCO Annual Meeting
J Clin Oncol 37, 2019 (suppl; abstr 4003)
Author(s): Angela Lamarca, Daniel H. Palmer, Harpreet Singh Wasan, Paul J. Ross, Yuk Ting Ma, Arvind Arora, Stephen Falk, Roopinder Gillmore, Jonathan Wadsley, Kinnari Patel, Alan Anthoney, Anthony Maraveyas, Justin S. Waters, Claire Hobbs, Safia Barber, David Ryder, John Ramage, Linda M Davies, John A. Bridgewater, Juan W. Valle, on behalf of the Advanced Biliary Cancer (ABC) Working Group; Department of Medical Oncology, The Christie NHS Foundation Trust / Institute of Cancer Sciences, University of Manchester, Manchester, United Kingdom; University of Liverpool, Liverpool, United Kingdom; Hammersmith Hospital, Department of Cancer Medicine, London, United Kingdom; Guy's Hospital, London, United Kingdom; University of Birmingham, Birmingham, United Kingdom; University Hospital of Nottingham NHS Trust, University of Nottingham, Nottingham, United Kingdom; Bristol Haematology and Oncology Centre, Bristol, United Kingdom; Royal Free, London, United Kingdom; Weston Park Hospital, Sheffield, United Kingdom; Oxford, Oxford, United Kingdom; Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom; Castle Hill Hospital, HULL, United Kingdom; Kent Oncology Centre, Maidstone, United Kingdom; Swindon, Swindon, United Kingdom; University of Manchester Clinical Trials Unit, Manchester, United Kingdom; Hampshire Hospitals NHS Foundation Trust, Basingstoke, United Kingdom; University of Manchester Health Economics Department, Manchester, United Kingdom; University College London Cancer Institute, London, United Kingdom; University of Manchester/The Christie, Manchester, United Kingdom
Background: Level A evidence supports use of CisGem as first-line chemotherapy for ABC; no robust evidence is available for second-line chemotherapy. Methods: Pts diagnosed with ABC with disease progression after prior CisGem were randomised (1:1) to either ASC+mFOLFOX or ASC. Randomisation was stratified by serum albumin levels ( < 35 vs ≥35 g/L), platinum sensitivity (determined from first-line CisGem) and disease extent (locally advanced vs metastatic). Pts with ECOG PS0-1, adequate haematological, renal and liver function, and adequate biliary drainage were eligible. Primary end-point was overall survival (OS) (multivariable Cox regression adjusted for stratification factors); sample size: 162 pts delivering 148 events were required (80% power; 5% two-sided alpha) for a hypothesised hazard ratio (HR) of 0.63. Assumed median survival for ASC was 4 months. Results: 162 pts (81 in each arm) were randomised (27 March ‘14 - 04 Jan ‘18); median age 65 yrs (range 26-84); sex: 80 (49%) male, 82 (51%) female; primary site: intrahepatic 72 (44%), extrahepatic 45 (28%), gallbladder 34 (21%) and ampullary 11 (7%). Baseline characteristics were balanced between arms except platinum sensitivity (ASC+mFOLFOX 27 pts (33%); ASC 34 pts (42%)). After 150 OS events, the adjusted HR was 0.69 (95% CI 0.50-0.97; p = 0.031; ASC+mFOLFOX vs ASC). Median OS (months (m)), 6m and 12m OS-rate (%) were 6.2m, 50.6% and 25.9% for the ASC+mFOLFOX and 5.3m, 35.5%, 11.4% for the ASC arm, respectively. Grade 3/4 toxicities were reported in 48 (59%) and 32 (39%) pts in the ASC+mFOLFOX and ASC arm, respectively; these were balanced between arms except for fatigue and neutropenia (more frequent in ASC+mFOLFOX arm); data cleaning is ongoing. No chemotherapy-related deaths were reported. Conclusion: Survival with ASC was greater than assumed; ASC+mFOLFOX improved OS after progression to CisGem with a clinically meaningful increase in 6m and 12m OS rate. ASC+mFOLFOX should become standard of care in second-line for ABC. Clinical trial information: NCT01926236