Three Versus 6 Months of Adjuvant Oxaliplatin-Fluoropyrimidine Chemotherapy for Colorectal Cancer: Final Results of SCOT—An International, Randomized, Phase III, Noninferiority Trial
Abstract
Adjuvant chemotherapy for colorectal cancer (CRC) with oxaliplatin and fluoropyrimidine was traditionally given for 6 months but is associated with cumulative peripheral neuropathy. The SCOT study (ISRCTN59757862) was an international, randomized, phase III, noninferiority trial investigating treatment reduction from 6 to 3 months. It originally reported noninferior disease-free survival with reduced toxicity and improved quality of life for 3 months of treatment in 6,088 patients. Here, we report overall survival (OS) with 38 months of additional follow-up. Patients with high-risk stage II and stage III CRC were assigned (1:1) to receive 3 or 6 months of either capecitabine and oxaliplatin (CAPOX) or infusional fluorouracil, leucovorin, and oxaliplatin (FOLFOX; bolus and infused fluorouracil with oxaliplatin) that were selected before random assignment. With a median of 113 months follow-up and 1,255 OS events, 5-year OS for 3 versus 6 months of treatment was 82.4% in both groups (hazard ratio, 0.96; 95% CI, 0.8 to 1.07), proving noninferiority of 3 months of treatment. Noninferiority of 3 months of treatment for OS was also shown in 1,087 patients with rectal cancer. The duration effect is regimen-dependent with noninferiority shown for CAPOX but not for FOLFOX. In summary, SCOT has shown noninferiority for OS with 3 months of adjuvant chemotherapy treatment, which should be recommended for most patients.
Article Details
Journal Info
Journal of Clinical Oncology
Lippincott Williams & Wilkins
Authors (32)
Timothy Iveson
University of Southampton, Southampton, United Kingdom
Mark P. Saunders
The Christie NHS Foundation Trust, Manchester, United Kingdom
Caroline Kelly
Glasgow Oncology Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
Rachel S. Kerr
Jim Cassidy
Glasgow Oncology Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
Niels Henrik Hollander
Department of Oncology and Palliative Care, Zealand University Hospital, Naestved, Denmark
Josep Tabernero
Vall d’Hebron Hospital Campus, Barcelona
Andrew Haydon
Alfred Health, Melbourne, VIC, Australia
Bengt Glimelius
Andrea Harkin
Glasgow Oncology Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
Karen Allan
Glasgow Oncology Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
John McQueen
Glasgow Oncology Clinical Trials Unit, School of Cancer Sciences, University of Glasgow, Glasgow, United Kingdom
Sarah Pearson
OCTO, Department of Oncology, University of Oxford, Oxford, United Kingdom
Kathleen A. Boyd
Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
Andrew H. Briggs
Institute of Health and Wellbeing, University of Glasgow, Glasgow, United Kingdom
Ashita Waterston
Beatson West of Scotland Cancer Centre, NHS GGC HB, Glasgow, United Kingdom
Louise Medley
Royal United Hospital, Bath, United Kingdom
Richard Ellis
Royal Cornwall Hospitals NHS Trust, Cornwall, United Kingdom
Amandeep S. Dhadda
Castle Hill Hospital, Hull, United Kingdom
Mark Harrison
Mount Vernon Cancer Centre, Northwood, United Kingdom
Stephen Falk
Bristol Cancer Institute, Bristol, United Kingdom
Charlotte Rees
Southampton University Hospital NHS Foundation Trust, Southampton, United Kingdom
René K. Olesen
Department of Oncology, Aalborg University Hospital, Aalborg, Denmark
David Propper
Barts Cancer Institute, Queen Mary, University of London, London, United Kingdom
John Bridgewater
Ashraf Azzabi
Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle, United Kingdom
David Cunningham
Tamas Hickish
University Hospitals Dorset/Bournemouth University, Bournemouth, United Kingdom
Simon Gollins
North Wales Cancer Treatment Centre, Rhyl, United Kingdom
Harpreet S. Wasan
Hammersmith Hospital, Imperial College London, London, United Kingdom
David Church
Department of Oncology, University of Oxford, Oxford, United Kingdom
Enric Domingo
Department of Oncology, University of Oxford, Oxford, United Kingdom