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3 versus 6 months of adjuvant oxaliplatin-fluoropyrimidine combination therapy for colorectal cancer (SCOT) : an international, randomised, phase 3, non-inferiority trial

Iveson, Timothy J. (författare)
Southampton Univ Hosp NHS Fdn Trust, Southampton SO16 0YD, Hants, England
Kerr, Rachel S. (författare)
Univ Oxford, Dept Oncol, Oxford, England
Saunders, Mark P. (författare)
Christie Hosp, Manchester, Lancs, England
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Cassidy, Jim (författare)
Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
Henrik Hollander, Niels (författare)
Zealand Univ Hosp, Dept Oncol & Palliat Care, Naestved, Denmark
Tabernero, Josep (författare)
Vall dHebron Univ Hosp, Barcelona, Spain;Univ Autonoma Barcelona, CIBERONC, Inst Oncol, Barcelona, Spain
Haydon, Andrew (författare)
Australasian Gastrointestinal Trials Grp, Melbourne, Vic, Australia
Glimelius, Bengt (författare)
Uppsala universitet,Experimentell och klinisk onkologi
Harkin, Andrea (författare)
Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
Allan, Karen (författare)
Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
McQueen, John (författare)
Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
Scudder, Claire (författare)
Univ Oxford, Dept Oncol, OCTO, Oxford, England
Boyd, Kathleen Anne (författare)
Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland
Briggs, Andrew (författare)
Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland;Mem Sloan Kettering Canc Ctr, Dept Epidemiol & Biostat, Ctr Hlth & Policy Outcomes, New York, NY 10021 USA
Waterston, Ashita (författare)
Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
Medley, Louise (författare)
Royal United Hosp, Bath, Avon, England
Wilson, Charles (författare)
Addenbrookes Hosp, Cambridge, England
Ellis, Richard (författare)
Royal Cornwall Hosp NHS Trust, Truro, England
Essapen, Sharadah (författare)
Royal Surrey Cty Hosp NHS Fdn Trust, St Lukes Canc Ctr, Guildford, Surrey, England
Dhadda, Amandeep S. (författare)
Castle Hill Hosp, Kingston Upon Hull, N Humberside, England
Harrison, Mark (författare)
Mt Vernon Canc Ctr, Northwood, Middx, England
Falk, Stephen (författare)
Bristol Canc Inst, Bristol, Avon, England
Raouf, Sherif (författare)
Barking Havering & Redbridge Univ Hosp NHS Trust, Barking, England
Rees, Charlotte (författare)
Southampton Univ Hosp NHS Fdn Trust, Southampton SO16 0YD, Hants, England
Olesen, Rene K. (författare)
Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark
Propper, David (författare)
Queen Mary Univ London, Barts Canc Inst, London, England
Bridgewater, John (författare)
UCL, UCL Canc Inst, London, England
Azzabi, Ashraf (författare)
Newcastle Upon Tyne Hosp NHS Fdn Trust, Newcastle, England
Farrugia, David (författare)
Cheltenham Gen Hosp, Gloucestershire Oncol Ctr, Cheltenham, Glos, England
Webb, Andrew (författare)
Brighton & Sussex Univ Hosp Trust, Brighton, E Sussex, England
Cunningham, David (författare)
Royal Marsden Hosp, London, England
Hickish, Tamas (författare)
Bournemouth Univ, Poole Hosp, Bournemouth, Dorset, England
Weaver, Andrew (författare)
Oxford Univ Hosp Fdn Trust, Dept Oncol, Oxford, England
Gollins, Simon (författare)
North Wales Canc Treatment Ctr, Rhyl, Wales
Wasan, Harpreet S. (författare)
Imperial Coll London, Hammersmith Hosp, London, England
Paul, James (författare)
Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
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 (creator_code:org_t)
ELSEVIER SCIENCE INC, 2018
2018
Engelska.
Ingår i: The Lancet Oncology. - : ELSEVIER SCIENCE INC. - 1470-2045 .- 1474-5488. ; 19:4, s. 562-578
Relaterad länk:
https://doi.org/10.1...
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https://uu.diva-port... (primary) (Raw object)
https://urn.kb.se/re...
https://doi.org/10.1...
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  • Tidskriftsartikel (refereegranskat)
Abstract Ämnesord
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  • Background: 6 months of oxaliplatin-containing chemotherapy is usually given as adjuvant treatment for stage 3 colorectal cancer. We investigated whether 3 months of oxaliplatin-containing chemotherapy would be non-inferior to the usual 6 months of treatment.Methods: The SCOT study was an international, randomised, phase 3, non-inferiority trial done at 244 centres. Patients aged 18 years or older with high-risk stage II and stage III colorectal cancer underwent central randomisation with minimisation for centre, choice of regimen, sex, disease site, N stage, T stage, and the starting dose of capecitabine. Patients were assigned (1: 1) to receive 3 months or 6 months of adjuvant oxaliplatin-containing chemotherapy. The chemotherapy regimens could consist of CAPOX (capecitabine and oxaliplatin) or FOLFOX (bolus and infused fluorouracil with oxaliplatin). The regimen was selected before randomisation in accordance with choices of the patient and treating physician. The primary study endpoint was disease-free survival and the non-inferiority margin was a hazard ratio of 1.13. The primary analysis was done in the intention-to-treat population and safety was assessed in patients who started study treatment. This trial is registered with ISRCTN, number ISRCTN59757862, and follow-up is continuing.Findings: 6088 patients underwent randomisation between March 27, 2008, and Nov 29, 2013. The intended treatment was FOLFOX in 1981 patients and CAPOX in 4107 patients. 3044 patients were assigned to 3 month group and 3044 were assigned to 6 month group. Nine patients in the 3 month group and 14 patients in the 6 month group did not consent for their data to be used, leaving 3035 patients in the 3 month group and 3030 patients in the 6 month group for the intention-to-treat analyses. At the cutoff date for analysis, there had been 1482 disease-free survival events, with 740 in the 3 month group and 742 in the 6 month group. 3 year disease-free survival was 76.7% (95% CI 75.1-78.2) for the 3 month group and 77.1% (75.6-78.6) for the 6 month group, giving a hazard ratio of 1.006 (0.909-1.114, test for non-inferiority p=0.012), significantly below the non-inferiority margin. Peripheral neuropathy of grade 2 or worse was more common in the 6 month group (237 [58%] of 409 patients for the subset with safety data) than in the 3 month group (103 [25%] of 420) and was long-lasting and associated with worse quality of life. 1098 serious adverse events were reported (492 reports in the 3 month group and 606 reports in the 6 month group) and 32 treatment-related deaths occurred (16 in each group).Interpretation: In the whole study population, 3 months of oxaliplatin-containing adjuvant chemotherapy was non-inferior to 6 months of the same therapy for patients with high-risk stage II and stage III colorectal cancer and was associated with reduced toxicity and improved quality of life. Despite the fact the study was underpowered, these data suggest that a shorter duration leads to similar survival outcomes with better quality of life and thus might represent a new standard of care.

Ämnesord

MEDICIN OCH HÄLSOVETENSKAP  -- Klinisk medicin -- Cancer och onkologi (hsv//swe)
MEDICAL AND HEALTH SCIENCES  -- Clinical Medicine -- Cancer and Oncology (hsv//eng)

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