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3-month versus 6-mo...
3-month versus 6-month adjuvant chemotherapy for patients with high-risk stage II and III colorectal cancer : 3-year follow-up of the SCOT non-inferiority RCT
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- Ivesono, Timothy (författare)
- Southampton Univ Hosp NHS Fdn Trust, Southampton, Hants, England
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- Boydo, Kathleen A. (författare)
- Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland
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- Kerro, Rachel S. (författare)
- Univ Oxford, Dept Oncol, Oxford, England
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- Robles-Zuritao, Jose (författare)
- Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland
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- Saunders, Mark P. (författare)
- Christie Hosp NHS Fdn Trust, Manchester, Lancs, England
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- Briggso, Andrew H. (författare)
- Univ Glasgow, Inst Hlth & Wellbeing, Glasgow, Lanark, Scotland
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- Cassidyo, Jim (författare)
- Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
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- Hollandero, Niels Henrik (författare)
- Zealand Univ Hosp, Dept Oncol & Palliat Care, Naestved, Denmark
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- Taberneroo, Josep (författare)
- Univ Autonoma Barcelona, Vall dHebron Univ Hosp, Barcelona, Spain;Univ Autonoma Barcelona, Inst Oncol, Barcelona, Spain
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- Haydon, Andrew (författare)
- Australasian Gastrointestinal Trials Grp, Camperdown, NSW, Australia
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- Glimelius, Bengt (författare)
- Uppsala universitet,Experimentell och klinisk onkologi
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- Harkino, Andrea (författare)
- Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
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- Allano, Karen (författare)
- Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
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- McQueeno, John (författare)
- Univ Glasgow, Inst Canc Sci, Canc Res UK Clin Trials Unit, Glasgow, Lanark, Scotland
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- Pearsono, Sarah (författare)
- Univ Oxford, Dept Oncol, Oncol Clin Trials Off, Oxford, England
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- Waterstono, Ashita (författare)
- Beatson West Scotland Canc Ctr, Glasgow, Lanark, Scotland
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- Medleyo, Louise (författare)
- Royal United Hosp, Bath, Avon, England
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- Wilsono, Charles (författare)
- Addenbrookes Hosp, Cambridge, England
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- Elliso, Richard (författare)
- Royal Cornwall Hosp NHS Trust, Truro, Cornwall, England
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- Essapen, Sharadah (författare)
- Royal Surrey Cty Hosp NHS Fdn Trust, St Lukes Canc Ctr, Guildford, Surrey, England
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- Dhaddao, Amandeep S. (författare)
- Castle Hill Hosp, Kingston Upon Hull, N Humberside, England
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- Harrison, Mark (författare)
- Mt Vernon Canc Ctr, Northwood, Middx, England
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- Falko, Stephen (författare)
- Bristol Canc Inst, Bristol, Avon, England
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- Raoufo, Sherif (författare)
- Barking Havering & Redbridge Univ Hosp NHS Trust, Barking, England
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- Rees, Charlotte (författare)
- Southampton Univ Hosp NHS Fdn Trust, Southampton, Hants, England
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- Oleseno, Rene K. (författare)
- Aarhus Univ Hosp, Dept Oncol, Aarhus, Denmark
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- Proppero, David (författare)
- Queen Mary Univ London, Barts Canc Inst, London, England
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- Bridgewatero, John (författare)
- UCL, Dept Oncol, London, England
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- Azzabio, Ashraf (författare)
- Newcastle Upon Tyne Hosp NHS Fdn Trust, Newcastle Upon Tyne, Tyne & Wear, England
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- Farrugiao, David (författare)
- Cheltenham Gen Hosp, Gloucestershire Oncol Ctr, Cheltenham, Glos, England
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- Webbo, Andrew (författare)
- Brighton & Sussex Univ Hosp Trust, Brighton, E Sussex, England
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- Cunninghamo, David (författare)
- Royal Marsden NHS Fdn Trust, London, England
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- Hickish, Tamas (författare)
- Poole Hosp NHS Fdn Trust, Poole, Dorset, England
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- Weavero, Andrew (författare)
- Oxford Univ Hosp Fdn Trust, Dept Oncol, Oxford, England
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- Gollins, Simon (författare)
- North Wales Canc Treatment Ctr, Rhyl, Wales
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- Wasano, Harpreet (författare)
- Imperial Coll Healthcare NHS Trust, Hammersmith Hosp, London, England
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- Paulo, James (författare)
- Christie Hosp NHS Fdn Trust, Manchester, Lancs, England
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(creator_code:org_t)
- 2019-12
- 2019
- Engelska.
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Ingår i: Health Technology Assessment. - : NIHR JOURNALS LIBRARY. - 1366-5278 .- 2046-4924. ; 23:64, s. 1-88
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https://uu.diva-port... (primary) (Raw object)
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https://njl-admin.ni...
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https://urn.kb.se/re...
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https://doi.org/10.3...
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Abstract
Ämnesord
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- Background: Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standard adjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen is associated with cumulative toxicity, characterised by chronic and often irreversible neuropathy.Objective: To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectal cancer and to compare the toxicity, health-related quality of life and cost-effectiveness of the durations.Design: An international, randomised, open-label, non-inferiority, Phase III, parallel-group trial.Setting: A total of 244 oncology clinics from six countries: UK (England, Scotland, Wales and Northern Ireland), Denmark, Spain, Sweden, Australia and New Zealand.Participants: Adults aged >= 18 years who had undergone curative resection for high-risk stage II or III adenocarcinoma of the colon or rectum.Interventions: The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin and capecitabine, randomised to be administered over 3 or 6 months.Main outcomes measures: The primary outcome was disease-free survival. Overall survival, adverse events, neuropathy and health-related quality of life were also assessed. The main cost categories were chemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental cost comparisons and quality-adjusted life-year gains between the options and was reported as net monetary benefit using a willingness-to-pay threshold of 30,000 pound per quality-adjusted life-year per patient.Result: Recruitment is closed. In total, 6088 patients were randomised (3044 per group) between 27 March 2008 and 29 November 2013, with 6065 included in the intention-to-treat analyses (3-month analysis, n = 3035; 6-month analysis, n = 3030). Follow-up for the primary analysis is complete. The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the 6-month treatment group was 77.1% (standard error 0.8%), equating to a hazard ratio of 1.006 (95% confidence interval 0.909 to 1.114; p-value for non-inferiority = 0.012), confirming non-inferiority for 3-month adjuvant chemotherapy. Frequent adverse events (alopecia, anaemia, anorexia, diarrhoea, fatigue, hand-foot syndrome, mucositis, sensory neuropathy, neutropenia, pain, rash, altered taste, thrombocytopenia and watery eye) showed a significant increase in grade with 6-month duration; the greatest difference was for sensory neuropathy (grade >= 3 was 4% for 3-month vs.16% for 6-month duration), for which a higher rate of neuropathy was seen for the 6-month treatment group from month 4 to >= 5 years (p < 0.001). Quality-of-life scores were better in the 3-month treatment group over months 4-6. A cost-effectiveness analysis showed 3-month treatment to cost 4881 pound less over the 8-year analysis period, with an incremental net monetary benefit of 7246 pound per patient.Conclusions: The study achieved its primary end point, showing that 3-month oxaliplatin-containing adjuvant chemotherapy is non-inferior to 6 months of the same regimen; 3-month treatment showed a better safety profile and cost less. For future work, further follow-up will refine long-term estimates of the duration effect on disease-free survival and overall survival. The health economic analysis will be updated to include long-term extrapolation for subgroups. We expect these analyses to be available in 2019-20. The Short Course Oncology Therapy (SCOT) study translational samples may allow the identification of patients who would benefit from longer treatment based on the molecular characteristics of their disease.
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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Till lärosätets databas
- Av författaren/redakt...
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Ivesono, Timothy
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Boydo, Kathleen ...
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Kerro, Rachel S.
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Robles-Zuritao, ...
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Saunders, Mark P ...
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Briggso, Andrew ...
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visa fler...
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Cassidyo, Jim
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Hollandero, Niel ...
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Taberneroo, Jose ...
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Haydon, Andrew
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Glimelius, Bengt
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Harkino, Andrea
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Allano, Karen
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McQueeno, John
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Pearsono, Sarah
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Waterstono, Ashi ...
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Medleyo, Louise
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Wilsono, Charles
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Elliso, Richard
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Essapen, Sharada ...
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Dhaddao, Amandee ...
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Harrison, Mark
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Falko, Stephen
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Raoufo, Sherif
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Rees, Charlotte
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Oleseno, Rene K.
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Proppero, David
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Bridgewatero, Jo ...
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Azzabio, Ashraf
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Farrugiao, David
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Webbo, Andrew
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Cunninghamo, Dav ...
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Hickish, Tamas
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Weavero, Andrew
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Gollins, Simon
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Wasano, Harpreet
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Paulo, James
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