RT Journal Article
T1 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
A1 Iveson, Timothy
A1 Boyd, Kathleen A
A1 Kerr, Rachel S
A1 Robles-Zurita, José Antonio
A1 Saunders, Mark P
A1 Briggs, Andrew H
A1 Cassidy, Jim
A1 Hollander, Niels Henrik
A1 Tabernero, Josep
A1 Haydon, Andrew
A1 Glimelius, Bengt
A1 Harkin, Andrea
A1 Allan, Karen
A1 McQueen, John
A1 Pearson, Sarah
A1 Waterston, Ashita
A1 Medley, Louise
A1 Wilson, Charles
A1 Ellis, Richard
A1 Essapen, Sharadah
A1 Dhadda, Amandeep S
A1 Harrison, Mark
A1 Falk, Stephen
A1 Raouf, Sherif
A1 Rees, Charlotte
A1 Olesen, Rene K
A1 Propper, David
A1 Bridgewater, John
A1 Azzabi, Ashraf
A1 Farrugia, David
A1 Webb, Andrew
A1 Cunningham, David
A1 Hickish, Tamas
A1 Weaver, Andrew
A1 Gollins, Simon
A1 Wasan, Harpreet
A1 Paul, James
K1 Quimioterapia - Ensayos
AB Background: Oxaliplatin and fluoropyrimidine chemotherapy administered over 6 months is the standardadjuvant regimen for patients with high-risk stage II or III colorectal cancer. However, the regimen isassociated with cumulative toxicity, characterised by chronic and often irreversible neuropathy.Objectives: To assess the efficacy of 3-month versus 6-month adjuvant chemotherapy for colorectalcancer 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 NorthernIreland), Denmark, Spain, Sweden, Australia and New Zealand.Participants: Adults aged ≥ 18 years who had undergone curative resection for high-risk stage II or IIIadenocarcinoma of the colon or rectum.Interventions: The adjuvant treatment regimen was either oxaliplatin and 5-fluorouracil or oxaliplatin andcapecitabine, randomised to be administered over 3 or 6 months.Main outcome measures: The primary outcome was disease-free survival. Overall survival, adverseevents, neuropathy and health-related quality of life were also assessed. The main cost categories werechemotherapy treatment and hospitalisation. Cost-effectiveness was assessed through incremental costcomparisons and quality-adjusted life-year gains between the options and was reported as net monetarybenefit using a willingness-to-pay threshold of £30,000 per quality-adjusted life-year per patient.Results: The 3-year disease-free survival rate in the 3-month treatment group was 76.7% (standard error 0.8%) and in the6-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 for3-month adjuvant chemotherapy.
PB NIHR JOURNALS LIBRARY
YR 2019
FD 2019-12
LK https://hdl.handle.net/10630/37234
UL https://hdl.handle.net/10630/37234
LA eng
NO Iveson T, Boyd KA, Kerr RS, Robles-Zurita J, Saunders MP, Briggs AH, et al. 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. Health Technol Assess 2019;23(64). https://doi.org/10.3310/hta23640
NO This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme. This research was supported by the Medical Research Council (transferred to NIHR Evaluation, Trials and Studies Coordinating Centre – Efficacy and Mechanism Evaluation; grant reference G0601705), the Swedish Cancer Society and Cancer Research UK Core Clinical Trials Unit Funding (funding reference C6716/A9894).
DS RIUMA. Repositorio Institucional de la Universidad de Málaga
RD 21 ene 2026