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
| Title: | 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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| Authors: | Timothy Iveson, Kathleen A Boyd, Rachel S Kerr, Jose Robles-Zurita, Mark P Saunders, Andrew H Briggs, Jim Cassidy, Niels Henrik Hollander, Josep Tabernero, Andrew Haydon, Bengt Glimelius, Andrea Harkin, Karen Allan, John McQueen, Sarah Pearson, Ashita Waterston, Louise Medley, Charles Wilson, Richard Ellis, Sharadah Essapen, Amandeep S Dhadda, Mark Harrison, Stephen Falk, Sherif Raouf, Charlotte Rees, Rene K Olesen, David Propper, John Bridgewater, Ashraf Azzabi, David Farrugia, Andrew Webb, David Cunningham, Tamas Hickish, Andrew Weaver, Simon Gollins, Harpreet Wasan, James Paul |
| Source: | Health Technology Assessment, Vol 23, Iss 64 (2019) |
| Publisher Information: | NIHR Journals Library, 2019. |
| Publication Year: | 2019 |
| Collection: | LCC:Medical technology |
| Subject Terms: | oxaliplatin, capecitabine, disease-free survival, chemotherapy, adjuvant, quality-adjusted life-years, colorectal neoplasms, fluorouracil, randomised controlled trial, Medical technology, R855-855.5 |
| More Details: | 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. Objectives: 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 outcome 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 per quality-adjusted life-year per patient. Results: 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 |
| Document Type: | article |
| File Description: | electronic resource |
| Language: | English |
| ISSN: | 1366-5278 2046-4924 |
| Relation: | https://doaj.org/toc/1366-5278; https://doaj.org/toc/2046-4924 |
| DOI: | 10.3310/hta23640 |
| Access URL: | https://doaj.org/article/4215111445164519a465163178fd46e0 |
| Accession Number: | edsdoj.4215111445164519a465163178fd46e0 |
| Database: | Directory of Open Access Journals |
| ISSN: | 13665278 20464924 |
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| DOI: | 10.3310/hta23640 |
| Published in: | Health Technology Assessment |
| Language: | English |