SCOT: a comparison of cost-effectiveness from a large randomised phase III trial of two durations of adjuvant Oxaliplatin combination chemotherapy for colorectal cancer

Abstract

BACKGROUND The Short Course Oncology Therapy (SCOT) study is an international, multicentre, non-inferiority randomised controlled trial assessing the efficacy, toxicity, and cost-effectiveness of 3 months (3 M) versus the usually given 6 months (6 M) of adjuvant chemotherapy in colorectal cancer. METHODS In total, 6088 patients with fully resected high-risk stage II or stage III colorectal cancer were randomised and followed up for 3–8 years. The within-trial cost-effectiveness analysis from a UK health-care perspective is presented using the resource use data, quality of life (EQ-5D-3L), time on treatment (ToT), disease-free survival after treatment (DFS) and overall survival (OS) data. Quality-adjusted partitioned survival analysis and Kaplan–Meier Sample Average Estimator estimated QALYs and costs. Probabilistic sensitivity and subgroup analysis was undertaken. RESULTS The 3 M arm is less costly (-£4881; 95% CI: -£6269; -£3492) and entails (non-significant) QALY gains (0.08; 95% CI: −0.086; 0.230) due to a better significant quality of life. The net monetary benefit was significantly higher in 3 M under a wide range of monetary values of a QALY. The subgroup analysis found similar results for patients in the CAPOX regimen. However, for the FOLFOX regimen, 3 M had lower QALYs than 6 M (not statistically significant). CONCLUSIONS Overall, 3 M dominates 6 M with no significant detrimental impact on QALYs. The results provide the economic case that a 3 M treatment strategy should be considered a new standard of care.

Model-based evaluation of the cost effectiveness of 3versus6 months’ adjuvant chemotherapy in high-risk stage II colon cancer patients

“…Results of the one-way sensitivity analysis, in which we varied the utility estimates according to the upper and lower limits of the confidence intervals reported in the SCOT trial. 29 At a willingness to pay of €50,000/QALY. CAPOX, capecitabine plus oxaliplatin; FOLFOX, fluorouracil, leucovorin and oxaliplatin; ICER, incremental cost-effectiveness ratio; LYs, life-years; NMB, net monetary benefit; QALY, quality-adjusted life-year; SE, the strategy is located in the southeast quadrant of the cost-effectiveness plane, indicating that a strategy is less costly and more effective compared with the reference strategy; SW, the strategy is located in the southwest quadrant of the cost-effectiveness plane, indicating that a strategy is less costly and less effective compared with the reference strategy.…”

“…In this sensitivity analysis, we changed the health utilities according to the upper and lower limit of the CI reported in the SCOT trial (Table 1). 29 Finally, a probabilistic sensitivity analysis was conducted to investigate the joint impact of parameter uncertainty. All parameters in the PATTERN model were varied simultaneously according to the most appropriate distribution.…”

“…14 To our knowledge, this is the first model-based study evaluating the cost effectiveness of a 3-month during-treatment regimen compared with a 6-month during-treatment regimen in high-risk stage II colon cancer patients only. An evaluation of the cost effectiveness of a 3-month strategy compared with a 6-month strategy in high-risk stage II and III colorectal cancer patients was conducted earlier for the SCOT trial by Robles-Zurita et al 29 and Iveson et al 10,36 These studies concluded that a 3-month regimen with either FOLFOX or CAPOX was cost effective compared with a 6-month regimen, and that a 3-month regimen should be considered as a new standard of care for both FOLFOX and CAPOX. 29 This conclusion is in line with the findings of our study for CAPOX, but in contrast to our findings for FOLFOX.…”

“…An evaluation of the cost effectiveness of a 3-month strategy compared with a 6-month strategy in high-risk stage II and III colorectal cancer patients was conducted earlier for the SCOT trial by Robles-Zurita et al 29 and Iveson et al 10,36 These studies concluded that a 3-month regimen with either FOLFOX or CAPOX was cost effective compared with a 6-month regimen, and that a 3-month regimen should be considered as a new standard of care for both FOLFOX and CAPOX. 29 This conclusion is in line with the findings of our study for CAPOX, but in contrast to our findings for FOLFOX. These contrasting results for FOLFOX can be explained by the HR of 1.16 for the 3-month FOLFOX regimen compared with the 6-month FOLFOX regimen reported in the SCOT trial.…”

Lessons learned from the maturation of a cancer drug: oxaliplatin in colorectal cancer

“…Controversies still exist about whether the two schedules, CAPOX or FOLFOX should be handled differently and for what subgroups, if any, the reference treatment still is 6 months. According to a substudy of the SCOT trial [11], the largest of the 5 trials in the IDEA consortium [10], 6 months of therapy is never costeffective [15]. It is beyond the purpose of this editorial to discuss pros and cons of 3 or 6 months of adjuvant therapy, but the clinical problem of long-lasting OIPN will diminish as a result of the practice changing 3 vs 6 months adjuvant trials.…”