Efficacy
After a median follow up of 30.3 months, the median DFS was 29.8 months in the surveillance group and was not reached in the chemotherapy group (HR=0.45; 95% CI 0.30-0.68; log-rank p=0.0001). There was no apparent heterogeneity of treatment effect and results were consistent across prespecified subgroups.r
Kaplan-Meier curve of disease-free survivalr
©Lancet 2020
Subgroup analysis of disease-free survivalr
©Lancet 2020
The risk of metastasis or death was lower in the chemotherapy group versus the surveillance group (HR=0.48; 95% CI 0.31-0.74; p=0.0007). 3-year event-free rates were 71% and 53% respectively, with an estimated absolute difference of 17% (95% CI 4-31). Data for OS is not yet mature.
Quality of life data showed the chemotherapy group had a lower mean overall global health status score during chemotherapy and immediately afterwards compared with the surveillance group, however this difference had resolved by 6 months.r