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Estimating adjuvant treatment effects in stage II colon cancer: Comparing the synthesis of randomized clinical trial data to real world data

International Journal of Cancer Aug 24, 2019

Jongeneel G, Klausch T, van Erning FN, et al. - By analyzing pooled disease-free survival (DFS) data from randomized clinical trials (RCT approach) and comparing this with real world data (RWD approach) estimates, researchers estimated the impact of adjuvant chemotherapy in stage II colon cancer. They used 7 trials and extracted patient level data of 4,489 patients (events: 853) who were assigned to either a control arm or to 5FU/LV or FOLFOX, in the RCT approach. Using matching, weighting and stratification, the estimated HRs for any adjuvant treatment vs control, in the RWD approach, were 0.95 (0.50;1.80), 0.88 (0.24;3.21) and 1.05 (0.04;2.06), respectively. Compared with the RCT approach, the estimates did not differ significantly. Albeit not statistically significant, a clinically relevant benefit of adjuvant chemotherapy on DFS was highlighted in the RCT data.

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