Statistical analyses
REGRESSION
The BR.36 study was powered to address the concordance between ctDNA and radiographic responses. The sample size was determined to ensure that the lower 95% confidence bound of the estimated sensitivity and specificity was higher than 50%, assuming the observed sensitivity and specificity were no less than 70%. The required sample size was 50 patients, assuming that 20% of patients will have undetectable ctDNA before therapyDiscrete variables were summarized with the number and proportion of study participants falling into the category of interest. Continuous and ordinal categorical variables were summarized using the mean, median, standard error, minimum and maximum and interquartiles values where appropriate. For the time-to-event outcomes, the distributions were estimated with the Kaplan–Meier product limit method and summarized with median survival and 90% CI. Cox proportional hazards regression analysis was employed to assess the association of continuous maxMAF values with OS. The specificity and sensitivity and their CIs were estimated using the exact binomial distribution method.We determined concordance between the depth of molecular response and radiographic RECIST response as follows. In each patient (Here, 