Statistics
REV
REGRESSION, INFILTRATION
All analyses were based on the intention-to-treat principle. Hence, patients were analyzed according to their randomized treatment. Patient characteristics are presented descriptively for patients with CON and REV and in total. “Lymphocyte function & infiltration” and “immunoassay” parameters at baseline, as well as changes in parameters between baseline and mid-therapy are presented and compared descriptively between patients with CON vs REV, RCB 0/I (≤ 1.36) vs. RCB II/III (> 1.36) and pCR yes vs. no by Wilcoxon tests. Scatterplots and boxplots show the change over time from baseline to surgery. A possible predictive role of “lymphocyte function & infiltration” parameters on RCB or pCR was assessed by logistic regression models. Primary analysis models included treatment arm only. Covariable models included treatment arm and the respective covariable (changes between baseline and mid-therapy) and were adjusted for the according covariable baseline value. Extended models additionally included a treatment-by-covariable interaction. Odds ratios (OR) with 95% confidence interval (CI) are provided. Measured parameters in the in vitro experiment of three BC cell lines in co-culture were presented descriptively. For each parameter, measurements were performed twice and the given value represents the mean. As the main ABCSG-34 study was planned for different objectives/endpoints, all results found in this subgroup analysis need to be considered exploratory. Analyses were carried out using the statistical analysis system (SAS) software (version 9.3 or higher) and GraphPad Prism (version 8.0.2.).