Statistical analysis
death, v.4.1.1
ADVERSE EVENTS
Thirty patients were enrolled for this study. A Simon optimal two-stage design was used. Six patients were accrued to the first stage, and if five or more patients proceeded to surgery without extended treatment-related delays, 21 patients would be enrolled on the second stage. If more than 23 of the first 27 patients proceed to surgery without extended treatment-related delays, the primary efficacy endpoint would be met and this regimen would be considered worthy of further testing. This design allowed early study termination for excessive surgery delay. The probabilities of a type I error and type II error were set at 5% and 20%, respectively. Throughout the study, side effects, adverse events and feasibility were continuously monitored. Similar to a previous studyAll statistical analyses were carried out using R (v.4.1.1) and python (v.3.7.9). In all boxplots, the center line and box boundaries represent the median, 25th and 75th percentiles, upper and lower whiskers represent 75th percentiles +1.5× interquartile range and 25th percentiles −1.5× interquartile range, respectively, and points indicate outliers. A nonparametric two-sided Wilcoxon rank-sum test was used to compare two populations, unless they followed normal distributions, in which case a two-sided RFS was defined as the time from surgery to the date of progression/recurrence or death (if a patient died without progression/recurrence). OS was defined as the time from the start neoadjuvant therapy to last known vital status. Patients alive at the last follow-up date were censored. OS and RFS rates were calculated by the Kaplan–Meier method using survminer (v.0.4.9). The package gtsummary (v.1.6.2) was used to summarize 12- and 24-month survival probabilities. The group difference in OS and RFS between well and poor responders was evaluated using a two-sided log-rank test. HR and 