Statistical Analysis
The sample size was based on assumptions of an estimated treatment effect with 50% survival in the study group and 20% survival in the control group after a 24-month follow-up. To reach a power of 80% with an α value of 0.05 and a treatment group ratio of 1:1 and using two-sided Fisher's exact test, a sample size of 90 patients (45 patients per study arm) was required. After an interim report from the data safety monitoring board, it was recommended to include an additional three patients to compensate for dropout, that is, a total of 93 patients.Time-to-event analysis was performed on all patients in the intention-to-treat (ITT) and PP populations using the Kaplan-Meier methodology and is reported using medians together with 95% CIs and estimated survival rates at 6, 12, and 24 months with 95% CI. Fisher's exact test was used to compare ORR.