Statistical Analysis
cancer, tumor, death
TUMOR, METASTASIS, RECURRENCE, CANCER, MINOR
For the concurrent phase, tolerability was measured by the percentage of patients receiving 2 or more cycles of cisplatin and bevacizumab with RT; it was scored by study chairs (N.Y.L., J.K., and D.G.P.) as no variation or minor variation for tumor volume contouring score and organs at risk contouring score. For the adjuvant phase, tolerability was measured by the percentage of patients receiving 2 or more cycles of cisplatin, fluorouracil, and bevacizumab. If either component had a tolerability rate of less than 50%, that component would not be recommended for further study without modification. Failure for LRPF rate was local or regional progression or recurrence or death due to study cancer or unknown causes with an undocumented site of failure. Failure for DMF rate was distant metastasis. Failure for PFS was local, regional, or distant recurrence or progression, or death due to any cause. Failure for OS was death due to any cause. All time-to-event end points were defined from the time of registration to failure; patients without failure were censored at the last follow-up. LRPF and DMF rates were estimated by subtracting cumulative incidence estimates from 100%; death without failure was considered a competing risk for both end points. PFS and OS rates were estimated by the Kaplan-Meier method. CIs for 5- and 7-year OS and PFS rates were calculated using Greenwood variance and normal approximation; LRPF and DMF interval rates were computed using a log-log transformation and normal approximation. Acute and late toxic effect periods were defined as 90 days or less vs greater than 90 days, respectively, after the end of treatment. CIs for treatment-associated AE rates across time were computed using the Wald method. Eligible patients who started protocol treatment were included in the analysis. DMF survival rates (with failure as distant metastasis or death) at 5 and 7 years are also presented as an unplanned sensitivity analysis to allow comparison with other published trials. Data were analyzed using SAS statistical software version 9.4 (SAS Institute), with analysis from June 26 to July 1, 2019.