Steven Lin, MD, PhD @StevenLin_MDPhD of @MDAndersonNews answers if this can be extended to the community on the randomized phase IIB trial of proton beam therapy versus intensity-modulated radiation therapy for locally advanced esophageal cancer.
It is uncertain if the dosimetric advantages of proton beam therapy (PBT) lead to better health results as opposed to intensity-modulated radiation therapy (IMRT). This randomized trial compared total toxicity burden (TTB) and progression-free survival (PFS) between these esophageal cancer modalities.
This phase IIB trial randomly allocated PBT or IMRT patients (50.4 Gy), stratified for histology, resectability, chemotherapy for induction, and level. TTB and PFS were the prespecified coprimary endpoints. TTB, a composite score of 11 distinct adverse effects (AEs), including specific toxicity as well as postoperative complications (POCs) in operated patients, quantified the frequency of AE encountered over a span of 1 year after treatment. The trial was performed using the sequential design of the Bayesian community with three targeted interim analyzes at 33%, 50% and 67% of the estimated accrual (adjusted for follow-up).