Don’t dis it till you try it.

Why do we talk so much about de-escalating therapy for favorable-risk head and neck cancer? Mucositis is a big reason. This randomized phase 2 trial enrolled patients undergoing chemoradiation for either intact or resected oral cavity / oropharyngeal carcinoma with a mucosal surface within the 50 Gy isodose line. They were then randomized to receive the superoxide dismutase mimetic GC4419 (either 30 mg or 90 mg) versus placebo for the prevention of grade 3-4 oral mucositis. GC4419 was infused over 1 hour just before each radiation treatment. The 90 mg dose of GC4419 significantly reduced grade 3-4 mucositis from 65 → 43%, reduced the median duration from 19 days to a measly 1.5 days, and halved the rate of grade 4 mucositis from 30→ 16%. But wait, couldn’t the reduction in reactive oxygen species also diminish the effects of radiation on, hmm, let’s say the tumor? That won’t become clear until the final 2-year results and/or the reporting of the phase 3 ROMAN trial. TBL: The superoxide dismutase mimetic GC4419 significantly reduces the incidence and duration of severe oral mucositis in patients receiving chemoradiation for head and neck cancer. | Anderson, J Clin Oncol 2019