Top Line: Could moderate hypofractionation one day be an option for adjuvant head and neck radiation?
The Study: HYPORT was a small phase 1 study that assessed the safety of hypofractionation for patients with head and neck cancer requiring radiation for intermediate risk factors such as pT3/4 and/or pN1+ disease, close margin(s), perineural invasion, and/or lymphovascular invasion. Volumes were standard and could be unilateral in the case of a well-lateralized oral cavity or oropharyngeal tumor. The first six patients received 46.5 Gy in 15 fractions delivered 5 days a week, and the subsequent six patients received 44.4 Gy in 12 fractions delivered 4 days a week. There were no dose limiting toxicity events in either group nor any grade 4 or 5 events. At a median follow-up of just over 18 months, there was one in-field recurrence of an oral tongue primary and one late grade 3 toxicity (persistent in-field abscess). While not a primary endpoint, the first dose-level resulted in less acute grade 2 oral mucositis, oral pain, dry mouth, dysgeusia, and dysphagia. With only 12 patients, we don’t know how toxicity or efficacy compares to conventional fractionation, but the authors plan to use the 46.5 Gy in 15 fractions regimen in a randomized phase 2 study.
TBL: In this small, phase 1 study, hypofractionated adjuvant RT for head and neck cancer did not result in severe or dose-limiting toxicity. | Moon, Int J Radiat Oncol Biol Phys 2023
The Study: HYPORT was a small phase 1 study that assessed the safety of hypofractionation for patients with head and neck cancer requiring radiation for intermediate risk factors such as pT3/4 and/or pN1+ disease, close margin(s), perineural invasion, and/or lymphovascular invasion. Volumes were standard and could be unilateral in the case of a well-lateralized oral cavity or oropharyngeal tumor. The first six patients received 46.5 Gy in 15 fractions delivered 5 days a week, and the subsequent six patients received 44.4 Gy in 12 fractions delivered 4 days a week. There were no dose limiting toxicity events in either group nor any grade 4 or 5 events. At a median follow-up of just over 18 months, there was one in-field recurrence of an oral tongue primary and one late grade 3 toxicity (persistent in-field abscess). While not a primary endpoint, the first dose-level resulted in less acute grade 2 oral mucositis, oral pain, dry mouth, dysgeusia, and dysphagia. With only 12 patients, we don’t know how toxicity or efficacy compares to conventional fractionation, but the authors plan to use the 46.5 Gy in 15 fractions regimen in a randomized phase 2 study.
TBL: In this small, phase 1 study, hypofractionated adjuvant RT for head and neck cancer did not result in severe or dose-limiting toxicity. | Moon, Int J Radiat Oncol Biol Phys 2023