HealthDay News — Findings from an open-label, phase 2 trial published in The Lancet Oncology showed acceptable toxicity and survival rates for the use of proton radiotherapy in children with medulloblastoma.
Torunn I. Yock, MD, of Massachusetts General Hospital in Boston, and colleagues enrolled 59 patients (aged 3 to 21 years) with medulloblastoma (standard risk, 39 participants; intermediate-risk, 6; and high-risk, 14) in a nonrandomized, open-label, single-center, phase 2 trial to examine the toxicity profile of proton radiotherapy.
The researchers found that the median craniospinal irradiation dose was 23.4 Gy radiobiological equivalents (GyRBE) and the median boost dose was 54.0 GyRBE. At 3 years, grade 3 to 4 ototoxicity in both ears was observed in four (9%) of 45 evaluable patients; 3 (7%) developed grade 3 to 4 ototoxicity in one ear, but one later reverted to grade 2. The cumulative incidence of grade 3 to 4 hearing loss was 12% (95% confidence interval [CI], 4 to 25%) at 3 years and 16% (95% CI, 6 to 29%) at 5 years. Progression-free survival for all patients was 83% (95% CI, 71 to 90%) at 3 years and 80% (95% CI, 67 to 88%) at 5 years (in post-hoc analyses).
“Proton radiotherapy resulted in acceptable toxicity and had similar survival outcomes to those noted with conventional radiotherapy, suggesting that the use of the treatment may be an alternative to photon-based treatments,” the authors write.
One author disclosed financial ties to ProCure.