Superoxide Dismutase Mimetic for Oral Mucositis in Patients With Head/Neck Cancer
Posted: Tuesday, January 14, 2020
GC4419, a superoxide dismutase mimetic, appears to significantly reduce severe oral mucositis in patients undergoing combined radiation therapy and chemotherapy for head and neck cancer, according to the results of a randomized, double-blind, placebo-controlled phase IIb clinical trial. “Our results demonstrate the potential for GC4419 to reduce the duration, incidence, and severity of radiation-induced severe oral mucositis and thereby become an important new tool in the management of this adverse event in at-risk patients,” according to Carryn M. Anderson, MD, of the University of Iowa Hospitals and Clinics, Iowa City. The trial results were published in the Journal of Clinical Oncology.
In total, 223 patients with locally advanced oral cavity or oropharyngeal cancer who planned to undergo definitive or postoperative intensity-modulated radiation therapy (60 to 72 Gy) plus cisplatin (weekly or every 3 weeks) were enrolled; 76 received 90 mg of GC4419, 73 received 30 mg of GC4419, and 74 received placebo. Baseline patient characteristics were balanced across all three treatment arms.
GC4419 demonstrated a 92% relative reduction in the median duration of severe oral mucositis in patients receiving the 90-mg treatment versus placebo. The incidence and severity of severe oral mucositis were also reduced by 34% and 47%, respectively. Those receiving the 30-mg dose experienced intermediate improvements compared with those who received placebo and 90 mg of GC4419, indicating a dose-response relationship.
The adverse-event profiles in each experimental arm of the trial were comparable to that in the placebo arm. Neither dose of GC4419 increased the known toxicity of radiation therapy plus cisplatin.
A phase III confirmatory trial (called ROMAN) is underway (ClinicalTrials.gov identifier: NCT03689712).
Disclosure: For full disclosures of the study authors, visit ascopubs.org.