Elizabeth Cullen Discusses Avasopasem Manganese As A Potential Mucositis Management Strategy in Head and Neck Cancers

Elizabeth R. Cullen, MSN, ARNP, an advanced registered nurse practitioner at the University of Iowa Hospitals & Clinics, joins Oncology Nursing News® to discuss the significance of the phase 3 ROMAN trial (NCT03689712).

During the 48th Oncology Nursing Society (ONS) Annual Congress, Cullen presented on the phase 3 ROMAN trial—the findings of which demonstrated that 54% of patients with head and neck cancer who received avasopasem manganese reported severe oral mucositis (SOM) throughout their intensity-modulated radiation therapy (IMRT). In comparison, 64% of patients who received placebo experienced SOM with IMRT (relative risk [RR], 0.84; P = .045). This reduction in SOM was consistent across radiation therapy landmarks and after treatment.

As Cullen explains in the discussion, the standard of care for patients with locally advanced head and neck cancer is 7 weeks of IMRT, in addition to cisplatin chemotherapy. Unfortunately, 70% of patients will experience SOM during the course of treatment, which is typically categorized as either a grade 3 or 4 event. Patients who experience grade 3 SOM have oral ulcerations and are unable to eat solid foods, she says, and those who have grade 4 SOM are unable to consume solid or liquids. Despite this there are no FDA approved drugs to manage radiotherapy-induced severe oral mucositis in this patient population.

According to Cullen, avasopasem manganese demonstrated a promising efficacy in this setting. The experimental agent met its primary end point and induced a statistically significant decrease in SOM mucositis among this patient population. Moreover, the agent mitigated the effects of cisplatin on the kidneys, and so acute and chronic kidney disease was decreased in the investigative arm as well. Cullen notes that patients receiving avasopasem manganese experienced a slight increase in nausea and vomiting, but no grade 3 cases were reported. She also noted that patients can have transient drops in blood pressure while receiving the infusion, and that the care team can correct this by giving patients a prophylactic infusion to improve their hydration status prior to treatment.

Reference

Cullen E, Brown H, Carringer JR, Amado AE, Pitre L, Anderson CM. ROMAN: phase 3 trial of avasopasem manganese (GC4419) for severe oral mucositis (SOM) in patients receiving chemoradiotherapy (CRT) for locally advanced head and neck cancer (LAHNC). Presented at: 48th Annual Oncology Nursing Society Congress; April 25-30, 2023; San Antonio, TX. Accessed May 12, 2023. https://ons.confex.com/ons/2023/meetingapp.cgi/Paper/12846