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Location: Marriott Marquis
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PQA 10 - PQA 10 Head & Neck Cancer and Health Services Research/Global Oncology Poster Q&A

3714 - Analysis of Avasopasem Manganese on Swallowing Outcomes for Oropharynx and Oral Cavity Patients Following Chemoradiation - A Single Institution Report

Wednesday, October 2, 2024
10:30 AM – 11:45 AM ET
Location: Hall C

Screen: 23

S. Rajan1, A. Halupnik2, B. Loeffler3, B. Peterson4, and C. M. Anderson5; 1Department of Radiation Oncology, University of Iowa Health Care, Iowa City, IA, 2University of Iowa Carver College of Medicine, Iowa City, IA, 3University of Iowa, Iowa City, IA, 4Department of Otolaryngology, University of Iowa Health Care, Iowa City, IA, 5Department of Radiation Oncology, University of Iowa Hospitals and Clinics, Iowa City, IA

Purpose/Objective(s): Dysphagia-related morbidity is of significant concern when treating patients with locally advanced head and neck cancer. Avasopasem manganese (AVA) is a small molecule selective dismutase mimetic shown to decrease severe oral mucositis (Anderson et al 2019 and 2022). We aimed to analyze AVA’s impact on dysphagia for patients enrolled at our institution on two international placebo (PBO)-controlled randomized trials. Materials/

Methods: We conducted an IRB-approved retrospective review of oropharyngeal (OP) and oral cavity (OC) cancer patients treated with curative-intent chemoradiation at our institution from 2019-2022 who enrolled in double-blind, PBO-controlled trials for AVA. Dysphagia assessments were performed per physician discretion either routinely or due to new/worsening symptoms. Dysphagia metrics included imaging-based metrics as per Oropharyngeal Motility Scale (OPMS) and Penetration and Aspiration Scale (PAS), and patient perceived impairment using EAT-10 scores. Radiation dosimetry was reviewed for dose to pharyngeal constrictors.
Results: Sixty patients were included. 55 (91.7%) were male. 47 (78.3%) had HPV+ OP cancer, 8 (14.3%) had OC cancer. 31 (51.6%) received AVA and 29 (48.3%) received placebo. Of those that received AVA, 8 (13.3%) received AVA 30 mg and 23 (38.3%) received AVA 90 mg. Mean dose to the middle pharyngeal constrictor muscle was significantly different by OC (mean 4770.2 cGy) vs OP (5883.4 cGy, p<0.01) and treatment arm (AVA 30mg (Mean 4843.6 cGy), Placebo (Mean 5830.2 cGy), AVA 90mg (Mean 5969.2 cGy), p=0.04). This trend was also seen in both superior and inferior pharyngeal constrictor muscles, but not statistically significant. EAT-10 scores (n=11, median 1.2 months after RT) trended worse between baseline and first follow-up (p=0.09). OPMS (n=16, median 3.7 months after RT) showed the Pharyngeal Phase was significantly worsened from baseline to first follow-up (p=0.02, Mean Difference: 0.62 [95% CI 0.09 – 1.15]). PAS (n=17, median 3.8 months after RT) showed that mean PAS significantly worsened from baseline to first follow-up (p<0.01, Mean Difference: 2.56 [95% CI 0.89-4.22]). There were too few patients to statistically compare AVA vs PBO for dysphagia outcomes, but AVA trended better on EAT-10 (Mean Difference: -.0.31 vs 12.66), performed similarly on OPMS Pharyngeal Phase (Mean Difference: 0.68 vs 0.59), and trended worse on PAS (Mean Difference: 3.24 vs 2.08).
Conclusion: Radiation dose to pharyngeal constrictors differed by primary site and treatment arm in our study, which may impact assessment of AVA vs PBO on dysphagia outcomes. We had too few patients to statistically analyze the impact of AVA vs PBO on dysphagia but EAT-10 scores at approximately 1-month post-RT trended towards improvement with AVA. Later assessments with OPMS and PAS (3+ months) trended similar or worse in AVA group. Future studies are warranted on dose-matched cohorts with uniformly scheduled dysphagia assessments.