RRx-001 potentially reduces financial toxicity for patients and caregivers in head and neck cancer.

31 Background: Of all the toxicities that result from the treatment of head and neck cancer, perhaps the most insidious is financial burden or “out-of-pocket (OOP) expenses” for patients and their caregivers otherwise known as financial toxicity (FT) which is associated with decreased treatment adherence and poor clinical outcomes. A huge unmet need is interventions and strategies to mitigate this problem. Methods: PREVLAR was a Phase 2 study that randomized 53 head and neck cancer patients 1:1 to receive four doses of RRx-001 prior to the start of intensity modulated radiation therapy (IMRT) in 2.0-2.2 Gy fractions/weekday to a cumulative radiation dose of up to 72 Gy plus cisplatin administered either weekly (40 mg/m 2 ) or tri-weekly (100 mg/m 2 ) vs. cisplatin plus IMRT alone (control). The primary outcome was the incidence of severe oral mucositis. Adverse events were evaluated using NCTCAEv5 criteria. Results: The RRx-001 pre-treatment paradigm with four doses (“four before and no more”) dramatically reduced the incidence and duration of severe oral mucositis and associated grade 3-4 adverse events. These anti-toxicity effects translated to a shorter duration of hospitalization, less narcotic use, and less feeding tube placements. Extrapolating from cost estimates in the literature, we project a per patient total cost savings estimate of $12,500 - $22,500 with RRx-001 use based on an average 30% reduction in Grade 3-4 adverse events, a 50% reduction in hospital stay duration, and a 50% reduction in feeding tube placement. Conclusions: The RRx-001 “four before and no more” pre-treatment dosing regimen is not only convenient for patients and their caregivers but also reduces several toxicities including, most likely, financial toxicity. This is likely to bolster its adoption once RRx-001 becomes part of the medical armamentarium for the treatment of SOM. We plan more rigorously to test the effect of RRx-001 on financial toxicity in an upcoming Phase 2b trial in head and neck cancer called KEVLARx, n = 216. Clinical trial information: NCT03515538 .