A Retrospective Match Controlled Study of Supersaturated Calcium Phosphate Oral Rinse vs. Supportive Care for Radiation Induced Oral Mucositis

Abstract

Objectives: OM is a significant cause of morbidity during radiation (RT) and chemoradiotherapy for head and neck (HN) malignancies resulting in significant morbidity, treatment delays, premature treatment cessation and increased cost. Methods: 21 consecutive HN patients treated with intensity modulated radiation therapy (IMRT) who received SCPOR [Caphosol(registered trademark), EUSA Pharma] from the initiation of treatment were retrospectively match-controlled with concurrently treated IMRT patients receiving other supportive regimens including salt and soda rinses and nullmagic mouthwashnull. Data obtained included demographic and clinical characteristics, RT characteristics, grades of mucositis and xerostomia, weight loss, analgesic requirements, need for PEG tube, and OM related hospitalization during treatment. Costs related to treatment of OM were evaluated using two independent previously published cost models which were based on OM severity in HN patients treated with RT. Results: SCPOR treated and control patients were very similar with regard to demographic, disease and treatment characteristics. As compared to the control patients, a greater proportion of the SCPOR treated patients experienced mild (Grade 0 or 1) OM (48% vs 29%) and a smaller proportion experienced severe (Grade 3 or 4) OM (38% vs 71%). The reduction in severe OM was accompanied by a decreased need for PEG tube placement (33% vs 57%) and hospitalization (0% vs 19%). No adverse effects associated with the use of the SCPOR were observed. Per patient OM related costs for the treated patients were reduced by $1,700 based on one cost model and $6,900 for the second. Conclusions: These data suggest that SCPOR is an effective treatment for reducing the incidence and severity of OM in patients undergoing IMRT. Reductions in OM associated treatment costs based on existing models were corroborated by observed reductions in hospitalization and PEG tube requirements for the treated patients.