Abstract
Background:Grade 3 oral mucositis (OM) is historically observed in >90% of bone marrow transplant patients who received the cyclophosphamide + total body irradiation (CY+TBI) conditioning regimen. It was previously shown that orotopically applied adrenergic vasoconstrictor prevented up to 100% of radiation-induced oral mucositis in two preclinical animal models.Methods:Adrenergic vasoconstrictor (i.e., phenylephrine in an aqueous-alcohol NG11–1 formulation) was orotopically applied to three patients (ages 24–29) who received the CY+TBI conditioning regimen; they were compared to five matched controls who received no orotopical vasoconstrictor. All patients received the CY+TBI conditioning regimen for acute lymphoblastic leukemia within the University of Wisconsin Adult Bone Marrow Transplant Program. Over the seven-day Cy+TBI conditioning regimen, 20 min before each treatment, either radiation or chemotherapy, vasoconstrictor was applied topically to the oral cavity, and patients then received either 1.5 Gy whole-body radiation or IV cyclophosphamide.Results:OM severity was scored over a three-week period using: i) physican assessments, ii) daily photos of the oral cavity, iii) oral pain and oral function score sheets, and iv) recorded narcotic consumption. Both “Grade 3 OM” duration and “any OM” duration in vasoconstrictor-treated patients were substantially lower than for the five control patients. Though nasogastric tube or total parenteral nutrition were used in 3 out of 5 control patients, there was no use of these supportive care measures in the three vasoconstrictor-treated patients.Conclusion:Orotopically applied NG11–1 vasoconstrictor formulation substantially reduced the incidence and severity of “Grade 3” and “any” oral mucositis when compared to matched control patients, all of whom received the same CY+TBI conditioning regimen. The liquid orotopical formulation was easily tolerated by patients both in its ease of use and lack of side effects.
Highlights
Oral mucositis (OM) occurs commonly in 40-80% of patients receiving high-dose chemotherapy conditioning regimens prior to hematopoietic stem cell transplants, in >90% of patients who receive the cyclophosphamide plus total body irradiation (CY+TBI) conditioning regimen [1,2,3], and in nearly 100% of irradiated head and neck cancer patients [4]
The pathobiology of oral mucositis, which is initiated by chemotherapy or radiation insults to basal epithelial and vascular endothelial cells in the oral mucosa, has been described in detail by Sonis [6] and other groups [7]
There is currently no standard of care for either the prevention or treatment of the oral mucositis encountered in chemotherapy and radiotherapy treatment patients
Summary
Oral mucositis (OM) occurs commonly in 40-80% of patients receiving high-dose chemotherapy conditioning regimens prior to hematopoietic stem cell transplants, in >90% of patients who receive the cyclophosphamide plus total body irradiation (CY+TBI) conditioning regimen [1,2,3], and in nearly 100% of irradiated head and neck cancer patients [4]. The pathobiology of oral mucositis, which is initiated by chemotherapy or radiation insults to basal epithelial and vascular endothelial cells in the oral mucosa, has been described in detail by Sonis [6] and other groups [7]. 70% of ionizing radiation-induced death of cells, including the basal epithelial and vascular endothelial cells of oral mucosa, whose apoptosis is an early event in mucositis pathobiology, results from two rapid, sequential steps: i) radiation-induced reactive oxygen species (ROS) attack of DNA bases, and ii) molecular oxygen (O2) “fixation” of the ROS DNA base damage. Grade 3 oral mucositis (OM) is historically observed in >90% of bone marrow transplant patients who received the cyclophosphamide + total body irradiation (CY+TBI) conditioning regimen. It was previously shown that orotopically applied adrenergic vasoconstrictor prevented up to 100% of radiation-induced oral mucositis in two preclinical animal models
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