Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer

Anderson, Carryn M.; Lee, Christopher M.; Saunders, Deborah; Curtis, Amarinthia; Nangia, Chaitali Singh; Lee, Arielle S.; Kovoor, Philip; Bar‐Ad, Voichita; Pedadda, Abhinand V.; Holmlund, Jon; Downs, Matt; Sonis, Stephen T.

doi:10.1016/j.ijrobp.2022.06.063

Cited by 8 publications

(3 citation statements)

References 14 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The clinical presentation and course of mucositis can be complicated by the combination of a variety of chemotherapeutic agents with radiation. For example, epidermal growth factor receptor (EGFR) monoclonal antibodies (cetuximab) and immune checkpoint inhibitors (ICI), such as pembrolizumab or nivolumab, produce variable manifestations, including lichenoid mucositis (mixed white striations, erythema, and/or ulcerations), vesiculobullous features, erythema multiforme, or Stevens–Johnson syndrome/toxic epidermal necrolysis (SJS/TEN) [ 11 , 12 , 13 ]. The onset of immunotherapy-associated oral adverse events can range from weeks to months after the first initiation [ 14 ].…”

Section: Oral Mucositismentioning

confidence: 99%

Oral Complications from Oropharyngeal Cancer Therapy

Sankar,

2023

Cancers

View full text Add to dashboard Cite

Post-oropharyngeal cancer treatment complications include a multitude of oral side effects that impact overall survival and quality of life. These include acute and chronic conditions affecting the oral cavity and head and neck, such as mucositis, infection, xerostomia, dysgeusia, radiation caries, osteonecrosis, and trismus. This review will summarize the most common oral complications from oropharyngeal cancer therapy. The authors would like to point out that the literature cited frequently combines oropharyngeal and head and neck cancer results. If recommendations are made strictly related to oropharyngeal cancers, this will be highlighted.

show abstract

Section: Oral Mucositismentioning

confidence: 99%

Oral Complications from Oropharyngeal Cancer Therapy

Sankar,

2023

Cancers

View full text Add to dashboard Cite

show abstract

“…Currently, radioprotectors are widely used in medical practice in the treatment of cancer patients [12][13][14]. Clinical studies have shown the effectiveness of using radioprotectors in the radiotherapy of cancer patients to reduce both acute and distant radiation lesions of healthy tissues [15,16]. The use of radioprotectors in medical practice provides an increase in the degree of tolerability of radiation therapy by cancer patients [17][18][19].…”

Section: Introductionmentioning

confidence: 99%

Effect of The Rs-10 Radioprotector on Protein-Steroid Interaction in Irradiated Animals with Biphasic Adrenocortical Response to Irradiation

Omelchuk

2023

QAJ

View full text Add to dashboard Cite

The article is devoted to the influence of RS-10 radioprotector on the protein-steroid interaction in irradiated animals. Introduction. Increasing threats to the radiation safety of the population is now causing the need for comprehensive studies of the anti-beam properties of chemical radioprotectors. The aim of the study is to study the effect of the RS-10 radioprotector on protein-steroid interaction in irradiated guinea pigs with biphasic adrenocortical response to irradiation. Study methods: experiments were conducted on 146 guinea pigs weighing 300-350 g, which were exposed to total ƴ radiation at a dose of 3.5 Gy and 4.5 Gy at a dose rate of 5.76 Gy/min, which caused them radiation disease of II and III severity. Experimental animals were injected intraperitoneally with RS-10 (chitosan bitartrate) 15 minutes before irradiation. Control animals were administered an equal volume of saline. The total plasma content of 11-oxycorticosteroids (11-OKS) was determined by the fluorometric method of Guillemin et al. in the author's modification. The binding capacity of corticosteroid binding globulin (CSG) was determined by gel filtration of De Moor at al. in the author's modification. Conclusions. Prophylactic administration of RS-10 to irradiated animals with a two-phase adreno-cortical reaction to radiation causes a later onset of secondary hypercorticism in the midst of radiation sickness in animals. Prophylactic administration of RS-10 before irradiation reduces the level of free hormone and leads to a decrease in hypercorticism, increasing the reserve capabilities of the binding ability of the CSG at the height of radiation sickness. A leading role in the mechanism of reducing affected hypercorticism under protective conditions has a lesser degree of impairment of the binding capacity of the CSG, rather than a change in the total level of 11-OKS in the blood.

show abstract

“…Despite the prevalence of OM, no drugs or interventions with clear efficacy have been developed to prevent or treat chemoradiotherapy‐induced OM (Anderson et al, 2022; Moslemi et al, 2016). As a result, the management of OM remains an unmet clinical need.…”

Section: Introductionmentioning

confidence: 99%

Randomised controlled trial of Jiandu granule in preventing chemoradiotherapy‐induced oral mucositis

Li,

Ke,

Wang

et al. 2023

Oral Diseases

View full text Add to dashboard Cite

ObjectiveThis clinical trial aimed to evaluate the efficacy and safety of Jiandu granule, a Chinese herbal medicine formula, for preventing oral mucositis in patients with nasopharyngeal carcinoma undergoing concurrent chemoradiotherapy.Materials and MethodsA single‐centre, open‐label, randomised controlled trial was conducted, enrolling 138 patients with locally advanced nasopharyngeal carcinoma. Patients were randomly allocated to either the experimental group (n = 69) or the control group (n = 69). Both groups received concurrent chemoradiotherapy and standard care for oral mucositis, with the experimental group additionally receiving Jiandu granule intervention. The primary outcome was the incidence of severe oral mucositis (grade III to IV).ResultsIn the full‐analysis set, severe oral mucositis occurred in 14 of 69 (20.3%) patients in the experimental group and 31 of 69 (44.9%) patients in the control group (absolute risk reduction: 24.6%; relative risk reduction: 54.8%; p = 0.002; number needed to treat: 4). Jiandu granule was associated with mild/moderate gastrointestinal reactions, with an overall incidence of 5.9%.ConclusionJiandu granule reduced the incidence of severe oral mucositis in nasopharyngeal carcinoma patients during concurrent chemoradiotherapy and had an acceptable safety profile.

show abstract

Two-Year Tumor Outcomes of a Phase 2B, Randomized, Double-Blind Trial of Avasopasem Manganese (GC4419) Versus Placebo to Reduce Severe Oral Mucositis Owing to Concurrent Radiation Therapy and Cisplatin for Head and Neck Cancer

Cited by 8 publications

References 14 publications

Oral Complications from Oropharyngeal Cancer Therapy

Oral Complications from Oropharyngeal Cancer Therapy

Effect of The Rs-10 Radioprotector on Protein-Steroid Interaction in Irradiated Animals with Biphasic Adrenocortical Response to Irradiation

Randomised controlled trial of Jiandu granule in preventing chemoradiotherapy‐induced oral mucositis

Contact Info

Product

Resources

About