ABSTRACT
BACKGROUND: Severe oral mucositis associated with cancer therapy is a frequent complication that may affect a patient's systemic condition, resulting in interruption and/or prolongation of cancer therapy. Dentoxol® is a medical solution in the form of a mouthwash that has been shown to result in statistically significant improvement in the prevention of severe oral mucositis. However, knowing the measures of the clinical significance of this therapy is important for accurate decision-making. AIM: To describe the clinical impact of Dentoxol® use in severe oral mucositis. METHODS: Clinical significance was measured using the results obtained in a randomized controlled clinical trial previously conducted by the same group of researchers. The measures of clinical significance evaluated were the absolute risk or incidence, relative risk, absolute risk reduction, relative risk reduction, number needed to treat, and odds ratio. RESULTS: The data obtained show that the impact of Dentoxol® on reducing the severity of oral mucositis has important clinical relevance. CONCLUSION: The results of this study justify the incorporation of Dentoxol® mouth rinse into clinical protocols as a complement to cancer therapy to prevent and/or treat oral mucositis secondary to radiotherapy.
ABSTRACT
Glioblastoma (GB) is the most frequent and aggressive primary tumor of the central nervous system (CNS) in adults. Standard treatment is complete tumor resection followed by concomitant radiochemotherapy (RCT) and subsequent adjuvant temozolomide (TMZ). Information about brain tumors statistics in Latin American countries is scarce, so we aimed to measure the overall survival (OS) of patients with resected GB in a single institution in Chile. This is a retrospective report of 67 patients treated between 2012 and 2019 with resected GB and who received adjuvant treatment with radiotherapy (RT) with and without TMZ during 2012-2019 in this center (Chilean NCI). Most of them were men (72%), ages > 50 years old (57%), with Karnofsky performance status (KPS) scale ≥ 70% (94%) and recursive partitioning analysis-IV (RPA-IV) (60%). Some 54% received concomitant TMZ and RT. Median OS was 11.4 months, with 1-, 2-, and 5-year OS of 48%,15%, and 3% respectively. In conclusion, in patients with GB treated with RCT at the NCI, OS was the same as expected from international articles. Adjuvant RCT therefore is considered the standard of care at NCI.
ABSTRACT
PURPOSE: The aim of this study was to assess the efficacy and safety of Dentoxol mouthrinse in reducing the severity of oral mucositis (OM) secondary to radiation therapy (RT) for head and neck cancer. METHODS: A randomized, double-blind, placebo-controlled, multicenter phase II clinical trial was conducted. Subjects were asked to use Dentoxol (n = 55) or control (n = 53) mouthrinse 5 times/day during RT. Twice a week, OM was assessed clinically using the WHO scale and the Oral Mucositis Daily Questionnaire (OMDQ) was completed. RESULTS: The incidence of severe OM was 40.7% in the Dentoxol group and 51% in the control group (p = 0.265). Comparing all recorded clinical assessments, severe OM was seen in 13.3% of all assessments in the Dentoxol group vs. 21.8% in the control group (p = 0.000). There was a statistically significant lower proportion of assessments showing severe OM in the Dentoxol group at weeks 4, 5, and 6 of RT. The mean duration of severe OM was 11.95 days in the Dentoxol group vs. 14.59 days in the control group (p = 0.502). There was no difference between groups in mouth pain and its impact on function. The use of Dentoxol was safe and was not linked to any serious adverse events. CONCLUSION: The use of Dentoxol 5 times/day is safe and resulted in significantly fewer time-points with severe OM and a delay in the onset of severe OM, compared with a control rinse. A phase III clinical trial is warranted to confirm efficacy and address the limitations of this study.
