243 - Efficacy of Compound Glutamine Enteric-Coated Capsules Combined with Thalidomide for Radiation-Induced Oral Mucositis in Oral Cancer Patients Undergoing Radiotherapy: A Multicenter, Open-Label, Randomized Controlled Trial
Presenter(s)
J. B. Liu1, M. Zhang1, B. Hou1, C. Liu1, Y. Zhu2, Z. Yang3, S. GAO4, L. Zhao5, M. Shi6, and J. Zang1; 1Department of Radiation Oncology, Xijing Hospital, Air Force Medical University, Xi'an, China, 2Department of Radiation Oncology, Baoji Municipal Central Hospital, Baoji, China, 3Department of Radiation Oncology, General Hospital of Ningxia Medical University, yinchuan, China, 4department of radiation oncology, HanZhong center hospital, Han Zhong, China, 5Department of Radiation Oncology, Xijing Hospital, Air Force Medical University, xi an, shan xi, China, 6Department of Radiation Oncology, First Affiliated Hospital of Air Force Medical University, Xi'an, Shaanxi, China
Purpose/Objective(s): Clinical studies have demonstrated that both glutamine and thalidomide are effective in the management of radiation-induced oral mucositis (RIOM). However, additional research is required to evaluate whether their combination provides a more potent prophylactic approach for preventing acute radiation-induced oral mucositis. The aim of this multicenter, randomized controlled study was to investigate the efficacy and safety of combining thalidomide with Compound Glutamine Enteric-Coated Capsules (CGECC), in comparison to CGECC alone, for the prevention of RIOM.
Materials/Methods: All patients with oral squamous cell carcinoma who underwent radical or postoperative radiotherapy, with a cumulative oral radiation dose exceeding 50 Gy, were consecutively enrolled in the study. Participants were randomly assigned in a 1:1 ratio to either the thalidomide combined with CGECC group (n=70) or the CGECC-only group (n=70). The patient was prescribed CGECC at a dosage of 1 g per day, to be taken orally in three divided doses. Treatment began on the first day of radiotherapy and continued until one week after the completion of radiotherapy. Additionally, thalidomide 100 mg was administered orally at bedtime, starting on the same day as the initiation of radiotherapy and continuing for one week post-radiotherapy. The primary endpoint was the time to the onset of grade 2 RIOM. Secondary endpoints encompassed the incidence of grade 2 RIOM, dynamic changes in patients' quality of life, and the occurrence of adverse event.
Results: A total of 140 patients were enrolled in the study, with baseline characteristics between the two groups being comparable. The median time to the development of grade 2 RIOM was 26 days in the thalidomide combined with CGECC group and 21 days in the glutamine group (hazard ratio, 0.64; 95% CI, 0.51-0.79; p=0.027). The incidence of grade 2 RIOM (70.9% vs. 91.4%; p=0.033) and severe mucositis (grades 3-4) (11.4% vs. 28.6%; p=0.043) were also significantly lower in the combination therapy group. During radiotherapy, patients in the combination therapy group reported significantly less oral and pharyngeal pain intensity (p=0.012) and experienced less weight loss, as evidenced by a smaller decrease in BMI (-0.1±1.3 vs. -1.2±1.5; p=0.003). In terms of adverse events, the incidence of grades 1-2 constipation and nausea was comparable between the two groups. However, the incidence of insomnia was significantly lower in the combination therapy group. Five patients in the combination therapy group experienced thalidomide-related grade 1-2 rash, which improved after antiallergic treatment.
Conclusion: Thalidomide combined with CGECC significantly prolonged the time to the development of grade 2 RIOM, reduced the severity of RIOM, effectively improved pain and weight loss during treatment, and demonstrated good safety in in patients with oral cancer undergoing postoperative radiotherapy.(registration number: NCT06031012)