Background This multicenter clinical trial was designed to evaluate the efficacy and safety of thalidomide (THD) in preventing oral mucositis (OM) in patients with nasopharyngeal carcinoma (NPC) undergoing concurrent chemoradiotherapy (CCRT). Methods Patients with locally advanced NPC were randomly assigned to either a THD group or a control group. All 160 patients received radical intensity‐modulated radiotherapy plus cisplatin‐based concurrent chemotherapy and basic oral hygiene guidance. Patients in the THD group received additional THD at the beginning of CCRT. The primary end points were the latency period and the incidence of OM. The secondary end points were mouth and throat soreness (MTS), weight loss, short‐term efficacy, and adverse events. Results The median latency period of OM was 30 and 14 days in the THD and control groups, respectively (hazard ratio, 0.32; 95% confidence interval, 0.23‐0.35; P < .0001). The incidence of OM and severe OM (World Health Organization grade 3 or higher) was significantly lower in the THD group than the control group (87.5% vs 97.5% [P = .016] and 27.5% vs 46.3% [P = .014], respectively). THD treatment also remarkably reduced the intensity of MTS and the degree of weight loss. In comparison with the control group, the incidence of nausea, vomiting, and insomnia was significantly decreased, whereas the incidence of dizziness and constipation was obviously increased in the THD group. The objective response rates 3 months after CCRT were similar between the groups. Conclusions THD prolonged the latency period, reduced the incidence of OM, and did not affect the short‐term efficacy of CCRT in patients with NPC. Lay Summary Oral mucositis is the most common complication of nasopharyngeal carcinoma during chemoradiotherapy; it decreases the patient's quality of life, and ideal mucosal protective agents are lacking. A few basic research and preclinical studies have shown that thalidomide may be an approach to ameliorating oral mucositis. The results of the current study confirm that thalidomide has a protective effect against oral mucositis in patients who have received chemoradiotherapy for nasopharyngeal carcinoma.

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Haisheng Zhu and Yuzhi Tao contributed equally to this article.

Background To investigate the potential value of the pretreatment MRI-based radiomic model in predicting the overall survival (OS) of nasopharyngeal carcinoma (NPC) patients with local residual tumors after intensity-modulated radiotherapy (IMRT). Methods A total of 218 consecutive nonmetastatic NPC patients with local residual tumors after IMRT [training cohort (n = 173) and validation cohort (n = 45)] were retrospectively included in this study. Clinical and MRI data were obtained. Univariate Cox regression and the least absolute shrinkage and selection operator (LASSO) were used to select the radiomic features from pretreatment MRI. The clinical, radiomic, and combined models for predicting OS were constructed. The models’ performances were evaluated using Harrell’s concordance index (C-index), calibration curve, and decision curve analysis. Results The C-index of the radiomic model was higher than that of the clinical model, with the C-index of 0.788 (95% CI 0.724–0.852) versus 0.672 (95% CI 0.599–0.745) in the training cohort and 0.753 (95% CI 0.604–0.902) versus 0.634 (95% CI 0.593–0.675) in the validation cohort. Calibration curves showed good agreement between the radiomic model-predicted probability of 2- and 3-year OS and the actual observed probability in the training and validation groups. Decision curve analysis showed that the radiomic model had higher clinical usefulness than the clinical model. The discrimination of the combined model improved significantly in the training cohort (P < 0.01) but not in the validation cohort, with the C-index of 0.834 and 0.734, respectively. The radiomic model divided patients into high- and low-risk groups with a significant difference in OS in both the training and validation cohorts. Conclusions Pretreatment MRI-based radiomic model may improve OS prediction in NPC patients with local residual tumors after IMRT and may assist in clinical decision-making.

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