METHODS: This was an open-label, single-arm, and phase II trial. The primary endpoint was the incidence of grade 3-4 radiation-induced mucositis. The secondary endpoints were hematological toxicity, non-hematological toxicity, nutritional status, and quality of life. All patients received 20g Kanglaite daily concurrently with radiotherapy.
RESULTS: The data of 46 patients were available for analysis. The incidence rates of grade 3 mucositis, pain, dysphagia, and neutropenia were 10.9%, 2.2%, 10.9%, and 6.5%, respectively, while the incidence of grade 4 acute toxicities was zero. The rate of opioid use was 2.2%. Radiotherapy dose reduction was 2.2% and no irradiation field was modified. The nutritional supports were oro-enteral nutritional supplements (13.0%), TPN (10.9%), and feeding tubes (0%) during radiotherapy. After radiotherapy, 52.2% of patients lost weight, and the weight loss was <10%. The mean pain score in the QLQ-H&N35 and QLQ-C30 was <50. Patients had nearly normal physical, emotional, and cognitive functions.
CONCLUSIONS: A low incidence of grade 3-4 radiation-induced mucositis and no severe acute toxic events, with favorable nutritional status and quality of life, were observed in cancer patients after Kanglaite injection. Our findings highlight the need for a prospective, multicenter, and randomized study to investigate the effect of Kanglaite injection on the reduction of radiation-induced mucositis in patients with head and neck cancer.
方法:这是一个开放标签,单臂,和第二阶段试验。主要终点是3-4级放射性粘膜炎的发生率。次要终点是血液学毒性,非血液学毒性,营养状况,和生活质量。所有患者每天接受20g康莱特,同时接受放疗。
结果:46例患者的数据可用于分析。3级黏膜炎的发病率,疼痛,吞咽困难,中性粒细胞减少为10.9%,2.2%,10.9%,和6.5%,分别,而4级急性毒性的发生率为零。阿片类药物使用率为2.2%。放射治疗剂量减少了2.2%,没有改变照射场。营养支持为口肠内营养补充剂(13.0%),TPN(10.9%),放疗期间和饲管(0%)。放疗后,52.2%的患者体重下降,并且重量损失<10%。QLQ-H&N35和QLQ-C30的平均疼痛评分<50。患者的身体几乎正常,情感,和认知功能。
结论:3-4级放射性黏膜炎发生率低,无严重急性中毒性事件,良好的营养状况和生活质量,在康莱特注射后的癌症患者中观察到。我们的发现强调了对未来的需求,多中心,和随机研究,以探讨康莱特注射液对头颈部肿瘤患者放射性黏膜炎的减轻作用。