Two phase III clinical studies of cevimeline for post-radiation xerostomia in patients with head and neck cancer
Two phase III clinical studies of cevimeline for post-radiation xerostomia in patients with head and neck cancer
复制标题
西维美林治疗头颈癌患者放射后口干症的两项 III 期临床研究
DOI：
10.1200/jco.2005.23.16_suppl.5503
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发表时间：
2005
影响因子：
45.3
通讯作者：
R. Vitti
中科院分区：
文献类型：
--
作者：
M. Chambers;M. Posner;Christopher U. Jones;R. Weber;R. Vitti
5503 背景：口干症是头颈癌放射治疗中常见的使人衰弱的并发症。疾病包括龋齿、口腔感染和生活质量受损。方法：进行两项多中心双盲试验来评估西维美林治疗辐射引起的口干症的有效性和安全性。每项试验均纳入年龄≥18岁的头颈癌受试者，他们在入组前≥4个月接受过>4000cGy的辐射，并且有临床上显着的唾液腺功能障碍。受试者被随机接受西维美林 30 mg TID 或安慰剂治疗 12 周，如果没有报告改善，则在 6 周时升级至 45 mg TID 或安慰剂等效剂量。剂量递增后出现副作用的受试者可以将剂量逐渐降至 30 mg TID。主要疗效终点是口腔干燥的整体评估，次要终点是未刺激唾液流量的变化。结果：总共 570 名受试者（003 研究中 284 名，004 研究中 286 名）被随机分配...
5503 Background: Xerostomia is a frequent debilitating complication of head and neck cancer radiotherapy. Morbidities include dental caries, oral infections, and impaired quality of life. Methods: Two multicenter double-blind trials were conducted to assess the efficacy and safety of cevimeline in the treatment of radiation-induced xerostomia. Each trial enrolled subjects ≥18 years of age with head and neck cancer who had received >4000 cGy of radiation ≥4 months before entry and had clinically significant salivary gland dysfunction. Subjects were randomized to cevimeline 30 mg TID or placebo for 12 weeks, with escalation to 45 mg TID or placebo equivalent at 6 weeks if no improvement was reported. Subjects experiencing side effects after dose escalation could de-escalate to 30 mg TID. The primary efficacy endpoint was global evaluation of oral dryness, with a secondary endpoint being change in unstimulated salivary flow. Results: A total of 570 subjects (284 in the 003 and 286 in the 004 study) were rand...