Phase III randomized trial of amifostine as a radioprotector in head and neck cancer
Phase III randomized trial of amifostine as a radioprotector in head and neck cancer
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DOI：
10.1200/jco.2000.18.19.3339
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发表时间：
2000-10-01
影响因子：
45.3
通讯作者：
Sauer, R
中科院分区：
文献类型：
--
作者：
Brizel, DM;Wasserman, TH;Sauer, R
目的：头颈部恶性肿瘤放射治疗后引起急、慢性口腔干燥及急性粘膜炎。氨磷汀及其活性代谢物WR-1065在唾液腺中以高浓度蓄积。这项随机试验评估了氨磷汀是否可以改善这些副作用，而不影响这些patients.Patients和方法的放射治疗的有效性：以前未经治疗的头部和颈部鳞状细胞癌患者有资格。主要终点包括大于或等于2级急性口干、大于或等于3级急性粘膜炎和大于或等于2级晚期口干的发生率，并基于报告的最严重毒性。在照射前15至30分钟每日给予氨磷汀（200 mg/m2，静脉注射）。放射治疗每日1次（1.8 ~ 2.0戈伊），剂量为50 ~ 70戈伊。在放疗前和随访期间定期对全唾液的产生进行定量。患者在治疗期间和治疗后通过问卷调查评估他们的症状。结果：恶心、呕吐、低血压和过敏反应是最常见的副作用。接受氨磷汀的患者中有53%至少有一次恶心和/或呕吐，但在4，314次剂量中只有233次（5%）发生。氨磷汀使≥ 2级急性口干症从78%降至51%（P
Purpose: Radiotherapy for head and neck cancer causes acute and chronic xerostomia and acute mucositis. Amifositine and its active metabolite, WR-1065, accumulate with high concentrations in the salivary glands. This randomized trial evaluated whether amifostine could ameliorate these side effects without compromising the effectiveness of radiotherapy in these patients.Patients and Methods: Patients with previously untreated head and neck squamous cell carcinoma were eligible. Primary end points included the incidence of grade greater than or equal to 2 acute xerostomia, grade greater than or equal to 3 acute mucositis, and grade greater than or equal to 2 late xerostomia and were based on the worst toxicity reported. Amifostine was administered (200 mg/m(2) intravenous) daily 15 to 30 minutes before irradiation. Radiotherapy was given once daily (1.8 to 2.0 Gy) to doses of 50 to 70 Gy. Whole saliva production was quantitated preradiotherapy and regularly during follow-up. Patients evaluated their symptoms through a questionnaire during and after treatment. Local-regional control was the primary antitumor efficacy end point.Results: Nausea, vomiting, hypotension, and allergic reactions were the most common side effects. Fifty-three percent of the patients receiving amifostine had at least one episode of nausea and/or vomiting, but it only occurred with 233 (5%) of 4,314 doses. Amifostine reduced grade greater than or equal to 2 acute xerostomia from 78% to 51% (P