A phase I/II evaluation of metoclopramide as a radiosensitiser in patients with inoperable squamous cell carcinoma of the lung
A phase I/II evaluation of metoclopramide as a radiosensitiser in patients with inoperable squamous cell carcinoma of the lung
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DOI：
10.1016/0959-8049(95)00424-6
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发表时间：
1995-12-01
影响因子：
8.4
通讯作者：
Wennerberg, J
中科院分区：
文献类型：
--
作者：
Kjellen, E;Pero, RW;Wennerberg, J
应用甲氧氯普胺(MCA)作为放射增敏剂的可行性已经在23名经病理或细胞学诊断为肺鳞状细胞癌的患者中进行了评估，临床评估为不能手术。所有患者均接受40~60Gy分次放射治疗，每周5次(周一至周五)，每次1.8Gy.采用两种MCA治疗方案：(1)放疗前1~2小时静脉滴注2 mg/kg，每周3次(星期一、三、五)，(2)放疗前1~2小时静脉滴注1 mg/kg，每周5次(周一~周五)。接受放射治疗和大脑中动脉治疗的23例患者中，11例无至轻度肺炎或纤维化，另有8例中度。没有患者的治疗因辐射相关的副作用而中断。MCA相关副作用符合预期，78%的患者出现镇静/疲倦，48%的患者表现出躁动/焦虑症状。MCA的总剂量和血药浓度均与MCA副作用的发生率显著相关。肿瘤反应、肿瘤反应持续时间和生存期与患者在放疗期间给予MCA的总剂量和每周剂量呈显著正相关。这些有利的II期数据证明了在欧洲启动II/III期随机多中心试验的合理性，以评估MCA作为放射增敏剂的作用。
The feasibility of administering metoclopramide (MCA) as a radiosensitizer has been evaluated in 23 patients with a pathological or cytological diagnosis of a squamous cell carcinoma of the lung, clinically evaluated as inoperable. All patients received 40-60 Gy radiotherapy fractionated into 1.8 Gy fractions 5 times per week (Monday-Friday). Two MCA treatment regimens were used: (i) MCA at 2 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 3 times per week (Monday, Wednesday, Friday); and (ii) MCA at 1 mg/kg administered by intravenous infusion 1-2 h prior to radiotherapy 5 times per week (Monday-Friday). 11 of the 23 patients treated with radiotherapy and MCA had none to mild pneumonitis or fibrosis and another 8 of the 23 had moderate levels. No patient had their therapy interrupted due to radiation-related side-effects. The MCA-related side-effects were as expected, i.e. 78% of the patients experienced sedation/tiredness and 48% expressed restlessness/anxiety symptoms. Both the total dose and serum levels of MCA were significantly associated to the MCA side-effect profile. Tumour response, duration of tumour response and survival were significantly positively correlated to the total and weekly doses of MCA administered to the patients during their radiotherapy treatment. These favourable phase II data have justified the initiation of a phase II/III randomised multicentred trial being carried out in Europe to evaluate MCA as a radiosensitiser.