A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal-cord compression treated by radiotherapy: TROG 01.05 Superdex study
A pilot randomised comparison of dexamethasone 96 mg vs 16 mg per day for malignant spinal-cord compression treated by radiotherapy: TROG 01.05 Superdex study
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DOI：
10.1016/j.clon.2005.08.015
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发表时间：
2006-02-01
影响因子：
3.4
通讯作者：
Wirth, A
中科院分区：
文献类型：
--
作者：
Graham, PH;Capp, A;Wirth, A
目的：测试放射治疗恶性脊髓压迫(MSCC)时两种激素剂量的全面随机比较的可行性，测试互联网随机化，并比较不同的功能结果指标。材料和方法：保留8个招募中心的筛查患者的日志。患者通过Superdex网站随机接受地塞米松每日96毫克或16毫克的治疗。放射治疗30Gy10次/次。术后1个月采用步行、Barthel指数步行、功能独立性评分和功能改善评分进行疗效评定。结果：共筛选出131例患者。93例(71%)不合格，其中65%的原因是既往使用类固醇的时间超过12h，未能满足严格的磁共振成像定义，明确的MSCC，多节段疾病或既往脊髓压迫治疗。在38名符合条件的患者中，有20名是随机抽样的，其中包括7名标准办公时间以外的患者。严重不良事件的发生率很高(n=9)，但只有一例被认为可能与研究药物有关。基线时，75%的患者可以行走，70%的患者FIM步行评分大于5，50%的患者Barthel指数步行评分大于2。在第28天，包括所有随机分组的患者(根据不同的定义对4名死亡患者进行评分)，步行评分分别为60%、45%和40%。对于第28天可评估的16名患者，平均FIS为-1.4。中位生存期为69天，1年生存率为13%。结论：网络随机试验是成功的；然而，较高的不合格率阻碍了在澳大利亚进行全面的地塞米松剂量试验。行走测量的选择对结果有潜在的重大影响，并对未来任何MSCC试验的设计产生影响。转介延误令人担忧。
Aim: To test the viability of a full-scale randomised comparison of two steroid doses given with radiotherapy for malignant spinal-cord compression (MSCC), to test internet randomisation and to compare different functional outcome measures.Materials and methods: A log of screened patients at eight recruiting centres was maintained. Patients were randomised via the Superdex website to either 96 mg or 16 mg daily of dexamethasone. Radiotherapy treatment was 30 Gy in 10 fractions. Outcomes assessed used ambulation, Barthel Index ambulation, Functional Independence Measure (FIM) ambulation and Functional Improvement Score (FIS) at 1 month.Results: One hundred and thirty-one patients were screened. Ninety-three (71%) were ineligible, 65% of these were because duration of prior steroid use was greater than 12 h, failure to meet strict definition of magnetic resonance imaging, defined MSCC, multi-level disease or previous spinal-cord compression treatment. Twenty of the 38 eligible patients were randomised, including seven outside standard office hours. There was a high rate of serious adverse events (n = 9), but only one was considered likely to be related to study medication. At baseline, 75% were ambulant, 70% had FIM ambulation scores greater than 5 and 50% had Barthel Index ambulation scores greater than 2. At day 28, including all randomised patients (by scoring four dead patients as non-ambulant), ambulation scores by the various definitions were 60%, 45% and 40%, respectively. For the 16 patients evaluable at day 28, the mean FIS was -1.4. Median survival was 69 days and 1-year survival 13%.Conclusion: Web randomisation was successful; however, the high ineligibility rate precludes a full-scale dexamethasone dose trial in Australia. Choice of measure of ambulation has potentially significant effects on outcomes and implications for the design of any future MSCC trials. Referral delays are of concern.