A phase I/II study to evaluate the toxicity and efficacy of accelerated fractionation radiotherapy for the palliation of dysphagia from carcinoma of the oesophagus

A phase I/II study to evaluate the toxicity and efficacy of accelerated fractionation radiotherapy for the palliation of dysphagia from carcinoma of the oesophagus
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DOI:
10.1016/j.clon.2007.10.003
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发表时间:
2008-02-01
期刊:
影响因子:
3.4
通讯作者:
Davey, P.
Davey, P.
中科院分区:
医学2区
文献类型:
--
作者:
Kassam, Z.;Wong, R. K. S.;Davey, P.

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目标:我们假设加速分次放疗可能为无法治愈的食管癌患者的吞咽困难缓解提供一种良好的姑息性方法,显著缩短治疗的总体持续时间,同时提供具有可接受毒性特征的症状缓解。进行I/II期加速分割研究以评估这种方法的疗效和毒性。材料和方法:患有不可治愈的食管癌的患者,有吞咽困难的症状,东部肿瘤协作组表现状态=间隔6小时),每周5天,超过2周。在39例可评价患者中,吞咽困难缓解率为69%(27/39),中位缓解持续时间为5.5个月。中位缓解时间为4周。28%(11/39)的患者吞咽困难评分出现一过性恶化。41%(16/39)的患者发生急性毒性(第1-8周)。第8周时,42%的患者的总体生活质量得到改善。无晚期神经系统后遗症。中位总生存期为8(范围1.7-58+)months.Conclusion:理想的姑息治疗方案应相对较短,毒性最小,同时提供一个有利的反应。加速分割符合这些标准,是缓解吞咽困难的合适治疗替代方案,特别是如果目标是在较短(2周)时间内提供较高的总生物剂量。
Aims: We hypothesised that accelerated fractionated radiotherapy may provide a good palliative approach for dysphagia relief in patients with incurable oesophageal cancer, significantly reducing the overall duration of treatment, while providing symptom response with an acceptable toxicity profile. A phase I/II accelerated fractionation study was conducted to evaluate the efficacy and toxicity of this approach.Materials and methods: Patients with incurable oesophageal cancer, symptomatic with dysphagia, Eastern Cooperative Oncology Group performance status = 6 h apart), 5 days a week, over 2 weeks.Results: Of the 39 evaluable patients, the dysphagia response rate was 69% (27/39) with a median response duration of 5.5 months. The median time to response was 4 weeks. Twenty-eight per cent (11/39) of patients had transient worsening in their dysphagia scores. Acute toxicity (weeks 1-8) occurred in 41% (16/39) of patients. An improvement in global quality of life by week 8 was seen in 42% of patients. There were no late neurological sequelae. The median overall survival was 8 (range 1.7-58+) months.Conclusion: The ideal palliative regimen should be relatively short, with minimal toxicity, while offering a favourable response profile. Accelerated fractionation fulfils these criteria and is a suitable treatment alternative for the palliation of dysphagia, especially if the goal is to deliver a higher total biological dose within a shorter (2 week) period of time.