Derby Digestive Diseases Unit, Derby Hospitals NHS Foundation Trust, Derby, UK.
Eur J Cancer Care (Engl). 2011 Sep;20(5):593-600. doi: 10.1111/j.1365-2354.2011.01255.x. Epub 2011 Apr 27.
Oesophageal cancer cachexia is a significant clinical problem, resulting in excessive morbidity and mortality. In a pilot study, 10 patients with cachexia due to advanced cancer of the oesophagus gained weight, including lean tissue, after 14-day treatment with thalidomide. Here, we present randomised placebo controlled trial data over a 6-week period to test the hypothesis that thalidomide is superior to placebo in terms of weight gain in patients with cachexia caused by oesophageal cancer. Thalidomide, 200 mg daily, or an identical placebo was given to patients with advanced oesophageal cancer. Total body weight and lean body mass were assessed in addition to drug tolerability and performance indices. Thirty-four patients were recruited. Of these, six given thalidomide and 16 given placebo completed the protocol; all withdrawals were due to adverse drug reactions or complications of disease. Thalidomide showed no benefit over placebo in participants who completed the protocol. These data suggest that thalidomide is poorly tolerated in patients with advanced cancer of the oesophagus and may not ameliorate the progression of cachexia. In the absence of hard supportive evidence, off-licence treatment with thalidomide should be used with great caution as an adjunct to nutritional support in patients with advanced cancer.
食管癌恶病质是一个严重的临床问题，导致发病率和死亡率过高。在一项初步研究中，10 名因晚期食管癌恶病质而导致的患者在接受沙利度胺治疗 14 天后体重增加，包括瘦组织。在这里，我们提出了为期 6 周的随机安慰剂对照试验数据，以检验沙利度胺在增加食管癌恶病质患者体重方面优于安慰剂的假设。每天给予 200 毫克沙利度胺或相同的安慰剂给患有晚期食管癌的患者。除了药物耐受性和表现指标外，还评估了总体体重和瘦体重。共招募了 34 名患者。其中，6 名接受沙利度胺治疗，16 名接受安慰剂治疗的患者完成了方案；所有退出都是由于药物不良反应或疾病并发症。在完成方案的参与者中，沙利度胺并未显示出优于安慰剂的效果。这些数据表明，沙利度胺在晚期食管癌患者中耐受性差，并且可能不能改善恶病质的进展。在缺乏确凿支持证据的情况下，沙利度胺应谨慎地作为营养支持的辅助药物，用于晚期癌症患者。
