Cancer Incidence in a Trial of an Antiapoptotic Agent for Parkinson's Disease
Cancer Incidence in a Trial of an Antiapoptotic Agent for Parkinson's Disease
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DOI：
10.1002/mds.23006
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发表时间：
2010-09-15
影响因子：
8.6
通讯作者：
Shoulson, Ira
中科院分区：
文献类型：
--
作者：
Schwid, Steven R.;Bausch, Janice;Shoulson, Ira
我们在早期帕金森病（PD）患者中进行了CEP 1347（一种神经元凋亡细胞死亡抑制剂）的安慰剂对照试验，以确定长期治疗是否会减缓残疾进展。这也提供了一个机会，以监测癌症的发病率在一个大型队列的PD患者的前瞻性随访，包括之前和之后的时期，患者发展残疾需要多巴胺能治疗。这是一项多中心研究，806例早期PD患者，无需要多巴胺能治疗的残疾，随机分配至安慰剂组或三种剂量的CEP-1347之一组。患者平均监测1.8年（1，467患者年），由皮肤科医生进行常规癌症筛查评估和年度皮肤检查。对于任何癌症类型，与安慰剂相比，服用CEP-1347的患者中的癌症没有显著增加（均P > 0.1）。非黑素瘤皮肤癌是观察到的最常见的癌症类型。黑色素瘤的发病率是一般人群的20.9倍。大多数黑色素瘤发生在从未接受过多巴胺能治疗的患者中。我们发现没有证据表明CEP-1347在2年的随访中影响癌症发病率。与一般人群相比，我们的PD患者中黑色素瘤的发生率高于预测值，且与多巴胺能治疗无关。可能需要对PD患者进行黑色素瘤的临床监测。(C)2010年运动障碍协会
We performed a placebo-controlled trial of CEP1347, an inhibitor of neuronal apoptotic cell death, in patients with early Parkinson's disease (PD) to determine whether long-term therapy would slow disability progression. This also provided an opportunity to monitor cancer incidence in a large cohort of PD patients followed prospectively including periods before and after patients developed disability requiring dopaminergic therapy. This was a multicenter study of 806 patients with early PD, without disability requiring dopaminergic therapy, assigned randomly to placebo or one of three doses of CEP-1347. Patients were monitored for an average of 1.8 years (1,467 patient-years) with routine cancer screening evaluations and annual skin examinations by a dermatologist. There was no significant excess of cancers among patients taking CEP-1347 compared with placebo for any cancer type (all P > 0.1). Nonmelanoma skin cancers were the most common cancer type observed. The incidence of melanomas was 20.9 times that predicted in the general population. Most melanomas occurred in patients who had never taken dopaminergic therapy. We found no evidence that CEP-1347 affected cancer incidence within 2 years of follow-up. Melanoma occurrence in our PD patients was greater than predicted compared with the general population and was unrelated to dopaminergic therapy. Clinical surveillance of PD patients for melanoma may be warranted. (C) 2010 Movement Disorder Society