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2015年ASCO GI研讨会于1月15日~17日在美国旧金山举行。根据WHO估计,中国2012年有>400000新的胃癌病例发生,这样的话,胃癌成为中国第二大最常见恶性肿瘤。然而,中国对于胃癌的流行病学数据很少有人知道。在此次会议上,中国研究人员发表了一份国内非mGC患者横断面分析,这份数据是对EVIDENCE胃癌注册研究更新。
研究目的
本次分析的目的是评估中国非-mGC患者的临床病理学和社会经济学特征。
研究方法
EVIDENCE是一项前瞻性研究注册研究。在该项研究中计划招募2600例新近诊断为胃癌的患者,这些患者来自中国85家医院。在入组前,经组织学病例证实胃癌诊断并在6个月内有对应的HER2 ICH状态诊断性结果的患者符合试验要求。根据疾病的整体分期,HER2状态,和曲妥珠单抗的使用,患者连续地分配到5个不同的队列直到患者人数已经达到每个队列的指定限制。
研究结果
截止到2014年5月31日,885例符合条件的患者在任何队列招募完成前连续地入组。这些患者中,538例(60.8%)诊断为非-mGC的患者被列入该项分析。在这部分人群中,这些患者中的15.6%是HER2-阳性(IHC3+或者IHC2+/ISH+),73.6%的患者为男性,中位诊断年龄是60岁(范围:26~85)。
患者的73.5%(403/535)是通过上消化道内镜检查诊断,65%(348/535)经过活检,23.9%(128/535)是利用手术。
37.2%(191/514)患者的原发肿瘤部位是在胃窦部(胃下部三分之一处),22.8%(117/514)是在胃体内(胃中部三分之一),17.7%(91/514)是在胃食管交界处,10.9%(56/514)在胃底部(胃下部三分之一)。
43.0%的患者之前或者现在是吸烟者,30.3%报告显示有轻到中度酗酒习惯。大多数患者(39.5%)已经完成小学或以下教育,53.6%的患者报告称他们的家庭年收入为RMB 35000(US $5700)或以下。
研究结论
综上所述,中国胃癌患者的临床病理学和社会经济学特征分析将有助于提高这些患者的疾病管理。患者招募和更多分析将会根据计划正在继续。临床试验信息:NCT01839500。
英文摘要:
Cross-sectional analysis of patients with non-mGC in China: An update of EVIDENCE gastric cancer registry study.(Abstract 49)
Background:According to WHO estimation, >400,000 new cases of gastric cancer have occurred in 2012 in China, making it the second most common malignancy in the country. However, little is known about epidemiological data of gastric cancer in China. This analysis aimed to evaluate clinicopathological and socioeconomic characteristics of Chinese patients with non-mGC.
Methods:EVIDENCE was a prospective registry study. 2,600 patients with newly diagnosed gastric cancer from 85 hospitals across China were planned to be enrolled into this study. Patients who have histopathologically confirmed diagnosis of gastric cancer and corresponding HER2 IHC status diagnostic results within 6 months before enrollment are eligible. According to overall stage of disease, HER2 status, and use of trastuzumab (Herceptin®), patients are continuously assigned to 5 different cohorts until number of patients has reached the designated limit of each cohort.
Results:Until 31st May 2014, 885 eligible patients were continuously enrolled before completion of recruitment of any cohort. Of these patients, 538 (60.8%) patients who were diagnosed with non-mGC were included in this analysis. In this population, 15.6% of these patients were HER2-positive (IHC3+ or IHC2+/ISH+), 73.6% were male, median age of diagnosis was 60 (range: 26-85). 75.3% (403/535) of patients were diagnosed with upper endoscopy, 65% (348/535) with biopsy, and 23.9% (128/535) with surgery. Primary tumor site of 37.2% (191/514) of patients was at the antrum (the lower third of stomach), 22.8% (117/514) was at the body (the middle third of stomach), 17.7% (91/514) was at the gastro-oesophageal junction, and 10.9% (56/514) was at the fundus (the upper third of stomach). 43.0% were former or current smokers, 30.3% had reported light to moderate alcohol consumption habit. Most of the patients (39.5%) had completed primary education or below, 53.6% reported their family annual income of RMB 35,000 (US$5,700) or below.
Conclusions:Analysis of clinicolpathological and socioeconomic characteristics of Chinese patients with GC will help to improve disease management of these patients. Patient recruitment and additional analyses will be continued as planned. Clinical trial information: NCT01839500
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