Incidence and mortality of nasopharyngeal carcinoma: interim analysis of a cluster randomized controlled screening trial (PRO-NPC-001) in southern China

Incidence and mortality of nasopharyngeal carcinoma: interim analysis of a cluster randomized controlled screening trial (PRO-NPC-001) in southern China
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鼻咽癌的发病率和死亡率:中国南方整群随机对照筛查试验(PRO-NPC-001)的中期分析

DOI:
10.1093/annonc/mdz231
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发表时间:
2019-10-01
期刊:
影响因子:
50.5
通讯作者:
Cao, S. M.
Cao, S. M.
中科院分区:
医学1区
文献类型:
--
作者:
Ji, M. F.;Sheng, W.;Cao, S. M.

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工作背景:以往的大规模筛查研究表明,针对EB病毒(EBV)的伊加抗体可以促进鼻咽癌(NPC)的早期发现,但EBV抗体筛查对NPC特异性死亡率的影响仍不清楚。患者和方法:一项前瞻性、随机分组、从2008年开始在中山市3个乡镇和四会市13个乡镇进行了鼻咽癌筛查(PRO-NPC-001)的对照试验。对筛选组的血清样品检测两种先前选择的抗EBV抗体。血清学中等风险的受试者随后每年复检一次,持续3年,血清学高风险的受试者被转诊至耳鼻喉科医生进行诊断性检查。以鼻咽癌特异性死亡率和早期诊断率为主要终点,以鼻咽癌发病率为次要终点,与中山市数据库进行关联分析。在70296例受试者中,29413例受试者接受了筛选筛选组50636例,占受试者总数的41.8%,对照组153例,分别为43.3例/10万人年、62例55.3例/10万人年和99例33.1例/10万人年。鼻咽癌的早期诊断率明显高于对照组(79.0%,P
Background: Previous mass screening studies have shown that IgA antibodies against Epstein-Barr Virus (EBV) can facilitate early detection of nasopharyngeal carcinoma (NPC), but the impact of EBV-antibody screening for NPC-specific mortality remains unknown.Patients and methods: A prospective, cluster randomized, controlled trial for NPC screening (PRO-NPC-001) was conducted in 3 selected towns of Zhongshan City and 13 selected towns of Sihui City in southern China beginning in 2008. Serum samples of the screening group were tested for two previously selected anti-EBV antibodies. Subjects with serological medium risk were subsequently retested annually for 3 years, and those with serological high risk were referred to otorhinolaryngologists for diagnostic check-up. An interim analysis was carried out to evaluate the primary end points of the NPC-specific mortality and the early diagnostic rate, and the secondary end point of the NPC incidence, through linkage with the database of Zhongshan City.Results: Among 70 296 total subjects, 29 413 screened participants (41.8% of the total subjects) in the screening group and 50 636 in the control group, 153 (43.3 per 100 000 person-year), 62 (55.3 per 100 000 person-year) and 99 (33.1 per 100 000 person-year) NPC cases were identified. The early diagnostic rates of NPC were significantly higher in the participants (79.0%, P