Bridging the Gap between Evidence and Real-World Practice for Liver Cancer Screening in South Korea

Chang-Mo Oh

摘要

Although incidence and mortality rates for liver cancer have decreased continuously since 1999 in South Korea, 1 the burden of liver cancer is still high. In 2018, more than 10,000 people died of liver cancer, and death from liver cancer accounts for about 13% of all cancer deaths in South Korea. South Korea has the highest mortality rate of liver cancer among the Organisation for Economic Co-operation and Development (OECD) countries, and it is about two times higher than liver cancer mortality rates in Japan, which ranks 2nd among the OECD countries. One of the main reasons for the high disease burden of liver cancer is the high prevalence of hepatitis B virus infection in South Korea. 2 In 2003, the Korean government introduced the national liver cancer screening program for groups at high risk of contracting hepatitis B, hepatitis C, or other liver diseases using liver ultrasonography and serum alpha-fetoprotein measurement to reduce the high disease burden of liver cancer. However, liver cancer is very rare in Western countries. Hence, few countries except for Japan, China, and South Korea have introduced a nationwide liver cancer screening program. Moreover, there was a lack of evidence that liver cancer screening using liver ultrasonography and serum alpha-fetoprotein measurement could reduce mortality rates from liver cancer. Only one randomized controlled trial in China has reported that liver cancer screening with combined liver ultrasonography and serum alpha-fetoprotein measurement can reduce the mortality risk from liver cancer. 3 However, this study was criticized by the American Association for the Study of Liver Disease for improper study design and statistical invalidation. 4 A mass screening program should not be implemented unless it can be shown that the benefit outweighs the risk of harm. 5 Until now, the rationale for implementing a national liver cancer screening program was not clear. 4 , 6 However, some clinicians who support national liver cancer screening expected that liver ultrasonography and serum alpha-fetoprotein measurement would help detect liver cancer in asymptomatic patients earlier, and therefore, the earlier treatment for liver cancer would increase the overall survival rate of patients with liver cancer. 7 , 8 Although a randomized controlled trial is considered the golden standard to evaluate the effectiveness of a screening program, it is very difficult to perform a randomized controlled trial in a real-world setting. 4 Therefore, in reality, well-designed observational studies would be necessary to assess the effectiveness of liver cancer screening at reducing mortality using liver ultrasonography and serum alpha-fetoprotein measurement. However, observational studies aimed at evaluating the effectiveness of the cancer screening program were destined to be biased owing to self-selection bias, lead time bias, and length bias. 9 After adjusting for lead time, and assigning all-cause mortality as the primary outcome, the cohort study may have had a high level of evidence among the observational studies. In addition, this study has another advantage of using the National Health Insurance Service database which can be representative for all liver cancer patients in South Korea. Considering this, a study by Kwon et al. 10 showed great importance for national liver cancer screening in South Korea. Kwon et al. 10 showed that liver cancer screening using liver ultrasonography and serum alpha-fetoprotein measurement reduced all-cause mortality risk among participants after adjustment for lead time and possible covariates in the real-world setting. This new finding will provide a basis for clinicians to strongly recommend patients with liver diseases such as hepatitis B, hepatitis C, or liver cirrhosis to participate in a national liver cancer screening program. Until now, only two out of five high-risk patients with hepatitis B, hepatitis C, or liver diseases had participated in the national liver cancer screening program. The nationwide efforts will be necessary to increase participation rates and improve the quality of the liver cancer screening program in South Korea.

机译：虽然自1999年韩国自1999年以来肝癌的发病率和死亡率持续下降，但肝癌的负担仍然很高。 2018年，超过10,000人死于肝癌，肝癌的死亡占韩国所有癌症死亡的约13％。韩国在经济合作和发展（经合组织）国家组织中具有最高的肝癌死亡率，而且日本的肝癌死亡率大概约为2次，其中在经合组织国家排名第二。肝癌高疾病负担的主要原因之一是韩国乙型肝炎病毒感染的高普遍性。 2 2003年，韩国政府介绍了利用肝脏超声和血清α-胎儿蛋白测量的收缩乙型肝炎，丙型肝炎或其他肝脏疾病的高风险的国家肝癌筛查计划，以降低肝癌的高疾病负担。然而，西方国家的肝癌非常罕见。因此，除日本，中国和韩国外，还有一些国家介绍了全国肝癌筛查计划。此外，缺乏证据表明使用肝超声和血清α-胎儿测量筛选肝癌筛选可以降低肝癌的死亡率。在中国中只有一个随机对照试验据报道，肝癌筛查组合肝超声和血清α-胎儿测量测量可以降低肝癌的死亡风险。 3但是，本研究受到美国肝病的肝病的批评，以获得不正当的研究设计和统计无效。 4不应实施大规模筛选计划，除非可以表明益处超过危害的风险。 5直到现在，实施国家肝癌筛查计划的理由尚不清楚。 4,6然而，一些支持国家肝癌筛查的临床医生预期肝超声和血清α-胎蛋白测量将有助于检测无症状患者的肝癌，因此，肝癌的早期治疗将增加患者的整体生存率用肝癌。 7,8虽然随机对照试验被认为是评估筛查计划的有效性的黄金标准，但很难在真实的环境中进行随机控制试验。因此，实际上，在使用肝超声检查和血清α-胎儿测量测量时，需要精心设计的观察性研究以评估肝癌筛选在降低死亡率时的有效性。然而，旨在评估癌症筛查计划的有效性的观察研究注定是由于自我选择偏差，提前时间偏见和长度偏差而偏见。 9调整汇总时间后，并将全因死亡率作为主要结果分配，队列研究可能在观察研究中具有高水平的证据。此外，本研究还具有使用国家健康保险服务数据库的另一个优势，该数据库可以代表韩国所有肝癌患者。考虑到这一点，由kwon等人进行一项研究。图10显示了韩国国家肝癌筛查的重要意义。 kwon等人。图10显示使用肝超声检查和血清α-胎儿测量的肝癌筛选在调整后的牛仔时间和可能的协变者在现实世界环境中进行调整后降低了与参与者的所有导致死亡率风险。这一新发现将为临床医生提供依据，强烈建议肝病如乙型肝炎，丙型肝炎或肝硬化等肝脏疾病患者参与国家肝癌筛查计划。到目前为止，只有五个高风险患者患有乙型肝炎，丙型肝炎或肝脏疾病中的两种患者参加了国家肝癌筛查计划。全国范围内的努力将有必要增加参与率，提高韩国肝癌筛查计划的质量。

Bridging the Gap between Evidence and Real-World Practice for Liver Cancer Screening in South Korea

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