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临床试验/NCT04984174
NCT04984174已完成不适用

Survival Rate and Treatment Cost in Patients With Pancreatic Cancer With the Advent of New Chemotherapeutic Agents in Korea: An Analysis Using NHIS Database and K-PaC Registry Focusing on the Newest One, Liposomal Irinotecan

National Cancer Center, Korea1 个研究点 分布在 1 个国家目标入组 14,760 人开始时间: 2021年8月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14,760
试验地点
1
主要终点
Cost-effectiveness analysis of chemotherapy

研究概览

简要总结

The past 15 years, using National Health Insurance Service (NHIS) database and K-PaC registry, and to analyze the cost and cost-effectiveness along with the change in survival rate after the emergence of the aforementioned regimens, which is very important for policy decisions such as reimbursement of second-line treatment.

详细描述

Pancreatic cancer is a disease with a very poor prognosis and incurs large medical and economic costs in a short course of disease. According to data from Cancer registration Statistics Program released in 2020, 243,837 new cancers occurred in Korea in 2018, of which pancreatic cancer (C25) was ranked 8th with 7,611 cases, 3.1% of total cancer incidences. The crude incidence rate was 14.8 cases/100,000 (https://www.cancer.go.kr/). According to a 2002 report, Korean pancreatic cancer patient's per capita medical expenses and income loss totaled 93 million won, showing the largest economic loss among cancers.

Pancreatic cancer is known to have a 5-year survival rate of around 10% worldwide, and it is thought that the survival rate is gradually increasing after the introduction of FOLFIRINOX, and albumin-bound paclitaxel (GnP). Since the measures to strengthen the coverage of severe diseases in 2005, the coverage of severe diseases has also been strengthened. Since 2016, with the reimbursement of the use of FOLFIRINOX and GnP, one of these two regimens has been the first-line chemotherapy in most pancreatic cancer patients who are eligible for chemotherapy in Korea. In addition, these two regimens can be administered in the first and second alternations of each other. Recently, after the first gemcitabine-based treatment for metastatic pancreatic cancer, the second-line treatment with 5-FU and folinic acid with liposomal irinotecan demonstrated significant increased survival rates compared with 5FU/LV in a randomized Phase 3 Trial (NAPOLI-1).

Since the introduction of the aforementioned chemotherapy, the change in survival rate is not yet well known, and real-world data on the cost and cost-effectiveness of pancreatic cancer treatment are still lacking in Korea. In the United States, in 2012, research results on the cost and trend analysis of pancreatic cancer treatment were published, and in that paper, the treatment cost for pancreatic cancer was a high economic burden, especially in the elderly, and targeted therapy or screening tests are required to reduce future treatment costs. A recent study reported by Investigator research group showed that FOLFIRINOX and GnP have similar efficacy and comparable toxicity in patients with metastatic pancreatic cancer using Korean Pancreatic Cancer (K-PaC) registry. In particular, patients who could receive second-line chemotherapy survived for about 17 months in the K-PaC registry. The K-PaC results provided the actual results of pancreatic cancer treatment in Korea relatively well, but the data has disadvantages that do not represent all pancreatic cancer patients in Korea, and cost analysis was not performed. Therefore, it is necessary to evaluate the change in survival rate and costs with the advent of the aforementioned chemotherapy by analyzing big data representing the whole pancreatic cancer patients in Korea.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Pancreatic cancer patients with records of medical users and billing data from 2005 to 2020

排除标准

  • Patients who underwent surgery for pancreatic cancer

结局指标

主要结局

Cost-effectiveness analysis of chemotherapy

时间窗: 15 years

Analysis of chemotherapy to report annual survival rates and treatment-related for past 15 years in Korea

age, sex, types of institutions and chemotherapy regimens

时间窗: 15 years

Subgroup analysis to report annual survival rates and treatment-related for past 15 years in Korea

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Sang Myung Woo

medical doctor, Senior scientist

National Cancer Center, Korea

研究点 (1)

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