Clinical trial NCT04984174: Survival Rate and Treatment Cost in Patients With Pancreatic Cancer: An Analysis Using NHIS Database and K-PaC Registry Focusing on Liposomal Irinotecan
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
Lead sponsor: National Cancer Center, Korea
Sponsor class: OTHER_GOV
Collaborators: name: Seoul National University Bundang Hospital
First posted: 2021-07-30
Enrollment: 14760
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: \* Codes: malignant neoplasm of pancreas (C25 code) + registered cancer patients codes (V026, V027, V008, V193, V011, V198, V194)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients who underwent surgery for pancreatic cancer

Primary outcomes:
measure: Cost-effectiveness analysis of chemotherapy
timeFrame: 15 years
measure: age, sex, types of institutions and chemotherapy regimens
timeFrame: 15 years
Secondary outcomes:
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: NATIONAL CANCER CENTER 323, Ilsan-ro, Ilsandong-gu,
state: Gyeonggi-do
Study officials:
affiliation: Nation Cancer Center, Republic of Korea
name: Sangmyung Woo, MD
role: PRINCIPAL_INVESTIGATOR
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