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Survival Rate and Treatment Cost in Patients With Pancreatic Cancer: An Analysis Using NHIS Database and K-PaC Registry Focusing on Liposomal Irinotecan


2021-08-04


2024-12-28


2024-12-28


54000

Study Overview

Survival Rate and Treatment Cost in Patients With Pancreatic Cancer: An Analysis Using NHIS Database and K-PaC Registry Focusing on Liposomal Irinotecan

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.

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.

  • Pancreatic Cancer
    • NCC2021-0211

    Study Record Dates

    These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

    Study Registration Dates Results Reporting Dates Study Record Updates

    2021-07-16  

    N/A  

    2024-09-19  

    2021-07-25  

    N/A  

    2024-09-23  

    2021-07-30  

    N/A  

    2024-09  

    Study Plan

    This section provides details of the study plan, including how the study is designed and what the study is measuring.

    Design Details

    Primary Purpose:
    N/A


    Allocation:
    N/A


    Interventional Model:
    N/A


    Masking:
    N/A


    Arms and Interventions

    Participant Group/ArmIntervention/Treatment
    Primary Outcome MeasuresMeasure DescriptionTime Frame
    Cost-effectiveness analysis of chemotherapyAnalysis of chemotherapy to report annual survival rates and treatment-related for past 15 years in Korea15 years
    age, sex, types of institutions and chemotherapy regimensSubgroup analysis to report annual survival rates and treatment-related for past 15 years in Korea15 years
    Secondary Outcome MeasuresMeasure DescriptionTime Frame

    Contacts and Locations

    This section provides the contact details for those conducting the study, and information on where this study is being conducted.

    Study Contact

    Name: Sangmyung Woo, MD

    Phone Number: 82 31 920 1733

    Email: wsm@ncc.re.kr

    Study Contact Backup

    Name: Meeyoung Lee, bachelor

    Phone Number: 82 31 920 0740

    Email: leemyyoung@ncc.re.kr

    Participation Criteria

    Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

    Ages Eligible for Study:
    ALL

    Sexes Eligible for Study:

    Accepts Healthy Volunteers:

      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

    Collaborators and Investigators

    This is where you will find people and organizations involved with this study.

    • Seoul National University Bundang Hospital

    • PRINCIPAL_INVESTIGATOR: Sangmyung Woo, MD, Nation Cancer Center, Republic of Korea

    Publications

    The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

    General Publications

    • Kim SG, Hahm MI, Choi KS, Seung NY, Shin HR, Park EC. The economic burden of cancer in Korea in 2002. Eur J Cancer Care (Engl). 2008 Mar;17(2):136-44. doi: 10.1111/j.1365-2354.2007.00818.x. Epub 2007 Sep 20.
    • Mizrahi JD, Surana R, Valle JW, Shroff RT. Pancreatic cancer. Lancet. 2020 Jun 27;395(10242):2008-2020. doi: 10.1016/S0140-6736(20)30974-0.
    • Conroy T, Desseigne F, Ychou M, Bouche O, Guimbaud R, Becouarn Y, Adenis A, Raoul JL, Gourgou-Bourgade S, de la Fouchardiere C, Bennouna J, Bachet JB, Khemissa-Akouz F, Pere-Verge D, Delbaldo C, Assenat E, Chauffert B, Michel P, Montoto-Grillot C, Ducreux M; Groupe Tumeurs Digestives of Unicancer; PRODIGE Intergroup. FOLFIRINOX versus gemcitabine for metastatic pancreatic cancer. N Engl J Med. 2011 May 12;364(19):1817-25. doi: 10.1056/NEJMoa1011923.
    • Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013 Oct 31;369(18):1691-703. doi: 10.1056/NEJMoa1304369. Epub 2013 Oct 16.
    • Wang-Gillam A, Li CP, Bodoky G, Dean A, Shan YS, Jameson G, Macarulla T, Lee KH, Cunningham D, Blanc JF, Hubner RA, Chiu CF, Schwartsmann G, Siveke JT, Braiteh F, Moyo V, Belanger B, Dhindsa N, Bayever E, Von Hoff DD, Chen LT; NAPOLI-1 Study Group. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet. 2016 Feb 6;387(10018):545-557. doi: 10.1016/S0140-6736(15)00986-1. Epub 2015 Nov 29. Erratum In: Lancet. 2016 Feb 6;387(10018):536. doi: 10.1016/S0140-6736(15)01306-9.
    • O'Neill CB, Atoria CL, O'Reilly EM, LaFemina J, Henman MC, Elkin EB. Costs and trends in pancreatic cancer treatment. Cancer. 2012 Oct 15;118(20):5132-9. doi: 10.1002/cncr.27490. Epub 2012 Mar 13.
    • Lee JC, Woo SM, Shin DW, Kim J, Yang SY, Kim MJ, Kim JW, Kim JW, Lee WJ, Cha HS, Park P, Kim J, Hwang JH. Comparison of FOLFIRINOX and Gemcitabine Plus Nab-paclitaxel for Treatment of Metastatic Pancreatic Cancer: Using Korean Pancreatic Cancer (K-PaC) Registry. Am J Clin Oncol. 2020 Sep;43(9):654-659. doi: 10.1097/COC.0000000000000730.