A Study for Building a Real-World Database of Cancer Patients in Japan
Ontology highlight
ABSTRACT:
DISEASE(S): Esophageal Cancer, Stomach, And Esophagogastric Junction Cancers, Colorectal Cancer, Hepatocellular Carcinoma, Pancreatic Cancer
PROVIDER: 2724054 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description:ObjectivesChronic rhinosinusitis (CRS) is a heterogeneous disease, which can be subdivided into CRS with (CRSwNP) or without (CRSsNP) nasal polyps. An intractable form of CRSwNP that is associated with an eosinophil-dominant inflammatory cell infiltration (eosinophilic CRS) has become more prevalent in Japan. There is currently limited information on the burden of CRS in Japan and treatment approaches used in real-world practice.MethodsThis retrospective, observational, comparative cohort study used information from the Japanese JMDC insurance claims database (study period April 1, 2015, to March 31, 2020). A CRS cohort was identified and matched with a control group without CRS. The primary objective was to clarify disease burden and treatment approaches by comparing comorbidities, healthcare resource utilization (HRU), and drug prescriptions in the CRS and non-CRS groups.ResultsIn total, 23,256 individuals with CRS (1762 with CRSwNP and 21,494 with CRSsNP) were matched with 23,256 controls. The mean age was 45 years and the majority of individuals were male (57%). Individuals with CRS had a higher disease burden than controls, with more frequent comorbidities (particularly, type 2 inflammatory disease [e.g., allergic rhinitis and asthma], and those caused by systemic corticosteroids [SCS]), and higher HRU (including outpatient visits, laboratory examinations and surgical procedures). Further, individuals with CRS were prescribed more medications, both for CRS (including SCS) and non-CRS conditions, than controls.ConclusionIn Japan, CRS is associated with a high disease burden, and multiple treatment approaches are used in affected individuals, including long-term SCS, which is generally not recommended.Level of evidence3.
| S-EPMC10116956 | biostudies-literature
Project description:Pulmonary arterial hypertension (PAH) is a fatal disease that often occurs at an early age. In recent years, aggressive treatment with multiple drugs from the early-stage diagnosis is expected to improve the prognosis. Indeed, a high rate of initial combination therapy and excellent treatment outcomes have been reported from specialized centers for PAH in Japan. However, information on PAH epidemiology, including non-PAH specialized centers in Japan, is unclear. To address the above, we conducted a retrospective observational cohort study from April 2008 to September 2020 using real-world evidence from a large-scale administrative database (Medical Data Vision) to examine baseline characteristics, comorbidities, and treatment profiles of Japanese patients with PAH. Five hundred and eighteen patients with PAH (treatment-naive PAH, age 67.2 ± 15.9) were identified through our comprehensive approach which combined PAH disease codes, medications, and diagnostic procedures. Moreover, we showed that a larger proportion of patients received monotherapy in their initial treatment (66%) compared to those receiving combination therapy (34%). During the 1-year follow-up after PAH diagnosis, 13% of patients increased their PAH medications while other patients either decreased their PAH medications (6%) or discontinued PAH treatment (27%). The 3- and 5-year event-free survival rates of all-cause death were 72% and 64%, respectively. This is the first large-scale administrative database study that provides insights into real-world PAH management in Japan. This study highlighted a different PAH clinical landscape which included a larger portion of the elderly population, higher initial monotherapy treatment, and lower survival rates than previous studies.
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Project description:Mantle cell lymphoma (MCL) accounts for approximately 3% of all cases of malignant lymphoma in Japan. The CLIMBER-DBR (Treatment practices and patient burden in chronic lymphocytic leukemia and mantle cell lymphoma patients in the real world: An observational database research in Japan) study examined the clinical characteristics, treatment patterns, and healthcare resource utilization of MCL in a real-world clinical setting in Japan. Using the Japanese Medical Data Vision database, we extracted data for 1130 patients with MCL (ICD-10 code C83.1) registered between March 1, 2013 and February 28, 2018. The date of first MCL diagnosis was taken as the index date. The mean (standard deviation) age, body weight, and modified Charlson Comorbidity Index were 71.4 (10.9) years, 58.3 (11.7) kg, and 1.9 (1.6), respectively, and 24.6% were ≤65 years old. The median follow-up period was 654 days (first-third quartile 290.5 E049 days). A total of 802 patients (71.0%) underwent first-line treatment. The most common first-line treatment was bendamustine/rituximab (BR; 27.8%), followed by rituximab/cyclophosphamide/doxorubicin/vincristine/prednisolone (R-CHOP; 15.6%) and rituximab/tetrahydropyranyl-adriamycin/cyclophosphamide/vincristine/prednisolone (R-THP-COP; 6.5%). The median (95% confidence interval) times to initial (first-line), second-line, and third-line treatments were 45 (36 E2), 687 (624 E34), and 1188 (1099 E444) days, respectively. Treatment practices for MCL in Japan are consistent with trends observed in Western countries. Our study can serve as a benchmark to assess future MCL treatments in Japan.
| S-EPMC8519241 | biostudies-literature
Project description:PurposeTo describe the real-world treatment patterns of systemic therapies for biliary tract cancer (BTC) and to examine the frequency and management of biliary infection in Japan.MethodsPatients diagnosed with BTC and prescribed systemic therapy between January 2011 and September 2020 were retrieved from the Japanese Medical Data Vision database. The look-back period was set to 5 years. Patient characteristics, treatment patterns, and biliary infection-induced treatment interruption were analyzed.ResultsThe full analysis set comprised 22 742 patients with a mean age of 71.0 years and 61.6% were male. The most common BTC type was extrahepatic cholangiocarcinoma (44.6%). The three most common first-line regimens were S-1 monotherapy (33.0%), gemcitabine+cisplatin (32.5%), and gemcitabine monotherapy (18.7%) over the entire observation period (January 2011-September 2021). Patients who received monotherapies tended to be older. Biliary infection-induced treatment interruption occurred in 29.5% of patients, with a median time to onset of 64.0 (interquartile range 29.0-145.0) days. The median duration of intravenous antibiotics was 12.0 (interquartile range 4.0-92.0) days.ConclusionsThese results demonstrated potential challenges of BTC in Japanese clinical practice particularly use of multiple regimens, commonly monotherapies, which are not recommended as first-line treatment, and the management of biliary infections during systemic therapy.
| S-EPMC11503459 | biostudies-literature
Project description:BackgroundTrifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard therapies for refractory metastatic colorectal cancer (mCRC). No results of large real-world data directly comparing FTD/TPI + bevacizumab (BEV) with FTD/TPI or REG monotherapy have been reported. We evaluated the efficacy and safety of FTD/TPI + BEV in a real-world setting.Materials and methodsThis retrospective study used a Japanese claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). Eligible patients were aged 20 years and over with a diagnosis of mCRC, and received their first dose of FTD/TPI or REG from 2014 to 2021. The primary endpoint was overall survival (OS) in a propensity score matching (PSM) population in which PSM was carried out by matching using a 1 : 1 ratio for the FTD/TPI + BEV group and the control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were carried out using the inverse probability treatment weighted (IPTW) approach and the analysis in the all eligible population. Secondary endpoints included time to treatment discontinuation (TTD), incidence of adverse events, and post-treatment.ResultsEligible population was 2369 for the FTD/TPI + BEV group and 9318 for the control group. The PSM population was 1787 for each group. Median OS (mOS) was longer in the FTD/TPI + BEV group compared to the control group [17.0 versus 11.6 months, hazard ratio (HR) = 0.70, P < 0.001] in the PSM population. Similarly, mOS was longer for the FTD/TPI + BEV group compared to that for the control group in IPTW analyses and in the all eligible population (both HRs = 0.68). Median TTD was 3.3 months for the FTD/TPI + BEV group and 1.8 months for the control group in the PSM population (P < 0.001).ConclusionsReal-world data showed that FTD/TPI + BEV was significantly associated with OS and TTD compared to FTD/TPI or REG. In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC.
| S-EPMC10515287 | biostudies-literature
Project description:The aim of this article is to help develop a common understanding of the current status, challenges, and future perspectives of real-world data (RWD) and real-world evidence (RWE) in Japan. RWD and RWE are very widely used terms, but standardized definitions are lacking. Given broad and growing applications of RWD/RWE from the perspective of clinical development and medical affairs, the PhRMA Japan Medical Affairs Committee Working Group 1 have proposed the following definitions: "RWD are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources" and "RWE is the evidence derived from analysis of RWD." The key challenges for RWD and RWE in Japan include restricted access and linkage of RWD, as well as a lack of universally accepted methodological approaches, which reduces the potential for patient and healthcare benefits. These challenges for RWD/RWE are by no means unique to Japan and similar challenges exist for countries in Europe and the USA. The quality of data and analysis, study design, and the transparency of reporting should be discussed more to ensure credibility and acceptance by decision-makers as the demand for RWD and RWE increases. The future developments around Japan's RWD and RWE are expected to include improved RWD access, data linkage, and increased acceptance by decision-makers, all supported by innovative technology. Improvements in RWD access and database linkage will enable both public and private sectors to assemble more comprehensive health information in Japan.
| S-EPMC8605941 | biostudies-literature
Project description:Many descriptive epidemiological and comparative studies using big data have been reported recently from outside Japan. Within Japan, diagnosis procedure combination (DPC) data and medical receipt data are being stored in electronic media, and real-world evidence in various fields has started to be reported. We reviewed clinical studies on disseminated intravascular coagulation (DIC) using DPC data obtained from an insurance database with large numbers of cases and a related commercially available dataset including DPC and laboratory data. After DPC was introduced in 2003, 19 studies on DIC using Japanese national DPC data and two studies using the Medical Data Vision database were reported. Epidemiological findings in seven studies showed that the proportion of drugs administered for each underlying disease differed, with antithrombin and recombinant thrombomodulin (rTM) being used more frequently in clinical settings. In 14 comparative studies on anti-DIC agents, antithrombin for severe pneumonia, postoperative intestinal perforation, and severe burn, and rTM for acute cholangitis were associated with improved survival rates. Large-scale observational studies using big data can show results similar to those of randomized control trials if the quality of individual research is high. Real-world data analysis will be increasingly necessary to complement the evidence gap unfilled by randomized control trials.
| S-EPMC10083461 | biostudies-literature
Project description:IntroductionThe persistence of golimumab (GLM) treatment in Japanese patients with rheumatoid arthritis (RA) has been evaluated previously, but evidence of long-term real-world use is lacking. This study assessed the long-term persistence of GLM use, its influencing factors, and impact of prior medications in patients with RA in actual clinical practice in Japan.MethodsThis is a retrospective cohort study of patients with RA using data from a hospital insurance claims database in Japan. The identified patients were stratified as only GLM treatment (naïve), had one biological disease-modifying anti-rheumatic drug (bDMARD)/Janus kinase (JAK) inhibitor treatment prior to GLM [switch (1)] and had at least two bDMARDs/JAK prior to GLM treatment [switch (≥ 2)]. Patient characteristics were evaluated using descriptive statistics. Kaplan-Meier survival and Cox regression methods were used to analyze GLM persistence at 1, 3, 5, and 7 years and the associated factors. Treatment differences were compared using a log-rank test.ResultsGLM persistence rate in the naïve group was 58.8%, 32.1%, 21.4%, and 11.4% at 1, 3, 5, and 7 years, respectively. Overall persistence rates in the naïve group were higher than in switch groups. Higher GLM persistence was observed among patients aged 61-75 years and those concomitantly using methotrexate (MTX). Also, women were less likely to discontinue treatment compared to men. Higher Charlson Comorbidity Index score, initial GLM dose of 100 mg, and switch from bDMARDs/JAK inhibitor were related to a lower persistence rate. As a prior medication, infliximab showed the longest persistence for subsequent GLM, and using this as a reference, tocilizumab, sarilumab, and tofacitinib subgroups had significantly shorter persistence, respectively (p = 0.001, 0.025, 0.041).ConclusionThis study presents the long-term real-world results for persistence of GLM and its potential determinants. These most recent and long-term observations demonstrated that GLM and other bDMARDs continue to benefit patients with RA in Japan.
| S-EPMC10140228 | biostudies-literature
Project description:BackgroundChemotherapy-induced nausea and vomiting (CINV) is a major concern of patients with cancer, leading to suboptimal treatment.AimThis study assessed the emetic risk associated with intravenous and oral chemotherapy and the prophylactic antiemetic drugs by cancer type in a real-world setting.Methods and resultsWe used the health services utilisation data for patients with cancer diagnosed in 2016. Patients aged at least 20 years at the time of diagnosis and who started their first course of chemotherapy were included. The emetic risk of chemotherapy was determined according to the cancer type and was classified based on clinical practice guidelines. The prescription of antiemetic drugs was assessed. Overall, 172 133 patients were evaluated, of whom 121 103 (70.4%) received intravenous chemotherapy. High-emetic-risk chemotherapy (HEC) was prescribed in 46 458 (27.0%) patients. HEC was prescribed most for patients with oesophageal cancer (80.3%), followed by malignant lymphoma (60.2%) and breast cancer (53.8%). Moderate-emetic-risk chemotherapy (MEC) was prescribed in 60 528 (35.2%) patients and was mostly prescribed for small cell lung cancer (59.9%). Meanwhile, more than 50% of the chemotherapy prescribed for patients with gastric, colorectal, and pancreatic cancer was low-emetic-risk chemotherapy. HEC was accompanied by three-drug antiemetic prophylaxis in more than 90% of patients with small cell lung, non-small cell lung, breast, and oesophageal cancer, whereas only 13.5% of patients with malignant lymphoma were administered CHOP (cyclophosphamide, doxorubicin, vincristine sulphate, and prednisolone) with prophylaxis.ConclusionThe risk of CINV differs with cancer type. HEC was less prescribed compared with MEC. Most patients received the recommended anti-emetic prophylaxis.
| S-EPMC8955058 | biostudies-literature
Project description:IntroductionChronic hepatitis B (CHB) is one of the world's major healthcare problems, especially in the Western Pacific regions. This study describes the prevalence, incidence, treatment profiles and clinical and economic burden of chronic hepatitis B patients in Japan using the Japan Medical Data Center (JMDC) Claims Database.MethodsThis is a retrospective observational study. Prevalence cases were identified as patients with ≥ 1 inpatient or ≥ 2 outpatient CHB diagnoses and ≥ 2 records for hepatitis B tests or ≥ 1 prescription for CHB treatment between January 2010 and December 2019. Newly diagnosed CHB patients were defined as patients diagnosed from 2010 to 2018 with no history of the disease up to 2 years prior to the diagnosis. The index date is defined as the first CHB diagnosis day. We only used patients' data with ≥ 1-year post-index date.ResultsWe identified 13,061 CHB prevalent cases (2010-2019), yielding a crude period prevalence of 0.32%. Newly diagnosed CHB patients (n = 1973; median age 52 years) were followed for a median period of 3.1 years, during which 15% received a CHB treatment. Entecavir was the most common first treatment (66%). During this period, 3.4% of the patients developed compensated cirrhosis (CC), 1.5% decompensated cirrhosis (DC) and 3.0% hepatocellular carcinoma (HCC). Around 43.3% of CHB patients were hospitalized at least once. Hospitalizations, treatment rates, serologic testing and screening for liver diseases increased as the severity of the disease progressed. The average total healthcare cost was 870,568 JPY (7779 USD) per person per year. DC and HCC resulted in the highest management costs.ConclusionsChronic hepatitis B represents a high clinical and economic burden for patients and caregivers, given its morbidity and associated costs.
| S-EPMC10229495 | biostudies-literature