Trends in the prescription of systemic anticancer therapy and mortality among patients with advanced non-small cell lung cancer: a real-world retrospective observational cohort study from the I-O optimise initiative.
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ABSTRACT: Objectives
To assess how a decade of developments in systematic anticancer therapy (SACT) for advanced non-small cell lung cancer (NSCLC) affected overall survival (OS) in a large UK University Hospital.Design
Real-world retrospective observational cohort study using existing data recorded in electronic medical records.Setting
A large National Health Service (NHS) university teaching hospital serving 800 000 people living in a diverse metropolitan area of the UK.Participants
2119 adults diagnosed with advanced NSCLC (tumour, node, metastasis stage IIIB or IV) between 2007 and 2017 at Leeds Teaching Hospitals NHS Trust.Main outcomes and measures
OS following diagnosis and the analysis of factors associated with receiving SACT.Results
Median OS for all participants was 2.9 months, increasing for the SACT-treated subcohort from 8.4 months (2007-2012) to 9.1 months (2013-2017) (p=0.02); 1-year OS increased from 33% to 39% over the same period for the SACT-treated group. Median OS for the untreated subcohort was 1.6 months in both time periods. Overall, 30.6% (648/2119) patients received SACT; treatment rates increased from 28.6% (338/1181) in 2007-2012 to 33.0% (310/938) in 2013-2017 (p=0.03). Age and performance status were independent predictors for SACT treatment; advanced age and higher performance status were associated with lower SACT treatment rates.Conclusion
Although developments in SACT during 2007-2017 correspond to some changes in survival for treated patients with advanced NSCLC, treatment rates remain low and the prognosis for all patients remains poor.
SUBMITTER: Snee M
PROVIDER: S-EPMC8098989 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:As part of the multinational I-O Optimise research initiative, this retrospective cohort study of patients with advanced non-small cell lung cancer (NSCLC) evaluated real-world treatment patterns and survival prior to immunotherapy reimbursement in Portugal. METHODS:This study utilized a database held by IPO-Porto, Portugal's largest oncology hospital. Adult patients diagnosed with stage IIIB or IV NSCLC from January 2012 to December 2016 at IPO-Porto, with follow-up to June 2017, were included. Treatment analyses were performed from 2015 onwards. Kaplan-Meier methods were used for overall survival (OS). Factors associated with OS and systemic anti-cancer therapy (SACT) treatment were assessed using multivariate statistical models. RESULTS:Of 1524 patients diagnosed with NSCLC at IPO-Porto, 1008 patients had advanced disease (stage IIIB: 10.1%, 154/1524, stage IV: 56.0%, 854/1524). For those with advanced disease, median age was 65?years (range: 21-92) and 75.6% (762/1008) were male. Median OS (interquartile range [IQR]) was 11.4 (5.2-26.9) months for stage IIIB and 6.3 (2.4-15.0) months for stage IV. Factors associated with decreased risk of death included female sex and epidermal growth factor receptor gene (EGFR)/anaplastic lymphoma kinase gene (ALK) mutations/rearrangements; factors associated with increased risk of death included older age and stage IV disease. Among patients diagnosed in 2015 or 2016, 75.8% (297/392) received ?1 line of SACT. Platinum-based chemotherapy was the most common first-line therapy (non-squamous cell carcinoma [NSQ]: 72.9%; squamous cell carcinoma [SQ] 87.3%, 55/63; patients with EGFR/ALK mutations/rearrangements primarily received tyrosine kinase inhibitors). The likelihood of receiving SACT was lower in older patients and those diagnosed with stage IV disease. Patients not receiving SACT had poor survival outcomes (median OS [IQR]: NSQ, 1.8 [1.1-3.1] months; SQ, 2.3 (1.3-3.4) months), while median OS (IQR) in SACT-treated patients was 12.6 (6.1-24.5) months for NSQ and 10.3 (5.7-15.9) months for SQ. CONCLUSIONS:This real-world data analysis from a large Portuguese oncology hospital demonstrates a high disease burden for advanced NSCLC in the pre-immunotherapy era, with nearly one-quarter of patients not receiving SACT. Even in patients receiving SACT, median survival was only about 1?year.
| S-EPMC7488009 | biostudies-literature
Project description:ObjectivesThe aim was to characterize disease severity, clinical manifestations, treatment patterns and flares in a longitudinal cohort of adults with SLE in the UK.MethodsAdults with SLE were identified in the Clinical Practice Research Datalink-Hospital Episode Statistics database (1 January 2005-31 December 2017). Patients were required to have ≥12 months of data before and after the index date (earliest SLE diagnosis date available). SLE disease severity and flares were classified using adapted claims-based algorithms, which are based on SLE-related conditions, medications and health-service use.ResultsOf 802 patients, 369 had mild, 345 moderate and 88 severe SLE at baseline. A total of 692 initiated treatment in the first year after diagnosis. Five hundred and fifty-seven received antimalarials, 203 immunosuppressants and 416 oral CSs. Information on biologic use in hospitals was unavailable. The mean (S.d.) time to initiating any medication was 177 (385.3) days. The median time to first flare was 63 days (95% CI: 57, 71). At least one flare was experienced by 750 of 802 patients during follow-up; the first flare was mild for 549 of 750, moderate for 116 of 750 and severe for 85 of 750. The mean (S.d.) annual overall flare rate (year 1) was 3.5 (2.5). A shorter median time to first flare was significantly associated with moderate/severe disease (P < 0.001) and clinical manifestations (P < 0.001).ConclusionOur findings suggest some delay in the initiation of SLE treatment. Most patients experience a flare within 2 months of diagnosis. Early treatment might delay or reduce the severity of the first SLE flare and might translate to slower disease progression, lower accrual of organ damage and better outcomes.
| S-EPMC8452998 | biostudies-literature
Project description:ObjectiveThe aim was to describe direct health-care costs for adults with SLE in the UK over time and by disease severity and encounter type.MethodsPatients aged ≥18 years with SLE were identified using the linked Clinical Practice Research Datalink-Hospital Episode Statistics database from January 2005 to December 2017. Patients were classified as having mild, moderate or severe disease using an adapted claims-based algorithm based on prescriptions and co-morbid conditions. We estimated all-cause health-care costs and incremental costs associated with each year of follow-up compared with a baseline year, adjusting for age, sex, disease severity and co-morbid conditions (2017 UK pounds).ResultsWe identified 802 patients; 369 (46.0%) with mild, 345 (43.0%) moderate and 88 (11.0%) severe disease. The mean all-cause cost increased in the 3 years before diagnosis, peaked in the first year after diagnosis and remained high. The adjusted total mean annual increase in costs per patient was £4476 (95% CI: £3809, £5143) greater in the year of diagnosis compared with the baseline year (P < 0.0001). The increase in costs per year was 4.7- and 1.6-fold higher among patients with severe SLE compared with those with mild and moderate SLE, respectively. Primary care utilization was the leading component of costs during the first year after diagnosis.ConclusionThe health-care costs for patients with SLE in the UK are substantial, remain high after diagnosis and increase with increasing severity. Future research should assess whether earlier diagnosis and treatment might reduce disease severity and associated high health-care costs.
| S-EPMC8493101 | biostudies-literature
Project description:Pembrolizumab has been approved in the United States for treating advanced melanoma for >4 years. We examined real-world pembrolizumab use and associated outcomes in US oncology clinical practices, including patients who would not be eligible for clinical trials.Flatiron Health longitudinal database was used to identify adult patients with advanced melanoma initiating ?1 dose of pembrolizumab from September 4, 2014, through December 31, 2016, with follow-up through December 31, 2017. Patients in any clinical trial during the study period were excluded. Overall survival (OS) and time on treatment from pembrolizumab initiation were analyzed using the Kaplan-Meier (KM) method. Subgroup analyses were conducted to examine OS for several patient characteristics including Eastern Cooperative Oncology Group (ECOG) performance status >1, brain metastases, and corticosteroids before pembrolizumab initiation.Pembrolizumab was administered to 315 (59%), 152 (29%), and 65 (12%) patients as first-, second-, and third-line/later therapy. Median age at pembrolizumab initiation was 68 years (range, 18-84); most patients were male (66%) and white (94%). Of those with available data, 38% had BRAF-mutant melanoma, 21% had elevated lactate dehydrogenase (LDH) level, and 23% had ECOG?>1. Overall, 18% had brain metastases, and 23% were prescribed corticosteroids <3 months before initiating pembrolizumab. Median study follow-up was 12.9 months (range, 0.03-39.6). Median OS was 21.8 months (95% confidence interval [CI] 16.8-29.1); KM 1-year and 2-year survival rates were 61% and 48%, respectively; and median time on pembrolizumab treatment was 4.9 months (95% CI 3.7-5.5). Median OS for first-line pembrolizumab was not reached, and for second-line and third-line/later was 13.9 and 12.5 months, respectively (log-rank P?=?.0095). Significantly better OS (all P ?.0014, log-rank test) was evident for patients with ECOG performance status (PS) of 0 to 1 (vs?>1), normal (vs elevated) LDH level, and no (vs yes) corticosteroid prescription <3 months before. No difference was recorded in OS by brain metastases (log-rank P?=?.22) or BRAF mutation status (log-rank P?=?.90).These findings support effectiveness of pembrolizumab in the real-world clinical setting and provide important insights into patient characteristics and outcomes associated with pembrolizumab therapy for a heterogeneous patient population with advanced melanoma, including patients who would not be eligible for clinical trials.
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Project description:IntroductionThe power of 'real world' data to improve our understanding of the clinical aspects of multiple sclerosis (MS) is starting to be realised. Disease modifying therapy (DMT) use across the UK is driven by national prescribing guidelines. As such, the UK provides an ideal country in which to gather MS outcomes data. A rigorously conducted observational study with a focus on pharmacovigilance has the potential to provide important data to inform clinicians and patients while testing the reliability of estimates from pivotal trials when applied to patients in the UK.Methods and analysisThe primary aim of this study is to characterise the incidence and compare the risk of serious adverse events in people with MS treated with DMTs. The OPTIMISE:MS database enables electronic data capture and secure data transfer. Selected clinical data, clinical histories and patient-reported outcomes are collected in a harmonised fashion across sites at the time of routine clinical visits. The first patient was recruited to the study on 24 May 2019. As of January 2021, 1615 individuals have baseline data recorded; follow-up data are being captured and will be reported in due course.Ethics and disseminationThis study has ethical permission (London City and East; Ref 19/LO/0064). Potential concerns around data storage and sharing are mitigated by the separation of identifiable data from all other clinical data, and limiting access to any identifiable data. The results of this study will be disseminated via publication. Participants provide consent for anonymised data to be shared for further research use, further enhancing the value of the study.
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Project description:IntroductionThe prevalence of ulcerative colitis (UC) is increasing in Japan but recent disease burden estimates are unavailable. This study was conducted to explore the prescription pattern and to estimate the economic burden in Japanese patients with UC.MethodsThis retrospective cohort study was conducted from 1 January 2009 to 30 June 2018 using healthcare claims data from the Japan Medical Data Center (JMDC) database. Patients with a UC diagnosis before the index date (the first UC treatment claim) or within 6 months after the index date, a UC treatment claim registered within ≥ 6 months during the selection period, and a continuous enrollment for 6 months pre-index and 12 months follow-up period were included in the study. Prescription pattern was analyzed by calendar years and lines of treatment (LoT). Healthcare resource utilization and cost per month were determined by LoTs.ResultsAmong 10,337 patients with UC diagnosis, 1,861 (18.0%) met the eligibility criteria for this study. 5-Aminosalicylic acid (5-ASA) was the most used treatment over the study period and across all LoTs. 5-ASA was also the most prescribed treatment (88.7%) across all the first LoTs, followed by steroids (20.4%). Use of biologics increased over the study period (biologics + 5-ASA: 0.0% in 2009 to 3.0% in 2018). Biologics were most used as the sixth LoT (7.1%, biologics + 5-ASA; 7.1%, biologics + 5-ASA + steroids). Mean total cost per month was JPY 52,782, with the highest (JPY 112,997) total healthcare cost per month in the fourth LoT and the lowest in the first LoT (JPY 56,782).ConclusionPrescription pattern in Japanese patients with UC enrolled in the JMDC database were largely consistent with the clinical guidelines in Japan. UC puts a substantial economic burden on patients, and an effective treatment is warranted to reduce the UC disease burden.
| S-EPMC8107172 | biostudies-literature
Project description:Background and Purpose- Recent landmark trials provided overwhelming evidence for effectiveness of endovascular stroke therapy (EST). Yet, the impact of these trials on clinical practice and effectiveness of EST among lower volume centers remains poorly characterized. Here, we determine population-level patterns in EST performance in US hospitals and compare EST outcomes from higher versus lower volume centers. Methods- Using validated diagnosis codes from data on all discharges from hospitals and Emergency Rooms in Florida (2006-2016) and the National Inpatient Sample (2012-2016) we identified patients with acute ischemic stroke treated with EST. The primary end point was good discharge outcome defined as discharge to home or acute rehabilitation facility. Multivariate regressions adjusted for medical comorbidities, intravenous tPA (tissue-type plasminogen activator) usage and annual hospital stroke volume were used to evaluate the likelihood of good outcome over time and by annual hospital EST volume. Results- A total of 3890 patients (median age, 73 [61-82] years, 51% female) with EST were identified in the Florida cohort and 42?505 (median age, 69 [58-79], 50% female) in the National Inpatient Sample. In both Florida and the National Inpatient Sample, the number of hospitals performing EST increased continuously. Increasing numbers of EST procedures were performed at lower annual EST volume hospitals over the studied time period. In adjusted multivariate regression, there was a continuous increase in the likelihood of good outcomes among patients treated in hospitals with increasing annual EST procedures per year (odds ratio, 1.1; 95% CI, 1.1-1.2 in Florida and odds ratio, 1.3; 95% CI, 1.2-1.4 in National Inpatient Sample). Conclusions- Analysis of population-level datasets of patients treated with EST from 2006 to 2016 demonstrated an increase in the number of centers performing EST, resulting in a greater number of procedures performed at lower volume centers. There was a positive association between EST volume and favorable discharge outcomes in EST-performing hospitals.
| S-EPMC6407696 | biostudies-literature
Project description:This study is a prospective and effective research study. The aim is to assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. The hypothesis is that the application of mobile-based disease management system significantly improves the quality of life of the patients’ family members, thereby improving the quality of life of the patients’ families.
Approximately 100 families of colorectal cancer patients who had been diagnosed as high-risk stage II or stage III and required adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis were randomly assigned to the control and study groups at a 1: 1 ratio, with approximately 50 cases in the control group and about 50 patients in the study group. The reason for choosing these tumors is because the patients with these tumors will present a series of clinical symptoms during the treatment, which requires family members to take care of them. All patient and their family demographics, questionnaires on quality of life of patient’s family, adverse events and other information will be collected.
The study uses a network-centric randomization system. In the randomization process, stratified randomization will be carried out according to the education level of the patient’s family members (junior college degree or above vs. below college degree). The family members of the patients participating in the study will be randomly assigned to the tumor patient management platform or clinical routine treatment follow-up group.
Family members of all patients will be followed up to 2 months after randomization, or withdrew from the study (with the preceding events as the end point). Unless the patient’s family member withdraws from the study, lost to follow-up, or the study is terminated, the patient is considered to be in the study. Family members of patients who are randomly assigned to the full management platform need to participate in a 60 minutes concentrated training session for 27 days, taught by experts online. The content of the lectures includes medical treatment guidelines, pain relief, family rehabilitation, family communication, family roles, early screening prevention, Medical insurance and other aspects. The contents of the online courses are: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don’t panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level ; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation.
| 2365943 | ecrin-mdr-crc
Project description:BackgroundMyopia is a complex disease caused by a combination of multiple pathogenic factors. Prevalence trends and developmental patterns of myopia exhibit substantial variability that cannot be clearly assessed using limited sample sizes. This study aims to determine the myopia prevalence over the past 60 years and trace the myopia development in a school-aged population using medical big data.MethodsThe refraction data from electronic medical records in eight hospitals in South China were collected from January 2005 to October 2018; including patients' year of birth, refraction status, and age at the exam. All optometry tests were performed in accordance with standard procedures by qualified senior optometrists. The cross-sectional datasets (individuals with a single examination) and longitudinal datasets (individuals with multiple examinations) were analyzed respectively. SAS statistical software was used to extract and statistically analyse all target data and to identify prevalence trends and developmental patterns related to myopia.ResultsIn total, 1,112,054 cross-sectional individual refraction records and 774,645 longitudinal records of 273,006 individuals were collected. The myopia prevalence significantly increased among individuals who were born after the 1960s and showed a steep rise until reaching a peak of 80% at the 1980s. Regarding developmental patterns, the cross-sectional data demonstrated that the myopia prevalence increased dramatically from 23.13% to 82.83% aging from 5 to 11, and the prevalence stabilized at the age of 20. The longitudinal data confirmed the results that the age of myopic onset was 7.47±1.67 years, the age of myopia stabilized at 17.14±2.61 years, and the degree of myopia stabilized at -4.35±3.81 D.ConclusionsThe medical big data used in this study demonstrated prevalence trends of myopia over the past 60 years and revealed developmental patterns in the onset, progression and stability of myopia in China.
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