Breakthrough Clinical Results
Cizzle Bio, a biotechnology company, submitted a grant application to the NIH for a two-year study validating its CIZ1B biomarker for early-stage lung cancer detection. The study will utilize pre-diagnostic blood samples from the PLCO Cancer Screening Trial to analyze CIZ1B expression and determine its accuracy in predicting lung cancer onset. The research will involve a large cohort (1,730 cases) and collaborations with the Florida Institute for Human and Machine Cognition (IHMC) and the Southwest Research Institute (SwRI). The CIZ1B test is a minimally invasive ELISA assay intended to improve early detection and reduce the high false-positive rate associated with current LDCT screening.
Key Highlights
- NIH grant application submitted to validate CIZ1B biomarker for early lung cancer detection.
- Two-year study will use pre-diagnostic blood samples from the PLCO Cancer Screening Trial.
- Collaboration with IHMC and SwRI to leverage expertise in deep learning and biomarker assay validation.
- CIZ1B test aims to improve early detection and reduce costs associated with late-stage lung cancer treatment.
Incidence and Prevalence
Global Epidemiology of Lung Cancer: Latest Statistics and Trends
Global Burden and Mortality
Lung cancer is the most prevalent neoplasm throughout the world with 1.2 million deaths per year. It stands as the most prevalent and deadliest cancer worldwide and is the first cancer mortality cause in Italy as well as the most frequent cancer in China and all over the world.
A study analyzing data from Northern America and Europe between 2015 and 2017, covering a total population of 872.5 million people, found that the average annual age-standardised mortality from lung cancer was 54.6 deaths per 100,000. Lung cancer was reported as the primary cause of death in 5.4 cases per 100 deaths.
Survival rates for population-based lung cancer cases were at maximum 17% in the last decades, highlighting the poor prognosis associated with this disease.
Recent Incidence Data
In 2022, there were 1,572,045 new cases of lung cancer worldwide among male individuals and 908,630 new cases among female individuals.
In one European study, over 93,733,929 person-years of follow-up, 111,949 incident lung cancer cases occurred.
Histological Subtypes Distribution
Among male cases in 2022: - 717,211 (45.6%) were adenocarcinoma - 461,171 (29.4%) were squamous cell carcinoma (SCC) - 180,063 (11.5%) were small-cell carcinoma - 101,861 (6.5%) were large-cell carcinoma
Among female cases in 2022: - 541,971 (59.7%) were adenocarcinoma - 155,598 (17.1%) were SCC - 87,902 (9.7%) were small-cell carcinoma - 59,271 (6.5%) were large-cell carcinoma
Geographical Variations
Male Individuals
- The highest age-standardized incidence rates (ASRs) for adenocarcinoma were in east Asia (27.12 per 100,000 people)
- East Europe had the highest rates for SCC (21.70 per 100,000 people) and small-cell carcinoma (9.85 per 100,000 people)
- North Africa had the highest rates for large-cell carcinoma (4.33 per 100,000 people)
Female Individuals
- The highest ASRs for adenocarcinoma were in east Asia (19.04 per 100,000 people)
- North America had the highest rates for SCC (5.28 per 100,000 people) and small-cell carcinoma (4.28 per 100,000 people)
- North Europe had the highest rates for large-cell carcinoma (2.87 per 100,000 people)
Trends by Gender
While mortality in men dropped annually by an average of -2.3%, mortality in women decreased by only -0.3% between 2000 and 2017. Notably, 21 out of 31 countries registered a significant increase in female lung cancer mortality during this period, with Spain (AAPC 4.1%) and France (AAPC 3.6%) showing the highest increases.
Among men, 22 out of 38 countries showed declining incidence trends with average annual percent changes (AAPCs) ranging from -2.8 to -0.6. In contrast, among women, 19 countries showed increasing incidence trends with AAPCs ranging from 0.4 to 8.9. Brazil, Spain, and Cyprus had the greatest incidence increase among women.
Development Index and Age Factors
Country-specific Human Development Index (HDI) was strongly correlated with age-standardized incidence (r = 0.70) and mortality (r = 0.67) of lung cancer. Regions with high and very high HDI exhibit substantially higher incidence and mortality burden compared to regions with low and very low HDI.
The incidence and mortality burden is significantly higher among the elderly population (aged 65 years and above) compared to the working-age population (aged 15-64 years).
Environmental Factors
An estimated 114,486 adenocarcinoma cases among male individuals and 80,378 adenocarcinoma cases among female individuals were attributable to ambient particulate matter pollution worldwide in 2022. The ASRs for adenocarcinoma attributable to ambient PM pollution were 2.35 per 100,000 male individuals and 1.46 per 100,000 female individuals.
Economic Burden
Economic Burden of Treating Lung Cancer in USA and Europe
United States Economic Burden
In the United States, the monthly treatment costs for a 72-year-old lung cancer patient diagnosed in 2000 ranged from $2,687 (no active treatment) to $9,360 (chemo-radiotherapy). Patient liability represented up to 21.6% of care costs and increased over the period 1992-2003, with the greatest monthly patient liability incurred by chemo-radiotherapy patients ranging from $1,617 to $2,004 per month across cancer stages. Medicare has been paying a smaller proportion of the total cost over time.
Surgical approaches show cost differences, with VATS lobectomy associated with lower 90-day costs - $3,476 lower than thoracotomy. Prolonged length of stay (PLOS) was associated with the highest cost differential (+$50,820).
According to the National Institute of Health (NIH), healthcare spending for cancer was estimated at US$171.6 billion (2002), with lung cancer estimated as the diagnosis with the second highest cost. As additional lines of therapy and newer targeted agents are incorporated into lung cancer treatment, these costs will further increase.
European Economic Burden
Cancer cost the EU €126 billion in 2009, with health care accounting for €51.0 billion (40%). Lung cancer had the highest economic cost at €18.8 billion, representing 15% of overall cancer costs. Health-care costs of cancer were equivalent to €102 per citizen across the EU, varying from €16 per person in Bulgaria to €184 per person in Luxembourg.
In the Netherlands, mean costs over the lung cancer treatment pathway were estimated to be €48,443 per patient. Monthly treatment for stage IV lung cancer was significantly more expensive than for early-stage disease (€8,293 per month of initial care relative to €3,228 for stage IA). Stage IV lung cancer became significantly more expensive to treat in 2018-2021 relative to 2013-2017, with monthly expenditures rising 55% in initial care and 148% in continuing care. Population-wide spending on lung cancer care in the Netherlands was €900.6 million in 2021, €433 million more than in 2016.
In Italy, low-dose computed tomographic screening is associated with an incremental cost of €2,944 per life-year gained in high-risk populations.
In 2019, there were 41,468 lung cancer deaths in Belgium, the Netherlands, Norway, and Poland resulting in 59,246 YPLL and more than €981 million in productivity losses due to premature mortality. From 2015 to 2019, the PVFLP of lung cancer decreased by 26% in Belgium, 27% in the Netherlands, 14% in Norway, and 38% in Poland.
NSCLC and SCLC Treatment Costs in Europe
In France, the average cost per patient was €12,518 for the whole group (78% with NSCLC, 22% with SCLC), €13,969 for patients with NSCLC and €7,369 for patients with SCLC. The higher cost of treatment in patients with NSCLC is explained by longer survival and duration of chemotherapy. In patients with NSCLC, 51% of the total cost corresponded to terminal care, with up to seven lines of chemotherapy. In patients with SCLC, the costs of diagnosis and terminal care each represented 41% of the total cost.
In Portugal, a cost-minimization analysis compared five commonly used doublet regimens for stage IIIB or IV NSCLC. The least and most costly chemotherapy regimens were Gem/Cis and Pac/Carb, respectively. Total mean cost per patient was estimated at €7,083 for Gem/Cis and €10,008 for Pac/Carb, a mean cost savings of €2,925 per patient for Gem/Cis.
In Germany, lung cancer-related expenditures per case were estimated at €20,400 (53% of all-cause expenditures) with variance by treatment: Surgery: €20,400, Chemotherapy/Radiotherapy: €26,300, No specific treatment: €4,200. Cost per year survived in Germany amounted to €15,500 (55% of all-cause expenditures): Surgery: €11,600, Chemotherapy/Radiotherapy: €20,200, No specific treatment: €7,600.
The type of PD-L1 testing used can impact the cost of therapy, which varies according to methods used and to the country where PD-L1 testing is performed. The effect of PD-L1 testing on cost-effectiveness of immune checkpoint inhibitors depends on the antibody and platform used for patient selection.
Drug used in other indications
CDKN1A-interacting zinc finger protein 1B (CIZ1B) Biomarker Clinical Trials
Based on the available information, there is no data regarding clinical trials for CDKN1A-interacting zinc finger protein 1B (CIZ1B) biomarker for any indications, including lung cancer or non-small cell lung carcinoma (NSCLC).
The information about: - Other clinical indications besides NSCLC - Interventional methodologies - Study designs - Investigational protocols
is not available in the provided context.