Daily Respiratory Research Analysis
Three impactful studies span oncology, maternal respiratory care, and pediatric infectious disease. A randomized phase 3 trial shows 6 or 12 months of adjuvant icotinib improves DFS and OS after resection of EGFR-mutated stage II–IIIA NSCLC versus observation. A large UK cohort identifies reduced inhaled corticosteroid use during pregnancy as a major, modifiable risk factor for asthma exacerbations, while a Spanish two-season analysis finds nirsevimab substantially lowers RSV hospitalizations in
Summary
Three impactful studies span oncology, maternal respiratory care, and pediatric infectious disease. A randomized phase 3 trial shows 6 or 12 months of adjuvant icotinib improves DFS and OS after resection of EGFR-mutated stage II–IIIA NSCLC versus observation. A large UK cohort identifies reduced inhaled corticosteroid use during pregnancy as a major, modifiable risk factor for asthma exacerbations, while a Spanish two-season analysis finds nirsevimab substantially lowers RSV hospitalizations in newborns.
Research Themes
- Adjuvant targeted therapy in EGFR-mutated resected NSCLC
- Asthma management and exacerbation risk during pregnancy
- Real-world effectiveness of RSV immunoprophylaxis in newborns
Selected Articles
1. Adjuvant icotinib for resected EGFR-mutated stage II-IIIA non-small-cell lung cancer (ICTAN, GASTO1002): a randomized comparison study.
In a three-arm, phase 3 randomized study after adjuvant chemotherapy for resected EGFR-mutated stage II–IIIA NSCLC, both 6- and 12-month icotinib significantly improved DFS and OS versus observation. No DFS or OS difference was observed between 12 and 6 months, and grade ≥3 adverse events were infrequent.
Impact: Provides randomized evidence that shorter (6-month) adjuvant EGFR-TKI is as effective as 12 months and superior to observation, directly informing adjuvant therapy duration decisions.
Clinical Implications: Supports adjuvant icotinib after chemotherapy for resected EGFR-mutated stage II–IIIA NSCLC, with 6 months appearing sufficient versus 12 months, potentially reducing toxicity, cost, and treatment burden.
Key Findings
- Icotinib 12 months vs observation: DFS HR 0.40 (95% CI 0.27–0.61) and OS HR 0.55 (95% CI 0.32–0.96).
- Icotinib 6 months vs observation: DFS HR 0.41 (95% CI 0.27–0.62) and OS HR 0.56 (95% CI 0.32–0.98).
- No difference between 12 vs 6 months in DFS (HR 0.97) or OS (HR 1.00).
- Grade ≥3 adverse events: 8.3% (12 months), 6.0% (6 months), 2.4% (observation).
Methodological Strengths
- Phase 3 randomized, three-arm design with explicit DFS and OS endpoints
- Hazard ratios with confidence intervals enable effect size estimation
Limitations
- Trial was terminated early, which may affect power and precision
- Moderate sample size (N=251) and observation comparator; blinding not described
Future Directions: Head-to-head trials across different EGFR-TKIs and durations, cost-effectiveness analyses, and biomarker-guided tailoring of adjuvant duration.
The efficacy, safety and ideal treatment duration of an adjuvant epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) for patients with resected EGFR-mutated non-small-cell lung cancer (NSCLC) were not known until 2014, when this study was initiated. In this phase 3 ICTAN trial (GASTO1002, NCT01996098), patients with completely resected, EGFR-mutated, stage II-IIIA NSCLC after adjuvant chemotherapy were assigned in a 1:1:1 ratio to receive icotinib (125 mg, three times daily) for 12 months, to receive icotinib for 6 months, or to undergo observation. The primary endpoint was disease-free survival (DFS). This trial was terminated early. A total of 251 patients were randomized. Adjuvant icotinib for 12 months significantly improved DFS (hazard ratio [HR]: 0.40, 95% confidence interval [CI], 0.27-0.61; P < 0.001) and overall survival (OS; HR: 0.55, 95% CI, 0.32-0.96; P = 0.032) compared with observation. Adjuvant icotinib of 6 months also significantly improved DFS (HR: 0.41, 95% CI, 0.27-0.62; P < 0.001) and OS (HR: 0.56, 95% CI, 0.32-0.98; P = 0.038) compared with observation. Adjuvant icotinib for 12 months did not improve DFS (HR: 0.97; P = 0.89) or OS (HR: 1.00; P = 0.99) compared with 6 months of this drug. Rates of adverse events of grade 3 or higher were 8.3%, 6.0% and 2.4% for the 12-month icotinib, 6-month icotinib, and observation groups, respectively. Adjuvant icotinib for 12 months or 6 months following adjuvant chemotherapy improved DFS and OS compared with observation in patients with resected EGFR-mutated stage II-IIIA NSCLC with a manageable safety profile, supporting it as a potential treatment option.
2. Pregnancy, asthma and exacerbations: a population-based cohort.
In over 40,000 pregnant women with asthma, total exacerbations decreased during pregnancy but hospital-admission-associated exacerbations rose in the second and third trimesters. Notably, 31% reduced ICS prescriptions during pregnancy, and decreased ICS use independently increased exacerbation risk (aOR 2.29), alongside prior exacerbations, high preventer use, eosinophilia, smoking, and obesity.
Impact: Identifies a common, modifiable prescribing pattern—reduced ICS use during pregnancy—as a key driver of severe exacerbations, enabling immediate quality-improvement interventions.
Clinical Implications: Maintain and optimize ICS therapy during pregnancy and address type 2 inflammation, smoking, and obesity; implement counseling to avoid ICS de-escalation unless clinically justified.
Key Findings
- Total asthma exacerbations fell by ~30% during pregnancy, but hospital-associated exacerbations rose by 30–45% in trimesters 2–3.
- 31% of women reduced ICS prescriptions during pregnancy; reduced ICS independently increased exacerbation risk (aOR 2.29, 95% CI 2.12–2.47).
- Strongest risk factors: prior exacerbations (aOR 4.09), reduced ICS, and ≥4 annual preventer prescriptions pre-pregnancy (aOR 2.11); eosinophilia, smoking, and obesity also associated.
Methodological Strengths
- Large population-based cohort (N=40,196) integrating primary care and hospital data
- Multivariable modeling with trimester-specific analyses of exacerbation patterns
Limitations
- Observational design with potential residual confounding and misclassification
- ICS prescription data may not capture adherence or inhaler technique
Future Directions: Interventions to sustain ICS adherence during pregnancy; pragmatic trials and implementation studies targeting modifiable risks (smoking cessation, weight management, eosinophilic inflammation).
BACKGROUND: Asthma exacerbations during pregnancy are associated with adverse maternal and perinatal outcomes. Identifying modifiable risk factors are essential for improving health outcomes. We aimed to describe exacerbation patterns during pregnancy and identify exacerbation risk factors, particularly modifiable risk factors such as inhaled corticosteroid (ICS) use. METHODS: A cohort study using UK primary care and hospital data (2004-2020) to identify pregnant women with asthma. Exacerbations were defined as a short course of oral corticosteroids, emergency department visit, or unscheduled hospital admission. Multivariable logistic regression was used to assess associations between maternal characteristics and exacerbations (primary outcome) and ICS use (secondary outcome). RESULTS: Among 40 196 pregnant women with asthma, total exacerbations declined by ∼30% during pregnancy. However, exacerbations associated with hospital admission increased by 30-45% during the second and third trimesters, declining abruptly after delivery. ICS prescriptions were reduced in 31% of women during pregnancy. Decreased ICS use was associated with suboptimal asthma control pre-pregnancy, age, ethnicity and smoking. The strongest exacerbation risk factors were a history of exacerbations (adjusted-OR, 95% CI: 4.09, 3.81-4.39), reduced ICS during pregnancy (2.29, 2.12-2.47) and ≥4 prescriptions/year for ICS+another-preventer before pregnancy (2.11, 1.87-2.37). Additional risk factors included blood eosinophilia, smoking and obesity. CONCLUSIONS: Despite fewer total exacerbations, exacerbations associated with a hospital admission increased during pregnancy. One-third of women reduced ICS use during pregnancy, yet this was the second largest exacerbation risk factor, and completely modifiable. Other major risk factors were type-2 inflammation and another modifiable risk factor, suboptimal asthma control pre-pregnancy.
3. [Nirsevimab immunization effectiveness against respiratory syncytial virus hospitalization in newborns: two season of use in Navarre, Spain].
In a regional implementation across two seasons with 94% uptake, nirsevimab reduced PCR-confirmed RSV hospitalizations in newborns by 79.5% overall, with season-specific effectiveness of 89.9% and 52.8%. One hospitalization was averted per 22.6 immunized infants.
Impact: Provides real-world effectiveness across two seasons, supporting population-level immunoprophylaxis programs to reduce RSV hospitalization burden in infants.
Clinical Implications: Supports broad nirsevimab immunization in newborns ahead of RSV season with expectation of substantial hospitalization reduction; surveillance should continue given season-to-season variability.
Key Findings
- Uptake was 94.1% (2,541/2,699 newborns received nirsevimab).
- Overall effectiveness against RSV hospitalization: 79.5% (95% CI 59.2–89.7).
- Season-specific effectiveness: 89.9% (2023–2024) and 52.8% (2024–2025); p=0.055 between seasons.
- Number needed to immunize to prevent one hospitalization: 22.6.
Methodological Strengths
- Population-wide implementation with PCR-confirmed outcomes and Cox regression
- Two-season evaluation allows assessment of temporal variability
Limitations
- Observational design in a single region with relatively few hospitalization events
- Potential confounding by healthcare-seeking behavior and unmeasured risk factors
Future Directions: Multi-region effectiveness and safety monitoring, equity analyses, durability across seasons, and integration with maternal immunization strategies.
BACKGROUND: Respiratory syncytial virus (RSV) is the leading cause of infant hospitalisation. In 2022, nirsevimab was approved in the European Union to prevent severe respiratory disease due to RSV during the first year of life. Our aim is to evaluate the effectiveness of nirsevimab immunoprophylaxis in new-borns for preventing RSV -related hospitalisations in Navarre, Spain, during its first two seasons of use. METHODS: Nirsevimab was offered free of charge to infants born from October to December 2023 and from September to December 2024. Each cohort was followed until February of the following year. Cases were infants hospitalised for PCR-confirmed RSV infection. Cox regression was used to estimate the hazard ratio of hospitalisation for immunised versus non-immunised children. RESULTS: Nirsevimab was offered to 2,699 new-borns; of them, 2,541 (94.1%) received nirsevimab. In the 2023-2024 season, 17 RSV-related hospitalisations were recorded and 24 in the 2024-2025 season. The average risk of RSV hospitalisation was 7.6% in non-immunised new-borns versus 1.1% in immunised ones. Overall, effectiveness of nirsevimab was 79.5% (95% CI: 59.2 - 89.7), with estimates of 89.9% in 2023-2024 and 52.8% in 2024-2025, with no significant differences between seasons (p=0.055). On average, one RSV hospitalisation was prevented per 22.6 immunised infants. CONCLUSIONS: Nirsevimab immunoprophylaxis substantially reduces RSV hospitalisations, helping ease paediatric hospital burden. However, as some immunised infants were still hospitalised, additional preventive measures remain necessary. FUNDAMENTO:: La infección por el virus respiratorio sincitial (VRS) es la principal causa de hospitalización en lactantes. En 2022 se autorizó el nirsevimab en la Unión Europea para prevenir la enfermedad respiratoria grave por VRS durante el primer año de vida. Evaluamos la efectividad de la inmunoprofilaxis con nirsevimab en recién nacidos para prevenir hospitalizaciones por VRS en Navarra durante las dos primeras temporadas de implementación. MÉTODOS:: Se ofreció nirsevimab a las cohortes de recién nacidos de octubre a diciembre de 2023 y de septiembre a diciembre de 2024, que se siguieron hasta febrero del año siguiente. Se consideraron casos a las hospitalizaciones por VRS confirmadas por PCR. Mediante regresión de Cox se estimó la razón de riesgos de hospitalización por VRS de inmunizados frente a no inmunizados. RESULTADOS:: Se ofreció nirsevimab a 2.699 recién nacidos, y 2.541 lo recibieron (94,1%). Se registraron 17 hospitalizaciones por VRS en la temporada 2023-2024 y 24 en la 2024-2025. El riesgo promedio de hospitalización por VRS fue 7,6% en no inmunizados y 1,1% en inmunizados. La efectividad promedio del nirsevimab para prevenir hospitalizaciones por VRS fue 79,5% (IC95%: 59,2-89,7), 89,9% en la temporada 2023-2024 y 52,8% en la 2024-2025, sin diferencias significativas entre ambas (p=0,055). La inmunoprofilaxis previno en promedio una hospitalización por VRS por cada 22,6 inmunizados. CONCLUSIONES:: La inmunoprofilaxis con nirsevimab resultó efectiva para prevenir hospitalizaciones por VRS y alivió la sobrecarga de ingresos pediátricos. Ante la posibilidad de casos en inmunizados, debe complementarse con otras medidas preventivas.