A brief report on stable disease among amivantamab-treated patients with post-platinum epidermal growth factor receptor exon 20 insertion-mutated non-small cell lung cancer: A response-based analysis from the CHRYSALIS study.

Background: Amivantamab, an EGFR-MET bispecific antibody, is the first approved targeted therapy for patients with EGFR Ex20ins NSCLC after prior platinum-based chemotherapy-a population with historically poor outcomes before amivantamab approval. As antitumor activity in single-arm studies typically focuses on responders, the evaluation of outcomes in patients with stable disease (SD) as best response is of clinical interest.

Patients And Methods: Among 114 patients with post-platinum EGFR Ex20ins NSCLC in CHRYSALIS (NCT02609776; data cutoff: March 30, 2021), response was assessed by blinded independent central review via RECIST v1.

An Adjusted Treatment Comparison Comparing Amivantamab Versus Real-World Clinical Practice in Europe and the United States for Patients with Advanced Non-Small Cell Lung Cancer with Activating Epidermal Growth Factor Receptor Exon 20 Insertion Mutations.

Introduction: Patients with advanced, epidermal growth factor receptor (EGFR)-mutated, non-small cell lung cancer (NSCLC) with Exon 20 insertion mutations (Exon20ins) have poor prognoses, exacerbated by a previous lack of specific treatment guidelines and unmet need for targeted therapies. Amivantamab, an EGFR and MET bispecific antibody, demonstrated efficacy and tolerability in patients with advanced EGFR-mutated NSCLC with Exon20ins following platinum-based therapy in CHRYSALIS (NCT02609776; Cohort D+). Since CHRYSALIS was single-arm, individual patient data (IPD)-based adjusted analyses versus similar patients in real-world clinical practice (RWCP) were conducted to generate comparative evidence.

Frequency, underdiagnosis, and heterogeneity of epidermal growth factor receptor exon 20 insertion mutations using real-world genomic datasets.

Epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) account for ≤ 12% of all EGFR-mutant nonsmall cell lung cancers. We analysed real-world datasets to determine the frequency of ex20ins variants, and the ability of polymerase chain reaction (PCR) and next-generation sequencing (NGS) to identify them. Three real-world United States NGS databases were used: GENIE, FoundationInsights, and GuardantINFORM.

Comparative Clinical Outcomes Between EGFR Ex20ins and Wildtype NSCLC Treated with Immune Checkpoint Inhibitors.

Introduction: The activity of immune checkpoint inhibitors (ICIs) in NSCLC harboring EGFR exon 20 insertion mutations (ex20ins) has not been closely examined due to the frequent exclusion of patients with EGFR mutations from large immunotherapy-based NSCLC trials.

Patients And Methods: A real-world, retrospective study was conducted to compare outcomes of ICI-treated patients with EGFR ex20ins and wildtype NSCLC (wt-NSCLC; defined as EGFR and ALK test negative). Patients with advanced NSCLC from the Flatiron Health database (2015-2020) were included in the analysis.

Amivantamab compared with real-world therapies in patients with advanced non-small cell lung cancer harboring EGFR exon 20 insertion mutations who progressed after platinum-based chemotherapy.

Background: In the single-arm CHRYSALIS study, amivantamab showed durable responses and manageable safety in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) exon 20 insertion mutations (ex20ins) who progressed on prior platinum-based chemotherapy. External controls can provide context for interpreting amivantamab efficacy.

Methods: External controls were selected from three US-based databases (ConcertAI, COTA, and Flatiron).

Comparative clinical outcomes for patients with advanced NSCLC harboring EGFR exon 20 insertion mutations and common EGFR mutations.

Introduction: Real-world clinical outcomes in patients with advanced NSCLC harboring EGFR exon 20 insertion (exon20ins) mutations have not been extensively studied. We conducted a retrospective cohort study to assess the clinical outcomes of EGFR exon20ins compared with common EGFR (cEGFR) mutations.

Methods: Adults with advanced NSCLC harboring any EGFR mutations in the NSCLC Flatiron registry (2011 through May 2020) were included.

Prognostic Value of Exon-20 Insertions in Czech Patients With Advanced Non-small Cell Lung Cancer.

Background/aim: Per literature, patients with epidermal growth factor receptor (EGFR) exon-20 insertions respond poorly to tyrosine kinase inhibitors (TKIs). This study analyzed real-world data to examine the prognostic and predictive value of these mutations.

Patients And Methods: We conducted a retrospective cohort study using Czech TULUNG Registry data, with data on multiple mutation types, collected in 2011-2020.

Epidemiological and clinical burden of EGFR Exon 20 insertion in advanced non-small cell lung cancer: A systematic literature review.

Objectives: The burden of epidermal growth factor receptor (EGFR) exon 20 insertion mutation (Exon 20ins) in non-small cell lung cancer is not well understood. A systematic review was conducted to identify evidence on mutation frequency, prognostic impact, clinical, patient-reported, and economic outcomes associated with Exon 20ins.

Materials And Methods: Searches were conducted in Embase and Medline and supplemented with recent conference proceedings.

Partial palivizumab prophylaxis and increased risk of hospitalization due to respiratory syncytial virus in a Medicaid population: a retrospective cohort analysis.

Background: Infection with respiratory syncytial virus (RSV) is common among young children insured through Medicaid in the United States. Complete and timely dosing with palivizumab is associated with lower risk of RSV-related hospitalizations, but up to 60% of infants who receive palivizumab in Medicaid population do not receive full prophylaxis. The purpose of this study was to evaluate the association of partial palivizumab prophylaxis with the risk of RSV hospitalization among high-risk Medicaid-insured infants.

Risk factors for respiratory syncytial virus illness among patients with chronic obstructive pulmonary disease.

Respiratory syncytial virus (RSV), although not typically considered an important pathogen in adults, may cause acute exacerbation of chronic obstructive pulmonary disease (COPD). It is unclear which COPD patients are at highest risk for developing serious RSV illness. Our objective was to identify risk factors for RSV illness among adult patients with COPD.

Systematic literature review assessing tobacco smoke exposure as a risk factor for serious respiratory syncytial virus disease among infants and young children.

Background: The role of environmental tobacco smoke (ETS) exposure as a risk factor for serious respiratory syncytial virus (RSV) disease among infants and young children has not been clearly established. This systematic review was conducted to explore the association between ETS exposure and serious RSV disease in children younger than 5 years, including infants and young children with elevated risk for serious RSV disease.

Methods: A systematic review of English-language studies using the PubMed and EMBASE databases (1990-2009) was performed to retrieve studies that evaluated ETS as a potential risk factor for serious RSV illness.

Detection of nodular pulmonary amyloid by PET positive scan--deception for lung cancer.

Amyloidosis results from proteins being deposited as insoluble β-pleated sheets and disrupting organ function. Each precursor protein induces a separate spectrum of organ involvement, and different disease manifestations within the lung. Although autopsy findings often demonstrate amyloid deposits in various compartments of the lung, few are manifested pathologically.

Agreement between Internet-based self- and proxy-reported health care resource utilization and administrative health care claims.

Objectives: Although Internet-based surveys are becoming more common, little is known about agreement between administrative claims data and Internet-based survey self- and proxy-reported health care resource utilization (HCRU) data. This analysis evaluated the level of agreement between self- and proxy-reported HCRU data, as recorded through an Internet-based survey, and administrative claims-based HCRU data.

Methods: The Child and Household Influenza-Illness and Employee Function study collected self- and proxy-reported HCRU data monthly between November 2007 and May 2008.

Cost utility of palivizumab prophylaxis among pre-term infants in the United States: a national policy perspective.

Objective: The cost-effectiveness of palivizumab has previously been reported among certain guideline-eligible, high-risk premature infants in Medicaid. Because guideline authorities base decisions on a national perspective, the economic model of palivizumab was adapted to include all infants, that is, public and privately insured patients (60% of palivizumab use is public, 40% is private).

Methods: This study examined four groups of premature infants without chronic lung disease of prematurity or congenital heart disease: (1) <32 weeks gestational age (wGA) and ≤ 6 months chronologic age (CA); (2) 32-34 wGA, ≤ 3 months CA, with 2009 American Academy of Pediatrics (AAP) risk factors (RFs); (3) 32-35 wGA, ≤ 6 months CA, with 2006 AAP RFs; and (4) 32-35 wGA, ≤ 6 months CA, with ≤ 1 RF.

Residential crowding and severe respiratory syncytial virus disease among infants and young children: a systematic literature review.

Background: The objective of this literature review was to determine whether crowding in the home is associated with an increased risk of severe respiratory syncytial virus (RSV) disease in children younger than 5 years.

Methods: A computerized literature search of PubMed and EMBASE was conducted on residential crowding as a risk factor for laboratory-confirmed RSV illness in children younger than 5 years. Study populations were stratified by high-risk populations, defined by prematurity, chronic lung disease of prematurity, hemodynamically significant congenital heart disease, or specific at-risk ethnicity (i.

Cost-effectiveness analysis of palivizumab among pre-term infant populations covered by Medicaid in the United States.

Objective: Medicaid infants are at high risk of severe respiratory syncytial virus (RSV) disease. The study objective was to estimate the cost-effectiveness of palivizumab in a Medicaid population.

Methods: A societal cost-utility analysis was conducted of prophylaxis with palivizumab vs no prophylaxis among four groups of premature infants: (1) <32 weeks gestational age (wGA) and ≤ 6 months chronologic age (CA); (2) 32-34 wGA, ≤ 3 months CA with 2009 American Academy of Pediatrics (AAP) risk factors (RF); (3) 32-35 wGA, ≤ 6 months CA with 2006 AAP RF; and (4) 32-35 wGA, ≤ 6 months CA with ≤ 1 RF.

Association of RSV lower respiratory tract infection and subsequent healthcare use and costs: a Medicaid claims analysis in early-preterm, late-preterm, and full-term infants.

Objective: Healthcare use and costs within 1 year of a respiratory syncytial virus lower respiratory tract infection (RSV-LRI) among Medicaid early-preterm and late-preterm infants compared with full-term infants were evaluated.

Methods: Infants born during 2003-2005 were identified from the Thomson Reuters MarketScan Multi-State Medicaid Database. Infants <1 year of age were grouped based on RSV-LRI and unspecified bronchiolitis/pneumonia (UBP) diagnosis codes and stratified by inpatient or outpatient setting.

Children's perceptions of influenza illness and preferences for influenza vaccine.

Introduction: In this qualitative study we explored children's perceptions of influenza, preferences for influenza vaccines, and ability to understand "risk" of vaccine adverse effects and different attributes between injectable and intranasal vaccines.

Method: In-person, semi-structured interviews were conducted among 28 U.S.

A survey of children's preferences for influenza vaccine attributes.

Background: While annual influenza vaccination is recommended by the CDC for children 6 months and older, vaccination rates remain suboptimal. For healthy, US children 2 years of age and older, influenza vaccine is available as an intramuscular injection (TIV) or an intranasal spray (LAIV), respectively. Little is known about children's experiences and preferences for influenza vaccine attributes.

Should CT play a greater role in preventing the resection of granulomas in the era of PET?

Objective: PET cannot distinguish between bronchogenic carcinoma and granuloma, but positive scans may prompt surgery. We systematically evaluated the CT appearance of resected carcinomas and granulomas to identify features that could be used to reduce granuloma resections.

Materials And Methods: We retrospectively identified 93 consecutive patients between January 2005 and November 2008 who had resection of a pulmonary nodule pathologically diagnosed as bronchogenic carcinoma or granuloma and preoperative imaging with CT and PET.

Serious early childhood wheezing after respiratory syncytial virus lower respiratory tract illness in preterm infants.

Background: Respiratory syncytial virus (RSV) lower respiratory tract infection (LRI) in early life has been associated with sustained airway hyperreactivity during childhood; however, corresponding data in premature infants are sparse.

Objective: The objective of this study was to determine whether RSV-LRI during early infancy of preterm infants was associated with an increased risk for serious early childhood wheezing (SECW) by age 3 years.

Methods: A retrospective cohort study was conducted using data from a large (∼14 million members) US health plan database.

Mortality and morbidity among infants at high risk for severe respiratory syncytial virus infection receiving prophylaxis with palivizumab: a systematic literature review and meta-analysis.

Objectives: A systematic literature review and meta-analysis was performed to evaluate the impact of prophylaxis with palivizumab on mortality and morbidity associated with respiratory syncytial virus infection in infants at high risk (≤ 35 wks of gestational age, chronic lung disease, or congenital heart disease).

Data Sources: MEDLINE, EMBASE, and Current Contents were used. MEDLINE was searched from January 1, 1990 to May 16, 2007.