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Purpose: To describe the distribution of diagnostic procedures, rates of complications, and total cost of biopsies for patients with lung cancer., Patients and Methods: Observational study using data from IBM Marketscan ® Databases for continuously insured adult patients with a primary lung cancer diagnosis and treatment between July 2013 and June 2017. Costs of lung cancer diagnosis covered 6 months prior to index biopsy through treatment. Costs of chest CT scans, biopsy, and post-procedural complications were estimated from total payments. Costs of biopsies incidental to inpatient admissions were estimated by comparable outpatient biopsies., Results: The database included 22,870 patients who had a total of 37,160 biopsies, of which 16,009 (43.1%) were percutaneous, 14,997 (40.4%) bronchoscopic, 4072 (11.0%) surgical and 2082 (5.6%) mediastinoscopic. Multiple biopsies were performed on 41.9% of patients. The most common complications among patients receiving only one type of biopsy were pneumothorax (1304 patients, 8.4%), bleeding (744 patients, 4.8%) and intubation (400 patients, 2.6%). However, most complications did not require interventions that would add to costs. Median total costs were highest for inpatient surgical biopsies ($29,988) and lowest for outpatient percutaneous biopsies ($1028). Repeat biopsies of the same type increased costs by 40-80%. Complications account for 13% of total costs., Conclusion: Costs of biopsies to confirm lung cancer diagnosis vary substantially by type of biopsy and setting. Multiple biopsies, inpatient procedures and complications result in higher costs., Competing Interests: OW and JL are employees of Intuitive Surgical. YWC, YHK, MJS, DEO, RAC, and DGS received grants for the development of this publication from Intuitive Surgical. MJS is the principal investigator and FDA Medical Expert for the new national multicenter trial of injectable chemotherapeutic and was a consultant for product development for Auris Health. The authors received no honoraria related to the development of this publication. The authors report no other conflicts of interest in this work., (© 2021 Chiu et al.)

Background and Purpose: To investigate the correlation between normal lung CT density changes with dose accuracy and outcome after stereotactic body radiation therapy (SBRT) for patients with early stage non-small-cell lung cancer (NSCLC)., Materials and Methods: Thirty-one patients (with a total of 33 lesions) with non-small cell lung cancer were selected out of 270 patients treated with SBRT at a single institution between 2003 and 2009. Out of these 31 patients, 10 patients had developed radiation pneumonitis (RP). Dose distributions originally planned using a 1-D pencil beam-based dose algorithm were retrospectively recomputed using different algorithms. Prescription dose was 48 Gy in 4 fractions in most patients. Planning CT images were rigidly registered to follow-up CT datasets at 3-9 months after treatment. Corresponding dose distributions were mapped from planning to follow-up CT images. Hounsfield Unit (HU) changes in lung density in individual, 5 Gy, dose bins from 5 to 45 Gy were assessed in the peri-tumoral region. Correlations between HU changes in various normal lung regions, dose indices (V20, MLD, generalized equivalent uniform dose (gEUD)), and RP grade were investigated., Results: Strong positive correlation was found between HU changes in the peri-tumoral region and RP grade (Spearman's r = 0.760; p  < 0.001). Positive correlation was also observed between RP and HU changes in the region covered by V20 for all algorithms (Spearman's r ≥ 0.738; p  < 0.001). Additionally, V20, MLD, and gEUD were significantly correlated with RP grade ( p  < 0.01). MLD in the peri-tumoral region computed with model-based algorithms was 5-7% lower than the PB-based methods., Conclusion: Changes of lung density in the peri-tumoral lung and in the region covered by V20 were strongly associated with RP grade. Relative to model-based methods, PB algorithms over-estimated mean peri-tumoral dose and showed displacement of the high-dose region, which correlated with HU changes on follow-up CT scans., (© 2020 The Authors.)

Numerous organizations, including the United States Preventive Services Task Force, recommend annual lung cancer screening (LCS) with low-dose CT for high risk adults who meet specific criteria. Despite recommendations and national coverage for screening eligible adults through the Centers for Medicare and Medicaid Services, LCS uptake in the United States remains low (<4%). In recognition of the need to improve and understand LCS across the population, as part of the larger Population-based Research to Optimize the Screening PRocess (PROSPR) consortium, the NCI (Bethesda, MD) funded the Lung PROSPR Research Consortium consisting of five diverse healthcare systems in Colorado, Hawaii, Michigan, Pennsylvania, and Wisconsin. Using various methods and data sources, the center aims to examine utilization and outcomes of LCS across diverse populations, and assess how variations in the implementation of LCS programs shape outcomes across the screening process. This commentary presents the PROSPR LCS process model, which outlines the interrelated steps needed to complete the screening process from risk assessment to treatment. In addition to guiding planned projects within the Lung PROSPR Research Consortium, this model provides insights on the complex steps needed to implement, evaluate, and improve LCS outcomes in community practice., (©2019 American Association for Cancer Research.)

Rationale: When stereotactic ablative radiotherapy is an option for patients with non-small cell lung cancer (NSCLC), distinguishing between N0, N1, and N2 or N3 (N2|3) disease is important. Objectives: To develop a prediction model for estimating the probability of N0, N1, and N2|3 disease. Methods: Consecutive patients with clinical-radiographic stage T1 to T3, N0 to N3, and M0 NSCLC who underwent endobronchial ultrasound-guided staging from a single center were included. Multivariate ordinal logistic regression analysis was used to predict the presence of N0, N1, or N2|3 disease. Temporal validation used consecutive patients from 3 years later at the same center. External validation used three other hospitals. Measurements and Main Results: In the model development cohort ( n  = 633), younger age, central location, adenocarcinoma, and higher positron emission tomography-computed tomography nodal stage were associated with a higher probability of having advanced nodal disease. Areas under the receiver operating characteristic curve (AUCs) were 0.84 and 0.86 for predicting N1 or higher (vs. N0) disease and N2|3 (vs. N0 or N1) disease, respectively. Model fit was acceptable (Hosmer-Lemeshow, P  = 0.960; Brier score, 0.36). In the temporal validation cohort ( n  = 473), AUCs were 0.86 and 0.88. Model fit was acceptable (Hosmer-Lemeshow, P  = 0.172; Brier score, 0.30). In the external validation cohort ( n  = 722), AUCs were 0.86 and 0.88 but required calibration (Hosmer-Lemeshow, P  < 0.001; Brier score, 0.38). Calibration using the general calibration method resulted in acceptable model fit (Hosmer-Lemeshow, P  = 0.094; Brier score, 0.34). Conclusions: This prediction model can estimate the probability of N0, N1, and N2|3 disease in patients with NSCLC. The model has the potential to facilitate decision-making in patients with NSCLC when stereotactic ablative radiotherapy is an option.

Purpose of Review: This article provides the most recent literature and experienced guidance about diagnosis and management of tracheal tumors, including future directions., Recent Findings: Tracheal tumors are challenging to diagnose given their nonspecific and late-onset symptoms. Critical airway obstruction is the most feared complication. The cornerstone in management of them is surgical resection whenever is possible. Different diagnostic tests (i.e., imaging and bronchoscopy) help in the assessment of resectability. Alternative management including interventional bronchoscopic techniques can be offered to patients who are not suitable for surgical resection. Radiation and chemotherapy can also be used as adjuvant, neoadjuvant or sole treatment in malignant tumors. Recent advances in tracheal transplantation and bioengineering with tracheal reconstruction have shown a new direction in the management of these tumors. All these topics will be discussed in this article., Summary: Despite advances in diagnostic and therapeutic techniques, tracheal tumors are still a medical challenge. Although studies are still trying to find the best surgical techniques as well as the role for chemotherapy and radiation, most recent studies are addressing tracheal reconstruction and transplantation as the new horizon for management.

Background: Chronic obstructive pulmonary disease (COPD) is a heterogeneous condition with respect to onset, progression, and response to therapy. Incorporating clinical- and imaging-based features to refine COPD phenotypes provides valuable information beyond that obtained from traditional clinical evaluations. We characterized the spectrum of COPD-related phenotypes in a sample of former and current smokers and evaluated how these subgroups differ with respect to sociodemographic characteristics, COPD-related comorbidities, and subsequent risk of lung cancer., Methods: White ( N = 659) and African American ( N = 520) male and female participants without lung cancer (controls) in the INHALE study who completed a chest CT scan, interview, and spirometry test were used to define distinct COPD-related subgroups based on hierarchical clustering. Seven variables were used to define clusters: pack years, quit years, FEV 1 /FVC, % predicted FEV 1 , and from quantitative CT (qCT) imaging, % emphysema, % air trapping, and mean lung density ratio. Cluster definitions were then applied to INHALE lung cancer cases ( N = 576) to evaluate lung cancer risk., Results: Five clusters were identified that differed significantly with respect to sociodemographic (e.g., race, age) and clinical (e.g., BMI, limitations due to breathing difficulties) characteristics. Increased risk of lung cancer was associated with increasingly detrimental lung function clusters (when ordered from most detrimental to least detrimental)., Conclusions: Measures of lung function vary considerably among smokers and are not fully explained by smoking intensity., Impact: Combining clinical (spirometry) and radiologic (qCT) measures of COPD defines a spectrum of lung disease that predicts lung cancer risk differentially among patient clusters., (©2019 American Association for Cancer Research.)

Competing Interests: Conflicts of Interest: The authors have no conflicts of interest to declare.

Rationale: Lung cancer screening registries can monitor screening outcomes and improve quality of care., Objectives: To describe nascent lung cancer screening programs and share efficient data collection approaches for mandatory registry reporting in four integrated health care systems of the National Cancer Institute-funded Cancer Research Network., Methods: We documented the distinctive characteristics of lung cancer screening programs, and we provide examples of strategies to facilitate data collection and describe early challenges and possible solutions. In addition, we report preliminary data on use and outcomes of screening with low-dose computed tomography at each of the participating sites., Results: Programs varied in approaches to confirming patient eligibility, ordering screening low-dose computed tomographic scans, and coordinating follow-up care. Most data elements were collected from structured fields in electronic health records, but sites also made use of standardized order templates, local procedure codes, identifiable hashtags in radiology reports, and natural language processing algorithms. Common challenges included incomplete documentation of tobacco smoking history, difficulty distinguishing between scans performed for screening versus diagnosis or surveillance, and variable adherence with use of standardized templates. Adherence with eligibility criteria as well as the accuracy and completeness of data collection appeared to depend at least partly on availability of personnel and other resources to support the successful implementation of screening., Conclusions: To maximize the effectiveness of lung cancer screening, minimize the burden of data collection, and facilitate research and quality improvement, clinical workflow and information technology should be purposefully designed to ensure that patients meet eligibility criteria and receive appropriate follow-up testing.

Rationale: Advanced bronchoscopy techniques such as electromagnetic navigation (EMN) have been studied in clinical trials, but there are no randomized studies comparing EMN with standard bronchoscopy., Objectives: To measure and identify the determinants of diagnostic yield for bronchoscopy in patients with peripheral lung lesions. Secondary outcomes included diagnostic yield of different sampling techniques, complications, and practice pattern variations., Methods: We used the AQuIRE (ACCP Quality Improvement Registry, Evaluation, and Education) registry to conduct a multicenter study of consecutive patients who underwent transbronchial biopsy (TBBx) for evaluation of peripheral lesions., Measurements and Main Results: Fifteen centers with 22 physicians enrolled 581 patients. Of the 581 patients, 312 (53.7%) had a diagnostic bronchoscopy. Unadjusted for other factors, the diagnostic yield was 63.7% when no radial endobronchial ultrasound (r-EBUS) and no EMN were used, 57.0% with r-EBUS alone, 38.5% with EMN alone, and 47.1% with EMN combined with r-EBUS. In multivariate analysis, peripheral transbronchial needle aspiration (TBNA), larger lesion size, nonupper lobe location, and tobacco use were associated with increased diagnostic yield, whereas EMN was associated with lower diagnostic yield. Peripheral TBNA was used in 16.4% of cases. TBNA was diagnostic, whereas TBBx was nondiagnostic in 9.5% of cases in which both were performed. Complications occurred in 13 (2.2%) patients, and pneumothorax occurred in 10 (1.7%) patients. There were significant differences between centers and physicians in terms of case selection, sampling methods, and anesthesia. Medical center diagnostic yields ranged from 33 to 73% (P = 0.16)., Conclusions: Peripheral TBNA improved diagnostic yield for peripheral lesions but was underused. The diagnostic yields of EMN and r-EBUS were lower than expected, even after adjustment.

Background: There are significant variations in how therapeutic bronchoscopy for malignant airway obstruction is performed. Relatively few studies have compared how these approaches affect the incidence of complications., Methods: We used the American College of Chest Physicians (CHEST) Quality Improvement Registry, Evaluation, and Education (AQuIRE) program registry to conduct a multicenter study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was the incidence of complications. Secondary outcomes were incidence of bleeding, hypoxemia, respiratory failure, adverse events, escalation in level of care, and 30-day mortality., Results: Fifteen centers performed 1,115 procedures on 947 patients. There were significant differences among centers in the type of anesthesia (moderate vs deep or general anesthesia, P < .001), use of rigid bronchoscopy (P < .001), type of ventilation (jet vs volume cycled, P < .001), and frequency of stent use (P < .001). The overall complication rate was 3.9%, but significant variation was found among centers (range, 0.9%-11.7%; P = .002). Risk factors for complications were urgent and emergent procedures, American Society of Anesthesiologists (ASA) score > 3, redo therapeutic bronchoscopy, and moderate sedation. The 30-day mortality was 14.8%; mortality varied among centers (range, 7.7%-20.2%, P = .02). Risk factors for 30-day mortality included Zubrod score > 1, ASA score > 3, intrinsic or mixed obstruction, and stent placement., Conclusions: Use of moderate sedation and stents varies significantly among centers. These factors are associated with increased complications and 30-day mortality, respectively.

Background: There is significant variation between physicians in terms of how they perform therapeutic bronchoscopy, but there are few data on whether these differences impact effectiveness., Methods: This was a multicenter registry study of patients undergoing therapeutic bronchoscopy for malignant central airway obstruction. The primary outcome was technical success, defined as reopening the airway lumen to > 50% of normal. Secondary outcomes were dyspnea as measured by the Borg score and health-related quality of life (HRQOL) as measured by the SF-6D., Results: Fifteen centers performed 1,115 procedures on 947 patients. Technical success was achieved in 93% of procedures. Center success rates ranged from 90% to 98% (P = .02). Endobronchial obstruction and stent placement were associated with success, whereas American Society of Anesthesiology (ASA) score > 3, renal failure, primary lung cancer, left mainstem disease, and tracheoesophageal fistula were associated with failure. Clinically significant improvements in dyspnea occurred in 90 of 187 patients measured (48%). Greater baseline dyspnea was associated with greater improvements in dyspnea, whereas smoking, having multiple cancers, and lobar obstruction were associated with smaller improvements. Clinically significant improvements in HRQOL occurred in 76 of 183 patients measured (42%). Greater baseline dyspnea was associated with greater improvements in HRQOL, and lobar obstruction was associated with smaller improvements., Conclusions: Technical success rates were high overall, with the highest success rates associated with stent placement and endobronchial obstruction. Therapeutic bronchoscopy should not be withheld from patients based solely on an assessment of risk, since patients with the most dyspnea and lowest functional status benefitted the most.

Strategies to enhance the already established doublet chemotherapy regimen for lung cancer have been investigated for more than 20 years. Initially, the concept was to administer chemotherapy drugs locally to the tumor site for efficient diffusion through passive transport within the tumor. Recent advances have enhanced the diffusion of pharmaceuticals through active transport by using pharmaceuticals designed to target the genome of tumors. In the present study, five patients with non-small cell lung cancer epidermal growth factor receptor (EGFR) negative stage IIIa-IV International Union Against Cancer 7 (UICC-7), and with Eastern Cooperative Oncology Group (ECOG) 2 scores were administered platinum-based doublet chemotherapy using combined intratumoral-regional and intravenous route of administration. Cisplatin analogues were injected at 0.5%-1% concentration within the tumor lesion and proven malignant lymph nodes according to pretreatment histological/cytological results and the concentration of systemic infusion was decreased to 70% of a standard protocol. This combined intravenous plus intratumoral-regional chemotherapy is used as a first line therapy on this short series of patients. To the best of our knowledge this is the first report of direct treatment of involved lymph nodes with cisplatin by endobronchial ultrasound drug delivery with a needle without any adverse effects. The initial overall survival and local response are suggestive of a better efficacy compared to established doublet cisplatin-based systemic chemotherapy in (higher) standard concentrations alone according to the UICC 7 database expected survival. An extensive search of the literature was performed to gather information of previously published literature of intratumoral chemo-drug administration and formulation for this treatment modality. Our study shows a favorable local response, more than a 50% reduction, for a massive tumor mass after administration of five sessions of intratumoral chemotherapy plus two cycles of low-dose intravenous chemotherapy according to our protocol. These encouraging results (even in very sick ECOG 2 patients with central obstructive non-small cell lung cancer having a worse prognosis and quality of life than a non-small cell lung cancer in ECOG 0 of the same tumor node metastasis [TNM]-stage without central obstruction) for a chemotherapy-only protocol that differs from conventional cisplatin-based doublet chemotherapy by the route, target site, and dose paves the way for broader applications of this technique. Finally, future perspectives of this treatment and pharmaceutical design for intratumoral administration are presented.

Background: Multiple new diagnostic bronchoscopic technologies are available, but little is known about their comparative performance and specific yield when adjusted for location of lesions, target size, and diagnosis. We present a multi-institutional prospective-outcomes database to assess diagnostic yields of advanced bronchoscopic procedures, as well as related morbidity and mortality., Methods: Data were extracted and reviewed from an ongoing, paper-based, prospective, multi-institutional outcomes database for advanced diagnostic bronchoscopic procedures. All consecutive eligible patients are entered into this database, and information on demographics, procedure, and lesion characteristics as well as complications were documented. Descriptive statistical analyses were performed., Results: A total of 310 diagnostic procedures were performed over a 1-year period in four institutions by 15 different clinicians. The majority of the patients were white (66%), male (56%), former smokers (55%), with a mean age of 61 +/- 14 years. The average procedure time was 36 min, and the most common procedure was transbronchial needle aspiration (TBNA) (n = 198). Nodal tissue was obtained in 82.3% from TBNA sampling with a mean of three passes using endobronchial ultrasound guidance with a 22-gauge needle and mostly without on-site cytology. The overall diagnostic yield for all procedures was 75%. There were few complications, and none required a change in disposition., Conclusions: Prospective and ongoing data analysis for bronchoscopic procedures is feasible and valuable. Lesion-adjusted diagnostic yields can be documented and potentially used for comparative assessment of different technologies and operators, as well as benchmarking and quality improvement initiatives. Extending the number of participating centers and web-based submission to minimize missing data components are the next, already-initiated steps.

Rationale: Bronchial thermoplasty (BT) is a bronchoscopic procedure in which controlled thermal energy is applied to the airway wall to decrease smooth muscle., Objectives: To evaluate the effectiveness and safety of BT versus a sham procedure in subjects with severe asthma who remain symptomatic despite treatment with high-dose inhaled corticosteroids and long-acting beta(2)-agonists., Methods: A total of 288 adult subjects (Intent-to-Treat [ITT]) randomized to BT or sham control underwent three bronchoscopy procedures. Primary outcome was the difference in Asthma Quality of Life Questionnaire (AQLQ) scores from baseline to average of 6, 9, and 12 months (integrated AQLQ). Adverse events and health care use were collected to assess safety. Statistical design and analysis of the primary endpoint was Bayesian. Target posterior probability of superiority (PPS) of BT over sham was 95%, except for the primary endpoint (96.4%)., Measurements and Main Results: The improvement from baseline in the integrated AQLQ score was superior in the BT group compared with sham (BT, 1.35 +/- 1.10; sham, 1.16 +/- 1.23 [PPS, 96.0% ITT and 97.9% per protocol]). Seventy-nine percent of BT and 64% of sham subjects achieved changes in AQLQ of 0.5 or greater (PPS, 99.6%). Six percent more BT subjects were hospitalized in the treatment period (up to 6 wk after BT). In the posttreatment period (6-52 wk after BT), the BT group experienced fewer severe exacerbations, emergency department (ED) visits, and days missed from work/school compared with the sham group (PPS, 95.5, 99.9, and 99.3%, respectively)., Conclusions: BT in subjects with severe asthma improves asthma-specific quality of life with a reduction in severe exacerbations and healthcare use in the posttreatment period. Clinical trial registered with www.clinialtrials.gov (NCT00231114).

We encountered a 46-year-old immunocompetent male patient who presented with a right upper lobe collapse on a chest x-ray. A flexible bronchoscopic examination revealed an endobronchial mass emanating from the right upper lobe and obstructing the right mainstem bronchus. Bronchial washings and biopsy of the lesion were consistent with cryptococcal infection. The response to oral diflucan therapy was suboptimal. Subsequently, the patient underwent a successful bronchoscopic resection of this mass with the placement of an endobronchial stent. We report this rare case of endobronchial cryptococcal infection treated with a combination of an antifungal agent and bronchoscopic debulking.

Background: The extent of disease in patients with lung carcinoma is reflected morphologically by stage and pathophysiologically by sign/symptoms. This study evaluates the associations between symptoms and stage, the independent impact of symptoms on survival, predictors of symptoms, and the extent to which symptoms mediate survival disparities., Methods: Data from 1154 patients with lung carcinoma were collected from the authors' tumor registry and by abstraction of medical records. Associations were evaluated by logistic and Cox regression analyses., Results: Symptomatic diagnoses were associated with advanced disease stage (odds ratio [OR], 4.53; 95% confidence interval [95%CI], 3.17-6.48). Hoarseness, hemoptysis, dyspnea, noncardiac chest pain, extrathoracic pain, neurologic symptoms, weight loss, and weakness/fatigue (adverse symptoms) were associated independently with relatively higher/advanced stage and/or reduced survival. Adverse symptoms (> or = 1 vs. 0) predicted reduced survival independently of stage and other prognosticators (hazard ratio [HR], 1.84; 95%CI, 1.52-2.21). Independent predictors of adverse symptoms included gender (OR(male vs. female), 1.50; 95%CI, 1.11-2.01), race/ethnicity (OR(black vs. white), 1.62; 95%CI, 1.18-2.21), and marital status (OR(spouseless vs. not), 1.79; 95%CI 1.31-2.45). The hazard ratios (HR; black vs white), univariate, adjusted for stage, and adjusted for stage and adverse symptoms, was 1.206 (95%CI, 1.05-1.38), 1.165 (95%CI, 1.01-1.34), and 1.075 (95%CI, 0.94-1.26), respectively. Adverse symptoms explained 43% of race/ethnic survival disparity beyond stage., Conclusions: Symptoms were associated with disease stage, yet both were important, independent predictors of survival; and symptoms explained an important amount of race/ethnic disparity in the survival of patients with lung carcinoma. Symptomatology needs to be incorporated into cancer clinical trials and into outcomes and disparities research., ((c) 2004 American Cancer Society.)