Background: Malignant pleural effusion (MPE) portends a poor prognosis in non-small cell lung cancer (NSCLC). However, the yield of pleural fluid cytology as well as survival of patients with MPE associated with squamous cell carcinoma versus adenocarcinoma is not well understood. We conducted this study to assess the diagnostic yield of pleural cytology and survival of patients with NSCLC related MPE.Methods: We performed a single-center, retrospective analysis of patients with NSCLC related MPE between 2010 and 2017. Kaplan-Meier method was used to compare survival and Cox proportional hazards analysis to assess if squamous cell cytopathology was associated with mortality.Results: We identified 277 patients, 29 with squamous cell and 248 with adenocarcinoma MPE. Pleural fluid cytology from initial thoracentesis was diagnostic in 13.8% (4/29) patients with squamous cell and 80.2% (199/248) with adenocarcinoma (P<0.001). Cytology from second thoracentesis was diagnostic in 13.3% (2/15) patients with squamous cell carcinoma, compared to 37.5% (12/32) with adenocarcinoma (P=0.17). There was no statistically significant difference in the pleural biopsy yield from medical pleuroscopy or video-assisted thoracoscopic surgery (VATS) in the two groups. The median survival of patients with squamous cell MPE was 112 (interquartile range, IQR: 44-220) days versus 194 (IQR: 54-523) days in adenocarcinoma (Log-rank test P=0.04). Multivariate Cox proportional hazards analysis showed that squamous cell cytopathology was independent predictor of mortality (hazard ratio for death of 1.73, 95% CI:1.1-2.6; P=0.01).Conclusions: Pleural fluid cytology has a low diagnostic yield in squamous cell carcinoma MPE, and these patients have a poor survival compared to lung adenocarcinoma.
Introduction: Chronic respiratory disease causes substantial patient morbidity, and represents the fourth leading cause of death in the United States. More effective treatments are therefore needed for a wide range of pulmonary disorders. As clinical trials are the gold standard by which new therapies are evaluated, we leveraged annotated data from ClinicalTrials.gov, a comprehensive multinational database in which trials are prospectively registered, to understand study characteristics among clinical trials conducted in pulmonary, critical care, and sleep medicine (PCCSM). Methods: We identified all interventional clinical trials registered at ClinicalTrials.gov from January 2008 through December 2016 (n = 146,919) and applied disease condition terms provided by data submitters and medical subject heading terms generated by a National Library of Medicine algorithm to create a dataset of PCCSM trials (n = 7,919). We extracted key trial characteristics and used descriptive statistics to summarize trial attributes by registration year, funding source, and condition studied. Results: Clinical trials in PCCSM account for only 5.4% of all registered interventional trials. The most commonly studied conditions were chronic obstructive pulmonary disease (21.3%) and asthma (19.5%). The most common primary outcome was lung function (14.8%). Many trials were single center (66.8%) and enrolled 100 or fewer patients (66.6%). With regards to funding source, 4.2% of PCCSM studies were funded by the National Institutes of Health (NIH) and 35.0% were funded by industry. Study characteristics varied by funding source and condition studied (Table ). For example, while median enrollment was similar among NIH and industryfunded trials (79 [IQR, vs. 60 [IQR 24 -211] respectively), a higher proportion of trials with greater than 1,000 participants was sponsored by industry (5.1%) compared to NIH (2.1%). NIH-funded trials were also more likely than industryfunded trials to include biomarkers (13.3% vs. 6.1%) or quality of life measures (13.3% vs. 5.8%) as the primary outcome. From 2008 to 2016, the number of industry (365 vs. 286) and NIH (42 vs. 36) funded trials registered each year slightly decreased. Conclusions: Despite the morbidity and mortality associated with chronic respiratory disease, PCCSM studies make up only a small proportion of interventional trials registered in ClinicalTrials.gov. Among PCCSM trials, NIH and industry sponsored studies differ in disease focus and primary outcomes, providing complementary approaches to advance the field. However, the relatively small number of both industry and NIH-funded trials over the past decade in PCCSM clearly underrepresents the needs of patients with respiratory disease.
Pulmonary embolism (PE) is a rare, yet serious post-operative complication for lung transplant recipients (LTR). The association between timing and severity of PE and the subsequent development of chronic allograft lung dysfunction (CLAD) is not well described. We sought to identify whether PE and Pulmonary Embolism Severity Index (PESI) risk categorization are associated with CLAD and survival in a lung transplant cohort with an extended follow-up period. METHODS: We performed a single-center, retrospective analysis of first LTR from May 2005 to August 2015 with follow-up until October 2018. We included both bilateral and single lung transplants, while multi-organ transplants and retransplants were excluded. PE were confirmed by computed tomography angiography (CTA), as well as ventilation and perfusion (VQ) scans. PESI was used to score each PE event and individually stratify the clinical risk. PESI clinical risk were categorized by low (I-II), intermediate (III-IV) and high risk (V). PE was analyzes as a time independent (within 180 days of transplant) and time dependent variable in the time dependent outcomes of CLAD and death. RESULTS: We identified 57 (6.2%) patients that had at least one acute PE from the study cohort of 927 LTR over the follow-up period (median 1427 days). Of the patients with PE, 42 (73.7%) occurred within the first 180 days post-transplant. In this cohort, the median PESI score was 85 (75.5, 97.0). The majority of the PESI scores (53 of the 56 available) where in the low and intermediate risk categories. Of the cohort of 927 LTR, PE within 180 days of transplantation was significantly associated with decreased survival (HR 1.8, p=0.007) and CLAD (HR 2.1, p=0.006). Further, when considering PE as a time dependent variable and controlling for type of transplant, PE was found to associate with the development of CLAD (HR 1.8, p=0.011) and death (HR 2.0, p<0.001). PESI risk category was not a significant predictor of death or CLAD after the PE event. CONCLUSION: Post-transplant PE is associated with the development of CLAD and death in LTR, particularly if PE occurs in the first 180 days of transplantation. PESI risk categories were not associated with death or CLAD in this cohort. Further studies need to assess how the PESI at time of PE affects the onset of CLAD.
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