Bronchial Thermoplasty in Patients With Severe Asthma at 5 Years: The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma Study.

BACKGROUND: Bronchial thermoplasty is a device-based treatment for subjects ≥ 18 years of age with severe asthma poorly controlled with inhaled corticosteroids and long-acting beta-agonists. The Post-FDA Approval Clinical Trial Evaluating Bronchial Thermoplasty in Severe Persistent Asthma (PAS2) study collected data on patients with severe asthma undergoing this procedure. RESEARCH QUESTION: What are the 5-year efficacy and safety results in patients with severe asthma who have undergone bronchial thermoplasty? STUDY DESIGN AND METHODS: This was a prospective, open-label, observational, multicenter study conducted in the United States and Canada. Subjects 18 to 65 years of age who were taking inhaled corticosteroids ≥ 1,000 µg/d (beclomethasone or equivalent) and long-acting beta-agonists ≥ 80 µg/d (salmeterol or equivalent) were included. Severe exacerbations, hospitalization, ED visits, and medication usage were evaluated for the 12 months prior to and at years 1 through 5 posttreatment. Spirometry was evaluated at baseline and at years 1 through 5 posttreatment. RESULTS: A total of 284 subjects were enrolled at 27 centers; 227 subjects (80%) completed 5 years of follow-up. By year 5 posttreatment, the proportion of subjects with severe exacerbations, ED visits, and hospitalizations was 42.7%, 7.9%, and 4.8%, respectively, compared with 77.8%, 29.4%, and 16.1% in the 12 months prior to treatment. The proportion of subjects on maintenance oral corticosteroids decreased from 19.4% at baseline to 9.7% at 5 years. Analyses of subgroups based on baseline clinical and biomarker characteristics revealed a statistically significant clinical improvement among all subgroups. INTERPRETATION: Five years after treatment, subjects experienced decreases in severe exacerbations, hospitalizations, ED visits, and corticosteroid exposure. All subgroups demonstrated clinically significant improvement, suggesting that bronchial thermoplasty improves asthma control in different asthma phenotypes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; No.: NCT01350336; URL: www. CLINICALTRIALS: gov.

Lymphocytic pneumonitis as the manifestation of acute graft-versus-host disease of the lung.

Acute graft-versus-host disease is a common complication after allogeneic stem cell transplantation. It normally affects the skin, liver, and gut. We report a 54-year-old male who developed shortness of breath, cough, and bilateral pulmonary infiltrates in which the work-up failed to demonstrate an infectious etiology 165 days post-HLA-matched allogeneic peripheral blood stem cell transplant. Eighteen days before, his tacrolimus had been tapered and it was subtherapeutic on admission. A transbronchial biopsy showed a perivascular and interstitial lymphocytic infiltrate without evident pathogens on histology or extensive work-up. The clinical picture was suggestive of pulmonary acute graft-versus-host disease. No disease was present elsewhere. Accordingly, the patient was treated with steroids and tacrolimus. After 12 hr on methylprednisolone, his symptoms disappeared with eventual resolution radiologically. Acute graft-versus-host disease of the lung is a very uncommon complication after stem cell transplant, but it should be considered in patients who are at high risk for graft-versus-host disease or developing symptoms soon after discontinuing immunosuppression. Its diagnosis requires work-up to rule out an infectious etiology and a biopsy to confirm histology.

Lung cancer in elderly patients.

Lung cancer is one of the most common causes of death in elderly patients in the United States. Treatment advances have improved survival in selected patients. The available treatments carry the risk of morbidity and mortality but the benefit in most patients far outweighs the risks, given the dismal prognosis of untreated disease. Elderly patients with lung cancer need careful attention during pretreatment assessment. Advanced age alone, however, should not contraindicate aggressive treatment. In the high-risk groups it is important to involve a team of physicians including surgeons, radiation oncologists, medical oncologists, and pulmonologists, who are familiar with current treatment options and their risks.