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Background: The FIBRONET study was an observational study of patients with idiopathic pulmonary fibrosis (IPF) in Italy., Objectives: In this post hoc descriptive analysis, we describe changes in lung function, anxiety/depression, coughing, exacerbations, and adverse events (AEs) in patients receiving nintedanib treatment., Methods: Patients with IPF from 20 centers in Italy, aged ≥40 years who received nintedanib for ≥7 months, were followed up for 12 months from study enrollment, attending clinic visits every 3 months. Outcomes included change in forced vital capacity (FVC)% predicted from baseline to 12 months, anxiety/depression measured by the Hospital Anxiety and Depression Scale (HADS), and the proportion of patients with cough, AEs, and exacerbations., Results: In total, 52 patients received nintedanib (mean duration of 11.6 months). Ten patients had dose reductions from 150 mg to 100 mg twice daily, due to AEs. FVC% predicted was unchanged in the overall nintedanib population (78.7% at baseline; 79.8% at 12 months) and those with a reduced dose (77.7% at baseline; 81.0% at 12 months). HADS score was low at baseline and throughout the study. The proportion of patients with cough decreased from 50.0% to 21.2% over 12 months. Two patients experienced exacerbations, 2 patients discontinued treatment, and 27 (51.9%) reported AEs. The most common AE was diarrhea (34.6%)., Conclusions: In patients with IPF who received nintedanib in the FIBRONET study, FVC% predicted was stable over 12 months, and the proportion of patients with cough decreased. The safety profile was consistent with the known safety profile for nintedanib in IPF., (© 2022 The Author(s). Published by S. Karger AG, Basel.)

Background: Bronchoscopy with bronchoalveolar lavage (BAL) during the SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) pandemic should be reserved to a limited number of clinical indications. The yield of BAL for the diagnosis of suspected or confirmed pulmonary SARS-CoV-2 infection is still unknown., Objectives: We aimed to evaluate the diagnostic ratio of BAL in detecting SARS-CoV-2 pulmonary infection in patients undergoing bronchoscopy for different indications as well as describe the clinical, radiological, and endoscopic characteristics of patients with SARS-CoV-2 on BAL., Method: We conducted a multicenter retrospective study including all patients who underwent bronchoscopy for the detection of SARS-CoV-2 on BAL. Clinical, computed tomography (CT), endoscopic, and microbiologic data were gathered from March 16th to May 27th, 2020., Results: 131 patients were included. Bronchoscopy was performed for suspected SARS-CoV-2 infection (65.5%), alternative diagnosis (12.9%), suspected superinfections (19.8%), and lung atelectasis (1.5%). SARS-CoV-2 was isolated on BAL 43 times (32.8%) and the highest isolation rate was in patients with suspected SARS-CoV-2 infection (74.4%); 76% of positive patients had a double-negative nasopharyngeal swab. Peripheral, posterior and multilobar CT opacities were more frequent in SARS-CoV-2 patients, and the number of CT findings was higher in positive patients, particularly those with suspected SARS-CoV-2 infection. We recorded a progressive reduction of SARS-CoV-2 isolation during the observation period., Conclusions: In our centers, the rate of detection of SARS-CoV-2 on BAL in patients with suspected infection was 37.2%. The agreement of BAL with nasopharyngeal swabs was high; CT alterations could predict the pretest probability of SARS-CoV-2 infection, but suspicion of viral infection should be always considered., (© 2020 S. Karger AG, Basel.)

Background: RECAP (NCT00662038) was an open-label extension study in patients with idiopathic pulmonary fibrosis (IPF) who completed either the Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis (ASCEND) 016 phase 3 trial or the Clinical Studies Assessing Pirfenidone in Idiopathic Pulmonary Fibrosis: Research of Efficacy and Safety Outcomes (CAPACITY) 004/006 phase 3 trials., Objective: To obtain long-term safety data for pirfenidone in patients with IPF in RECAP., Methods: Of the 1,334 patients who participated in the phase 3 trials, 1,058 entered RECAP. The final analysis from enrollment (September 2008) to June 2015 is presented., Results: Mean (SD) and median (range) pirfenidone exposures in RECAP were 122 (98) weeks and 88 (>0 to 349) weeks, respectively, with a mean daily dose of 2,091.1 mg. Cumulative total exposure was 2,482 patient exposure years (PEY). The treatment-emergent adverse event (TEAE) rate was 701.9 per 100 PEY. The serious TEAE rate was 53.5 per 100 PEY, with the most common serious TEAE being IPF (11.1 per 100 PEY). Of the 231 deaths (9.3 per 100 PEY), the most common cause was IPF (5.4 per 100 PEY). The treatment discontinuation rate due to a TEAE was 17.9 per 100 PEY; discontinuations were due to IPF (7.2 per 100 PEY), pneumonia, respiratory failure, acute respiratory failure, rash (0.5 per 100 PEY each), and nausea (0.4 per 100 PEY). For patients from CAPACITY 004/006 who entered RECAP, the mean change in percent predicted forced vital capacity from RECAP baseline at 180 weeks was -9.6%. Median on-treatment survival from the first pirfenidone dose in RECAP was 77.2 months., Conclusions: RECAP provides long-term follow-up and safety data for pirfenidone that were consistent with the known profile, with no new safety signals observed., (© 2017 The Author(s) Published by S. Karger AG, Basel.)

Lymphocyte subpopulations analysis by an 11-monoclonal antibody (MoAb) panel was carried out in pleural fluid and in peripheral blood in 30 patients affected by newly diagnosed, untreated pleural effusion of different etiology determinated with bacteriological, cytological or histological criteria. Lymphocytes were the predominant cell type, in pleural fluid, in neoplastic pleural effusions as well as in congestive heart failure pleural effusions and, especially, in tuberculous pleural effusions. Lymphocyte analysis in pleural fluid and in peripheral blood suggests the involvement of different mechanisms for the lymphocyte accumulation in the pleural space according to different etiologies. Tuberculous pleural effusions showed an evident CD4+ and TEC T5.9+ lymphocyte accumulation from peripheral blood. In these patients, cutaneous skin test response to purified protein derivative was strongly related to this situation. In neoplastic pleural effusions there was a lower percentage of CD4+ lymphocytes, reflecting circulating lymphocyte pool; however, in neoplastic pleural effusions, various lymphocyte patterns may be sometimes observed depending on different histologies. Passive lymphocyte accumulation seems to be the most important mechanism in congestive-heart-failure pleural effusions.

In order to assess the importance of circulating interferons and immune complexes as hypothetical mediators of some immune derangements observed in sarcoidosis, we evaluated serum interferon and immune complex levels in 45 patients with active disease. In none of our patients could circulating interferon be detected, suggesting that an infectious (viral) etiology is very unlikely, and that a great difference exists between sarcoidosis and true autoimmune diseases. On the other hand, circulating immune complexes could be found in 64.4% of our patients. A good correlation could be found with disease stage and duration, but only with 67Ga lung scan among other activity indexes.

69 patients with unresectable non-small cell lung cancer, previously untreated, received cisplatin 100 mg/m2 on day 1 and etoposide 120 mg/m2 on days 4, 6, 8 at 4-week intervals. 66 patients were evaluable for tumor response and toxicity. Overall objective response was 25.7% (3 complete responses and 14 partial responses). Response rate in limited disease was 41% and in patients with performance score 0 it was 40%. Squamous cell carcinoma and adenocarcinoma responded in 31 and 24% of evaluable patients. Complete response was associated with a long duration of remission. Median survival time of responding patients was significantly superior to the median of nonresponding patients (p less than 0.001) but compared to stable disease no statistical significance was demonstrable (p greater than 0.05). Hematological and renal toxicity of proposed regimen was generally mild. Nausea and vomiting were the most noxious side effects.

Lonidamine (LND) interferes with the energy mechanisms of neoplastic cells and decreases the oxygen consumption in human and experimental tumors. The present study was performed in advanced non-small cell lung cancer patients, previously untreated, to confirm the preliminary data of activity against this kind of tumor. LND was given orally in three divided doses increasing to 250 mg/m2 over 4 days. Thirty-six patients were evaluable for toxicity and 33 for response. Partial responses were 3 (9%) and stabilization of disease 15 (45,5%). Recorded side effects (testicular pain, nausea and vomiting, skin hyperesthesia) were mostly mild to moderate with the exclusion of myalgias. Chronic treatment was devoid of haematological, renal, cardiac and pulmonary toxicities. LND as single agent seems to be marginally active in advanced non-small cell lung cancer.