Although median survival after LM-diagnosis in EGFR-mutated NSCLC-patients was poor, a substantial part of the patients had a prolonged survival of more than 6 months. PS of 0-1 at time of diagnosis of LM was associated with prolonged survival. No other patient- or treatment-related characteristics were identified. Further research is warranted to identify treatment strategies that improve survival in EGFR+ NSCLC-patients with LM.
Procalcitonin (PCT) is a 13-kDa peptide and a precursor of calcitonin. In a healthy population, PCT concentrations are negligible (1 ). In systemic bacterial and fungal infections, plasma concentrations are raised, whereas concentrations remain fairly low in infections of viral or nonspecific cause (2 ). Recent studies have demonstrated the potential of PCT as a parameter to guide antibiotic therapy in different groups of patients, i.e., patients with chronic obstructive pulmonary disease experiencing respiratory tract infections (3,4 ). The most frequently used medical decision points at which the use of antibiotic therapy is considered are 0.25 g/L and 0.50 g/L, depending on the patient population (3, 4 ).The first PCT assays were based on manual immunochemistry methods (Brahms PCT LIA). These assays have been replaced by fully automated immunochemistry methods (Brahms Kryptor, Brahms LIAISON, Olympus SphereLight 180). Recently, the PCT assay has been modified for use on a consolidated routine immunochemistry analyzer family, the Roche Elecsys, cobas, and the Roche Modular E170 systems. We evaluated the analytical performance of this new assay by following the EP10 protocol, a document from the Clinical and Laboratory Standards Institute to test precision, linearity, recovery, carryover, and drift. Samples were prepared at different concentrations, from 0.24 -2.85 g/L. Three aliquots of each concentration were assayed on 5 different days, in a specific assay order. The within-run CV ranged from 3.0% for the lowest concentration to 1.3% for the highest concentration. The between-day CV ranged from 6.3% for the lowest concentration to 2.8% for the highest. These levels of imprecision were comparable with those reported for the PCT assay on the Brahms Kryptor (5 ). The mean recovery was 99%. There was no evidence of nonlinearity or sample carryover. The limit of quantification, i.e., the lowest concentration of analyte that can be quantified with a between-run imprecision of Ͻ20%, met the manufacturer's specification of 0.06 g/L. In addition, we compared the new PCT assay from Roche on the Modular 170 with the widely accepted PCT assay from Brahms on the Kryptor (5 ). For analytical comparison, we used 229 samples of patient serum obtained from 195 different patients who were admitted to our hospital for lower respiratory tract infections (81, exacerbation of chronic obstructive pulmonary disease; 114, pneumonia). The patients participated in an ongoing study in our hospital on the etiology of exacerbations of chronic obstructive pulmonary disease, a study approved by the local ethics committee. Samples were also collected from 34 patients after antibiotic treatment. The majority of the serum samples were obtained within 24 h of admission. Samples not immediately analyzed were stored at Ϫ80°C until analysis. PCT concentrations ranged from 0.02 g/L (limit of detection, i.e., the lowest concentration of analyte that can be reliably measured as being qualitatively present in the sample) to 57 g/L. PCT concentrations...
Background Use of long-term tobramycin inhalation solution (TIS) has been shown beneficial in cystic fibrosis (CF) and earlier findings also suggest a benefit in non-CF bronchiectasis. We investigated the efficacy and safety of maintenance TIS once daily (OD) in frequent exacerbating bronchiectasis patients chronically infected by different pathogens sensitive for tobramycin. Objective The primary outcome was the frequency of exacerbations during the 12-month study period. Secondary outcomes were time to first exacerbation, change in lung function and quality of life (QoL), bacterial analysis and safety. Materials/patients In this multicenter RCT patients aged ≥ 18-year-old were included with confirmed bronchiectasis and ≥ 2 exacerbations in the preceding year. Patients were assigned (1:1) to receive TIS or placebo OD for 1-year. Results 58 patients were included of which 52 were analyzed in the mITT analysis. TIS reduced exacerbation frequency with a RR of 0.74 (95% CI 0.49–1.14) (p = 0.15). Within the TIS population a decrease in number of exacerbations was found (2; p = 0.00), which was also seen in the placebo-treated patients (1.5; p = 0.00). In the TIS-treated patients the QoL improved (LRTI-VAS p = 0.02 Leicester Cough p = 0.02) without additional safety concerns. No differences were found for the other secondary outcomes. Conclusion Long-term TIS OD is a safe treatment modality and showed a non-significant reduced exacerbation frequency of 0.74 as compared to placebo in bronchiectasis patients chronically infected by tobramycin sensitive pathogens. TIS OD may be a potential therapeutic strategy in selected patients with bronchiectasis suffering from a high burden of disease. Trail registration number: The BATTLE study was registered at Clinical trials.gov number: NCT02657473. Date: 13 august 2016.
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