BACKGROUND Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is superior to conventional transbronchial needle aspiration (cTBNA) in the staging of lung cancer. However, ...its efficiency in diagnosis of sarcoidosis when combined with endobronchial biopsy (EBB) and transbronchial lung biopsy (TBLB) has not been studied. This randomized controlled trial compares diagnostic yield of EBUS-TBNA vs cTBNA in combination with EBB and TBLB. METHODS Patients with clinical diagnosis of sarcoidosis were randomized 1:1 to EBUS-TBNA or cTBNA. All patients underwent TBLB and EBB. The primary outcome was detection of granulomas. The secondary end points were the individual and cumulative yields of various procedures, serious adverse events, and procedure time. RESULTS Of the 130 patients, sarcoidosis was diagnosed in 117 (62 cTBNA, 55 EBUS-TBNA). The two groups were similar at baseline. Granulomas were demonstrated in 104 (53 cTBNA, 51 EBUS-TBNA) patients and were similar in two groups (85.5% vs 92.7%, P = .34). Individually, EBUS-TBNA had the highest yield (41 of 55, 74.5%), which was better than cTBNA (30 of 62, 48.4%, P = .004) or EBB (40 of 111, 36.3%, P < .0001) but not TBLB (78 of 112, 69.6%, P = .54). Adding EBB/TBLB to cTBNA led to an increase in granuloma detection, whereas the addition of TBLB (but not EBB) significantly enhanced the yield of EBUS-TBNA. The procedure time was significantly longer with EBUS-TBNA. No major adverse events occurred. CONCLUSIONS Individually, EBUS-TBNA has the highest diagnostic yield in sarcoidosis, but it should be combined with TBLB for the optimal yield. The diagnostic yield of cTBNA (plus EBB and TBLB) is similar to EBUS-TBNA plus TBLB. TRIAL REGISTRY ClinicalTrials.gov ; No.: NCT01908868; URL: www.clinicaltrials.gov
Objective The differential diagnosis of sarcoidosis and tuberculosis is difficult, especially in countries with a high tuberculosis burden. We hypothesized that sonographic features on endobronchial ...ultrasonography (EBUS) would help in differentiating tuberculosis from sarcoidosis. In this study, the endosonographic features of tuberculosis and sarcoidosis are compared. Methods This was a retrospective analysis of prospectively collected data of patients with intrathoracic lymphadenopathy who underwent EBUS-guided transbronchial needle aspiration (TBNA), and were finally diagnosed with sarcoidosis or tuberculosis. Sonographic features such as size, shape (round or oval), margin (distinct or indistinct), echogenicity (heterogeneous or homogeneous), presence or absence of a central hilar structure, and coagulation necrosis sign were recorded and compared in the 2 groups. Results During the study period, 249 EBUS-guided TBNA procedures were performed and a diagnosis of sarcoidosis (n = 118) or tuberculosis (n = 47) was made in 165 patients. A total of 358 lymph node stations were examined. Heterogeneous echotexture (53.4% vs 12.6%, P < .001) and coagulation necrosis (26.1% vs 3.3%; P < .001) were significantly higher in tuberculous lymph nodes. A combination of a positive tuberculin skin test (TST) and either heterogeneous echotexture or coagulation necrosis sign had specificity of 98% and positive predictive value of 91% for a diagnosis of tuberculosis. Conclusions Sonographic features of heterogeneous echotexture or coagulation necrosis in the lymph nodes on EBUS are fairly specific for tuberculosis. Along with a positive TST, these features strongly favor a diagnosis of tuberculosis over sarcoidosis.
Summary Background Cilengitide is a selective αvβ3 and αvβ5 integrin inhibitor. Data from phase 2 trials suggest that it has antitumour activity as a single agent in recurrent glioblastoma and in ...combination with standard temozolomide chemoradiotherapy in newly diagnosed glioblastoma (particularly in tumours with methylated MGMT promoter). We aimed to assess cilengitide combined with temozolomide chemoradiotherapy in patients with newly diagnosed glioblastoma with methylated MGMT promoter. Methods In this multicentre, open-label, phase 3 study, we investigated the efficacy of cilengitide in patients from 146 study sites in 25 countries. Eligible patients (newly diagnosed, histologically proven supratentorial glioblastoma, methylated MGMT promoter, and age ≥18 years) were stratified for prognostic Radiation Therapy Oncology Group recursive partitioning analysis class and geographic region and centrally randomised in a 1:1 ratio with interactive voice response system to receive temozolomide chemoradiotherapy with cilengitide 2000 mg intravenously twice weekly (cilengitide group) or temozolomide chemoradiotherapy alone (control group). Patients and investigators were unmasked to treatment allocation. Maintenance temozolomide was given for up to six cycles, and cilengitide was given for up to 18 months or until disease progression or unacceptable toxic effects. The primary endpoint was overall survival. We analysed survival outcomes by intention to treat. This study is registered with ClinicalTrials.gov , number NCT00689221. Findings Overall, 3471 patients were screened. Of these patients, 3060 had tumour MGMT status tested; 926 patients had a methylated MGMT promoter, and 545 were randomly assigned to the cilengitide (n=272) or control groups (n=273) between Oct 31, 2008, and May 12, 2011. Median overall survival was 26·3 months (95% CI 23·8–28·8) in the cilengitide group and 26·3 months (23·9–34·7) in the control group (hazard ratio 1·02, 95% CI 0·81–1·29, p=0·86). None of the predefined clinical subgroups showed a benefit from cilengitide. We noted no overall additional toxic effects with cilengitide treatment. The most commonly reported adverse events of grade 3 or worse in the safety population were lymphopenia (31 12% in the cilengitide group vs 26 10% in the control group), thrombocytopenia (28 11% vs 46 18%), neutropenia (19 7% vs 24 9%), leucopenia (18 7% vs 20 8%), and convulsion (14 5% vs 15 6%). Interpretation The addition of cilengitide to temozolomide chemoradiotherapy did not improve outcomes; cilengitide will not be further developed as an anticancer drug. Nevertheless, integrins remain a potential treatment target for glioblastoma. Funding Merck KGaA, Darmstadt, Germany.
Endobronchial ultrasound (EBUS) is the preferred minimally invasive technique for the evaluation of intrathoracic lymphadenopathy. Enlarged lymph nodes on computed tomography (CT) are defined as ...those 1 cm or larger in short-axis diameter. Whether there is agreement between the measurements of lymph node size on CT and EBUS remains unknown.
This was a retrospective analysis of prospectively collected data from patients who underwent EBUS-guided transbronchial needle aspiration (TBNA) for intrathoracic lymphadenopathy. The diameters of lymph nodes were measured in an axis perpendicular to the airway on both CT and EBUS. The correlation and agreement between the two measurements were analyzed.
During the study period, 617 patients (mean age, 46.0 years standard deviation, 15.2), of whom 239 (38.7%) were women, underwent EBUS. A total of 1,153 lymph nodes were measured by CT and EBUS. Although there was a moderate correlation between the two modalities for lymph node size (Pearson correlation coefficient = 0.49, p < 0.001), the limits of agreement between CT and EBUS were wide (mean bias, 0.1; limits of agreement, -15.6 to 15.9 mm). The limits of agreement were wide for all categories of lymph nodes (benign vs malignant, distinct vs indistinct margin, and ≤2-cm vs >2-cm nodes).
Despite a significant correlation between CT of the chest and EBUS for measuring the size of intrathoracic lymph nodes, the limits of agreement were fairly wide enough to be clinically acceptable for allowing the use of the two modalities interchangeably for this purpose.