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PubMed | Dr. Horst Schmidt Kliniken GmbH, Oncology, Lungenklinik Hemer, Pius Hospital Oldenburg and 10 more.
Type: Clinical Trial, Phase II | Journal: Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer | Year: 2016

Adjuvant chemotherapy in non-small cell lung cancer (NSCLC) improves survival but is associated with significant toxicity. The Randomized Phase II Trial on Refinement of Early-Stage NSCLC Adjuvant Chemotherapy with Cisplatin and Pemetrexed versus Cisplatin and Vinorelbine (TREAT study) was designed to test the hypothesis that a protocol with reduced toxicity might improve feasibility of postoperative delivery of adjuvant chemotherapy drugs to patients with NSCLC, thereby improving compliance and, potentially, survival.Two adjuvant regimens were evaluated for feasibility in 132 patients with NSCLC: the standard regimen of cisplatin and vinorelbine (CVb) (cisplatin 50 mg/m(2) on day 1 and day 8 and vinorelbine 25 mg/m(2) on days 1, 8, 15, and 22 every 4 weeks) and a regimen consisting of cisplatin and pemetrexed (CPx) (cisplatin 75 mg/m(2) and pemetrexed 500 mg/m(2) on day 1 every 3 weeks). The primary end-point analysis showing that CPx is safe and feasible with dose delivery superior to that of CVb has already been published. Here we report the 3-year follow-up results of the secondary efficacy end points-overall, relapse-free, distant metastasis-free, and local relapse-free survival-also with regard to histologic diagnosis.After a median of 39 months, no significant differences in any of the outcome parameters between CVb and CPx were observed. Also, histologic diagnosis and tumor size in stage IB did not influence survival in the CPx-treated patients. Yet, Cox regression analyses showed that overall survival at 3 years was significantly correlated with feasibility and the occurrence of dose-limiting toxicity.Although adjuvant chemotherapy with CPx is safe and characterized by less toxicity and better dose delivery than CVb, overall survival was not influenced by treatment arm in the context of this phase II trial.


Ewig S.,Thoraxzentrum Ruhrgebiet | Klapdor B.,Thoraxzentrum Ruhrgebiet | Pletz M.W.,Jena University Hospital | Rohde G.,Maastricht University | And 4 more authors.
Thorax | Year: 2012

Objective: To determine differences in aetiologies, initial antimicrobial treatment choices and outcomes in patients with nursing-home-acquired pneumonia (NHAP) compared with patients with community-acquired pneumonia (CAP), which is a controversial issue. Methods: Data from the prospective multicentre Competence Network for Community-acquired pneumonia (CAPNETZ) database were analysed for hospitalised patients aged ≥65 years with CAP or NHAP. Potential differences in baseline characteristics, comorbidities, physical examination findings, severity at presentation, initial laboratory investigations, blood gases, microbial investigations, aetiologies, antimicrobial treatment and outcomes were determined between the two groups. Results: Patients with NHAP presented with more severe pneumonia as assessed by CRB-65 (confusion, respiratory rate, blood pressure, 65 years and older) score than patients with CAP but received the same frequency of mechanical ventilation and less antimicrobial combination treatment. There were no clinically relevant differences in aetiology, with Streptococcus pneumoniae the most important pathogen in both groups, and potential multidrug-resistant pathogens were very rare (<5%). Only Staphylococcus aureus was more frequent in the NHAP group (n=12, 2.3% of the total population, 3.1% of those with microbial sampling compared with 0.7% and 0.8% in the CAP group, respectively). Short-term and long-term mortality in the NHAP group was higher than in the CAP group for patients aged ≥65 years (26.6% vs 7.2% and 43.8% vs 14.6%, respectively). However, there was no association between excess mortality and potential multidrug-resistant pathogens. Conclusions: Excess mortality in patients with NHAP cannot be attributed to a different microbial pattern but appears to result from increased comorbidities, and consequently, pneumonia is frequently considered and managed as a terminal event.


PubMed | Coswig Specialist Hospital, Immunology and Laboratory Medicine, Charité - Medical University of Berlin, Lungenklinik Heckeshorn and 7 more.
Type: Journal Article | Journal: Pneumologie (Stuttgart, Germany) | Year: 2016

Non-tuberculous mycobacterioses comprise a group of diseases caused by mycobacteria which do not belong to the Mycobacterium (M.) tuberculosis-complex and are not ascribed to M. leprae. These mycobacteria are characterized by a broad variety as to environmental distribution and adaptation. Some of the species may cause specific diseases, especially in patients with underlying immunosuppressive diseases, chronic pulmonary diseases or genetic predisposition, respectively. Worldwide, a rising prevalence and significance of non-tuberculous mycobacterioses is recognized. The present recommendations summarise current aspects of epidemiology, pathogenesis, clinical aspects, diagnostics - especially microbiological methods including susceptibility testing -, and specific treatment for the most relevant species. Diagnosis and treatment of non-tuberculous mycobacterioses during childhood and in HIV-infected individuals are described in separate chapters.


PubMed | University of Belgrade, Cancer Research and Biostatistics, Mayo Clinic and Mayo Foundation and Lungenklinik Heckeshorn
Type: Editorial | Journal: Journal of thoracic disease | Year: 2017

Although survival analyses represent one of the cornerstones in oncology in general, some aspects of the reported survival data in lung cancer patients are still not fully elucidated.After having defined several open questions, an evidence based approach was applied in order to answer these questions. Areas of interest were: (I) possible uncertainties in reported survival data; (II) survival surrogates; (III) recommended methods for evaluating progression free survival (PFS) as a surrogate endpoint in future datasets; (IV) postoperative lung cancer recurrence and survival.In recent years, PFS has seen increasing use as a primary endpoint, particularly in phase II trials. This article focuses on the statistical aspects, and particularly on evaluating the ability of PFS to accurately predict the overall survival (OS) outcome. If the data are available from randomized trials, then the evaluation of trial level surrogacy should be carried out, in addition to the methods described in the paper. If it is not a case, the patient-level methods should be applied. Suggestions for landmark analysis are also given: (I) classify your cases according to progression status (progressed, progression-free, or unknown) at one or more time points of interest; (II) perform a separate Cox proportional hazards regression analysis for each time point; (III) determine and report the landmark time point where progression status best predicts survival according to the hazard ratios and P values; (IV) calculate the concordance index for each landmark analysis model. The concordance index (or c-Index) is essentially the probability that for any two randomly selected cases, the case that is predicted to have the worst outcome, does in fact have the worst outcome.the widening spectrum of diagnostic and treatment in pulmonary oncology imposes the need for an updated knowledge about statistical method that would fit best for the analysed problem.


Otto-Knapp R.,Lungenklinik Heckeshorn | Cortes C.P.,University of Chile | Saavedra F.,University of Chile | Wolff M.,University of Chile | Weitzel T.,University for Development
International Journal of Infectious Diseases | Year: 2013

Objectives: To analyze the prevalence of hepatitis B virus (HBV) co-infection and its influence on mortality and treatment outcome within a large AIDS cohort in Chile. Methods: Clinical and epidemiological data from the Chilean AIDS Cohort were retrospectively analyzed. Adult patients tested for hepatitis B surface antigen (HBsAg) during the time period of October 2001 to October 2007 were included. Results: Of 5115 cohort patients, 1907 met the inclusion criteria. The prevalence of HBV co-infection was 8.4%. Overall mortality rates were 2.15 and 1.77 per 100 person-years for HBsAg-positive and HBsAg-negative HIV patients, respectively, with a mortality rate ratio of 1.22 (95% confidence interval 0.58-2.54). Kaplan-Meier survival and Cox regression analysis did not show significant differences between the groups. Virological and immunological responses to antiretroviral therapy (ART) were not influenced by HBsAg status, but in co-infected patients, initial ART was more frequently changed. Conclusions: The prevalence of hepatitis B co-infection was 8.4%, indicating a markedly elevated hepatitis B risk compared to the general population in Chile. Neither treatment outcome nor overall mortality was influenced by hepatitis B co-infection. Still, patients with hepatitis B co-infection had less stable ART regimens, which might be related to a higher risk of hepatotoxic drug effects. © 2013.


Griff S.,Institute of Pathology | Ammenwerth W.,Lungenklinik Heckeshorn | Schonfeld N.,Lungenklinik Heckeshorn | Bauer T.T.,Lungenklinik Heckeshorn | And 4 more authors.
Diagnostic Pathology | Year: 2011

The recent introduction of bronchoscopically recovered cryobiopsy of lung tissue has opened up new possibilities in the diagnosis of neoplastic and non-neoplastic lung diseases in various aspects. Most notably the morphological diagnosis of peripheral lung biopsies promises to achieve a better yield with a high quality of specimens. To better understand this phenomenon, its diagnostic options and perspectives, this study morphometrically compares 15 cryobiopsies and 18 transbronchial forceps biopsies of peripheral lung tissue a priori without considering clinical hit ratio or integration of results in the clinical diagnostic processing. Cryotechnically harvested specimens were significantly larger (mean: 17.1 ± 10.7 mm2versus 3.8 ± 4.0 mm2) and contained alveolar tissue more often. If present, the alveolar part in cryobiopsies exceeded the one of forceps biopsies. The alveolar tissue of crybiopsy specimens did not show any artefacts. Based on these results cryotechnique seems to open up new perspectives in bronchoscopic diagnosis of lung disease. © 2011 Griff et a; licensee BioMed Central Ltd.


Background: Pre-existing underlying bronchopulmonary diseases and relative impairments of the immune system are risk factors that predispose to the development of pulmonary infections with non-tuberculous mycobacteria (NTM), even if the impairment is not severe. Methods: In a prospective study n=111 patient diagnoses between 1992 and 2004 were included. The criterion for inclusion was laboratory evidence of non-tuberculous mycobacteria. The local risk factors and general risks were recorded for each case and the total number of risks for each patient was counted. Risk profiles were drawn up and risk scores calculated for different groups. Results: N=66 patients met the ATS criteria for NTM disease. The disease rates for the most frequent species varied widely (M. avium complex 57%, M. kansasii 100%, M. xenopi 73%). Older women (>65 years) with M. avium complex were rarely ill. The risk factors were almost equally frequent for patients meeting criteria for disease status and those who did not and patients under 65 years of age had fewer local risk factors than older patients. Patients with M. gordonae showed fewer local risk factors than patients with M. avium complex or M. xenopi. Conclusions: Even local risk factors predispose towards infections with mycobacteria and do not only lead to disease after infection. Bullous changes of the lungs, cavities and bronchiectasis are local risk factors, but can also develop as sequelae of mycobacteriosis. There is sufficient evidence to support the continued use of the concept of colonisation alongside those of infection with and infection without disease status. In our region, a thorough evaluation is needed to establish whether older women with M. avium complex actually have mycobacteriosis. © Georg Thieme Verlag KG Stuttgart New York.


Misch D.,Lungenklinik Heckeshorn | Kollmeier J.,Lungenklinik Heckeshorn
Atemwegs- und Lungenkrankheiten | Year: 2016

Gemcitabin and pemetrexed are 3rd generation chemotherapeutic agents. Both are implemented in standard therapy algorithms in combination with platinum agents or as monotherapy for the treatment of non-smallcell lung cancer (NSCLC) and pleural mesothelioma. © 2016 Dustri-Verlag Dr. Karl Feistle.


Nontuberculous mycobacterioses are rare but nonetheless extremely polymorphic diseases. Their incidence has never been systematically recorded. Diagnosis and treatment of diseases follow recommendations that are mainly not based on the evidence of prospective studies, but on a broad base of experience. Semiquantitative microbiological criteria on the detection of bacteria for a reliable diagnosis have been propagated for more than two decades, but need to be evaluated for their practicality repeatedly. Susceptibility tests for antimycobacterial drugs in vitro as the basis of therapeutic concepts are judged very controversial, their benefits, however, are increasingly regarded as plausible. © 2016 Dustri-Verlag Dr. Karl Feistle.


PubMed | Institute of Microbiology and Lungenklinik Heckeshorn
Type: | Journal: Tuberculosis (Edinburgh, Scotland) | Year: 2016

Due to an increase of drug resistant TB, alternative drugs that are not currently listed in the WHO guidelines on MDR TB treatment are currently being evaluated. Our group tested 100 susceptible, 20 MDR and 2 XDR Mtb strains against the phenothiazine derivatives thioridazine, trifluoperazine and triflupromazine. MIC testing was performed on Middlebrook 7H10 agar and was defined as the lowest drug concentration that inhibits 99% of the bacterial population. We confirm very good invitro activity of phenothiazines against Mycobacterium tuberculosis. In >77% of all strains MICs of 10g/ml were found.

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