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An open-label randomized trial comparing itraconazole oral solution with fluconazole oral solution for primary prophylaxis of fungal infections in patients with haematological malignancy and profound neutropenia

Glasmacher, Axel ; Cornely, Oliver ; Ullmann, Andrew J. ; [et al.]

Oxford University Press (OUP) ; 2006

In: Journal of Antimicrobial Chemotherapy Vol. 57, No. 2 ( 2006-02-01), p. 317-325

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In: Journal of Antimicrobial Chemotherapy, Oxford University Press (OUP), Vol. 57, No. 2 ( 2006-02-01), p. 317-325

Type of Medium: Online Resource

ISSN: 1460-2091 , 0305-7453

URL: Article

DOI: 10.1093/jac/dki440

Language: English

Publisher: Oxford University Press (OUP)

Publication Date: 2006

detail.hit.zdb_id: 1467478-6

SSG: 15,3

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Randomized Trial of Single Compared With Tandem High-Dose Chemotherapy Followed by Autologous Stem-Cell Transplantation in Patients With Chemotherapy-Sensitive Metastatic Breast Cancer

Kröger, Nicolaus ; Frick, Markus ; Gluz, Oleg ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2006

In: Journal of Clinical Oncology Vol. 24, No. 24 ( 2006-08-20), p. 3919-3926

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 24, No. 24 ( 2006-08-20), p. 3919-3926

Abstract: To compare progression-free survival between single and tandem high-dose chemotherapy (HDT) followed by autologous stem-cell transplantation in chemotherapy-sensitive metastatic breast cancer patients. Patients and Methods Between February 1997 and June 2001, 187 patients with complete and partial remission were randomly assigned to receive either one or two cycles of HDT, consisting of thiotepa (125 mg/m 2 /d for 4 days), cyclophosphamide (1,500 mg/m 2 /d for 4 days), and carboplatin (200 mg/m 2 /d for 4 days), followed by autologous stem-cell transplantation. Results One hundred seventy one of 187 randomly assigned patients completed first HDT, but only 52 of 85 completed the second HDT cycle in the tandem HDT arm. The rate of complete remission on an intent-to-treat-basis was 33% in the single-dose HDT arm and 37% in the tandem HDT arm (P = .48). The median progression-free survival times in single and tandem HDT arms were 9.4 and 11.2 months, respectively (one-sided P = .06; two one-sided P = .12), whereas median overall survival time tended to be greater after single versus tandem HDT (29 v 23.5 months, respectively; P = .4). In a multivariate analysis for progression-free survival, tandem HDT (hazard ratio [HR] = 0.71; 95% CI, 0.52 to 0.98; P = .03) and achievement of complete remission after induction chemotherapy (HR = 0.59; 95% CI, 0.37 to 0.96; P = .03) were factors for a better progression-free survival, whereas the factor of three or more sites of metastases (HR = 1.66; 95% CI, 1.12 to 2.47; P = .01) was associated with a worse progression-free survival. Conclusion Despite a trend of improved progression-free survival, tandem HDT cannot be recommended for patients with chemotherapy-sensitive metastatic breast cancer because of a trend for shorter overall survival and higher toxicity compared with single HDT.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2005.04.0352

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2006

detail.hit.zdb_id: 2005181-5

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Final Results of a Randomized Phase III Trial of Sequential High-Dose Methotrexate, Fluorouracil, and Doxorubicin Versus Etoposide, Leucovorin, and Fluorouracil Versus Infusional Fluorouracil and Cisplatin in Advanced Gastric Cancer: A Trial of the European Organization for Research and Treatment of Cancer Gastrointestinal Tract Cancer Cooperative Group

Vanhoefer, Udo ; Rougier, Philippe ; Wilke, Hansjochen ; [et al.]

American Society of Clinical Oncology (ASCO) ; 2000

In: Journal of Clinical Oncology Vol. 18, No. 14 ( 2000-07-14), p. 2648-2657

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In: Journal of Clinical Oncology, American Society of Clinical Oncology (ASCO), Vol. 18, No. 14 ( 2000-07-14), p. 2648-2657

Abstract: PURPOSE: To compare the efficacy and tolerability of etoposide, leucovorin, and bolus fluorouracil (ELF) or infusional fluorouracil plus cisplatin (FUP) with that of the reference protocol of fluorouracil, doxorubicin, and methotrexate (FAMTX) in advanced gastric cancer. PATIENTS AND METHODS: A total of 399 patients with advanced adenocarcinoma of the stomach were randomized and analyzed for toxicity, tumor response, and progression-free and overall survival. Only reviewed and confirmed responses were considered. The analysis of remission was based on assessable patients with documented measurable lesions. The intent-to-treat principle, log-rank test, and Cox regression model were used for the statistical analysis of time-to-event end points. RESULTS: The overall response rate for 245 eligible patients with measurable disease was 9% with ELF, 20% with FUP, and 12% with FAMTX, with no significant differences. One hundred twelve patients were eligible for efficacy in assessable, nonmeasurable disease. No change was observed in 66% of patients treated with ELF, 56% with FUP, and 55% with FAMTX. Two patients achieved a complete tumor regression (one each for ELF and FAMTX). With a median follow-up time of 4.5 years, the median survival times were 7.2 months with ELF, 7.2 months with FUP, and 6.7 months with FAMTX, respectively, with no significant differences. Nonhematologic and hematologic toxicities of ELF, FUP, and FAMTX were acceptable, with neutropenia being the major toxicity for all three regimens. Seven treatment-related deaths occurred (two with FUP and five with FAMTX). CONCLUSION: All three investigated regimens demonstrate modest clinical efficacy and should not be regarded as standard treatment for advanced gastric cancer. New strategies should be considered to achieve a better clinical efficacy in the treatment of advanced gastric cancer.

Type of Medium: Online Resource

ISSN: 0732-183X , 1527-7755

URL: Article

DOI: 10.1200/JCO.2000.18.14.2648

RVK:

XA 52760

RVK:

XA 10000

Language: English

Publisher: American Society of Clinical Oncology (ASCO)

Publication Date: 2000

detail.hit.zdb_id: 2005181-5

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Quality of inter-hospital transportation in 431 transport survivor patients suffering from acute respiratory distress syndrome referred to specialist centers

Blecha, Sebastian ; Dodoo-Schittko, Frank ; Brandstetter, Susanne ; [et al.]

Springer Science and Business Media LLC ; 2018

In: Annals of Intensive Care Vol. 8, No. 1 ( 2018-12)

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In: Annals of Intensive Care, Springer Science and Business Media LLC, Vol. 8, No. 1 ( 2018-12)

Abstract: The acute respiratory distress syndrome (ARDS) is a life-threatening condition. In special situations, these critically ill patients must be transferred to specialized centers for escalating treatment. The aim of this study was to evaluate the quality of inter-hospital transport (IHT) of ARDS patients. Methods We evaluated medical and organizational aspects of structural and procedural quality relating to IHT of patients with ARDS in a prospective nationwide ARDS study. The qualification of emergency staff, the organizational aspects and the occurrence of critical events during transport were analyzed. Results Out of 1234 ARDS patients, 431 (34.9%) were transported, and 52 of these (12.1%) treated with extracorporeal membrane oxygenation. 63.1% of transferred patients were male, median age was 54 years, and 26.8% of patients were obese. All patients were mechanically ventilated during IHT. Pressure-controlled ventilation was the preferred mode (92.1%). Median duration to organize the IHT was 165 min. Median distance for IHT was 58 km, and median duration of IHT 60 min. Forty-two patient-related and 8 technology-related critical events (11.6%, 50 of 431 patients) were observed. When a critical event occurred, the PaO 2 /FiO 2 ratio before transport was significant lower (68 vs. 80 mmHg, p = 0.017). 69.8% of physicians and 86.7% of paramedics confirmed all transfer qualifications according to requirements of the German faculty guidelines (DIVI). Conclusions The transport of critically ill patients is associated with potential risks. In our study the rate of patient- and technology-related critical events was relatively low. A severe ARDS with a PaO 2 /FiO 2 ratio 〈 70 mmHg seems to be a risk factor for the appearance of critical events during IHT. The majority of transport staff was well qualified. Time span for organization of IHT was relatively short. ECMO is an option to transport patients with a severe ARDS safely to specialized centers. Trial registration NCT02637011 (ClinicalTrials.gov, Registered 15 December 2015, retrospectively registered)

Type of Medium: Online Resource

ISSN: 2110-5820

URL: Article

DOI: 10.1186/s13613-018-0357-y

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2018

detail.hit.zdb_id: 2617094-2

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Tracheostomy in patients with acute respiratory distress syndrome is not related to quality of life, symptoms of psychiatric disorders or return-to-work: the prospective DACAPO cohort study

Blecha, Sebastian ; Brandl, Magdalena ; Zeman, Florian ; [et al.]

Springer Science and Business Media LLC ; 2020

In: Annals of Intensive Care Vol. 10, No. 1 ( 2020-12)

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In: Annals of Intensive Care, Springer Science and Business Media LLC, Vol. 10, No. 1 ( 2020-12)

Abstract: Acute respiratory distress syndrome (ARDS) is a life-threatening condition that often requires prolonged mechanical ventilation. Tracheostomy is a common procedure with some risks, on the other hand with potential advantages over orotracheal intubation in critically ill patients. This study investigated the association of tracheostomy with health-related quality of life (HRQoL), symptoms of psychiatric disorders and return-to-work of ARDS survivors. Methods Data were collected in the context of the prospective observational German-wide DACAPO study. Clinical and demographic patient data and treatment characteristics were obtained from the participating intensive care units (ICU). HRQoL and return-to-work were assessed using patient-reported questionnaires 3, 6 and 12 months after ICU discharge. HRQoL was measured with the Physical and Mental Component Scale of the Short-Form 12 Questionnaire (PCS-12, MCS-12). The prevalence of psychiatric symptoms (depression and post-traumatic stress disorder [PTSD]) was assessed using the Patient Health Questionnaire-9 and the Post-Traumatic Stress Syndrome-14. Physician-diagnosed anxiety and obsessive–compulsive disorder were recorded by patient self-report in the follow-up questionnaires. The associations of tracheostomy with HRQoL, psychiatric symptoms and return-to-work after 12 months were investigated by means of multivariable linear and logistic regression models. Results Primary 877 ARDS patients (mean ± standard deviation: 54 ± 16 years, 68% male) survived and were discharged from ICU. Out of these patients, 478 (54.5%) were tracheotomised during ICU treatment. After 12 months, patient-reported outcomes could be analysed of 388 (44.2%) respondents, 205 with tracheostomy and 183 without. One year after ICU discharge, tracheostomy showed no significant association with physical or mental health-related quality of life (PCS-12: − 0.73 [− 3.96, 2.51]; MCS-12: − 0.71 [− 4.92, 3.49] ), symptoms of psychiatric disorders (depression: 0.10 [− 1.43, 1.64]; PTSD: 3.31 [− 1.81, 8.43] ; anxiety: 1.26 [0.41, 3.86]; obsessive–compulsive disorder: 0.59 [0.05, 6.68] ) or return-to-work (0.71 [0.31, 1.64]) in the multivariable analysis (OR [95%-CI] ). Conclusions Up to 1 year after ICU discharge, neither HRQoL nor symptoms of psychiatric disorders nor return-to-work was affected by tracheostomy. Trial registration NCT02637011 (ClinicalTrials.gov, Registered 15 December 2015, retrospectively registered)

Type of Medium: Online Resource

ISSN: 2110-5820

URL: Article

DOI: 10.1186/s13613-020-00671-x

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2020

detail.hit.zdb_id: 2617094-2

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A novel prognostic model in elderly patients with acute myeloid leukemia: results of 909 patients entered into the prospective AML96 trial

Röllig, Christoph ; Thiede, Christian ; Gramatzki, Martin ; [et al.]

American Society of Hematology ; 2010

In: Blood Vol. 116, No. 6 ( 2010-08-12), p. 971-978

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In: Blood, American Society of Hematology, Vol. 116, No. 6 ( 2010-08-12), p. 971-978

Abstract: We present an analysis of prognostic factors derived from a trial in patients with acute myeloid leukemia older than 60 years. The AML96 trial included 909 patients with a median age of 67 years (range, 61-87 years). Treatment included cytarabine-based induction therapy followed by 1 consolidation. The median follow-up time for all patients is 68 months (5.7 years). A total of 454 of all 909 patients reached a complete remission (50%). Five-year overall survival (OS) and disease-free survival were 9.7% and 14%, respectively. Multivariate analyses revealed that karyotype, age, NPM1 mutation status, white blood cell count, lactate dehydrogenase, and CD34 expression were of independent prognostic significance for OS. On the basis of the multivariate Cox model, an additive risk score was developed that allowed the subdivision of the largest group of patients with an intermediate-risk karyotype into 2 groups. We are, therefore, able to distinguish 4 prognostic groups: favorable risk, good intermediate risk, adverse intermediate risk, and high risk. The corresponding 3-year OS rates were 39.5%, 30%, 10.6%, and 3.3%, respectively. The risk model allows further stratification of patients with intermediate-risk karyotype into 2 prognostic groups with implications for the therapeutic strategy. This study was registered at www.clinicaltrials.gov as #NCT00180115.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood-2010-01-267302

RVK:

XA 33000

RVK:

XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2010

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

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Risk Stratification Using a New Prognostic Model for Patients with Secondary Acute Myeloid Leukemia - Results of the DSIL-AML96 Trial.

Stölzel, Friedrich ; Aulitzky, Walter E. ; Bodenstein, Heinrich ; [et al.]

American Society of Hematology ; 2009

In: Blood Vol. 114, No. 22 ( 2009-11-20), p. 2652-2652

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In: Blood, American Society of Hematology, Vol. 114, No. 22 ( 2009-11-20), p. 2652-2652

Abstract: Abstract 2652 Poster Board II-628 Background: Secondary acute myeloid leukemia (sAML) following a myelodysplastic syndrome (mdsAML) or deriving as therapy-related AML (tAML) is regarded as an entity with a poor prognosis and patients are normally treated as high risk AML. However due to progress in elucidating the impact of molecular and cytogenetic markers and therefore combining biological and clinical data for prognosis and treatment outcome the aim of this analysis was to provide a prognostic scoring system for this entity by including clinical and laboratory data from patients being treated in the prospective AML96 trial of the DSIL study group. Patients and methods: A total of 318 patients with sAML (mdsAML = 239 and tAML = 79) were treated within the AML96 trial with a median follow-up for patients alive of 5.66 years (95% CI 4.426 – 6.895). All patients received double induction chemotherapy. Consolidation therapy contained high-dose cytosine arabinoside and for patients ' 60 years of age the option of autologous or allogeneic hematopoietic stem cell transplantation (HSCT) according to donor availability. Prognostic factors for survival were analyzed in the whole group of sAML patients in a multivariate Cox regression model for overall survival (OS) stratified by treatment groups (chemo-consolidation vs. allogeneic HSCT). Model selection was performed by backward selection applying the Likelihood-Ratio-Test. Results: Complete remission (CR) rate for all patients was 30.8% (n = 96). CR rate was lower in patients with mdsAML compared to patients with tAML (25.9% vs. 44.3%, p=.003). Patients with mdsAML were older and had a higher percentage of CD34+ blasts at diagnosis but to a lower extend aberrant karyotypes than patients with tAML. OS and disease free survival (DFS) at three years for all patients was 15.8% and 20.6%, respectively. While disease status (mdsAML vs. tAML) had no independent influence on survival, the dichotomized prognostic factors platelet count in the peripheral blood at diagnosis [HR = 0.535 (95% CI .415 – .689), p= 〈 .000] as well as the NPM1 mutational status in the bone marrow at diagnosis [HR = 0.572 (95% CI .351 – .933), p=.025] were detected as independent predictors for overall survival. By combining these two variables, a prognostic model for OS with two risk groups for patients with sAML could be established with the low risk group being NPM1 positive or having platelets of 〉 50 Gpt/l at diagnosis and the high risk group being NPM1 negative and having platelets of '50 Gpt/l at diagnosis. Three year OS for patients who received chemo-consolidation in the low risk group was 19.9% [95% CI = .128 - .270] and for patients in the high risk group 5.1% [95% CI = .014 - .088] , p 〈 .001. For patients who underwent allogeneic HSCT in first CR belonging to the low risk group the three year OS was 53.8% [95% CI = .346 - .730] and for patients in the high risk group 15.4% [95% CI = .000 - .35] , p 〈 .001. Conclusions: For patients with sAML we provide a new prognostic model for risk stratification: 1) NPM1+ or Platelets 〉 50 Gpt/l defining a low risk group and 2) NPM1- and Platelets ' 50 Gpt/l defining a high risk group. Disclosures: No relevant conflicts of interest to declare.

Type of Medium: Online Resource

ISSN: 0006-4971 , 1528-0020

URL: Article

DOI: 10.1182/blood.V114.22.2652.2652

RVK:

XA 33000

RVK:

XA 10000

Language: English

Publisher: American Society of Hematology

Publication Date: 2009

detail.hit.zdb_id: 1468538-3

detail.hit.zdb_id: 80069-7

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dic(9; 20): A new recurrent chromosome abnormality in adult acute lymphoblastic leukemia

Rieder, Harald ; Schnittger, Susanne ; Bodenstein, Heinrich ; [et al.]

Wiley ; 1995

In: Genes, Chromosomes and Cancer Vol. 13, No. 1 ( 1995-05), p. 54-61

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In: Genes, Chromosomes and Cancer, Wiley, Vol. 13, No. 1 ( 1995-05), p. 54-61

Type of Medium: Online Resource

ISSN: 1045-2257 , 1098-2264

URL: Issue

URL: Journal

URL: Article

DOI: 10.1002/gcc.v13:1

DOI: 10.1002/(ISSN)1098-2264

DOI: 10.1002/gcc.2870130109

Language: English

Publisher: Wiley

Publication Date: 1995

detail.hit.zdb_id: 1018988-9

detail.hit.zdb_id: 1492641-6

SSG: 12

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Equitoxicity of bolus and infusional etoposide: results of a multicenter randomised trial of the German High-Grade Non-Hodgkins Lymphoma Study Group (DSHNHL) in elderly patients with refractory or relapsing aggressive non-Hodgkin lymphoma using the CEMP regimen (cisplatinum, etoposide, mitoxantrone and prednisone)

Zwick, Carsten ; Birkmann, Josef ; Peter, Norma ; [et al.]

Springer Science and Business Media LLC ; 2008

In: Annals of Hematology Vol. 87, No. 9 ( 2008-9), p. 717-726

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In: Annals of Hematology, Springer Science and Business Media LLC, Vol. 87, No. 9 ( 2008-9), p. 717-726

Type of Medium: Online Resource

ISSN: 0939-5555 , 1432-0584

URL: Article

DOI: 10.1007/s00277-008-0500-1

Language: English

Publisher: Springer Science and Business Media LLC

Publication Date: 2008

detail.hit.zdb_id: 1458429-3

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Epidermal Growth Factor Receptor-Related Tumor Markers and Clinical Outcomes with Erlotinib in Non-small Cell Lung Cancer: An Analysis of Patients from German Centers in the TRUST Study

Schneider, Claus-Peter ; Heigener, David ; Schott-von-Römer, Kathrin ; [et al.]

Elsevier BV ; 2008

In: Journal of Thoracic Oncology Vol. 3, No. 12 ( 2008-12), p. 1446-1453

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In: Journal of Thoracic Oncology, Elsevier BV, Vol. 3, No. 12 ( 2008-12), p. 1446-1453

Type of Medium: Online Resource

ISSN: 1556-0864

URL: Article

DOI: 10.1097/JTO.0b013e31818ddcaa

Language: English

Publisher: Elsevier BV

Publication Date: 2008

detail.hit.zdb_id: 2223437-8

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