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  • 1
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    German Medical Science; Düsseldorf, Köln
    In:  27. Deutscher Krebskongress; 20060322-20060326; Berlin; DOCPO138 /20060320/
    Publication Date: 2006-04-21
    Keywords: ddc: 610
    Language: English
    Type: conferenceObject
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  • 2
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    German Medical Science GMS Publishing House; Düsseldorf
    In:  124. Kongress der Deutschen Gesellschaft für Chirurgie; 20070501-20070504; München; DOC07dgch7452 /20071001/
    Publication Date: 2007-10-02
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 3
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    German Medical Science; Düsseldorf, Köln
    In:  27. Deutscher Krebskongress; 20060322-20060326; Berlin; DOCPO130 /20060320/
    Publication Date: 2006-04-21
    Keywords: ddc: 610
    Language: English
    Type: conferenceObject
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  • 4
    Keywords: Study protocol, PANUSCO, pancreatic adenocarcinoma
    Abstract: Background: Pancreatic cancer is an extremely aggressive malignancy. Subjects are afflicted with a variety of disconcerting symptoms, including profound cachexia. Recent data indicate that the outcome of oncological patients suffering from cancer cachexia could be improved by parenteral nutrition and that parenteral nutrition results in an improvement of quality of life and in prolonged survival. Currently, there is no recommendation of routine use of parenteral nutrition. Furthermore, there is no clear recommendation for 2nd line therapy (or higher) for pancreatic adenocarcinoma but often asked for. Methods/Design: PANUSCO is an open label, controlled, prospective, randomized, multicentre phase IIIb trial with two parallel arms. All patients will be treated with 5-fluorouracil, folinic acid and oxaliplatin on an outpatient basis at the study sites. Additionally, all patients will receive best supportive nutritional care (BSNC). In the experimental group BSNC will be expanded with parenteral nutrition (PN). In contrast, patients in the control group obtain solely BSNC. Parenteral nutrition will be applied overnight and at home by experienced medical staff. A total of 120 patients are planned to be enrolled. Primary endpoint is the comparison of the treatment groups with respect to event-free survival (EFS), defined as the time from randomization till time to development of an event defined as either an impairment (change from baseline of at least ten points in EORTC QLQ-C30, functional domain total score) or withdrawal due to fulfilling the special defined stopping criteria for chemotherapy as well as for nutritional intervention (NI) or death from any cause (whichever occurs first). Discussion: The aim of this clinical trial is to evaluate whether parenteral nutrition in combination with defined 2nd line or higher chemotherapy has an impact on quality of life for patients suffering from pancreatic adenocarcinoma. Trial registration: Current Controlled Trials ISRCTN60516908.
    Type of Publication: Journal article published
    PubMed ID: 19943918
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  • 6
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    German Medical Science; Düsseldorf, Köln
    In:  GMS German Medical Science; VOL: 4; DOC02 /20060213/
    Publication Date: 2006-02-14
    Description: Objective: Therapeutic vaccination with dendritic cells (DC) showed promising results in first clinical trials in cases of metastatic renal cell carcinoma (RCC). Human telomerase reverse transcriptase (hTERT) could be a potential target because it is detectable in more than 85% of human tumors including RCC.Design: 10 patients with progressive metastatic RCC were enrolled in a clinical phase I/II trial using DC pulsed with hTERT-peptide. Beside toxicity and feasibility aspects, a complex immune monitoring including in vitro data were evaluated. In addition to detection of tumor-specific effector cells we investigated their functionality like IFN-gamma secretion and cytotoxic activity against tumor cells.Results: The vaccine was well tolerated. Two patients showed a mixed response (MR) and one patient a stable disease (SD). Interestingly, responders showed cytotoxic activity already before start of therapy and there was a significant increase in cytotoxic activity of effector cells from all responders (SD and MR patients) after the first vaccination. In contrast non-responders showed no cytotoxic activity before and during treatment. Therefore, cytotoxic activity might be used as a predictive marker in the future. Tetramer staining detected higher amounts of tumor-specific cytotoxic cells in responding patients compared to non-responders. Also, responders possessed increasing amounts of IFN-gamma producing immunological effector cells.Conclusion: Telomerase-pulsed DC could enhance a tumor-specific immune response against RCC.
    Description: Ziel: Therapeutische Impfungen mit Antigen-beladenen dendritischen Zellen (DC) zeigten in ersten klinischen Versuchen bei Patienten mit metastasierendem Nierenzellkarzinom (RCC) vielversprechende Ergebnisse. Die menschliche Telomerase-reverse-Transkriptase (hTERT) könnte ein mögliches Zielantigen sein, da sie in 85% aller menschlichen Tumore einschließlich dem Nierenzellkarzinom nachweisbar ist.Methodik: 10 Patienten mit fortschreitend metastasierendem RCC wurden in einer klinischen Phase I/II-Studie untersucht, nachdem sie mehrere intratumorale Impfungen aus hTERT-beladenen autologen DCs erhalten haben. Neben Überprüfung der Verträglichkeit wurden verschiedenste in vitro Analysen durchgeführt, die Aussagen über den Immunstatus der Patienten geben sollen. Hierbei wurde sowohl nach tumor-spezifischen Effektorzellen geschaut, als auch deren Funktionalität in Form von IFN-gamma Sekretion oder Zytotoxizität gegenüber Tumorzellen untersucht.Ergebnisse: Die Impfungen wurden von allen Patienten gut vertragen. Zwei Patienten zeigten eine Mischantwort (MR) mit Rückbildung der punktierten Metastase und ein Patient zeigte eine Stabilisierung (SD) mit unverändertem Krankheitsverlauf. Erstaunlicherweise konnte bei den ansprechenden Patienten schon vor Studienbeginn eine Zytotoxizität von Effektorzellen nachgewiesen werden, die nach der 1. Impfung signifikant anstieg. Demgegenüber zeigten die nicht-ansprechenden Patienten vor, während und nach der Behandlung keine zytotoxische Aktivität gegenüber Tumorzellen. Folglich könnte die Zytotoxizität von Effektorzellen in Zukunft als Prognosemarker verwendet werden. Die ansprechenden Patienten besaßen im Vergleich zu den nicht-ansprechenden Patienten eine höhere Anzahl an Tumor-spezifischen zytotoxischen Zellen sowie IFN-gamma produzierenden Effektorzellen.Schlussfolgerung: Wir konnten zeigen, dass eine Impfung mit Telomerase-beladenen autologen DCs eine in geringem Ausmaß vorhandene Tumor-spezifische Immunantwort signifikant verstärken kann.
    Keywords: HUMANS ; MALE ; AGED ; MIDDLE AGED ; ANTIGENS, NEOPLASM/* ; ANTIGENS, NEOPLASM/*immunology ; CARCINOMA, RENAL CELL/* ; CARCINOMA, RENAL CELL/immunology ; CARCINOMA, RENAL CELL/*therapy ; KIDNEY NEOPLASMS/* ; KIDNEY NEOPLASMS/immunology ; KIDNEY NEOPLASMS/*therapy ; NEOPLASM METASTASIS/immunology ; NEOPLASM METASTASIS/therapy ; CELL LINE, TUMOR ; CYTOTOXICITY, IMMUNOLOGIC ; DENDRITIC CELLS/* ; DENDRITIC CELLS/*immunology ; TELOMERASE/* ; TELOMERASE/*immunology ; IMMUNOTHERAPY/* ; MENSCH ; MÄNNLICH ; ALTE MENSCHEN ; MENSCHEN IM MITTLEREN LEBENSALTER ; ANTIGENE, TUMOR-/* ; ANTIGENE, TUMOR-/*Immunologie ; KARZINOM, NIERENZELL-/* ; KARZINOM, NIERENZELL-/Immunologie ; KARZINOM, NIERENZELL-/*Therapie ; NIERENTUMOREN/* ; NIERENTUMOREN/Immunologie ; NIERENTUMOREN/*Therapie ; TUMORMETASTASIERUNG/Immunologie ; TUMORMETASTASIERUNG/Therapie ; ZELLINIE, TUMOR- ; ZYTOTOXIZITÄT, IMMUNOLOGISCHE ; DENDRITISCHE ZELLEN/* ; DENDRITISCHE ZELLEN/*Immunologie ; TELOMERASE/* ; TELOMERASE/*Immunologie ; IMMUNTHERAPIE/* ; dendritic cell vaccination ; telomerase ; immunotherapy ; renal cancer ; T-cell responses ; Dendritische Zellen ; Telomerase ; Immuntherapie ; Nierenzellkarzinom ; T-Zell-Antwort ; Antigens, Neoplasm ; Telomerase ; ddc: 610
    Language: English
    Type: article
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  • 7
    Keywords: TRIAL ; chemotherapy ; adenocarcinoma ; DOUBLE-BLIND ; ACQUIRED-RESISTANCE ; SUPPORTIVE CARE ; EGFR MUTATIONS ; tyrosine kinase inhibitors ; RANDOMIZED PHASE-II ; BIBW 2992
    Abstract: Background. Afatinib, an irreversible ErbB family blocker, demonstrated superiority to chemotherapy as first-line treatment in patients with EGFR-mutated non-small cell lung cancer (NSCLC). Afatinib is also active in patients progressing on EGFR tyrosine kinase inhibitors (EGFR-TKIs). We report the results of a large cohort of NSCLC patients receiving afatinib within a compassionate-use program (CUP). Patients and Methods. Patients with advanced NSCLC progressing after one line or more of chemotherapy and one line or more of EGFR-TKI treatment with either an EGFR mutation or documented clinical benefit were enrolled. Data collection was not monitored or verified by central review. The intention of this CUP was to provide controlled preregistration access to afatinib for patients with life-threatening diseases and no other treatment option. Results. From May 2010 to October 2013, 573 patients (65% female; medianage: 64years [range: 28-89years]) were enrolled, with strong participation of community oncologists. Comorbidities were allowed, including second malignancies in 11% of patients. EGFR mutation status was available in 391 patients (72%), and 83% tested mutation positive. Median time to treatment failure (TTF) of 541 patients treated with afatinib was 3.7 months (range: 0.0 to 〉29.0 months). Median TTF was 4.0 and 2.7 months in patients with adenocarcinomas and squamous cell carcinomas, respectively, and 4.6 months in patients with EGFR-mutated NSCLC. Adverse events were generally manageable. Conclusion. Afatinib was able to be given in areal-world setting to heavily pretreated patients with EGFR-mutated or EGFR-TKI-sensitive NSCLC. Acknowledging the constraints of data collection in a CUP, afatinib appears to be safe and to confer some clinical benefit in this population.
    Type of Publication: Journal article published
    PubMed ID: 25232040
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  • 8
    Keywords: CANCER ; tumor ; carcinoma ; CLINICAL-TRIAL ; Germany ; THERAPY ; POPULATION ; RISK ; TUMORS ; radiation ; PATIENT ; MARKER ; LYMPH-NODES ; FORM ; TARGET ; TRIAL ; TRIALS ; RADIATION-THERAPY ; CLINICAL-TRIALS ; chemotherapy ; adenocarcinoma ; SELECTION ; VALIDITY ; CISPLATIN ; pancreatic cancer ; pancreatic carcinoma ; ADJUVANT ; MULTICENTER ; GEMCITABINE ; pancreas ; PANCREATIC-CANCER ; THERAPIES ; radiation therapy ; pancreatic adenocarcinoma ; PROGNOSTIC MARKER ; USA ; CURATIVE RESECTION ; EXTENT ; CONTROLLED-TRIAL ; SELECTION BIAS ; 33 ; RESTRICTION ; clinical research ; adjuvant treatment ; CLINICAL-PRACTICE GUIDELINES ; ELIGIBILITY ; external validity
    Abstract: Objectives: Clinical trials are a prerequisite for evidence-based medicine. Trial representativity by internal and external validities is an assumption for a transfer into the real world. Methods: A questionnaire addressing several forms of bias was established. Randomized controlled trials for adjuvant treatment of pancreatic adenocarcinoma with an evidence level of lower than 2 were selected and evaluated for internal and external validities focusing on selection bias. Results: Four selected trials (European Study Group for Pancreatic Cancer 1 [ESPAC-1], Charite Onkologie Clinical Studies in GI Cancer 001 [CONKO 001], Radiation Therapy Oncology Group 97-04 [RTOG 97-04], and Adjuvant Chemoradioimmunotherapy of Pancreatic Carcinoma [CapRI]) proved to be evaluable. External validity was to a large extent given in the trials, whereby Radiation Therapy Oncology Group 97-04 included significantly more patients with better prognostic markers (negative for lymph nodes and T1/T2 tumors). Their inclusion and exclusion criteria are limited to the (unavoidable) restrictions for safety reasons and clinical restrictions. Comparison of participants with nonparticipants and with the target population via literature research proved to be preventive against selection and recruitment biases. A possible detection bias in the Charite Onkologie Clinical Studies in GI Cancer 001 trial cannot, however, be excluded. Conclusions: The analyzed trials have acceptable internal and external validities despite some minor criticisms. The protocols could be transferred into the clinical routine. It is recommended to open the inclusion criteria of trials wider and to implement the comparison with the target population
    Type of Publication: Journal article published
    PubMed ID: 19287330
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  • 9
    Keywords: CANCER ; CELLS ; tumor ; TUMOR-CELLS ; BLOOD ; carcinoma ; CELL ; Germany ; IN-VIVO ; DIAGNOSIS ; screening ; SYSTEM ; RISK ; PROTEIN ; PROTEINS ; MARKER ; BINDING ; CARCINOMA CELLS ; PLASMA ; COLORECTAL-CANCER ; inactivation ; MARKERS ; RECURRENCE ; adenocarcinoma ; IMMUNE-RESPONSE ; LUNG-CANCER CELLS ; ONCOLOGY ; PHASE ; COMPLEMENT ACTIVATION ; diagnostic marker ; FACTOR-H ; REGULATORY PROTEINS ; adjuvant treatment ; BENEFIT ; RANK STATISTICS ; 2 PARTS ; complement system pancreatic carcinoma ; iC3b
    Abstract: Pancreatic adenocarcinoma as an aggressive tumor still lacks specific markers. Resection offers the only potential cure, and earlier diagnosis could benefit many patients. Here, we analyzed siC3b as a potential diagnostic marker. Soluble iC3b is generated in the fluid phase after binding of autoantibodies to tumor cells and subsequent inactivation of the complement cascade by interaction with complement regulatory proteins. Two hundred thirty-two plasma samples from patients with adjuvant treatment after resection, from healthy volunteers, and from vulnerable patients were collected prospectively and analyzed for siC3b. Every 3 months, the patients underwent imaging and the results from siC3b enzyme-linked immunosorbent assay were categorized according to radiologically defined recurrence within 4 months after blood withdrawal. Furthermore, the regulatory factors of the complement system were analyzed in tumor cells and in urine. The most important finding was that up to 4 months before radiologically defined recurrence, siC3b plasma level is increased with a sensitivity and specificity resulting in an area under the curve of 0.85, which could be further increased by combining it with CA19.9 ( area under the curve = 0.92). Complement regulatory proteins are highly expressed in pancreatic carcinoma cells and detectable in the patient's urine. In summary, screening for siC3b in patients with an increased risk for pancreatic ductal adenocarcinoma ( patients with chronic pancreatitis, hereditary pancreatitis, after curative resection, and patients with a variety of familial cancer syndromes) allows for early detection with high sensitivity, as siC3b plasma levels are increased up to 4 months before radiologic evidence. Sensitivity could be further increased by combining this approach with CA19.9
    Type of Publication: Journal article published
    PubMed ID: 20139773
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  • 10
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