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  • 1
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    German Medical Science; Düsseldorf, Köln
    In:  121. Kongress der Deutschen Gesellschaft für Chirurgie; 20040427-20040430; Berlin; DOC04dgch0573 /20041007/
    Publication Date: 2004-10-07
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 2
    Keywords: CANCER ; radiotherapy ; carcinoma ; Germany ; imaging ; DRUG ; NUCLEAR-MEDICINE ; PATIENT ; MRI ; treatment ; metastases ; chemotherapy ; CERVICAL-CARCINOMA ; UTERINE CERVIX ; cervical carcinoma ; CISPLATIN ; nuclear medicine ; radiology ; ONCOLOGY ; SEIZURES ; NUCLEAR ; DRUGS ; UNIT ; RARE ; BRACHYTHERAPY ; MEDICINE ; intracranial ; medical imaging ; RADIOCHEMOTHERAPY ; cervix carcinoma ; leukoencephalopathy ; POSTERIOR LEUKOENCEPHALOPATHY SYNDROME ; toxic encephalopathy
    Abstract: Case Report: A 45-year-old patient with cervix carcinoma received combined radiochemotherapy including cisplatin. After a cumulative dose of 240 mg/m(2)supercript stop the patient suddenly became somnolent and developed a severe tetraparesis and generalized seizures. After ruling out intracranial bleeding, cerebral metastases as well as infectious and metabolic causes of this condition, a severe toxic encephalopathy was diagnosed based on the clinical findings and MRI scans. After symptomatic treatment on the intensive care unit all symptoms were completely reversible. Conclusion: Toxic encephalopathy is a rare but dramatic complication of various cytostatic drugs. With the widespread use of cisplatin this rare disorder should be kept in mind
    Type of Publication: Journal article published
    PubMed ID: 17762922
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  • 3
    Keywords: ANGIOGENESIS ; ADVANCED SOLID TUMORS ; carcinoma ; ENDOTHELIAL GROWTH-FACTOR ; THERAPY ; GENE-EXPRESSION ; CELL-LINES ; adenocarcinoma ; VEGF ; tyrosine kinase inhibitors
    Abstract: Background: Pancreatic ductal adenocarcinoma (PDAC) is one of the most common malignant tumours and is still associated with a poor prognosis in advanced disease. To improve the standard therapy with gemcitabine, we initiated a prospective randomised phase-II trial with gemcitabine (GEM) versus gemcitabine plus sunitinib (SUNGEM) based on data of in vitro trials and phase-I data for the combination treatment. The rational of adding sunitinib was its putative antiangiogenic mechanism of action. Methods: A total of 106 eligible patients with locally advanced, unresectable or metastatic PDAC without previous system therapy were randomised to receive GEM at a dosage of 1.000 mg/m(2) d1, 8, 15 q28 versus a combination of SUNGEM at a dosage of GEM 1.000 mg/m(2) d1 + 8 and sunitinib 50 mg p.o. d1-14, q21d. The primary end-point was progression free survival (PFS), secondary end-points were overall survival (OS), toxicity and overall response rate (ORR). Results: The confirmatory analysis of PFS was based on the intend-to-treat (ITT) population (N = 106). The median PFS was 13.3 weeks (95% confidence interval (95%-CI): 10.4-18.1 weeks) for GEM and 11.6 weeks for SUNGEM (95%-CI: 7.0-18.0 weeks; p = 0.78 one-sided log-rank). The ORR was 6.1% (95%-CI: 0.7-20.2%) for GEM and for 7.1% (95%-CI: 0.9-23.5%) for SUNGEM (p = 0.87). The median time to progression (TTP) was 14.0 weeks (95%-CI: 12.4-22.3 weeks) for GEM and 18.0 weeks (95%-CI: 11.3-19.3 weeks) for SUNGEM (p = 0.60; two-sided log-rank). The median OS was 36.7 weeks (95%-CI: 20.6-49.0 weeks) for the GEM arm and 30.4 weeks (95%-CI: 18.1-37.6 weeks) for the SUNGEM (p = 0.78, one-sided log-rank). In regard to toxicities, suspected SAEs were reported in 53.7% in the GEM arm and 71.2% in the SUNGEM arm. Grade 3 and 4 neutropenia was statistically significantly higher in the SUNGEM arm with 48.1% versus 27.8% in the GEM arm (p = 0.045, two sided log-rank). Conclusions: The combination SUNGEM was not sufficient superior in locally advanced or metastatic PDAC compared to GEM alone in regard to efficacy but was associated with more toxicity.
    Type of Publication: Journal article published
    PubMed ID: 25459392
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  • 4
    Keywords: CELLS ; IRRADIATION ; SURVIVAL ; Germany ; human ; IN-VIVO ; TOXICITY ; DISEASE ; DRUG ; TIME ; RAT ; RATS ; CONTRAST ; T cells ; T-CELLS ; treatment ; ANTITUMOR-ACTIVITY ; bone marrow ; BONE-MARROW ; RATES ; chemotherapy ; albumin ; SERUM ; WEIGHT ; RHEUMATOID-ARTHRITIS ; METHOTREXATE-ALBUMIN ; graft-versus-host disease ; LOSSES ; DRUGS ; ONSET ; bone marrow cells ; BONE ; spleen ; PROGRESS ; human serum albumin ; GvHD ; TUMOR-BEARING RATS ; TERM FOLLOW-UP ; allogeneic stem cell transplantation ; SERUM-ALBUMIN ; aminopterin-albumin ; CONTROLLED TRIAL ; IDENTICAL MARROW GRAFTS ; MTX-HSA ; MYCOPHENOLATE-MOFETIL
    Abstract: Background. During the last several years, major progress has been made in developing targeted chemotherapy using cytotoxic drugs covalently bound to human serum albumin (HSA). We explored the activity of two antifolates methotrexate (MTX) and aminopterin (AMPT) bound to HSA in prophylaxis and treatment of experimental acute graft-versus-host disease (aGVHD). Methods. In all, 113 female F1 hybrid BN/Lew-rats were irradiated with 8.2 Gy (n=103) or 9.9 Gy (n=10). One day after irradiation each rat received 4 x 10(7) bone marrow cells and 1.5 x 10(7) spleen T-cells from female Lew-rats. GVHD prophylaxis consisted of MTX-HSA 2 mg/kg (n=25), MTX-HSA 0.5 mg/kg (n=8), AMPT-HSA 0.65 mg/kg (n=8), MTX 0.5 mg/kg (n=17), or native HSA (n=39) given intraperitoneally (IP) on days 0, 4, 8, and 12. Treatment of aGVHD consisted of MTX-HSA 2 mg/kg (n=8) or AMPT-HSAO.5 mg/kg (n=8) given intraperitoneally at the time of onset of aGVHD and subsequently every fourth day (a total of four doses). Results. All animals receiving native HSA developed lethal aGVHD. Prophylactic treatment with MTX-HSA 2 mg/kg prevented aGVHD in 18 of 25 animals and in 6 of 8 receiving AMPT-HSA. In contrast, five out of nine rats receiving free MTX died due to aGVHD. The survival rates in the prophylactic MTX-HSA 2 mg/kg and AMPT-HSA groups were significantly higher compared to the MTX and control groups (P 〈 0.05), while non hematologic toxicity of MTX-HSA was not detectable. AMPT-HSA at a dose of 0.65 mg/kg as well as MTX at a dose of 0.5 mg/kg were associated with temporary weight loss and lethargy. Conclusions. The albumin conjugates MTX-HSA and AMPT-HSA effectively prevent experimental aGVHD
    Type of Publication: Journal article published
    PubMed ID: 16926597
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  • 5
    Keywords: PHASE-II ; CELL CARCINOMA ; ADULTS ; METHOTREXATE-ALBUMIN ; drug targeting ; human serum albumin ; INGESTION ; SERUM-ALBUMIN ; MTX-HSA ; DIGESTION ; aminofluorescein ; EXCRETORY SYSTEM ; LASER-SCANNING MICROSCOPY ; PARASITE ; pre-adults ; Schistosoma mansoni ; schistosomula ; TEXAS RED-BSA
    Abstract: Objective. Bilharziosis is one of the most important helminthal infections in humans and is caused by blood flukes of the genus Schistosoma. Three different life stages of the parasite occur within the mammalian host: schistosomula located in the skin, pre-adults located in the lung and adult worms located in the portal venous system. Erythrocytes are a major source of nutrient supply for adults. However, sources of nutrition for the developing stages are still unclear. Methods. To investigate whether schistosomula, pre-adults and adults of Schistosoma mansoni ingest human serum albumin (HSA) in vitro, these life stages were incubated with aminofluorescein-labelled human serum albumin (Afl-HSA) for 5 h. To test the uptake of albumin in vivo, the albumin conjugate was given intravenously to S. mansoni infected NMRI mice 24 h before harvesting the 3 life stages. Results. In comparison to the control group schistosomula, pre-adults, and adults showed an accumulation of Afl-HSA within the oesophagus and intestinal caecum in vitro and in vivo. Conclusion. Our findings suggest that albumin seems to be a major source of energy supply for the early schistosomal life stages and an additive energy support for adult worms. Since albumin has been used successfully as a drug carrier for chemotherapeutic substances against malignant disorders, further studies will focus on albumin as a carrier for anthelminthics in a drug-targeting model
    Type of Publication: Journal article published
    PubMed ID: 20500919
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  • 6
    Keywords: CANCER ; SURVIVAL ; tumor ; Germany ; THERAPY ; TOXICITY ; FOLLOW-UP ; COHORT ; DRUG ; MONOCLONAL-ANTIBODY ; PATIENT ; murine ; colon ; treatment ; antibodies ; antibody ; GLYCOPROTEIN ; TRIAL ; COLON-CANCER ; MONOCLONAL-ANTIBODIES ; FLUOROURACIL ; folinic acid ; ONCOLOGY ; colon cancer ; overall survival ; ADJUVANT THERAPY ; SWITZERLAND ; methods ; PHASE ; monoclonal antibodies ; monoclonal antibody ; edrecolomab ; MONOCLONAL-ANTIBODY THERAPY ; stage II
    Abstract: Background: In a phase III study recruiting patients with stage II colon cancer the effect of adjuvant therapy with edrecolomab, a murine monoclonal antibody to the cell-surface glycoprotein 17-1A, was compared to observation alone. Patients and Methods: From January 1997 until July 2000 a total of 377 patients were postoperatively stratified according to tumor stage (T3 vs. T4) and center, and randomly allocated to either treatment with edrecolomab ( cohort A, n = 183) or observation ( cohort B, n = 194). Patients in cohort A received a total of 900 mg edrecolomab. The study was terminated prematurely because of discontinuation of drug supply in Germany. Results: 305 patients were eligible for the primary endpoint of overall survival and 282 patients for disease-free survival. After a median follow-up of 42 months overall survival and disease-free survival were not significantly different. Toxicity was mild. Conclusions: In the present study, postoperative adjuvant treatment with edrecolomab in patients with resected stage II colon cancer did not improve overall or disease-free survival
    Type of Publication: Journal article published
    PubMed ID: 15933423
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  • 7
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    German Medical Science; Düsseldorf, Köln
    In:  123. Kongress der Deutschen Gesellschaft für Chirurgie; 20060502-20060505; Berlin; DOC06dgch4520 /20060502/
    Publication Date: 2006-05-09
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 8
    Keywords: STAGE ; OXALIPLATIN ; REGIMENS ; chemoradiation ; PREOPERATIVE RADIOTHERAPY ; ADJUVANT THERAPY ; III TRIAL ; METASTATIC COLORECTAL-CANCER ; LEUCOVORIN ; POSTOPERATIVE CHEMORADIOTHERAPY
    Abstract: BACKGROUND: Fluorouracil-based chemoradiotherapy is regarded as a standard perioperative treatment in locally advanced rectal cancer. We investigated the efficacy and safety of substituting fluorouracil with the oral prodrug capecitabine. METHODS: This randomised, open-label, multicentre, non-inferiority, phase 3 trial began in March, 2002, as an adjuvant trial comparing capecitabine-based chemoradiotherapy with fluorouracil-based chemoradiotherapy, in patients aged 18 years or older with pathological stage II-III locally advanced rectal cancer from 35 German institutions. Patients in the capecitabine group were scheduled to receive two cycles of capecitabine (2500 mg/m(2) days 1-14, repeated day 22), followed by chemoradiotherapy (50.4 Gy plus capecitabine 1650 mg/m(2) days 1-38), then three cycles of capecitabine. Patients in the fluorouracil group received two cycles of bolus fluorouracil (500 mg/m(2) days 1-5, repeated day 29), followed by chemoradiotherapy (50.4 Gy plus infusional fluorouracil 225 mg/m(2) daily), then two cycles of bolus fluorouracil. The protocol was amended in March, 2005, to allow a neoadjuvant cohort in which patients in the capecitabine group received chemoradiotherapy (50.4 Gy plus capecitabine 1650 mg/m(2) daily) followed by radical surgery and five cycles of capecitabine (2500 mg/m(2) per day for 14 days) and patients in the fluorouracil group received chemoradiotherapy (50.4 Gy plus infusional fluorouracil 1000 mg/m(2) days 1-5 and 29-33) followed by radical surgery and four cycles of bolus fluorouracil (500 mg/m(2) for 5 days). Patients were randomly assigned to treatment group in a 1:1 ratio using permuted blocks, with stratification by centre and tumour stage. The primary endpoint was overall survival; analyses were done based on all patients with post-randomisation data. Non-inferiority of capecitabine in terms of 5-year overall survival was tested with a 12.5% margin. This trial is registered with ClinicalTrials.gov, number NCT01500993. FINDINGS: Between March, 2002, and December, 2007, 401 patients were randomly allocated; 392 patients were evaluable (197 in the capecitabine group, 195 in the fluorouracil group), with a median follow-up of 52 months (IQR 41-72). 5-year overall survival in the capecitabine group was non-inferior to that in the fluorouracil group (76% [95% CI 67-82] vs 67% [58-74]; p=0.0004; post-hoc test for superiority p=0.05). 3-year disease-free survival was 75% (95% CI 68-81) in the capecitabine group and 67% (59-73) in the fluorouracil group (p=0.07). Similar numbers of patients had local recurrences in each group (12 [6%] in the capecitabine group vs 14 [7%] in the fluorouracil group, p=0.67), but fewer patients developed distant metastases in the capecitabine group (37 [19%] vs 54 [28%]; p=0.04). Diarrhoea was the most common adverse event in both groups (any grade: 104 [53%] patients in the capecitabine group vs 85 [44%] in the fluorouracil group; grade 3-4: 17 [9%] vs four [2%]). Patients in the capecitabine group had more hand-foot skin reactions (62 [31%] any grade, four [2%] grade 3-4 vs three [2%] any grade, no grade 3-4), fatigue (55 [28%] any grade, no grade 3-4 vs 29 [15%], two [1%] grade 3-4), and proctitis (31 [16%] any grade, one [〈1%] grade 3-4 vs ten [5%], one [〈1%] grade 3-4) than did those in the fluorouracil group, whereas leucopenia was more frequent with fluorouracil than with capecitabine (68 [35%] any grade, 16 [8%] grade 3-4 vs 50 [25%] any grade, three [2%] grade 3-4). INTERPRETATION: Capecitabine could replace fluorouracil in adjuvant or neoadjuvant chemoradiotherapy regimens for patients with locally advanced rectal cancer. FUNDING: Roche Pharma AG (Grenzach-Wyhlen, Germany).
    Type of Publication: Journal article published
    PubMed ID: 22503032
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  • 9
    ISSN: 0370-2693
    Source: Elsevier Journal Backfiles on ScienceDirect 1907 - 2002
    Topics: Physics
    Type of Medium: Electronic Resource
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  • 10
    ISSN: 1619-1560
    Keywords: Exercise recovery ; Noradrenaline ; Adrenaline ; Catecholamines ; Heart rate ; Blood pressure
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Notes: Abstract The purpose of this study was to evaluate whether or not the type of activity performed during recovery might influence the magnitude of catecholamine outflow following exercise. Six active, male volunteers between 40–52 years recovered from strenuous treadmill exercise in three different ways; standing, supine rest and walking (2 mph, 0% grade). Measurements of noradrenaline (NA), adrenaline (A), heart rate and blood pressure were made at rest, peak exercise, and at 30 s intervals through 5-min of recovery. Peak exercise NA concentrations were approximately 1000% above those recorded as rest. Early recovery was marked by a continued increase in NA from peak exercise concentrations (4614 ± 548vs. 3264 ± 485 pg/ml) which did not return to peak exercise levels until approximately 90 s of recovery. Adrenaline responses followed similar trends; however, the changes were not as sizable. Heart rate and diastolic blood pressure were significantly affected by the post-exercise condition; supine recovery produced significantly lower mean heart rates and mean diastolic blood pressures in comparison to standing or continued walking recovery conditions. Thus, these data indicate no specific recovery strategy will stem the rise in exercise-induced plasma catecholamines. Clinically, a strategy of continued walking, or better, supine recovery will best meet special clinical requirements, as well as limit the magnitude of the peak catecholamine increases.
    Type of Medium: Electronic Resource
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