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  • 1
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    German Medical Science GMS Publishing House; Düsseldorf
    In:  GMS German Medical Science; VOL: 7; DOC04 /20090610/
    Publication Date: 2009-06-11
    Description: Background: The highly vascular nature of renal carcinoma cells suggests that inhibition of angiogenesis may be beneficial in this disease. Thalidomide has been described as inhibitor of the fibroblast growth factor (FGF) and the vascular endothelial growth factor (VEGF). Therefore and in consideration of the promising response rates of the combination of IL-2, IFN-alpha and 5-FU in metastatic renal cancer, we found it reasonable to test the combination of 5-FU and thalidomide. Thus, we conducted a phase I trial to determine safety, side effects and responses to such a treatment. Methods: Patients with metastasized renal cell cancer after nephrectomy and progress after IL-2 and interferon treatment, received oral 5-FU at a dose of 1250 mg/qm2 twice a day for two weeks, then after pausing a week, the oral application was restarted. In addition, oral thalidomide was applied constantly at a maximum dose of 400 mg/d. The combined therapy was given for three months. The primary endpoint was duration until disease progression, the secondary endpoint the response to treatment. Response was determined by CT scans three months after the end of treatment. Results: In total, 12 male patients participated in the trial and received the combined oral therapy. Concerning clinical response, one mixed response (8%), a stable disease in 4/12 patients (33%) and progression was seen in 7 patients (58%). The survival from the start of the therapy showed a median of 21 months with three patients being alive. At present, the longest survival after the therapy is 51 months. Conclusions: The combination of oral 5-FU and thalidomide showed clinical response with tolerable side effects. Further studies will be required to assess the outcome of this treatment regimen.
    Description: Hintergrund: Die hohe Vaskularisierung beim Nierenzellkarzinom legt nahe, dass eine Inhibition der Angiogenese bei dieser Erkrankung von Vorteil sein könnte. Thalidomid wurde als Inhibitor von FGF (Fibroblastenwachstumsfaktor) und VEGF (vaskulärer endothelialer Wachstumsfaktor) beschrieben. Deshalb und aufgrund der erfolgversprechenden Daten von Interleukin-2, Interferon-alpha und 5-FU testeten wir die Kombination von Thalidomid und 5-FU. Wir führten eine Phase-I-Studie zur Testung von Sicherheit und Verträglichkeit durch. Methoden: Patienten mit metastasiertem Nierenzellkarzinom nach Nephrektomie und Progress nach IL-2 und Interferon-Behandlung erhielten orales 5-FU in einer Dosierung von 1250 mg/qm2 zweimal täglich über 2 Wochen. Nach einer einwöchigen Pause, wurde die Behandlung fortgesetzt. Zusätzlich wurde Thalidomid kontinuierlich bis zu einer maximalen Dosis von 400 mg/Tag gegeben. Diese Kombination erhielten die Patienten über 3 Monate. Primärer Endpunkt war die Dauer bis zur Progression der Krankheit, sekundärer Endpunkt das Ansprechen auf die Therapie. Das Ansprechen wurde mittels CT 3 Monate nach Ende der Therapie bestimmt. Ergebnisse: 12 männliche Patienten nahmen an dieser Studie teil. Ein gemischtes Ansprechen (8%), 4 stabile Erkrankungen (33%) und 〈TextGroup〉 7 Pr 〈/TextGroup〉ogresse (58%) wurden gesehen. Das mittlere Überleben betrug 21 Monate mit jetzt noch 3 lebenden Patienten. Zur Zeit beträgt das längste Überleben 51 Monate. Schlussfolgerung: Die Kombination von oralem 5-FU und Thalidomid zeigte bei diesen überwiegend vortherapierten Patienten klinisches Ansprechen bei tolerablen Nebenwirkungen. Weitere Studien sind notwendig, um den Stellenwert dieser Kombination nach Gabe der neuen Therapieoptionen beim metastasierten Nierenzellkarzinom zu untersuchen.
    Keywords: metastasized renal cell carcinoma ; 5-FU ; thalidomide ; phase I trial ; ddc: 610
    Language: English
    Type: article
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  • 2
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    German Medical Science GMS Publishing House; Düsseldorf
    In:  51. Kongress für Allgemeinmedizin und Familienmedizin; 20170921-20170923; Düsseldorf; DOC17degam031 /20170905/
    Publication Date: 2017-09-05
    Keywords: Lungenkarzinom ; Raucherentwöhnung ; Tabakabhängigkeit ; ddc: 610
    Language: German
    Type: conferenceObject
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  • 3
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    German Medical Science GMS Publishing House; Düsseldorf
    In:  64. Kongress der Nordrhein-Westfälischen Gesellschaft für Urologie; 20180322-20180323; Düsseldorf; DOCV 3.6 /20180215/
    Publication Date: 2018-02-26
    Keywords: ddc: 610
    Language: German
    Type: conferenceObject
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  • 4
    ISSN: 1279-8509
    Source: Springer Online Journal Archives 1860-2000
    Topics: Medicine
    Type of Medium: Electronic Resource
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  • 5
    Publication Date: 2018-10-02
    Description: Purpose: Although somatostatin analogues (SSA) and peptide receptor radionuclide therapy (PRRT) are validated therapies in patients with advanced gastroenteropancreatic neuroendocrine tumors (GEP-NET), it remains unclear whether SSA combined with PRRT or as maintenance therapy can provide prolonged survival compared with patients treated with PRRT alone. In this retrospective study, we aimed to investigate whether there is a survival benefit to adding SSA to PRRT as a combination therapy and/or maintenance therapy. Patients and Methods: The investigation included 168 patients with unresectable GEP-NETs treated at the University Hospital Bonn, Bonn, Germany. The patients were divided into two main groups: PRRT monotherapy ( N = 81, group 1) and PRRT plus SSA ( N = 87, group 2) as combined therapy with PRRT and/or as maintenance therapy after PRRT. Results: Data for overall survival (OS) were available from 168 patients, of whom 160 had data for progression-free survival (PFS). The median PFS was 27 months in group 1 versus 48 months in group 2 ( P = 0.012). The median OS rates were 47 months in group 1 and 91 months in group 2 ( P 〈 0.001). The death-event rates were lower in group 2 (26%) than in group 1 (63%). SSA as a combination therapy with PRRT and/or as a maintenance therapy showed a clinical benefit rate (objective response or stable disease) of 95%, which was significantly higher than group 1 (79%). Conclusions: SSA as a combination therapy and/or maintenance therapy may play a significant role in tumor control in patients with GEP-NET who underwent a PRRT. Clin Cancer Res; 24(19); 4672–9. ©2018 AACR .
    Print ISSN: 1078-0432
    Electronic ISSN: 1557-3265
    Topics: Medicine
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