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Verfasst von:Kasper, Bernd [VerfasserIn]   i
 Sommer, Michaela [VerfasserIn]   i
 Mathew, Monika [VerfasserIn]   i
 Rauch, Geraldine [VerfasserIn]   i
 Hohenberger, Peter [VerfasserIn]   i
Titel:Combination of trabectedin and gemcitabine for advanced soft tissue sarcomas
Titelzusatz:results of a phase I dose escalating trial of the German Interdisciplinary Sarcoma Group (GISG)
Verf.angabe:Bernd Kasper, Peter Reichardt, Daniel Pink, Michaela Sommer, Monika Mathew, Geraldine Rauch and Peter Hohenberger
E-Jahr:2015
Jahr:13 January 2015
Umfang:10 S.
Fussnoten:Gesehen am 20.09.2017
Titel Quelle:Enthalten in: Marine drugs
Ort Quelle:Basel : MDPI, 2003
Jahr Quelle:2015
Band/Heft Quelle:13(2015), 1, Seite 379-388
ISSN Quelle:1660-3397
Abstract:Background: Evaluation of the potential efficacy and safety of combination therapies for advanced soft tissue sarcomas (STS) has increased substantially after approval of trabectedin and pazopanib. Trabectedin's introduction in Europe in 2007 depended mainly on its activity in so-called L-sarcomas (liposarcoma and leiomyosarcoma); combination of trabectedin with other chemotherapies used in STS seems of particular interest. Methods: We initiated within the German Interdisciplinary Sarcoma Group (GISG) a phase I dose escalating trial evaluating the combination of trabectedin and gemcitabine in patients with advanced and/or metastatic L-sarcomas (GISG-02; ClinicalTrials.gov NCT01426633). Patients were treated with increasing doses of trabectedin and gemcitabine. The primary endpoint was to determine the maximum tolerated dose. Results: Five patients were included in the study. Two patients were treated on dose level 1 comprising trabectedin 0.9 mg/m2 on day 1 and gemcitabine 700 mg/m2 on days 1 + 8, every 3 weeks. Due to dose-limiting toxicity (DLT) in both patients (elevated transaminases and thrombocytopenia), an additional three patients were treated on dose level −1 with trabectedin 0.7 mg/m2 plus gemcitabine 700 mg/m2. Of these three patients, two demonstrated another DLT; therefore, the trial was stopped and none of the dose levels could be recommended for phase II testing. Conclusion: The GISG-02 phase I study was stopped with the conclusion that the combination of gemcitabine and trabectedin is generally not recommended for the treatment of patients with advanced and/or metastatic leiomyosarcoma or liposarcoma. Also, this phase I study strongly supports the necessity for careful evaluation of combination therapies.
DOI:doi:10.3390/md13010379
URL:Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.

kostenfrei: Volltext: http://dx.doi.org/10.3390/md13010379
 kostenfrei: Volltext: http://www.mdpi.com/1660-3397/13/1/379
 DOI: https://doi.org/10.3390/md13010379
Datenträger:Online-Ressource
Sprache:eng
Sach-SW:gemcitabine
 pazopanib
 phase I
 safety
 soft tissue sarcoma
 trabectedin
K10plus-PPN:1563665409
Verknüpfungen:→ Zeitschrift

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