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Heinemann, Volker; Quietzsch, Detlef; Gieseler, Frank; Gonnermann, Michael; Schönekäs, Herbert; Rost, Andreas; Neuhaus, Horst; Haag, Caroline; Clemens, Michael; Heinrich, Bernard; Vehling-Kaiser, Ursula; Fuchs, Martin; Fleckenstein, Doris; Gesierich, Wolfgang; Uthgenannt, Dirk; Einsele, Hermann; Holstege, Axel; Hinke, Axel; Schalhorn, Andreas; Wilkowski, Ralf

Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Gemcitabine Alone in Advanced Pancreatic Cancer

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  • Media type: E-Article
  • Title: Randomized Phase III Trial of Gemcitabine Plus Cisplatin Compared With Gemcitabine Alone in Advanced Pancreatic Cancer
  • Contributor: Heinemann, Volker; Quietzsch, Detlef; Gieseler, Frank; Gonnermann, Michael; Schönekäs, Herbert; Rost, Andreas; Neuhaus, Horst; Haag, Caroline; Clemens, Michael; Heinrich, Bernard; Vehling-Kaiser, Ursula; Fuchs, Martin; Fleckenstein, Doris; Gesierich, Wolfgang; Uthgenannt, Dirk; Einsele, Hermann; Holstege, Axel; Hinke, Axel; Schalhorn, Andreas; Wilkowski, Ralf
  • imprint: American Society of Clinical Oncology (ASCO), 2006
  • Published in: Journal of Clinical Oncology
  • Language: English
  • DOI: 10.1200/jco.2005.05.1490
  • ISSN: 0732-183X; 1527-7755
  • Origination:
  • Footnote:
  • Description: <jats:sec><jats:title>Purpose</jats:title><jats:p> To compare the effectiveness and tolerability of gemcitabine plus cisplatin with single-agent gemcitabine as first-line chemotherapy for locally advanced or metastatic pancreatic cancer. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> Patients with advanced adenocarcinoma of the pancreas were randomly assigned to receive either gemcitabine 1,000 mg/m<jats:sup>2</jats:sup> and cisplatin 50 mg/m<jats:sup>2</jats:sup> given on days 1 and 15 of a 4-week cycle (GemCis arm) or gemcitabine alone at a dose of 1,000 mg/m<jats:sup>2</jats:sup> on days 1, 8, and 15 of a 4-week regimen (Gem arm). The primary end point was overall survival; secondary end points were progression-free survival, response rate, safety, and quality of life. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> One hundred ninety-five patients were enrolled and showed baseline characteristics well balanced between treatment arms. Combination treatment in the GemCis arm was associated with a prolonged median progression-free survival (5.3 months v 3.1 months; hazard ratio [HR] = 0.75; P = .053). Also, median overall survival was superior for patients treated in the GemCis arm as compared with the Gem arm (7.5 v 6.0 months), an advantage which did not, however, reach statistical significance (HR = 0.80; P = .15). Tumor response rates were comparable between treatment arms (10.2% v 8.2%). The rate of stable disease was, however, greater in the combination arm (60.2% v 40.2%; P &lt; .001). Grade 3 to 4 hematologic toxicity did not exceed 15% in both treatment arms. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> These results support the efficacy and safety of an every-2-weeks treatment with gemcitabine plus cisplatin. Median overall survival and progression-free survival were more favorable in the combination arm as compared with gemcitabine alone, although the difference did not attain statistical significance. </jats:p></jats:sec>
  • Access State: Open Access