Phase II Trial of Gemcitabine in Refractory Germ Cell Tumors

  • Lawrence H. Einhorn
    From the Department of Medicine, Division of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN.
  • Michael J. Stender
    From the Department of Medicine, Division of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN.
  • Stephen D. Williams
    From the Department of Medicine, Division of Hematology/Oncology, Indiana University Medical Center, Indianapolis, IN.

書誌事項

公開日
1999-02
DOI
  • 10.1200/jco.1999.17.2.509
公開者
American Society of Clinical Oncology (ASCO)

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説明

<jats:p> PURPOSE: This phase II study was designed to determine the toxicity and activity of single-agent gemcitabine in heavily pretreated patients with germ cell tumors. </jats:p><jats:p> PATIENTS AND METHODS: From March 1996 through November 1997, 21 patients were enrolled onto a phase II study of gemcitabine 1,200 mg/m<jats:sup>2</jats:sup>, given on days 1, 8, and 15 every 4 weeks. One patient was unassessable because he never received any gemcitabine. Thirteen of 20 patients had received three prior regimens, and 13 patients were platinum refractory (progression during or within 4 weeks of platinum treatment). There were five extragonadal cases and two patients with late relapse (relapse beyond 2 years). </jats:p><jats:p> RESULTS: Gemcitabine was well tolerated. Only one patient had grade 3 or 4 nonhematologic toxicity (grade 3 nausea). Six of 20 patients had grade 3 leukopenia. There were no episodes of granulocytopenic fever, and no patient required platelet transfusion. Three (15%) of 20 patients achieved an objective response, including one complete remission. Three additional patients had a minor radiographic or serologic response. </jats:p><jats:p> CONCLUSION: Gemcitabine had definite activity in this heavily pretreated germ cell tumor patient population. </jats:p>

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