Phase II Trial of Gefitinib in Recurrent Glioblastoma

DOI Web Site 被引用文献11件
  • Jeremy N. Rich
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • David A. Reardon
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Terry Peery
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Jeannette M. Dowell
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Jennifer A. Quinn
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Kara L. Penne
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Carol J. Wikstrand
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Lauren B. Van Duyn
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Janet E. Dancey
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Roger E. McLendon
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • James C. Kao
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Timothy T. Stenzel
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • B.K. Ahmed Rasheed
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Sandra E. Tourt-Uhlig
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • James E. Herndon
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • James J. Vredenburgh
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • John H. Sampson
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Allan H. Friedman
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Darell D. Bigner
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD
  • Henry S. Friedman
    From the Departments of Medicine, Surgery, Pathology, and Cancer Center Biostatistics, Duke University Medical Center, Durham, NC; and the National Cancer Institute, Bethesda, MD

書誌事項

公開日
2004-01-01
DOI
  • 10.1200/jco.2004.08.110
公開者
American Society of Clinical Oncology (ASCO)

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説明

<jats:sec><jats:title>Purpose</jats:title><jats:p> To evaluate the efficacy and tolerability of gefitinib (ZD1839, Iressa; AstraZeneca, Wilmington, DE), a novel epidermal growth factor receptor tyrosine kinase inhibitor, in patients with recurrent glioblastoma. </jats:p></jats:sec><jats:sec><jats:title>Patients and Methods</jats:title><jats:p> This was an open-label, single-center phase II trial. Fifty-seven patients with first recurrence of a glioblastoma who were previously treated with surgical resection, radiation, and usually chemotherapy underwent an open biopsy or resection at evaluation for confirmation of tumor recurrence. Each patient initially received 500 mg of gefitinib orally once daily; dose escalation to 750 mg then 1,000 mg, if a patient received enzyme-inducing antiepileptic drugs or dexamethasone, was allowed within each patient. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Although no objective tumor responses were seen among the 53 assessable patients, only 21% of patients (11 of 53 patients) had measurable disease at treatment initiation. Seventeen percent of patients (nine of 53 patients) underwent at least six 4-week cycles, and the 6-month event-free survival (EFS) was 13% (seven of 53 patients). The median EFS time was 8.1 weeks, and the median overall survival (OS) time from treatment initiation was 39.4 weeks. Adverse events were generally mild (grade 1 or 2) and consisted mainly of skin reactions and diarrhea. Drug-related toxicities were more frequent at higher doses. Withdrawal caused by drug-related adverse events occurred in 6% of patients (three of 53 patients). Although the presence of diarrhea positively predicted favorable OS from treatment initiation, epidermal growth factor receptor expression did not correlate with either EFS or OS. </jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p> Gefitinib is well tolerated and has activity in patients with recurrent glioblastoma. Further study of this agent at higher doses is warranted. </jats:p></jats:sec>

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