학술논문
Bevacizumab Alone and in Combination With Irinotecan in Recurrent Glioblastoma.
Document Type
Report
Author
Friedman HS; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Prados MD; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Wen PY; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Mikkelsen T; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Schiff D; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Abrey LE; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Yung WKA; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Paleologos N; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Nicholas MK; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Jensen R; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Vredenburgh J; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Huang J; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Zheng M; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.; Cloughesy T; From the Brain Tumor Center, Duke University, Durham, NC; Department of Neurosurgery, University of California, San Francisco, San Francisco; Genetech Inc, South San Francisco; and Department of Neurology, University of California, Los Angeles School of Medicine, Los Angeles, CA; Department of Neurology, Brigham and Women's Hospital and Center for Neuro-Oncology, Dana-Farber Cancer Institute, Boston, MA; Hermelin Brain Tumor Center, Henry Ford Hospital, Detroit, MI; Department of Neurology, University of Virginia, Charlottesville, VA; Department of Neurology, Memorial Sloan-Kettering Cancer Center, New York, NY; Department of Neuro-Oncology, M. D. Anderson Cancer Center, Houston, TX; Division of Neurology, Evanston Northwestern Healthcare, Evanston, IL; Department of Neurology, University of Chicago, Chicago, IL; and University of Utah Hospital, Salt Lake City, UT.
Source
Publisher: American Society of Clinical Oncology Country of Publication: United States NLM ID: 8309333 Publication Model: Print Cited Medium: Internet ISSN: 1527-7755 (Electronic) Linking ISSN: 0732183X NLM ISO Abbreviation: J Clin Oncol Subsets: PubMed not MEDLINE; MEDLINE
Subject
Language
English
Abstract
Purpose: We evaluated the efficacy of bevacizumab, alone and in combination with irinotecan, in patients with recurrent glioblastoma in a phase II, multicenter, open-label, noncomparative trial.
Patients and Methods: One hundred sixty-seven patients were randomly assigned to receive bevacizumab 10 mg/kg alone or in combination with irinotecan 340 mg/m2 or 125 mg/m 2 (with or without concomitant enzyme-inducing antiepileptic drugs, respectively) once every 2 weeks. Primary end points were 6-month progression-free survival and objective response rate, as determined by independent radiology review. Secondary end points included safety and overall survival.
Results: In the bevacizumab-alone and the bevacizumab-plus-irinotecan groups, estimated 6-month progression-free survival rates were 42.6% and 50.3%, respectively; objective response rates were 28.2% and 37.8%, respectively; and median overall survival times were 9.2 months and 8.7 months, respectively. There was a trend for patients who were taking corticosteroids at baseline to take stable or decreasing doses over time. Of the patients treated with bevacizumab alone or bevacizumab plus irinotecan, 46.4% and 65.8%, respectively, experienced grade ≥ 3 adverse events, the most common of which were hypertension (8.3%) and convulsion (6.0%) in the bevacizumab-alone group and convulsion (13.9%), neutropenia (8.9%), and fatigue (8.9%) in the bevacizumab-plus-irinotecan group. Intracranial hemorrhage was noted in two patients (2.4%) in the bevacizumab-alone group (grade 1) and in three patients (3.8%) patients in the bevacizumab-plus-irinotecan group (grades 1, 2, and 4, respectively).
Conclusion: Bevacizumab, alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma.
Patients and Methods: One hundred sixty-seven patients were randomly assigned to receive bevacizumab 10 mg/kg alone or in combination with irinotecan 340 mg/m
Results: In the bevacizumab-alone and the bevacizumab-plus-irinotecan groups, estimated 6-month progression-free survival rates were 42.6% and 50.3%, respectively; objective response rates were 28.2% and 37.8%, respectively; and median overall survival times were 9.2 months and 8.7 months, respectively. There was a trend for patients who were taking corticosteroids at baseline to take stable or decreasing doses over time. Of the patients treated with bevacizumab alone or bevacizumab plus irinotecan, 46.4% and 65.8%, respectively, experienced grade ≥ 3 adverse events, the most common of which were hypertension (8.3%) and convulsion (6.0%) in the bevacizumab-alone group and convulsion (13.9%), neutropenia (8.9%), and fatigue (8.9%) in the bevacizumab-plus-irinotecan group. Intracranial hemorrhage was noted in two patients (2.4%) in the bevacizumab-alone group (grade 1) and in three patients (3.8%) patients in the bevacizumab-plus-irinotecan group (grades 1, 2, and 4, respectively).
Conclusion: Bevacizumab, alone or in combination with irinotecan, was well tolerated and active in recurrent glioblastoma.