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Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma.

Publication ,  Journal Article
Friedman, HS; Prados, MD; Wen, PY; Mikkelsen, T; Schiff, D; Abrey, LE; Yung, WKA; Paleologos, N; Nicholas, MK; Jensen, R; Vredenburgh, J ...
Published in: J Clin Oncol
October 1, 2009

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/m(2) 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 > or = 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.

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Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 1, 2009

Volume

27

Issue

28

Start / End Page

4733 / 4740

Location

United States

Related Subject Headings

  • Young Adult
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Irinotecan
  • Humans
  • Glioblastoma
  • Female
 

Citation

APA
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MLA
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Friedman, H. S., Prados, M. D., Wen, P. Y., Mikkelsen, T., Schiff, D., Abrey, L. E., … Cloughesy, T. (2009). Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol, 27(28), 4733–4740. https://doi.org/10.1200/JCO.2008.19.8721
Friedman, Henry S., Michael D. Prados, Patrick Y. Wen, Tom Mikkelsen, David Schiff, Lauren E. Abrey, WK Alfred Yung, et al. “Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma.J Clin Oncol 27, no. 28 (October 1, 2009): 4733–40. https://doi.org/10.1200/JCO.2008.19.8721.
Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, et al. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733–40.
Friedman, Henry S., et al. “Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma.J Clin Oncol, vol. 27, no. 28, Oct. 2009, pp. 4733–40. Pubmed, doi:10.1200/JCO.2008.19.8721.
Friedman HS, Prados MD, Wen PY, Mikkelsen T, Schiff D, Abrey LE, Yung WKA, Paleologos N, Nicholas MK, Jensen R, Vredenburgh J, Huang J, Zheng M, Cloughesy T. Bevacizumab alone and in combination with irinotecan in recurrent glioblastoma. J Clin Oncol. 2009 Oct 1;27(28):4733–4740.

Published In

J Clin Oncol

DOI

EISSN

1527-7755

Publication Date

October 1, 2009

Volume

27

Issue

28

Start / End Page

4733 / 4740

Location

United States

Related Subject Headings

  • Young Adult
  • Oncology & Carcinogenesis
  • Neoplasm Recurrence, Local
  • Middle Aged
  • Male
  • Kaplan-Meier Estimate
  • Irinotecan
  • Humans
  • Glioblastoma
  • Female