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Phase II Study of Bevacizumab Plus Temozolomide During and After Radiation Therapy for Patients With Newly Diagnosed Glioblastoma Multiforme


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://jco.ascopubs.org/content/early/2010/12/02/JCO.2010.30.2729.abstract

Posted on: 12/07/2010

Phase II Study of Bevacizumab Plus Temozolomide During and After Radiation Therapy for Patients With Newly Diagnosed Glioblastoma Multiforme

  1. Albert Lai
  2. Anh Tran
  3. Phioanh L. Nghiemphu
  4. Whitney B. Pope,
  5. Orestes E. Solis
  6. Michael Selch
  7. Emese Filka
  8. William H. Yong,
  9. Paul S. Mischel
  10. Linda M. Liau
  11. Surasak Phuphanich
  12. Keith Black
  13. Scott Peak,
  14. Richard M. Green
  15. Cynthia E. Spier
  16. Tatjana Kolevska
  17. Jonathan Polikoff,
  18. Louis Fehrenbacher
  19. Robert Elashoff and 
  20. Timothy Cloughesy

+Author Affiliations

  1. From the David Geffen School of Medicine at UCLA, Los Angeles; Johnnie Cochran Brain Tumor Center, Cedars-Sinai Medical Center, Los Angeles; Kaiser Permanente Northern California, Vallejo and Redwood City; and Kaiser Permanente Southern California, Los Angeles and San Diego, CA.
  1. Corresponding author: Albert Lai, MD, PhD, University of California, Los Angeles, David Geffen School of Medicine, 710 Westwood Plaza, Reed Neurological Research Center, Suite 1-230, Los Angeles, CA 90095; e-mail:albertlai@mednet.ucla.edu.

Abstract

Purpose This open-label, prospective, multicenter single-arm phase II study combined bevacizumab (BV) with radiation therapy (RT) and temozolomide (TMZ) for the treatment of newly diagnosed glioblastoma (GBM). The objectives were to determine the efficacy of this treatment combination and the associated toxicity.

Patients and Methods Seventy patients with newly diagnosed GBM were enrolled between August 2006 and November 2008. Patients received standard RT starting within 3 to 6 weeks after surgery with concurrent administration of daily TMZ and biweekly BV. After completion of RT, patients resumed TMZ for 5 days every 4 weeks and continued biweekly BV. MGMT promoter methylation was assessed on patient tumor tissue. A University of California, Los Angeles/Kaiser Permanente Los Angeles (KPLA) control cohort of newly diagnosed patients treated with first-line RT and TMZ who had mostly received BV at recurrence was derived for comparison.

Results The overall survival (OS) and progression-free survival (PFS) were 19.6 and 13.6 months, respectively, compared to 21.1 and 7.6 months in the University of California, Los Angeles/KPLA control cohort, and 14.6 and 6.9 months in the European Organisation for Research and Treatment of Cancer-National Cancer Institute of Canada cohort. Correlation of MGMT promoter methylation and improved OS and PFS was retained in the study group. Comparative subset analysis showed that poor prognosis patients (recursive partitioning analysis class V/VI) may derive an early benefit from the use of first-line BV. Toxicity attributable to RT/TMZ was similar, and additional toxicities were consistent with those reported in other BV trials.

Conclusion Patients treated with BV and TMZ during and after RT showed improved PFS without improved OS compared to the University of California, Los Angeles/KPLA control group. Additional studies are warranted to determine if BV administered first-line improves survival compared to BV at recurrence.

 




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