Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma.

Abstract

Patients with unresectable glioblastomas have a poor prognosis, with median survival of 6-10 months. We conducted a phase II trial of upfront 5-day temozolomide (TMZ) and bevacizumab (BV) in patients with newly diagnosed unresectable or multifocal glioblastoma. Patients received up to four cycles of TMZ at 200 mg/m(2) on days 1-5, and BV at 10 mg/kg on days 1 and 15 of a 28-day cycle. Brain magnetic resonance imaging (MRI) was performed monthly. Therapy was continued as long as there was no tumor progression, grade 4 nonhematologic toxicity, or recurrent grade 4 hematologic toxicity after dose reduction. The primary end point was best tumor response as measured on MRI. Forty-one patients were accrued over 12 months; 39 had a full set of MRI scans available for evaluation. Assessment for best radiographic responses was as follows: partial responses in 24.4%, stable disease in 68.3%, and progressive disease in 2.4%. Treatment-related toxicities included seven grade 4 toxicities and one grade 5 toxicity (myocardial infarction). From this study, it was concluded that an upfront regimen of TMZ and BV for unresectable glioblastoma was well tolerated and provided a significant level of disease stabilization. Therapeutic toxicities were consistent with those seen in the adjuvant setting using these agents. The upfront approach to treatment of glioblastoma in the unresectable population warrants further investigation in randomized controlled phase III trials.

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Citation

Published Version (Please cite this version)

10.1002/cam4.58

Publication Info

Lou, Emil, Katherine B Peters, Ashley L Sumrall, Annick Desjardins, David A Reardon, Eric S Lipp, James E Herndon, April Coan, et al. (2013). Phase II trial of upfront bevacizumab and temozolomide for unresectable or multifocal glioblastoma. Cancer Med, 2(2). pp. 185–195. 10.1002/cam4.58 Retrieved from https://hdl.handle.net/10161/16113.

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Peters

Katherine Barnett Peters

Professor of Neurosurgery

Dr. Katy Peters, MD Ph.D. FAAN is an associate professor of neurology and neurosurgery at the Preston Robert Tisch Brain Tumor Center (PRTBTC) at Duke.   Her academic medical career started at Stanford University School of Medicine, receiving an MD and Ph.D. in Cancer Biology.  After completing a neurology residency at Johns Hopkins University and a fellowship in cognitive neurosciences, Katy joined the PRTBTC as a neuro-oncology fellow.  In 2009, she became a faculty member at PRTBTC.  With a fantastic team of nursing and advanced practice providers, she actively sees and cares for patients with primary brain tumors.  Her research interests include supportive care for brain cancer patients, cognitive dysfunction in cancer patients, and physical function and activity of brain cancer patients.   While she runs clinical trials to treat primary brain tumors, her key interest is on clinical trials that focus on improving brain tumor patients' quality of life and cognition.   In 2019, the PRTBTC designated her as the Director of Supportive Care, thus furthering the PRTBTC and her committee to better the quality of life for brain tumor patients.   She is active in teaching medical school students, residents, fellows, and advanced practice providers and is the Program Director of the PRTBRC neuro-oncology fellowship.     She is board certified by the American Board of Psychiatry and Neurology and the United Council of Neurologic Subspecialties for neuro-oncology.


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