1. A prospective, multicentre, single-arm clinical trial of bevacizumab for patients with surgically untreatable, symptomatic brain radiation necrosis.
- Author
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Motomasa Furuse, Naosuke Nonoguchi, Toshihiko Kuroiwa, Susumu Miyamoto, Yoshiki Arakawa, Jun Shinoda, Kazuhiro Miwa, Toshihiko Iuchi, Koji Tsuboi, Kiyohiro Houkin, Shunsuke Terasaka, Yusuke Tabei, Hideo Nakamura, Motoo Nagane, Kazuhiko Sugiyama, Mizuhiko Terasaki, Tatsuya Abe, Yoshitaka Narita, Nobuhito Saito, and Akitake Mukasa
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CANCER radiotherapy complications , *TREATMENT of brain cancer , *BEVACIZUMAB , *NECROSIS , *VASCULAR endothelial growth factors , *PREVENTION , *THERAPEUTICS - Abstract
Background. Brain radiation necrosis (BRN) can be a complication of radiotherapy for primary and secondary brain tumors, as well as head and neck tumors. Since vascular endothelial growth factor (VEGF) is also a vascular permeability factor in the brain, bevacizumab, a humanized antibody that inhibits VEGF, would be expected to reduce perilesional edema that often accompanies BRN. Methods. Patients with surgically untreatable, symptomatic BRN refractory to conventional medical treatments (eg, corticosteroid, anticoagulants, or hyperbaric oxygen therapy) were enrolled. We judged that a major cause of perilesional edema with a lesion-tonormal brain ratio ≤1.8 on 11C-methionine or ≤2.5 on 18F-boronophenylalanine PET was BRN, not tumor recurrence, and 6 cycles of biweekly bevacizumab (5 mg/kg) were administered. The primary endpoint was a ≥30% reduction from the patients' registration for perilesional edema continuing for ≥1 month. Results. Of the 41 patients enrolled, 38were fully eligible for the response assessment. The primary endpoint was achieved in 30 of the 38 (78.9%) patients at 3.0 months (median) after enrollment. Sixteen patients (42.1%) experienced improvement of their Karnofsy Performance Score. Corticosteroid use could be reduced in 29 patients (76.3%). Adverse events at grade≥3 occurred in 10 patients (24.4%). Conclusions. Bevacizumab treatment offers certain clinical benefits for patients with surgically untreatable, symptomatic BRN. The determination of BRN using amino-acid PET, not biopsy, is adequate and less invasive for determining eligibility to receive bevacizumab. [ABSTRACT FROM AUTHOR]
- Published
- 2016
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