Phase II Pilot Study of Bevacizumab in Combination with Temozolomide and Regional Radiation Therapy for Up-Front Treatment of Patients With Newly Diagnosed Glioblastoma Multiforme: Interim Analysis of Safety and Tolerability

摘要: Purpose To assess interim safety and tolerability of a 10-patient, Phase II pilot study using bevacizumab (BV) in combination with temozolomide (TMZ) regional radiation therapy (RT) the up-front treatment patients newly diagnosed glioblastoma. Methods Materials All received standard external beam RT 60.0 Gy 30 fractions started within 3 to 5 weeks after surgery. Concurrently TMZ was given daily at 75 mg/m 2 for 42 days during RT, BV every 10 mg/kg starting first day RT/TMZ. After 2-week interval upon completion post-RT phase commenced resumption 150 200 4 continuation weeks. Results For these patients, toxicities were compiled until discontinuation or up ∼40 from initial those remaining on-study. In terms serious immediate delayed neurotoxicity, 1 patient developed presumed radiation-induced optic neuropathy. Among that could be potentially related, relatively high incidences fatigue, myelotoxicity, wound breakdown, deep venous thrombosis/pulmonary embolism observed. Conclusion The observed acceptable continue enrollment toward overall target group 70 patients. Preliminary efficacy analysis shows encouraging mean progression-free survival. At this time data are not sufficient encourage routine off-label use combined TMZ/RT setting glioblastoma without longer follow-up, additional thorough assessment.