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A phase II trial of bevacizumab and everolimus as treatment for patients with refractory, progressive intracranial meningioma.

Abstract：

:Meningiomas that progress after standard therapies are challenging with limited effective chemotherapy options. This phase II trial evaluated the efficacy of everolimus plus bevacizumab in patients with recurrent, progressive meningioma after treatment with surgical resection and local radiotherapy when appropriate. Patients with recurrent meningioma (WHO grade I, II, or III) following standard treatments with surgical resection and radiotherapy received bevacizumab (10 mg/kg IV days 1 and 15) and everolimus (10 mg PO daily) each 28 day cycle. Evaluation of response occurred every 2 cycles. The primary endpoint was progression-free survival (PFS). Secondary endpoints included response rate, overall survival and safety. Seventeen patients with a median age of 59 years (29-84) received study treatment. WHO grades at study entry included: I, 5 (29 %); II, 7 (41 %); III, 4 (24 %); unknown, 1 (6 %). Patients received a median of 8 cycles (1-37); all patients are off study treatment. A best response of SD was observed in 15 patients (88 %), and 6 patients had SD for >12 months. Overall median PFS was 22 months (95 % CI 4.5-26.8) and was greater for patients with WHO grade II and III compared to grade I tumors (22.0 months vs 17.5 months). Four patients discontinued treatment due to toxicity (proteinuria, 2; colitis, 1, thrombocytopenia, 1). However, other grade 3 toxicity was uncommon, and no patient had grade 4 toxicity. The combination of everolimus and bevacizumab was well-tolerated, and produced stable disease in 88 % of patients; the median duration of disease stabilization of 10 months (2-29). The median PFS from this prospective trial was similar to previous retrospective reports of bevacizumab in the treatment of recurrent meningioma.

journal_name

J Neurooncol

journal_title

Journal of neuro-oncology

authors

Shih KC,Chowdhary S,Rosenblatt P,Weir AB 3rd,Shepard GC,Williams JT,Shastry M,Burris HA 3rd,Hainsworth JD

doi

10.1007/s11060-016-2172-3

subject

Has Abstract

pub_date

2016-09-01 00:00:00

pages

281-8

issue

eissn

0167-594X

issn

1573-7373

pii

10.1007/s11060-016-2172-3

journal_volume

129

pub_type

杂志文章,多中心研究,随机对照试验

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A phase II trial of bevacizumab and everolimus as treatment for patients with refractory, progressive intracranial meningioma.