Introduction
Methods
Patient registration
Selection criteria |
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Based on preoperative MRI, typically as ring-like enhancement on contrast administration with perifocal edema |
Other clinical/laboratory data, and clinical course |
Age 18–75 years |
Eastern Cooperative Oncology Group PS;0–2 (with PS 3 allowed if due to neurological deficit caused by brain tumor) |
Adequate hematologic, cardiac, pulmonary, renal, and hepatic function |
Absolute neutrophil count ≥1,500/μL |
Platelets ≥75,000/μL |
Hemoglobin 8.0 ≥g/dL |
Serum creatinine ≤1.5 mg/dL |
AST/ALT ≤3 × upper limit of normal |
Total bilirubin ≤2.0 mg/dL |
Exclusion criteria |
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An infectious disease needing systemic treatment |
History of cancer within 5 years |
History of radiotherapy to the skull |
Uncontrolled hypertension |
Serious cardiac disease |
Any symptomatic thromboembolic event within 6 months |
Broncho-pulmonary/symptomatic cerebral hemorrhage within 6 months |
Unhealed wound or bone fracture, active gastrointestinal ulcer, pulmonary fibrosis/interstitial pneumonia |
Hemoptysis ≥ CTCAE grade 2 within 28 days |
Bleeding diathesis or coagulation disorder (prophylactic antiplatelet/anticoagulant drug allowed when PT-INR is 1/5–2.5) |
Pregnant or breastfeeding woman, or history of allergic events to gadolinium |
Patients with the possibility of metastatic brain tumors or primary central nervous system lymphoma or abscess were also excluded based on serological tumor cell markers, chest x-ray, body CT, and brain MRI including DWI (robust high intensity signal) |
Assessment | |
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Radiological response | within 14 days before registration (baseline) within 7 days before resection within 72 h after resection 1 month after resction every 2 months thereafter |
KPS | within 5 days before registration; within 7 days before resection; 1 month after resection; and every 2 months thereafter |
MMSE | within 5 days before registration and within 7 days before resection (2–3 weeks after Bev administration) |
Endpoints | |
Primary endpoint | PFS as assessed by RANO criteria |
Secondary endpoint | Safety |
response to preoperative Bev and TMZ | |
2-year OS | |
Subsidiary endpoint | changes in KPS and MMSE by preoperative Bev and TMZ |
Treatment
Assessment and follow-up
Endpoints
Statistical analyses
Results
Patient characteristics
characteritics (n = 15) | % | ||
---|---|---|---|
Age | 62.2 ± 10.8 | ||
(36–74) | |||
Sex | Man | 9 | 60 |
woman | 6 | 40 | |
Side | Left | 10 | 66.7 |
Right | 5 | 33.3 | |
Location | frontal | 3 | 20.0 |
temporal | 8 | 53.3 | |
parietal | 3 | 20.0 | |
occipital | 1 | 6.7 | |
KPS | before neoBev | 83.3 ± 15.4 | |
(60–100) | |||
after neoBev | 94.7 ± 7.4 | ||
(80–100) | |||
MMSE | before neoBev | 21.3 ± 8.7 | |
(6–30) | |||
after neoBev | 27.5 ± 4.2 | ||
(18–30) | |||
MIB-1 index (%) | 31.6 ± 18.6 | ||
(10–80) | |||
Interval between neoBev to surgery (days) | 23.7 ± 2.8 | ||
(21–29) | |||
Response to preoperative Bev and TMZ | partial response | 4 | 26.6 |
Stable | 10 | 66.7 | |
progressive disease | 1 | 6.7 | |
Extent of resection | GTR | 11 | 73.3 |
STR | 3 | 20.0 | |
PR | 1 | 6.7 | |
Surgical modalities | Gliadel | 1 | 6.7 |
awake surgery | 2 | 13.3 | |
Salvage surgery | 6 | 40.0 | |
Pattern of recurrence | Local | 9 | 60.0 |
distant | 3 | 20.0 | |
local and distant | 2 | 13.3 | |
mPFS (months) | 9.5 | ||
mOS (months) | 16.5 |