Inclusion criteria: 1) Karnofsky Performance Scale (KPS) ≥60; 2) age ≥ 18 years old; 3) pathologically confirmed as World Health Organization Level IV glioblastoma (GBM); 4) recurrence after magnetic resonance imaging (MRI) review (including MR spectroscopy (MRS) and perfusion imaging) is assessed by surgeons, radiologists, and oncologists according to Response Assessment in Neuro-Oncology (RANO) criteria; 5) measurable lesions; 6) good bone marrow, liver, and kidney functions; 7) anlotinib combined with dose-intensive temozolomide (TMZ) in the treatment of relapse; 8) previous standard concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy (AC).
Exclusion criteria: 1) complications of other malignant tumors or serious diseases; 2) patients with hypertension whose blood pressure still cannot be reduced to the normal range after treatment with antihypertensive drugs, patients with grade I and above myocardial ischemia or myocardial infarction, and arrhythmias (including QT interval ≥440 ms), patients with grade II cardiac insufficiency, and patients with arteriovenous thrombosis, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, and pulmonary embolism within 6 months; 3) lack of follow-up data.
All the patients were younger than 75 years old and their KPS scores were above 60 points. Anlotinib was taken orally during postoperative concurrent chemoradiotherapy or after relapse. It was used as 12 mg once a day for 2 weeks and stopped for 1 week. Efficacy was evaluated according to the RANO criteria, and the cranial MR examination was conducted every 1–3 months. According to the MR results and clinical symptoms, the efficacy was divided into complete remission (CR), partial response (PR), stable disease (SD), and progressive disease (PD). The overall response rate (ORR) means CR and PR. The DCR means CR, PR, and SD. The primary study endpoints were PFS at 6 months and OS at 1 year (both were calculated at the start of anlotinib treatment).