Abstract
PurposeThe purpose of this study was to retrospectively analyze the safety and clinical efficacy of anlotinib combined with dose-dense temozolomide (TMZ) as the first-line therapy in the treatment of recurrent glioblastoma (rGBM).Patients and MethodsWe collected the clinical data of 20 patients with rGBM. All patients received anlotinib (12 mg daily, orally for 2 weeks, discontinued for 1 week, repeated every 3 weeks) combined with dose-dense TMZ (100 mg/m2, 7 days on with 7 days off) until the disease progressed (PD) or adverse effects (AEs) above grade 4 appeared. Grade 3 AEs need to be restored to grade 2 before continuing treatment, and the daily dose of anlotinib is reduced to 10 mg. The patients were reexamined by head magnetic resonance imaging (MRI) every 1 to 3 months. The therapeutic effect was evaluated according to Response Assessment in Neuro-Oncology (RANO) criteria. The survival rate was analyzed by Kaplan-Meier survival curve analysis. The baseline of all survival index statistics was the start of anlotinib combined with dose-dense of TMZ. National Cancer Institute-Common Terminology Criteria Adverse Events version 4.0 (NCI-CTCAE 4.0) was used to evaluate AEs.ResultsTwenty cases of rGBM were evaluated according to the RANO criteria after treatment with anlotinib and dose-dense TMZ, including five cases of stable disease (SD), thirteen cases of partial response (PR), one case of complete response (CR), and one case of PD. The median follow-up time was 13.4 (95% CI, 10.5–16.3) months. The 1-year overall survival (OS) rate was 47.7%. The 6-month progression-free survival (PFS) rate was 55%. In the IDH wild type group, the median PFS and median OS were 6.1 and 11.9 months, respectively. We observed that AEs associated with treatment were tolerable. One patient stopped taking the drug because of cerebral infarction. There were no treatment-related deaths.ConclusionAnlotinib combined with dose-dense TMZ for the first-line therapy showed good efficacy in OS, PFS, ORR, and DCR in the treatment of rGBM, and the AEs were tolerant. Randomized controlled clinical trials investigating the treatment of rGBM with anlotinib are necessary.
Highlights
Glioblastoma (GBM) is the most common and invasive primary nervous system tumor [1, 2]
The current standard treatment is to maximize surgical resection based on preserving brain function and to use temozolomide (TMZ), concurrent chemoradiotherapy (CCRT), and adjuvant chemotherapy (AC) after surgery as soon as possible
The inclusion criteria included the following: 1) Karnofsky performance scale (KPS) ≥ 60; 2) ≥18 years old; 3) pathologically confirmed as GBM World Health Organization Grade IV; 4) the evaluation of recurrence by surgeons, radiologists, and oncologists according to the Response Assessment in NeuroOncology (RANO) criteria after magnetic resonance imaging (MRI) reexamination, including MR spectroscopy(MRS) and perfusion imaging; 5) measurable lesions; 6) good bone marrow, liver, and renal function; 7) recurrence treated with anlotinib combined with dose-dense TMZ; and 8) previously standard CCRT and AC
Summary
Glioblastoma (GBM) is the most common and invasive primary nervous system tumor [1, 2]. The current standard treatment is to maximize surgical resection based on preserving brain function and to use temozolomide (TMZ), concurrent chemoradiotherapy (CCRT), and adjuvant chemotherapy (AC) after surgery as soon as possible. The median overall survival (OS) time of GBM is only 14.6 months (95% CI = 13.2–16.8 months), the 2-year OS rate is 26.5% (95% CI = 21.2%–31.7%), the median progression-free survival (PFS) time is 6.9 months (95% CI = 5.8–8.2 months), and approximately 85% of patients relapse within 2 years [3]. The prognosis of patients with recurrent GBM (rGBM) is still poor, with a median OS time of less than 6 months [4]. Researchers have been exploring a safe and effective treatment for rGMB. There is no level I recommendation for the treatment of rGMB in current major guidelines and consensus
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