Trial reportAnnals of medicine2024
A phase II study of anlotinib plus whole brain radiation therapy for patients with NSCLC with multiple brain metastases.
Trial report in Annals of medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers, 1 of them a synthesis that pooled it.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
7 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Efficacy and safety of anlotinib in the treatment of brain metastases from non-small cell lung cancer: a systematic review and meta-analysis.Frontiers in pharmacology · 2025Pooled it
- Preliminary results from a phase II trial of spatially fractionated radiotherapy combined with immunotherapy and anti-angiogenic therapy in patients with bulky solid tumors: early evidence of promising efficacy and favorable safety.Radiation oncology (London, England) · 2026Trial
- Anlotinib plus whole-brain radiotherapy for NSCLC brain metastases: a prospective, non-randomized, single-center cohort study.Scientific reports · 2026Article
- Anlotinib combined with temozolomide for brain metastases in small cell lung cancer with early recurrence after whole-brain radiotherapy: a case report.Frontiers in medicine · 2026Article
- Crosstalk in the brain tumor microenvironment: mechanisms, therapeutic strategies, and clinical advances.Military Medical Research · 2026Review
- Research progress of anti-angiogenic therapy combined with immunotherapy and radiotherapy for the treatment of brain metastases in non-small cell lung cancer (Review).Oncology letters · 2025Review
- Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundWhole brain radiotherapy (WBRT) is the mainstay of treatment for patients with non-small cell lung cancer (NSCLC) with multiple brain metastases (BMs); however, the BRAIN study showed that the efficacy of WBRT is unsatisfactory. This prospective phase II study aimed to evaluate the efficacy and safety of WBRT combined with anlotinib, a novel anti-angiogenic multi-target tyrosine kinase inhibitor (TKI), in patients with multiple BMs (>3) from advanced NSCLC.
methodsPatients with advanced NSCLC with multiple BMs who had received two or more lines of treatment were eligible for enrolment into this study. All patients were treated with anlotinib (8-12 mg, QD, on days 1-14 of a 21-day cycle) combined with WBRT (DT 30 Gy/12 F), followed by maintenance therapy with anlotinib until disease progression or treatment intolerance. The primary endpoint of this study was the intracranial progression-free survival (iPFS). The secondary endpoints were intracranial objective response rate (iORR), intracranial disease control rate (iDCR), overall survival (OS) and treatment safety.
resultsBetween May 2019 and January 2021, 28 patients were enrolled, all of whom were evaluable for efficacy and safety. The median age was 57.7 years, and 46.4% were male. Twenty-five patients had adenocarcinoma (89.3%), six had EGFR mutations (21.4%) and two had ALK mutations (7.1%). The median iPFS was 11.1 months (95% confidence interval (CI): 5.4-16.8 months) and the median OS was 13.4 months (95% CI: 5.2-21.6 months). The iORR was 71.4% (six complete responses + 14 partial responses). The most frequently observed adverse events (AEs) were hypertension (71.4%), fatigue (64.3%), anorexia (46.4%), and foot and hand skin reactions (25.0%). No patients developed ≥ grade 4 AEs. No intracranial haemorrhages occurred during treatment. Dose adjustment due to AEs occurred in 17.9% of patients.
conclusionsAnlotinib combined with WBRT is effective and well-tolerated in patients with NSCLC with multiple BMs.
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