Temozolomide and anlotinib as second-line therapy for non-small cell lung cancer patients with brain metastases: a retrospective cohort study.

Brain metastases (BM) are a common and challenging complication of advanced non-small cell lung cancer (NSCLC). This study aimed to evaluate the efficacy and safety of the combination of temozolomide (TMZ) and anlotinib as a second-line treatment in advanced NSCLC patients with BM. Clinical data of advanced NSCLC patients with BM between January 2020 and December 2023 were retrospectively reviewed and analyzed. All patients received TMZ combined with anlotinib as a second-line treatment. The primary endpoints included overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and adverse events (AEs). A total of 52 patients were enrolled, with 20 females and 32 males. The median PFS and OS were 5.0 months and 10.0 months. The ORR and DCR were 25% and 65%, respectively. Subgroup analysis demonstrated that patients who developed AEs such as hypertension, proteinuria, and hand-foot syndrome, as well as those with a favorable diagnosis-specified graded prognosis assessment score, had better efficacy outcomes, indicating these features may help to identify the priority population for this regimen. Common AEs, including hematological toxicity, fatigue, and hypertension, were generally manageable with dose adjustments and supportive care. TMZ combined with anlotinib could be a safe and effective second-line treatment option for advanced NSCLC patients with BM. Prospective trials are warranted to confirm these findings and optimize the treatment strategy.