Dataset Information

Third-line or above anlotinib in relapsed and refractory small cell lung cancer patients with brain metastases: A post hoc analysis of ALTER1202, a randomized, double-blind phase 2 study.

ABSTRACT:

Background

The prognosis of patients with small cell lung cancer (SCLC) and brain metastases (BM) was poor. This study aimed to explore the efficacy and safety of anlotinib as third-line or above treatment in SCLC with BM.

Methods

This was a subgroup analysis of the ALTER1202 trial, which was a randomized, placebo-controlled trial aimed to evaluate the role of anlotinib as third-line treatment or above in patients with SCLC. This study included patients with BM at baseline. The efficacy and safety outcomes included progression-free survival (PFS), overall survival (OS), central nervous system (CNS), objective response rate (ORR), CNS disease control rate (DCR), time to CNS progression, and adverse events (AEs).

Results

Twenty-one and nine patients with BM were included in the anlotinib and placebo groups, respectively. The median PFS and OS were 3.8 months (95% confidence interval [CI]: 1.8-6.1) and 6.1 months (95% CI: 4.1-8.0) in the anlotinib group. Anlotinib was associated with a significant improvement in PFS (hazard ratio [HR] = 0.15, 95% CI: 0.04-0.51, p = 0.0005) and OS (HR = 0.26, 95% CI: 0.09-0.73, p = 0.0061) than placebo. Anlotinib significantly prolonged the time to CNS progression (p < 0.0001). The anlotinib group had a higher CNS DCR than placebo (95.2% vs. 22.2%, p = 0.0001). The most common grade 3 or higher AEs were increased lipase (19.0%), hypertension (14.3%), and hyponatremia (14.3%) in the anlotinib group.

Conclusions

Anlotinib proved to have potential CNS activity and a manageable toxicity profile in patients with SCLC and BM, significantly delaying CNS progression.

SUBMITTER: Cheng Y

PROVIDER: S-EPMC10686170 | biostudies-literature | 2023 Jun

REPOSITORIES: biostudies-literature

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Publications

Third-line or above anlotinib in relapsed and refractory small cell lung cancer patients with brain metastases: A post hoc analysis of ALTER1202, a randomized, double-blind phase 2 study.

Cheng Ying Y Wang Qiming Q Li Kai K Shi Jianhua J Han Baohui B Wu Lin L Chen Gongyan G He Jianxing J Wang Jie J Qin Haifeng H Li Xiaoling X

Cancer innovation 20230117 3

<h4>Background</h4>The prognosis of patients with small cell lung cancer (SCLC) and brain metastases (BM) was poor. This study aimed to explore the efficacy and safety of anlotinib as third-line or above treatment in SCLC with BM.<h4>Methods</h4>This was a subgroup analysis of the ALTER1202 trial, which was a randomized, placebo-controlled trial aimed to evaluate the role of anlotinib as third-line treatment or above in patients with SCLC. This study included patients with BM at baseline. The ef ...[more]

PMID: 38089404

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Dataset Information

Third-line or above anlotinib in relapsed and refractory small cell lung cancer patients with brain metastases: A post hoc analysis of ALTER1202, a randomized, double-blind phase 2 study.

Background

Methods

Results

Conclusions

Publications

Third-line or above anlotinib in relapsed and refractory small cell lung cancer patients with brain metastases: A post hoc analysis of ALTER1202, a randomized, double-blind phase 2 study.

Similar Datasets

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