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. 2023 Jan 17;2(3):181-190.
doi: 10.1002/cai2.43. eCollection 2023 Jun.

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

Ying Cheng  1 , Qiming Wang  2 , Kai Li  3 , Jianhua Shi  4 , Baohui Han  5 , Lin Wu  6 , Gongyan Chen  7 , Jianxing He  8 , Jie Wang  9 , Haifeng Qin  10 , Xiaoling Li  11
Affiliations

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

Ying Cheng et al. Cancer Innov. .

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.

Keywords: advanced small cell lung cancer; angiogenesis inhibitors; anlotinib; brain metastasis; safety.

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Conflict of interest statement

The authors declare no conflict of interest.

Figures

Figure 1
Figure 1
Kaplan–Meier curves of (a) progression‐free survival (b) overall survival in two groups
Figure 2
Figure 2
Cumulative incidence rate of central nervous system (CNS) progression. The median times to CNS progression were not reached in the anlotinib group and 0.8 months (95% confidence interval: 0.7–2.1) in the placebo group (p < 0.0001), respectively.
See this image and copyright information in PMC

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