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Original Article | Open Access

Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer

Cuicui Zhang1Jing Wang1Xinyue Wang1Zhaoting Meng1Ying Cheng2 ( )Kai Li1 ( )
Department of Thoracic Oncology Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, Tianjin’s Clinical Research Center for Cancer, Tianjin 300060, China
Jilin Cancer Hospital, Changchun 130021, China
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Abstract

Objective

In the phase Ⅱ ALTER-1202 (NCT03059797) trial, anlotinib significantly improved progression-free survival (PFS) and overall survival (OS) in patients with advanced small-cell lung cancer (SCLC) who underwent at least 2 previous chemotherapy cycles, when compared with a placebo group. To identify potential factors for predicting efficacy and prognosis with anlotinib treatment, we analyzed hematological indices at baseline and adverse events (AEs) over the course of anlotinib treatment.

Methods

Data were collected from March 2017 to April 2019 from a randomized, double-blind, placebo-controlled, multicenter, phase Ⅱ trial of anlotinib. Eligible patients were randomly assigned 2:1 to receive anlotinib or placebo until disease progression, intolerable toxicity, or withdrawal of consent. The patients received anlotinib (12 mg) or an analogue capsule (placebo) orally once daily for 14 days every 3 weeks. The hematological indices at baseline and AEs that occurred in the initial 2 treatment cycles were recorded. The Kaplan-Meier test and Cox regression model were used to assess survival differences.

Results

A total of 82 patients (81 patients with complete data) were randomly assigned to receive anlotinib, with 38 receiving a placebo as a control. Multivariate analysis indicated that an elevated neutrophil to lymphocyte ratio > 7.75 and lactate dehydrogenase > 254.65 U/L at baseline were independent risk factors for PFS; basal elevated aspartate aminotransferase > 26.75 U/L, neuron specific enolase > 18.64 ng/mL, and fibrinogen > 4.645 g/L were independent risk factors for OS. During treatment, elevated γ glutamyltransferase and hypophosphatemia were independent predictors for a poor PFS, and elevated γ-glutamyl transferase and hypercholesterolemia were independent factors for OS.

Conclusions

Our study preliminarily defined potential factors that affected the PFS and OS at baseline and during anlotinib treatment in patients with advanced SCLC. Our findings provide a basis for screening the dominant population and for dynamic efficacy monitoring with anlotinib therapy.

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Cancer Biology & Medicine
Pages 1249-1258
Cite this article:
Zhang C, Wang J, Wang X, et al. Peripheral blood indices to predict PFS/OS with anlotinib as a subsequent treatment in advanced small-cell lung cancer. Cancer Biology & Medicine, 2022, 19(8): 1249-1258. https://doi.org/10.20892/j.issn.2095-3941.2020.0727

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Received: 26 November 2020
Accepted: 12 April 2021
Published: 29 August 2022
©2022 Cancer Biology & Medicine.

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