Anlotinib plus platinum-etoposide as a first-line treatment for extensive-stage small cell lung cancer: A single-arm trial

Pengbo Deng, Chengping Hu, Cen Chen, Liming Cao, Qihua Gu, Jian An, Ling Qin, Min Li, Baimei He, Juan Jiang, Huaping Yang, Pengbo Deng, Chengping Hu, Cen Chen, Liming Cao, Qihua Gu, Jian An, Ling Qin, Min Li, Baimei He, Juan Jiang, Huaping Yang

Abstract

Background: Anlotinib as a third-line or beyond therapy for extensive-stage small-cell lung cancer (ES-SCLC) was studied. This single-arm phase II trial was to investigate the value of anlotinib plus platinum-etoposide as first-line treatment in ES SCLC.

Methods: The primary endpoint was progression-free survival (PFS) and objective response rate (ORR). The secondary endpoints included overall survival (OS), disease control rate (DCR), time to progression (TTP), duration of remission (DoR), and safety. The subgroups of preset liver metastasis and brain metastasis were analyzed.

Results: In 35 ES-SCLC patients, the median PFS, ORR, DCR, and OS were 8.02 months [95% confidence interval (CI): 6.90-9.66], 85.71% (95% CI: 69.74-95.19), 94.29% (95% CI: 80.84-99.30), and 15.87 months (95% CI: 10.38-18.89), respectively. The median PFS in the liver metastasis and brain metastasis subgroups was 7.33 months (95% CI: 4.76-9.69) and 7.34 months (95% CI: 5.68-9.20), respectively. The most common AEs with grade 3-4 were hand-foot syndrome (17%), granulocytosis (17%), stomatitis (14%), hypertriglyceridemia (11%), hypercholesterolemia (11%), as well as nausea and vomiting (11%), and no grade 5 AEs were recorded.

Conclusions: Anlotinib combined with platinum-etoposide provided an effective and safe therapy for patients with ES-SCLC.

Trial registration: ClinicalTrials.gov NCT04675697.

Keywords: SCLC; anlotinib; extensive stage; first-line; phase II trial.

Conflict of interest statement

This study received funding from Chia Tai Tianqing Pharmaceutical Group Co., Ltd. The funder was not involved in the study design, collection, analysis, interpretation of data, the writing of this article or the decision to submit it for publication. All authors declare no other competing interests.

© 2022 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.

Figures

FIGURE 1
FIGURE 1
Flow chart of the single‐arm phase II trial
FIGURE 2
FIGURE 2
Progression‐free survival and overall survival of Kaplan–Meier curves in the whole patient cohort. (A) Median PFS was 8.02 months (95% CI: 6.90–9.66). (B) Median OS was 15.87 months (95% CI: 10.38–18.89) in the whole patient cohort
FIGURE 3
FIGURE 3
Progression‐free survival (PFS) of Kaplan–Meier curves in patients with hepatic metastases and brain metastases. (A) Median of PFS in patients with liver metastasis was 7.33 months (95% CI: 4.76–9.69). (B) Median of OS was 10.38 months (95% Cl: 5.22–15.87). (C) Median of PFS in patients with brain metastases was 7.34 months (95% CI: 5.68–9.20). (D) Median of OS was 10.58 months (95% Cl: 7.33, NE)

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