Clinical Study | Published:

Anlotinib as a third-line therapy in patients with refractory advanced non-small-cell lung cancer: a multicentre, randomised phase II trial (ALTER0302)

British Journal of Cancer volume 118, pages 654661 (06 March 2018) | Download Citation

Abstract

Background:

Anlotinib (AL3818) is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. The objective of this study was to assess the safety and efficacy of third-line anlotinib for patients with refractory advanced non-small-cell lung cancer (RA-NSCLC).

Methods:

Eligible patients were randomised 1 : 1 to receive anlotinib (12 mg per day, per os; days 1–14; 21 days per cycle) or a placebo. The primary end point was progression-free survival (PFS).

Results:

A total of 117 eligible patients enrolled from 13 clinical centres in China were analysed in the full analysis set. No patients received immune check-point inhibitors and epidermal growth factor receptor status was unknown in 60.7% of the population. PFS was better with anlotinib compared with the placebo (4.8 vs 1.2 months; hazard ratio (HR)=0.32; 95% confidence interval (CI), 0.20–0.51; P<0.0001), as well as overall response rate (ORR) (10.0%; 95% CI, 2.4–17.6% vs 0%; 95% CI, 0–6.27%; P=0.028). The median overall survival (OS) was 9.3 months (95% CI, 6.8–15.1) for the anlotinib group and 6.3 months (95% CI, 4.3–10.5) for the placebo group (HR=0.78; 95% CI, 0.51–1.18; P=0.2316). Adverse events were more frequent in the anlotinib than the placebo group. The percentage of grade 3–4 treatment-related adverse events was 21.67% in the anlotinib group.

Conclusions:

Anlotinib as a third-line treatment provided significant PFS benefits to patients with RA-NSCLC when compared with the placebo, and the toxicity profiles showed good tolerance.

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Change history

  • Corrected online 06 March 2018

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Acknowledgements

This study was funded by Chia Tai Tianqing Pharmaceutical Group Co., Ltd, Nanjing, Jiangsu Province, China. We acknowledge the invaluable participation of the patients.

Author information

Author notes

    • Baohui Han
    •  & Kai Li

    These authors contributed equally to this work.

Affiliations

  1. Shanghai Chest Hospital, Shanghai Jiaotong University, Shanghai 230030, China

    • Baohui Han
    • , Yizhuo Zhao
    •  & Liyan Jiang
  2. Tianjin Medical University Cancer Hospital, Tianjin 300040, China

    • Kai Li
  3. Beijing Chest Hospital, Capital Medical University, Beijing 101149, China

    • Baolan Li
  4. Jilin Province Tumor Hospital, Changchun 130012, China

    • Ying Cheng
  5. The First Affiliated Hospital, Medical School of Zhejiang University, Hangzhou 310009, China

    • Jianying Zhou
  6. West China Hospital, Sichuan University, Chengdu 610041, China

    • You Lu
  7. Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing 100021, China

    • Yuankai Shi
  8. Shandong Cancer Hospital, Jinan 250117, China

    • Zhehai Wang
  9. Hunan Cancer Hospital, Changsha 220633, China

    • Yi Luo
  10. Zhejiang Cancer Hospital, Hangzhou 310022, China

    • Yiping Zhang
  11. Fujian Cancer Hospital, Fuzhou 350001, China

    • Cheng Huang
  12. Changhai Hospital, Second Military Medical University, Shanghai 200433, China

    • Qiang Li
  13. The Second Affiliated Hospital, Third Military Medical University, Chongqing 400037, China

    • Guoming Wu

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Competing interests

BH has consulted for AstraZeneca, Roche Pharmaceutical Company. He also received payment for speaking from AstraZeneca Pharmaceutical Company and Lily Pharmaceutical Company. All remaining authors have declared no conflicts of interest.

Corresponding author

Correspondence to Baohui Han.

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DOI

https://doi.org/10.1038/bjc.2017.478

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Supplementary Information accompanies this paper on British Journal of Cancer website (http://www.nature.com/bjc)