Review ArticleReview

Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer

Nanlin Hu, Yiran Si, Jian Yue, Tingting Sun, Xue Wang, Zhuqing Jia, Songlin Gao, Qiao Li, Yang Shao, Jiayu Wang, Yang Luo, Fei Ma, Binghe Xu and Peng Yuan
Cancer Biology & Medicine August 2021, 18 (3) 849-859; DOI: https://doi.org/10.20892/j.issn.2095-3941.2020.0463

References

  1. 1.↵
    2. Siegel RL,
    3. Miller KD,
    4. Jemal A.
    Cancer statistics, 2019. CA Cancer J Clin. 2019; 69: 7–34.
    OpenUrlCrossRefPubMed
  2. 2.↵
    2. Mayer EL,
    3. Burstein HJ.
    Chemotherapy for metastatic breast cancer. Hematol Oncol Clin North Am. 2007; 21: 257–72.
    OpenUrlCrossRefPubMedWeb of Science
  3. 3.
    2. Stuckey A.
    Breast cancer: epidemiology and risk factors. Clin Obstet Gynecol. 2011; 54: 96–102.
    OpenUrlCrossRefPubMed
  4. 4.↵
    2. Mariotto AB,
    3. Etzioni R,
    4. Hurlbert M,
    5. Penberthy L,
    6. Mayer M.
    Estimation of the number of women living with metastatic breast cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2017; 26: 809–15.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    2. Wang Q,
    3. Li J,
    4. Zheng S,
    5. Li JY,
    6. Pang Y,
    7. Huang R, et al.
    Breast cancer stage at diagnosis and area-based socioeconomic status: a multicenter 10-year retrospective clinical epidemiological study in China. BMC Cancer. 2012; 12: 122.
    OpenUrlCrossRefPubMed
  6. 6.↵
    2. Cardoso F,
    3. Senkus E,
    4. Costa A,
    5. Papadopoulos E,
    6. Aapro M,
    7. Andre F, et al.
    4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4) dagger. Ann Oncol. 2018; 29: 1634–57.
    OpenUrlCrossRefPubMed
  7. 7.↵
    Network NCC. NCCN clinical practice guidelines in Oncology (NCCN Guidelines®) Breast Cancer Version 3 2019.
  8. 8.↵
    2. Folkman J.
    Tumor angiogenesis: therapeutic implications. N Engl J Med. 1971; 285: 1182–6.
    OpenUrlCrossRefPubMedWeb of Science
  9. 9.↵
    2. Banerjee S,
    3. Dowsett M,
    4. Ashworth A,
    5. Martin LA.
    Mechanisms of disease: angiogenesis and the management of breast cancer. Nat Clin Pract Oncol. 2007; 4: 536–50.
    OpenUrlCrossRefPubMed
  10. 10.↵
    2. Miles D,
    3. Cameron D,
    4. Bondarenko I,
    5. Manzyuk L,
    6. Alcedo JC,
    7. Lopez RI, et al.
    Bevacizumab plus paclitaxel vs. placebo plus paclitaxel as first-line therapy for HER2-negative metastatic breast cancer (MERiDiAN): a double-blind placebo-controlled randomised phase III trial with prospective biomarker evaluation. Eur J Cancer. 2017; 70: 146–55.
    OpenUrl
  11. 11.
    2. Miller K,
    3. Wang M,
    4. Gralow J,
    5. Dickler M,
    6. Cobleigh M,
    7. Perez EA, et al.
    Paclitaxel plus bevacizumab vs. paclitaxel alone for metastatic breast cancer. N Engl J Med. 2007; 357: 2666–76.
    OpenUrlCrossRefPubMedWeb of Science
  12. 12.
    2. Robert NJ,
    3. Dieras V,
    4. Glaspy J,
    5. Brufsky AM,
    6. Bondarenko I,
    7. Lipatov ON, et al.
    RIBBON-1: randomized, double-blind, placebo-controlled, phase III trial of chemotherapy with or without bevacizumab for first-line treatment of human epidermal growth factor receptor 2-negative, locally recurrent or metastatic breast cancer. J Clin Oncol. 2011; 29: 1252–60.
    OpenUrlAbstract/FREE Full Text
  13. 13.↵
    2. Brufsky AM,
    3. Hurvitz S,
    4. Perez E,
    5. Swamy R,
    6. Valero V,
    7. O’Neill V, et al.
    RIBBON-2: a randomized, double-blind, placebo-controlled, phase III trial evaluating the efficacy and safety of bevacizumab in combination with chemotherapy for second-line treatment of human epidermal growth factor receptor 2-negative metastatic breast cancer. J Clin Oncol. 2011; 29: 4286–93.
    OpenUrlAbstract/FREE Full Text
  14. 14.↵
    2. Bianchi G,
    3. Loibl S,
    4. Zamagni C,
    5. Salvagni S,
    6. Raab G,
    7. Siena S, et al.
    Phase II multicenter, uncontrolled trial of sorafenib in patients with metastatic breast cancer. Anticancer Drugs. 2009; 20: 616–24.
    OpenUrlCrossRefPubMed
  15. 15.↵
    2. Moreno-Aspitia A,
    3. Morton RF,
    4. Hillman DW,
    5. Lingle WL,
    6. Rowland KM,
    7. Jr. ,
    8. Wiesenfeld M, et al.
    Phase II trial of sorafenib in patients with metastatic breast cancer previously exposed to anthracyclines or taxanes: North Central Cancer Treatment Group and Mayo Clinic Trial N0336. J Clin Oncol. 2009; 27: 11–5.
    OpenUrlAbstract/FREE Full Text
  16. 16.↵
    2. Burstein HJ,
    3. Elias AD,
    4. Rugo HS,
    5. Cobleigh MA,
    6. Wolff AC,
    7. Eisenberg PD, et al.
    Phase II study of sunitinib malate, an oral multitargeted tyrosine kinase inhibitor, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2008; 26: 1810–6.
    OpenUrlCrossRefPubMed
  17. 17.↵
    2. Hu X,
    3. Zhang J,
    4. Xu B,
    5. Jiang Z,
    6. Ragaz J,
    7. Tong Z, et al.
    Multicenter phase II study of apatinib, a novel VEGFR inhibitor in heavily pretreated patients with metastatic triple-negative breast cancer. Int J Cancer. 2014; 135: 1961–9.
    OpenUrlCrossRefPubMed
  18. 18.↵
    2. Hu X,
    3. Cao J,
    4. Hu W,
    5. Wu C,
    6. Pan Y,
    7. Cai L, et al.
    Multicenter phase II study of apatinib in non-triple-negative metastatic breast cancer. BMC Cancer. 2014; 14: 820.
    OpenUrlPubMed
  19. 19.↵
    2. Sun Y,
    3. Niu W,
    4. Du F,
    5. Du C,
    6. Li S,
    7. Wang J, et al.
    Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors. J Hematol Oncol. 2016; 9: 105.
    OpenUrl
  20. 20.↵
    2. Lin B,
    3. Song X,
    4. Yang D,
    5. Bai D,
    6. Yao Y,
    7. Lu N.
    Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRbeta and FGFR1. Gene. 2018; 654: 77–86.
    OpenUrlCrossRefPubMed
  21. 21.↵
    2. Taurin S,
    3. Yang CH,
    4. Reyes M,
    5. Cho S,
    6. Coombs DM,
    7. Jarboe EA, et al.
    Endometrial cancers harboring mutated fibroblast growth factor receptor 2 protein are successfully treated with a new small tyrosine kinase inhibitor in an orthotopic mouse model. Int J Gynecol Cancer. 2018; 28: 152–60.
    OpenUrlAbstract/FREE Full Text
  22. 22.↵
    2. Han B,
    3. Li K,
    4. Wang Q,
    5. Zhang L,
    6. Shi J,
    7. Wang Z, et al.
    Effect of anlotinib as a third-line or further treatment on overall survival of patients with advanced non-small cell lung cancer: The ALTER 0303 phase 3 randomized clinical trial. JAMA Oncol. 2018; 4: 1569–75.
    OpenUrl
  23. 23.↵
    2. Chi Y,
    3. Fang Z,
    4. Hong X,
    5. Yao Y,
    6. Sun P,
    7. Wang G, et al.
    Safety and efficacy of anlotinib, a multikinase angiogenesis inhibitor, in patients with refractory metastatic soft-tissue sarcoma. Clin Cancer Res. 2018; 24: 5233–8.
    OpenUrlAbstract/FREE Full Text
  24. 24.↵
    2. Sun Y,
    3. Du F,
    4. Gao M,
    5. Ji Q,
    6. Li Z,
    7. Zhang Y, et al.
    Anlotinib for the treatment of patients with locally advanced or metastatic medullary thyroid cancer. Thyroid. 2018; 28: 1455–61.
    OpenUrlPubMed
  25. 25.↵
    2. Yang Z,
    3. Yang N,
    4. Ou Q,
    5. Xiang Y,
    6. Jiang T,
    7. Wu X, et al.
    Investigating novel resistance mechanisms to third-generation EGFR tyrosine kinase inhibitor osimertinib in non-small cell lung cancer patients. Clin Cancer Res. 2018; 24: 3097–107.
    OpenUrlAbstract/FREE Full Text
  26. 26.↵
    2. Simon R.
    Optimal two-stage designs for phase II clinical trials. Control Clin Trials. 1989; 10: 1–10.
    OpenUrlCrossRefPubMedWeb of Science
  27. 27.↵
    2. Xie C,
    3. Wan X,
    4. Quan H,
    5. Zheng M,
    6. Fu L,
    7. Li Y, et al.
    Preclinical characterization of anlotinib, a highly potent and selective vascular endothelial growth factor receptor-2 inhibitor. Cancer Sci. 2018; 109: 1207–19.
    OpenUrlCrossRefPubMed
  28. 28.↵
    2. He C,
    3. Wu T,
    4. Hao Y.
    Anlotinib induces hepatocellular carcinoma apoptosis and inhibits proliferation via Erk and Akt pathway. Biochem Biophys Res Commun. 2018; 503: 3093–9.
    OpenUrlPubMed
  29. 29.↵
    2. Tang L,
    3. Yu W,
    4. Wang Y,
    5. Li H,
    6. Shen Z.
    Anlotinib inhibits synovial sarcoma by targeting GINS1: a novel downstream target oncogene in progression of synovial sarcoma. Clin Transl Oncol. 2019; 21: 1624–33.
    OpenUrlCrossRef
  30. 30.↵
    2. Wang G,
    3. Sun M,
    4. Jiang Y,
    5. Zhang T,
    6. Sun W,
    7. Wang H, et al.
    Anlotinib, a novel small molecular tyrosine kinase inhibitor, suppresses growth and metastasis via dual blockade of VEGFR2 and MET in osteosarcoma. Int J Cancer. 2019; 145: 979–93.
    OpenUrl
  31. 31.↵
    2. Cobleigh MA,
    3. Langmuir VK,
    4. Sledge GW,
    5. Miller KD,
    6. Haney L,
    7. Novotny WF, et al.
    A phase I/II dose-escalation trial of bevacizumab in previously treated metastatic breast cancer. Semin Oncol. 2003; 30: 117–24.
    OpenUrlCrossRefPubMedWeb of Science
  32. 32.↵
    2. Kim JY,
    3. Park K,
    4. Jung HH,
    5. Lee E,
    6. Cho EY,
    7. Lee KH, et al.
    Association between mutation and expression of TP53 as a potential prognostic marker of triple-negative breast cancer. Cancer Res Treat. 2016; 48: 1338–50.
    OpenUrl
  33. 33.
    2. Meric-Bernstam F,
    3. Zheng X,
    4. Shariati M,
    5. Damodaran S,
    6. Wathoo C,
    7. Brusco L, et al.
    Survival outcomes by TP53 mutation status in metastatic breast cancer. JCO Precis Oncol. 2018; 2018: PO.17.00245.
  34. 34.
    2. Mosele F,
    3. Stefanovska B,
    4. Lusque A,
    5. Tran Dien A,
    6. Garberis I,
    7. Droin N, et al.
    Outcome and molecular landscape of patients with PIK3CA-mutated metastatic breast cancer. Ann Oncol. 2020; 31: 377–86.
    OpenUrlPubMed
  35. 35.↵
    2. Cristofanilli M,
    3. DeMichele A,
    4. Giorgetti C,
    5. Turner NC,
    6. Slamon DJ,
    7. Im SA, et al.
    Predictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3. Eur J Cancer. 2018; 104: 21–31.
    OpenUrl
  36. 36.↵
    2. Gawronski AR,
    3. Lin YY,
    4. McConeghy B,
    5. LeBihan S,
    6. Asghari H,
    7. Kockan C, et al.
    Structural variation and fusion detection using targeted sequencing data from circulating cell free DNA. Nucleic Acids Res. 2019; 47: e38.
  37. 37.↵
    2. Rossi G,
    3. Mu Z,
    4. Rademaker AW,
    5. Austin LK,
    6. Strickland KS,
    7. Costa RLB, et al.
    Cell-free DNA and circulating tumor cells: comprehensive liquid biopsy analysis in advanced breast cancer. Clin Cancer Res. 2018; 24: 560–8.
    OpenUrlAbstract/FREE Full Text
Back to top

In this issue

Print
Download PDF
Email Article
Citation Tools

Jump to section

Keywords