A randomized trial of eribulin monotherapy versus eribulin plus anlotinib in patients with locally recurrent or metastatic breast cancer

Sung, 2021, Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries, CA Cancer J Clin, 71, 209, 10.3322/caac.21660 Liu, 2022, Molecular landscape of TP53 mutations in breast cancer and their utility for predicting the response to HER-targeted therapy in HER2 amplification-positive and HER2 mutation-positive amplification-negative patients, Cancer Med, 11, 2767, 10.1002/cam4.4652 Hu, 2021, Anlotinib has good efficacy and low toxicity: a phase II study of anlotinib in pre-treated HER-2 negative metastatic breast cancer, Cancer Biol Med, 18, 849, 10.20892/j.issn.2095-3941.2020.0463 Smith, 2010, Eribulin binds at microtubule ends to a single site on tubulin to suppress dynamic instability, Biochemistry, 49, 1331, 10.1021/bi901810u Yuan, 2019, Eribulin mesilate versus vinorelbine in women with locally recurrent or metastatic breast cancer: a randomised clinical trial, Eur J Cancer, 112, 57, 10.1016/j.ejca.2019.02.002 Kaufman, 2015, Phase III open-label randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline and a taxane, J Clin Oncol, 33, 594, 10.1200/JCO.2013.52.4892 Cortes, 2011, Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study, Lancet, 377, 914, 10.1016/S0140-6736(11)60070-6 Banerjee, 2007, Mechanisms of disease: angiogenesis and the management of breast cancer, Nat Clin Pract Oncol, 4, 536, 10.1038/ncponc0905 Robert, 2011, 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, 29, 1252, 10.1200/JCO.2010.28.0982 Brufsky, 2011, J Clin Oncol, 29, 4286, 10.1200/JCO.2010.34.1255 Hardy-Bessard, 2020, First-line bevacizumab and eribulin combination therapy for HER2-negative metastatic breast cancer: efficacy and safety in the GINECO phase II ESMERALDA study, Breast, 54, 256, 10.1016/j.breast.2020.09.011 De Angelis, 2021, Eribulin in combination with bevacizumab as second-line treatment for HER2-negative metastatic breast cancer progressing after first-line therapy with paclitaxel and bevacizumab: a multicenter, phase II, single arm trial (GIM11-BERGI), ESMO Open, 6 Zhao, 2021, Real-world effectiveness of eribulin in heavily pretreated patients with metastatic breast cancer in China: a multicenter retrospective study, Ther Adv Med Oncol, 13, 10.1177/17588359211030210 Lin, 2018, Anlotinib inhibits angiogenesis via suppressing the activation of VEGFR2, PDGFRβ and FGFR1, Gene, 654, 77, 10.1016/j.gene.2018.02.026 Sun, 2016, Safety, pharmacokinetics, and antitumor properties of anlotinib, an oral multi-target tyrosine kinase inhibitor, in patients with advanced refractory solid tumors, J Hematol Oncol, 9, 105, 10.1186/s13045-016-0332-8 Fang, 2022, Anlotinib inhibits the proliferation, migration and invasion, and induces apoptosis of breast cancer cells by downregulating TFAP2C, Oncol Lett, 23, 46, 10.3892/ol.2021.13164 Chen, 2022, Anti-cancer drug anlotinib promotes autophagy and apoptosis in breast cancer, Front Biosci, 27, 125, 10.31083/j.fbl2704125 Zheng, 2022, Treatment response to eribulin and anlotinib in lung metastases from rare perianal adenoid cystic carcinoma: a case report, Anticancer Drugs, 33, e548, 10.1097/CAD.0000000000001171 Eisenhauer, 2009, New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1), Eur J Cancer, 45, 228, 10.1016/j.ejca.2008.10.026 Liu, 2022, The circulating tumor DNA (ctDNA) alteration level predicts therapeutic response in metastatic breast cancer: novel prognostic indexes based on ctDNA, Breast, 65, 116, 10.1016/j.breast.2022.07.010 Hu, 2022, Co-expression and combined prognostic value of CSPG4 and PDL1 in TP53-aberrant triple-negative breast cancer, Front Oncol, 12 Hu, 2018, Identifying circulating tumor DNA mutation profiles in metastatic breast cancer patients with multiline resistance, EBioMedicine, 32, 111, 10.1016/j.ebiom.2018.05.015 Liu, 2022, Eribulin mesylate versus eribulin plus anlotinib in patients with advanced or metastatic breast cancer: results of a phase II study, Am Soc Clin Oncol, 40, 1094, 10.1200/JCO.2022.40.16_suppl.1094 Yardley, 2016, Ramucirumab with eribulin versus eribulin in locally recurrent or metastatic breast cancer previously treated with anthracycline and taxane therapy: a multicenter, randomized, phase II study, Clin Breast Cancer, 16, 471, 10.1016/j.clbc.2016.07.005 Mackey, 2015, Primary results of ROSE/TRIO-12, a randomized placebo-controlled phase III trial evaluating the addition of ramucirumab to first-line docetaxel chemotherapy in metastatic breast cancer, J Clin Oncol, 33, 141, 10.1200/JCO.2014.57.1513 Tolaney, 2020, Effect of eribulin with or without pembrolizumab on progression-free survival for patients with hormone receptor-positive, ERBB2-negative metastatic breast cancer, JAMA Oncol, 6, 1598, 10.1001/jamaoncol.2020.3524 Liu, 2022, Multicenter phase II trial of camrelizumab combined with apatinib and eribulin in heavily pretreated patients with advanced triple-negative breast cancer, Nat Commun, 13, 3011, 10.1038/s41467-022-30569-0 Wozniak, 2018, Peripheral neuropathy induced by microtubule-targeted chemotherapies: insights into acute injury and long-term recovery, Cancer Res, 78, 817, 10.1158/0008-5472.CAN-17-1467 Benbow, 2017, Microtubule-targeting agents eribulin and paclitaxel differentially affect neuronal cell bodies in chemotherapy-induced peripheral neuropathy, Neurotox Res, 32, 151, 10.1007/s12640-017-9729-6 Liu, 2023, The efficacies and biomarker investigations of antiangiogenic agents and PD-1 inhibitors for metastatic soft tissue sarcoma: a multicenter retrospective study, Front Oncol, 13 Xu, 2022, Efficacy and safety of sintilimab plus anlotinib for PD-L1-positive recurrent or metastatic cervical cancer: a multicenter, single-arm, prospective phase II trial, J Clin Oncol, 40, 1795, 10.1200/JCO.21.02091 Kim, 2019, Exploratory biomarker analysis from a phase II clinical trial of eribulin plus gemcitabine versus paclitaxel plus gemcitabine for HER2-negative metastatic breast cancer patients (KCSG BR13-11), Breast Cancer Res Treat, 178, 367, 10.1007/s10549-019-05400-y Sukumar, 2021, Triple-negative breast cancer: promising prognostic biomarkers currently in development, Expert Rev Anticancer Ther, 21, 135, 10.1080/14737140.2021.1840984 Mcgrail, 2021, High tumor mutation burden fails to predict immune checkpoint blockade response across all cancer types, Ann Oncol, 32, 661, 10.1016/j.annonc.2021.02.006 Zeng, 2022, A real-world multicentre retrospective study of low-dose apatinib for human epidermal growth factor receptor 2-negative metastatic breast cancer, Cancers (Basel), 14, 4084, 10.3390/cancers14174084 Xie, 2020, FGFR aberrations increase the risk of brain metastases and predict poor prognosis in metastatic breast cancer patients, Ther Adv Med Oncol, 12, 10.1177/1758835920915305