J Breast Cancer.  2016 Mar;19(1):8-17. 10.4048/jbc.2016.19.1.8.

Patient Management with Eribulin in Metastatic Breast Cancer: A Clinical Practice Guide

Affiliations
  • 1Center for Breast Cancer, National Cancer Center, Goyang, Korea. jungsro@ncc.re.kr
  • 2Breast Cancer Center, Shin Kong Wu Ho-Su Memorial Hospital, Taipei, Taiwan.
  • 3Division of Medical Oncology, Department of Medicine, King Chulalongkorn Memorial Hospital, Chulalongkorn University, Bangkok, Thailand.
  • 4Department of Internal Medicine, Manila Doctor Hospital, Manila, Philippines.
  • 5Division of Medical Oncology, Bombay Hospital Institute of Medical Sciences & Lilavati Hospital, Mumbai, India.
  • 6Department of Clinical Oncology, Queen Mary Hospital, The University of Hong Kong, Hong Kong, China.
  • 7Department of Medical Oncology, National Cancer Centre Singapore, Singapore.

Abstract

Eribulin, an antimicrotubule chemotherapeutic agent, is approved for the treatment of pretreated metastatic breast cancer (mBC) based on the positive outcomes of phase II and phase III clinical trials, which enrolled mainly Western patients. Eribulin has recently been approved in an increasing number of Asian countries; however, there is limited clinical experience in using the drug in certain countries. Therefore, we established an Asian working group to provide practical guidance for eribulin use based on our clinical experience. This paper summarizes the key clinical trials, and the management recommendations for the reported adverse events (AEs) of eribulin in mBC treatment, with an emphasis on those that are relevant to Asian patients, followed by further elaboration of our eribulin clinical experience. It is anticipated that this clinical practice guide will improve the management of AEs resulting from eribulin treatment, which will ensure that patients receive the maximum treatment benefit.

Keyword

Asians; Breast neoplasms; Chemotherapy; Eribulin mesylate

MeSH Terms

Asian Continental Ancestry Group
Breast Neoplasms*
Breast*
Drug Therapy
Humans

Reference

1. Giordano SH, Buzdar AU, Simth TL, Kau SW, Yang Y, Hortobagyi GN. Is breast cancer survival improving? Cancer. 2004; 100:44–52.
Article
2. Pal SK, Dehaven M, Nelson RA, Onami S, Hsu J, Waliany S, et al. Impact of modern chemotherapy on the survival of women presenting with de novo metastatic breast cancer. BMC Cancer. 2012; 12:435.
Article
3. Chia SK, Speers CH, D'yachkova Y, Kang A, Malfair-Taylor S, Barnett J, et al. The impact of new chemotherapeutic and hormone agents on survival in a population-based cohort of women with metastatic breast cancer. Cancer. 2007; 110:973–979.
Article
4. Cardoso F, Senkus-Konefka E, Fallowfield L, Costa A, Castiglione M. ESMO Guidelines Working Group. Locally recurrent or metastatic breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2010; 21:Suppl 5. v15–v19.
Article
5. Jones SE. Considerations in treatment choice for metastatic breast cancer. Breast Cancer. 2008; 15:35–39.
Article
6. Towle MJ, Salvato KA, Budrow J, Wels BF, Kuznetsov G, Aalfs KK, et al. In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B. Cancer Res. 2001; 61:1013–1021.
7. Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, et al. The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth. Mol Cancer Ther. 2005; 4:1086–1095.
Article
8. Okouneva T, Azarenko O, Wilson L, Littlefield BA, Jordan MA. Inhibition of centromere dynamics by eribulin (E7389) during mitotic metaphase. Mol Cancer Ther. 2008; 7:2003–2011.
Article
9. Towle MJ, Salvato KA, Wels BF, Aalfs KK, Zheng W, Seletsky BM, et al. Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions. Cancer Res. 2011; 71:496–505.
Article
10. Agoulnik SI, Oestreicher JL, Taylor NH, Uesugi M, Muto H, Kawano S, et al. Eribulin and paclitaxel differentially affect gene expression profiling of blood vessel cells and in vitro angiogenesis in cocultures of human endothelial cells with pericytes. Cancer Res. 2013; 73:8 Suppl. Abstract #3830.
11. McCracken PJ, Ito K, Yanagimachi M, Tizon X, Provent P, Xu S, et al. Eribulin alters vascular function in human triple-negative (TN) breast MX-1 and MDA-MB-231 tumor xenograft models as measured by DCE-MRI. Cancer Res. 2013; 73:8 Suppl. Abstract #4502.
12. Matsui J, Toyama O, Ino M, Semba T, Uesugi M, Muto H, et al. Eribulin caused re-modeling of tumor vasculature altering gene expression profiling in angiogenesis and epithelial mesenchymal transition (EMT) signaling pathway of host cells within human breast cancer cell (BCC) xenografts in nude mice. Cancer Res. 2013; 73:8 Suppl. Abstract #1413.
13. Goel S, Mita AC, Mita M, Rowinsky EK, Chu QS, Wong N, et al. A phase I study of eribulin mesylate (E7389), a mechanistically novel inhibitor of microtubule dynamics, in patients with advanced solid malignancies. Clin Cancer Res. 2009; 15:4207–4212.
Article
14. Tan AR, Rubin EH, Walton DC, Shuster DE, Wong YN, Fang F, et al. Phase I study of eribulin mesylate administered once every 21 days in patients with advanced solid tumors. Clin Cancer Res. 2009; 15:4213–4219.
Article
15. European Medicines Agency. Eribulin: Summary of Product Characteristics. London: European Medicines Agency;2014.
16. Morgan RJ, Synold TW, Longmate JA, Quinn DI, Gandara D, Lenz HJ, et al. Pharmacodynamics (PD) and pharmacokinetics (PK) of E7389 (eribulin, halichondrin B analog) during a phase I trial in patients with advanced solid tumors: a California Cancer Consortium trial. Cancer Chemother Pharmacol. 2015; 76:897–907.
Article
17. Mukohara T, Nagai S, Mukai H, Namiki M, Minami H. Eribulin mesylate in patients with refractory cancers: a Phase I study. Invest New Drugs. 2012; 30:1926–1933.
Article
18. Cortes J, Vahdat L, Blum JL, Twelves C, Campone M, Roché H, et al. Phase II study of the halichondrin B analog eribulin mesylate in patients with locally advanced or metastatic breast cancer previously treated with an anthracycline, a taxane, and capecitabine. J Clin Oncol. 2010; 28:3922–3928.
Article
19. Vahdat LT, Pruitt B, Fabian CJ, Rivera RR, Smith DA, Tan-Chiu E, et al. Phase II study of eribulin mesylate, a halichondrin B analog, in patients with metastatic breast cancer previously treated with an anthracycline and a taxane. J Clin Oncol. 2009; 27:2954–2961.
Article
20. Aogi K, Iwata H, Masuda N, Mukai H, Yoshida M, Rai Y, et al. A phase II study of eribulin in Japanese patients with heavily pretreated metastatic breast cancer. Ann Oncol. 2012; 23:1441–1448.
Article
21. Cortes J, O'Shaughnessy J, Loesch D, Blum JL, Vahdat LT, Petrakova K, et al. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomized study. Lancet. 2011; 377:914–923.
Article
22. Kaufman PA, Awada A, Twelves C, Yelle L, Perez EA, Velikova G, et al. 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. 2015; 33:594–601.
Article
23. Twelves C, Cortes J, Vahdat L, Olivo M, He Y, Kaufman PA, et al. Efficacy of eribulin in women with metastatic breast cancer: a pooled analysis of two phase 3 studies. Breast Cancer Res Treat. 2014; 148:553–561.
Article
24. Twelves C, Akerele C, Wanders J, Cortes JA. Eribulin mesylate (E7389) vs treatment of physician's choice (TPC) in patients (pts) with metastatic breast cancer (MBC): subgroup analyses from the EMBRACE study. Ann Oncol. 2010; 21:Suppl 8. viii96. Abstract #2750.
25. Blum JL, Twelves CJ, Akerele C, Seegobin S, Wanders J, Cortes J. Impact of the number of prior chemotherapy regimens on overall survival (OS) among subjects with locally recurrent or metastatic breast cancer treated with eribulin mesylate: results from the phase III EMBRACE study. Cancer Res. 2010; 70:24 Suppl. Abstract #P6-13-01.
26. Simons W, Rodriguez-Villanueva J, Sheffield RE, Rege J, HE YP, Lin S. Does the prior chemotherapy treatment sequence affect the overall survival (OS) benefit associated with eribulin? Eur J Cancer. 2013; 49:Suppl 2. Abstract #1891.
27. Awada A, Kaufman PA, Yelle L, Cortes J, Wanders J, O'Shaughnessy J, et al. A phase III, open-label, randomized study of eribulin versus capecitabine in patients (pts) with metastatic breast cancer (MBC): effect of post-progression anti-cancer treatments (PPT) and metastatic progression events on overall survival. Cancer Res. 2013; 73:24 Suppl. Abstract #P3-13-03.
28. Kaufman PA, Cortes J, Awada A, Yelle L, Perez EA, Wanders J, et al. A Phase III, open-label, randomized study of eribulin mesylate versus capecitabine in patients with locally advanced or metastatic breast cancer (MBC) previously treated with anthracyclines and taxanes: subgroup analyses. J Clin Oncol. 2013; 31:Suppl 15. Abstract #1049.
Article
29. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Breast Cancer Version 3. Fort Washington: National Comprehensive Cancer Network;2014.
30. Partridge AH, Rumble RB, Carey LA, Come SE, Davidson NE, Di Leo A, et al. Chemotherapy and targeted therapy for women with human epidermal growth factor receptor 2-negative (or unknown) advanced breast cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol. 2014; 32:3307–3329.
Article
31. Cardoso F, Costa A, Norton L, Senkus E, Aapro M, André F, et al. ESOESMO 2nd international consensus guidelines for advanced breast cancer (ABC2). Ann Oncol. 2014; 25:1871–1888.
Article
32. Ellis LM, Bernstein DS, Voest EE, Berlin JD, Sargent D, Cortazar P, et al. American Society of Clinical Oncology perspective: raising the bar for clinical trials by defining clinically meaningful outcomes. J Clin Oncol. 2014; 32:1277–1280.
Article
33. Wilks S, Puhalla S, O'Shaughnessy J, Schwartzberg L, Berrak E, Song J, et al. Phase 2, multicenter, single-arm study of eribulin mesylate with trastuzumab as first-line therapy for locally recurrent or metastatic HER2-positive breast cancer. Clin Breast Cancer. 2014; 14:405–412.
Article
34. Twelves C, Nasim MY, Anthoney A, Savulsky CI, Yin S, Evans TR. Efficacy and safety of eribulin in combination with capecitabine in patients with metastatic breast cancer: an open-label, phase II dose-confirmation study. Cancer Res. 2015; 75:9 Suppl. Abstract #P3-13-04.
35. Lyman GH, Lyman CH, Agboola O. Risk models for predicting chemotherapy-induced neutropenia. Oncologist. 2005; 10:427–437.
Article
36. Aapro MS, Bohlius J, Cameron DA, Dal Lago L, Donnelly JP, Kearney N, et al. 2010 Update of EORTC guidelines for the use of granulocyte-colony stimulating factor to reduce the incidence of chemotherapy-induced febrile neutropenia in adult patients with lymphoproliferative disorders and solid tumours. Eur J Cancer. 2011; 47:8–32.
Article
37. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Myeloid Growth Factors Version 2.2014. Fort Washington: National Comprehensive Cancer Network;2014.
38. Crawford J, Caserta C, Roila F. ESMO Guidelines Working Group. Hematopoietic growth factors: ESMO Clinical Practice Guidelines for the applications. Ann Oncol. 2010; 21:Suppl 5. v248–v251.
Article
39. Lee JJ, Swain SM. Peripheral neuropathy induced by microtubule-stabilizing agents. J Clin Oncol. 2006; 24:1633–1642.
Article
40. Carlson K, Ocean AJ. Peripheral neuropathy with microtubule-targeting agents: occurrence and management approach. Clin Breast Cancer. 2011; 11:73–81.
Article
41. Kaufman P, Olivo M, He Y, McCutcheon S, Vahdat L. Peripheral neuropathy (PN) in patients (pts) with metastatic breast cancer treated with eribulin: resolution and association with efficacy. J Clin Oncol. 2014; 32:Suppl 26. Abstract #147.
Article
42. Donoghue M, Lemery SJ, Yuan W, He K, Sridhara R, Shord S, et al. Eribulin mesylate for the treatment of patients with refractory metastatic breast cancer: use of a "physician's choice" control arm in a randomized approval trial. Clin Cancer Res. 2012; 18:1496–1505.
Article
43. Polomano RC, Bennett GJ. Chemotherapy-evoked painful peripheral neuropathy. Pain Med. 2001; 2:8–14.
Article
44. Armstrong T, Almadrones L, Gilbert MR. Chemotherapy-induced peripheral neuropathy. Oncol Nurs Forum. 2005; 32:305–311.
Article
45. Hausheer FH, Schilsky RL, Bain S, Berghorn EJ, Lieberman F. Diagnosis, management, and evaluation of chemotherapy-induced peripheral neuropathy. Semin Oncol. 2006; 33:15–49.
Article
46. Wilkes G. Peripheral neuropathy related to chemotherapy. Semin Oncol Nurs. 2007; 23:162–173.
Article
47. Argyriou AA, Polychronopoulos P, Iconomou G, Chroni E, Kalofonos HP. A review on oxaliplatin-induced peripheral nerve damage. Cancer Treat Rev. 2008; 34:368–377.
Article
48. Visovsky C. Chemotherapy-induced peripheral neuropathy. Cancer Invest. 2003; 21:439–451.
Article
49. Repetto L. Greater risks of chemotherapy toxicity in elderly patients with cancer. J Support Oncol. 2003; 1:4 Suppl 2. 18–24.
50. Dropcho EJ. Neurotoxicity of cancer chemotherapy. Semin Neurol. 2004; 24:419–426.
Article
51. Kannarkat G, Lasher EE, Schiff D. Neurologic complications of chemotherapy agents. Curr Opin Neurol. 2007; 20:719–725.
Article
52. McWhinney SR, Goldberg RM, McLeod HL. Platinum neurotoxicity pharmacogenetics. Mol Cancer Ther. 2009; 8:10–16.
Article
53. Nurgalieva Z, Xia R, Liu CC, Burau K, Hardy D, Du XL. Risk of chemotherapy-induced peripheral neuropathy in large population-based cohorts of elderly patients with breast, ovarian, and lung cancer. Am J Ther. 2010; 17:148–158.
Article
54. Cavaletti G, Cornblath DR, Merkies IS, Postma TJ, Rossi E, Frigeni B, et al. The chemotherapy-induced peripheral neuropathy outcome measures standardization study: from consensus to the first validity and reliability findings. Ann Oncol. 2013; 24:454–462.
Article
55. Stubblefield MD, Burstein HJ, Burton AW, Custodio CM, Deng GE, Ho M, et al. NCCN task force report: management of neuropathy in cancer. J Natl Compr Canc Netw. 2009; 7:Suppl 5. S1–S26.
Article
56. Hershman DL, Lacchetti C, Dworkin RH, Lavoie Smith EM, Bleeker J, Cavaletti G, et al. Prevention and management of chemotherapy-induced peripheral neuropathy in survivors of adult cancers: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2014; 32:1941–1967.
Article
57. Trüeb RM. Chemotherapy-induced alopecia. Semin Cutan Med Surg. 2009; 28:11–14.
Article
58. National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology: Antiemesis Version 2.2014. Fort Washington: National Comprehensive Cancer Network;2014.
59. Roila F, Herrstedt J, Aapro M, Gralla RJ, Einhorn LH, Ballatori E, et al. Guideline update for MASCC and ESMO in the prevention of chemotherapy-and radiotherapy-induced nausea and vomiting: results of the Perugia consensus conference. Ann Oncol. 2010; 21:Suppl 5. v232–v243.
60. Basch E, Prestrud AA, Hesketh PJ, Kris MG, Feyer PC, Somerfield MR. Antiemetics: American Society of Clinical Oncology clinical practice guideline update. J Clin Oncol. 2011; 29:4189–4198.
Article
61. Devriese LA, Witteveen PO, Marchetti S, Mergui-Roelvink M, Reyderman L, Wanders J, et al. Pharmacokinetics of eribulin mesylate in patients with solid tumors and hepatic impairment. Cancer Chemother Pharmacol. 2012; 70:823–832.
Article
62. Kaufman PA, Yelle L, Cortes J, Perez EA, Awada A, Wanders J, et al. Effect of age on tolerability and efficacy of eribulin and capecitabine in patients with metastatic breast cancer treated in study 301. Cancer Res. 2013; 73:24 Suppl. Abstract #P3-13-04.
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