Skip to main content

Advertisement

SpringerLink
Log in

Ixabepilone plus capecitabine for Chinese patients with metastatic breast cancer progressing after anthracycline and taxane treatment

  • Clinical Trial Report
  • Published:
Cancer Chemotherapy and Pharmacology Aims and scope Submit manuscript

Abstract

Purpose

Effective treatment options for patients with metastatic breast cancer pretreated with or resistant to anthracyclines and taxanes are limited. Ixabepilone has single-agent activity in these patients and has demonstrated synergy with capecitabine in this setting. This study was designed as a prospective clinical trial to evaluate the efficacy and safety of ixabepilone plus capecitabine in both anthracycline-pretreated and resistant and taxane-resistant metastatic breast cancer of Chinese women.

Patients and methods

Patients with measurable disease who had anthracycline and taxanes as prior neoadjuvant, adjuvant or metastatic therapy were treated with ixabepilone at 40 mg/m2 intravenously on day 1 of 21-day cycle plus capecitabine 2,000 mg/m2 orally on day 1 through 14 of a 21-day cycle. The primary end point was the objective response rate. The secondary end points were time to progression, overall survival, and toxicity profiles.

Results

Twenty-one patients received 146 cycles with a median of 5 cycles (range 1–13 cycles) per patients. Fourteen patients (66.7%) had partial response, 5 patients (23.8%) had stable disease, and 2 patients (9.5%) had progressive disease. Median time to progression and duration of response were 6.2 and 6.0 months, respectively. The median overall survival was 16.7 months. Eight (38.1%) patients required dose reduction and 14 (66.7%) patients discontinued treatment for adverse effect. Grade 3/4 treatment-related events included fatigue (28.6%), peripheral sensory neuropathy (33.3%), neutropenia (61.9%), anemia (4.7%), hypokalemia (4.7%), hand and foot syndrome (19.0%) and infection (9.5%). Resolution of grade 3/4 peripheral neuropathy was reversible after a median period of 6 weeks.

Conclusion

Ixabepilone plus capecitabine demonstrated a clear activity and an acceptable safety profile in Chinese patients with anthracycline-pretreated/resistant and taxane-resistant metastatic breast cancer, and the majority of patients completed 6 cycles of the therapy with manageable neuropathy toxicities.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Fig. 1
Fig. 2

References

  1. Baselga J, Gianni L et al (2005) Predicting response to ixabepilone: genomics study in patients receiving single agent ixabepilone as neoadjuvant treatment for breast cancer. Breast Cancer Res Treat 94:S31–S32

    Google Scholar 

  2. Beslija S, Bonneterre J et al (2009) Third consensus on medical treatment of metastatic breast cancer. Ann Oncol 20(11):1771–1785

    Article  CAS  PubMed  Google Scholar 

  3. Biganzoli L, Cufer T et al (2002) Doxorubicin and paclitaxel versus doxorubicin and cyclophosphamide as first-line chemotherapy in metastatic breast cancer: the European Organization for Research and Treatment of Cancer 10961 Multicenter Phase III Trial. J Clin Oncol 20(14):3114–3121

    Article  CAS  PubMed  Google Scholar 

  4. Blum JL, Jones SE et al (1999) Multicenter phase II study of capecitabine in paclitaxel-refractory metastatic breast cancer. J Clin Oncol 17(2):485–493

    CAS  PubMed  Google Scholar 

  5. Ershler WB (2006) Capecitabine monotherapy: safe and effective treatment for metastatic breast cancer. Oncologist 11(4):325–335

    Article  CAS  PubMed  Google Scholar 

  6. Fojo T, Menefee M (2007) Mechanisms of multidrug resistance: the potential role of microtubule-stabilizing agents. Ann Oncol 18(Suppl 5): v3–v8

    Google Scholar 

  7. Fumoleau P, Largillier R et al (2004) Multicentre, phase II study evaluating capecitabine monotherapy in patients with anthracycline- and taxane-pretreated metastatic breast cancer. Eur J Cancer 40(4):536–542

    Article  CAS  PubMed  Google Scholar 

  8. Geyer CE, Forster J et al (2006) Lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 355(26):2733–2743

    Article  CAS  PubMed  Google Scholar 

  9. Jassem J, Pienkowski T et al (2009) Doxorubicin and paclitaxel versus fluorouracil, doxorubicin and cyclophosphamide as first-line therapy for women with advanced breast cancer: long-term analysis of the previously published trial. Onkologie 32(8–9):468–472

    CAS  PubMed  Google Scholar 

  10. Kamangar F, Dores GM et al (2006) Patterns of cancer incidence, mortality, and prevalence across five continents: defining priorities to reduce cancer disparities in different geographic regions of the world. J Clin Oncol 24(14):2137–2150

    Article  PubMed  Google Scholar 

  11. Moreno-Aspitia A, Perez EA (2009) Anthracycline- and/or taxane-resistant breast cancer: results of a literature review to determine the clinical challenges and current treatment trends. Clin Ther 31(8):1619–1640

    Article  CAS  PubMed  Google Scholar 

  12. Oken MM, Creech RH et al (1982) Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol 5(6):649–655

    Article  CAS  PubMed  Google Scholar 

  13. Reichardt P, Von Minckwitz G et al (2003) Multicenter phase II study of oral capecitabine (Xeloda(“)) in patients with metastatic breast cancer relapsing after treatment with a taxane-containing therapy. Ann Oncol 14(8):1227–1233

    Article  CAS  PubMed  Google Scholar 

  14. Roche H, Yelle L et al (2007) Phase II clinical trial of ixabepilone (BMS-247550), an epothilone B analog, as first-line therapy in patients with metastatic breast cancer previously treated with anthracycline chemotherapy. J Clin Oncol 25(23):3415–3420

    Article  CAS  PubMed  Google Scholar 

  15. Smigal C, Jemal A et al (2006) Trends in breast cancer by race and ethnicity: update 2006. CA Cancer J Clin 56(3):168–183

    Article  PubMed  Google Scholar 

  16. Thomas ES (2008) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 26(13):2223

    Article  PubMed  Google Scholar 

  17. Thomas ES, Gomez HL et al (2007) Ixabepilone plus capecitabine for metastatic breast cancer progressing after anthracycline and taxane treatment. J Clin Oncol 25(33):5210–5217

    Article  CAS  PubMed  Google Scholar 

  18. Toppmeyer DL, Goodin S (2009) Ixabepilone, a new treatment option for metastatic breast cancer. Am J Clin Oncol

  19. Wang T, Jiang ZF et al (2004) Single-agent Xeloda in the treatment of recurrent and metastatic breast cancer. Zhonghua Zhong Liu Za Zhi 26(6):379–381

    CAS  PubMed  Google Scholar 

  20. Wong IO, Cowling BJ et al (2007) Age-period-cohort projections of breast cancer incidence in a rapidly transitioning Chinese population. Int J Cancer 121(7):1556–1563

    Article  CAS  PubMed  Google Scholar 

  21. XU B, LI K et al (2003) Gemcitabine plus cisplatin for the treatment of anthracycine2resistant advanced breast cancer. China Oncol 113:579–581

    Google Scholar 

  22. Yang L, Li LD et al (2006) Time trends, estimates and projects for breast cancer incidence and mortality in China. Zhonghua Zhong Liu Za Zhi 28(6):438–440

    PubMed  Google Scholar 

  23. Yang L, Parkin DM et al (2005) Estimates of cancer incidence in China for 2000 and projections for 2005. Cancer Epidemiol Biomarkers Prev 14(1):243–250

    PubMed  Google Scholar 

Download references

Author information

Authors and Affiliations

  1. Department of Medical Oncology, Cancer Hospital (Institute), Chinese Academy of Medical Sciences, Peking Union Medical College, 100021, Beijing, China

    Jiayu Wang, Ying Fan & Binghe Xu

Authors
  1. Jiayu Wang
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Ying Fan
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Binghe Xu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Binghe Xu.

Rights and permissions

Reprints and permissions

About this article

Cite this article

Wang, J., Fan, Y. & Xu, B. Ixabepilone plus capecitabine for Chinese patients with metastatic breast cancer progressing after anthracycline and taxane treatment. Cancer Chemother Pharmacol 66, 597–603 (2010). https://doi.org/10.1007/s00280-010-1362-5

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s00280-010-1362-5

Keywords

Search

Navigation