Breast Cancer Research and Treatment

, Volume 123, Issue 3, pp 837–842

Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy

  • Phuong K. Morrow
  • Stephen Divers
  • Louise Provencher
  • Shiuh-Wen Luoh
  • Teresa M. Petrella
  • Marius Giurescu
  • Thomas Schmelter
  • Yao Wang
  • Gabriel N. Hortobagyi
  • Linda T. Vahdat
Clinical trial

Abstract

Sagopilone is a novel, fully synthetic epothilone that has shown promising preclinical activity in a range of tumor models, including platinum-resistant ovarian cancer and metastatic breast cancer (MBC). This open-label, multicenter, Phase II study investigated the efficacy, safety, and tolerability of sagopilone administered to patients with MBC. Women with MBC whose previous chemotherapy regimen included a taxane and an anthracycline received sagopilone 16 or 22 mg/m2 as a 3-h intravenous infusion every 21 days. Efficacy (using modified Response Evaluation Criteria in Solid Tumors), safety, and tolerability were assessed in this population. A total of 65 patients received sagopilone at either 16 mg/m2 (N = 39) or 22 mg/m2 (N = 26). Patients received a median of two cycles of sagopilone. Among the 65 patients who were evaluable for efficacy, there were three confirmed tumor responses over both treatment arms; however, the primary target of the study was not reached. The main treatment-related adverse events were sensory neuropathy (81.5%) and fatigue (44.6%). There were no deaths related to the study drug. Sagopilone was moderately tolerated in both treatment arms and showed limited activity in heavily pre-treated patients with MBC.

Keywords

Phase II Sagopilone Epothilones Breast cancer Metastatic 

Abbreviations

AE

Adverse event

MBC

Metastatic breast cancer

modRECIST

Modified Response Evaluation Criteria in Solid Tumors

PFS

Progression-free survival

PPS

Per protocol set

WHO

World Health Organization

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Copyright information

© Springer Science+Business Media, LLC. 2010

Authors and Affiliations

  • Phuong K. Morrow
    • 1
  • Stephen Divers
    • 2
  • Louise Provencher
    • 3
  • Shiuh-Wen Luoh
    • 4
  • Teresa M. Petrella
    • 5
  • Marius Giurescu
    • 6
  • Thomas Schmelter
    • 6
  • Yao Wang
    • 7
  • Gabriel N. Hortobagyi
    • 1
  • Linda T. Vahdat
    • 8
  1. 1.Department of Breast Medical OncologyThe University of Texas M.D. Anderson Cancer CenterHoustonUSA
  2. 2.Genesis Cancer CenterHot SpringsUSA
  3. 3.Centre des maladies du sein Deschênes-FabiaCHA Laval UniversityQuebec CityCanada
  4. 4.Oregon Health and Science University and Portland VA Medical CenterPortlandUSA
  5. 5.Sunnybrook Health Science CenterTorontoCanada
  6. 6.Bayer Schering Pharma AGBerlinGermany
  7. 7.Bayer HealthCare PharmaceuticalsWayneUSA
  8. 8.Weill Cornell Medical CollegeNew YorkUSA

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