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

    Research output: Contribution to journalArticle

    16 Citations (Scopus)

    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 openlabel, 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/m 2 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/m 2 (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.

    Original languageEnglish (US)
    Pages (from-to)837-842
    Number of pages6
    JournalBreast Cancer Research and Treatment
    Volume123
    Issue number3
    DOIs
    StatePublished - Oct 2010

    Fingerprint

    Breast Neoplasms
    Safety
    Drug Therapy
    Epothilones
    Anthracyclines
    Platinum
    Intravenous Infusions
    Ovarian Neoplasms
    Fatigue
    sagopilone
    Neoplasms
    Therapeutics
    Pharmaceutical Preparations
    Population

    Keywords

    • Breast cancer
    • Epothilones
    • Metastatic
    • Phase II
    • Sagopilone

    ASJC Scopus subject areas

    • Oncology
    • Cancer Research

    Cite this

    Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. / Morrow, Phuong K.; Divers, Stephen; Provencher, Louise; Luoh, Shiuh-Wen; Petrella, Teresa M.; Giurescu, Marius; Schmelter, Thomas; Wang, Yao; Hortobagyi, Gabriel N.; Vahdat, Linda T.

    In: Breast Cancer Research and Treatment, Vol. 123, No. 3, 10.2010, p. 837-842.

    Research output: Contribution to journalArticle

    Morrow, Phuong K. ; Divers, Stephen ; Provencher, Louise ; Luoh, Shiuh-Wen ; Petrella, Teresa M. ; Giurescu, Marius ; Schmelter, Thomas ; Wang, Yao ; Hortobagyi, Gabriel N. ; Vahdat, Linda T. / Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy. In: Breast Cancer Research and Treatment. 2010 ; Vol. 123, No. 3. pp. 837-842.
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    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 openlabel, 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/m 2 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/m 2 (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.",
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