title: Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy.
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/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/m(2) (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.
authors.affiliation: Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe, Box 1354, Houston, TX 77030, USA. pmorrow@mdanderson.org
authors.forename: Phuong K
authors.initials: PK
authors.lastname: Morrow
authors.forename: Stephen
authors.initials: S
authors.lastname: Divers
authors.forename: Louise
authors.initials: L
authors.lastname: Provencher
authors.forename: Shiuh-Wen
authors.initials: SW
authors.lastname: Luoh
authors.forename: Teresa M
authors.initials: TM
authors.lastname: Petrella
authors.forename: Marius
authors.initials: M
authors.lastname: Giurescu
authors.forename: Thomas
authors.initials: T
authors.lastname: Schmelter
authors.forename: Yao
authors.initials: Y
authors.lastname: Wang
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
authors.forename: Linda T
authors.initials: LT
authors.lastname: Vahdat
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D052160:Benzothiazoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000556:secondary; D002170:Canada; D018450:Disease Progression; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D034261:Epothilones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D005858:Germany; D006801:Humans; D007263:Infusions, Parenteral; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D011446:Prospective Studies; D013997:Time Factors; D017211:Treatment Failure; D014481:United States
chemical_list: D000970:Antineoplastic Agents; D052160:Benzothiazoles; D034261:Epothilones; C530494:sagopilone