Phase II study evaluating the efficacy and safety of sagopilone (ZK-EPO) in patients with metastatic breast cancer that has progressed following chemotherapy |
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Authors: | Phuong K Morrow Stephen Divers Louise Provencher Shiuh-Wen Luoh Teresa M Petrella Marius Giurescu Thomas Schmelter Yao Wang Gabriel N Hortobagyi and Linda T Vahdat |
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Institution: | (1) Department of Breast Medical Oncology, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe, Box 1354, Houston, TX 77030, USA;(2) Genesis Cancer Center, Hot Springs, AR, USA;(3) Centre des maladies du sein Desch?nes-Fabia, CHA Laval University, Quebec City, Canada;(4) Oregon Health and Science University and Portland VA Medical Center, Portland, OR, USA;(5) Sunnybrook Health Science Center, Toronto, Canada;(6) Bayer Schering Pharma AG, Berlin, Germany;(7) Bayer HealthCare Pharmaceuticals, Wayne, NJ, USA;(8) Weill Cornell Medical College, New York, NY, USA |
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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 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. |
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