A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer
Rustin, G., Reed, N., Jayson, G. C., Ledermann, J. A., Adams, M., Perren, T., Poole, Christopher, Lind, M., Persic, M., Essapen, S., Gore, M., Calvert, H., Stredder, C., Wagner, A., Giurescu, M. and Kaye, S.. (2011) A phase II trial evaluating two schedules of sagopilone (ZK-EPO), a novel epothilone, in patients with platinum-resistant ovarian cancer. Annals of Oncology, Vol.22 (No.11). pp. 2411-2416. ISSN 0923-7534Full text not available from this repository.
Official URL: http://dx.doi.org/10.1093/annonc/mdq780
Background: Sagopilone, the first fully synthetic epothilone, has shown promising preclinical activity in tumour models. This open-label randomised phase II study investigated two infusion schedules of sagopilone in women with ovarian cancer.
Patients and methods: Women with ovarian cancer recurring within 6 months of end of last platinum-containing treatment received sagopilone 16 mg/m2 as a 3- or 0.5-h i.v. infusion every 21 days for up to 6 weeks.
Results: Sixty-three patients received sagopilone as a 3-h (n = 38) or 0.5-h (n = 25) infusion. There were nine confirmed tumour responses [by modified RECIST (n = 8) and by Gynecologic Cancer Intergroup CA-125 criteria (n = 1)] in 57 patients assessable for efficacy overall [three (13%) with 0.5-h and six (18%) with 3-h infusions]. The 0.5-h arm was closed when it failed to meet its target efficacy. Main drug-related adverse events were peripheral sensory neuropathy (73%; 16% grade 3), nausea (37%; 2% grade 3), fatigue (35%; 3% grade 3) and arthralgia (30%; 5% grade 3). Overall incidence of peripheral sensory neuropathy was similar in both treatment arms, with no grade 4 neuropathy events. No acute allergic infusion reactions were observed.
Conclusion: Sagopilone is effective, with balanced tolerability, in patients with recurrent platinum-resistant ovarian cancer.
|Item Type:||Journal Article|
|Subjects:||R Medicine > R Medicine (General)|
|Divisions:||Faculty of Medicine > Warwick Medical School > Health Sciences
Faculty of Medicine > Warwick Medical School
|Journal or Publication Title:||Annals of Oncology|
|Publisher:||Oxford University Press|
|Official Date:||November 2011|
|Page Range:||pp. 2411-2416|
|Access rights to Published version:||Restricted or Subscription Access|
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