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 0923-7534

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Abstract

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
ISSN:	0923-7534
Date:	November 2011
Volume:	Vol.22
Number:	No.11
Page Range:	pp. 2411-2416
Identification Number:	10.1093/annonc/mdq780
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
URI:	http://wrap.warwick.ac.uk/id/eprint/45193

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