Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer |
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| Authors: | Dana M Roque Eric R Siegel Natalia Buza Stefania Bellone Dan-Arin Silasi Gloria S Huang Vaagn Andikyan Mitchell Clark Masoud Azodi Peter E Schwartz Gautam G Rao Jocelyn C Reader Pei Hui Joan R Tymon-Rosario Justin Harold Dennis Mauricio Burak Zeybek Gulden Menderes Gary Altwerger Elena Ratner Alessandro D Santin |
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| Institution: | 1.Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, MD USA ;2.University of Arkansas for Medical Sciences, Little Rock, AR USA ;3.Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT USA ;4.Division of Gynecologic Oncology, Mercy Clinic, St. Louis, MO USA |
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| Abstract: | Background This multi-center RP2 study assessed activity/safety of ixabepilone + bevacizumab compared to ixabepilone in platinum-resistant/refractory ovarian/fallopian tube/primary peritoneal cancer. Additional objectives were to examine the role of prior bevacizumab and taxanes, and explore class III-ß-tubulin (TUBB3) as a predictive biomarker.Methods Participants were randomised to receive ixabepilone 20 mg/m2 days 1, 8, 15 with (IXA + BEV) or without (IXA) bevacizumab 10 mg/kg days 1, 15 every 28 days. Patients were stratified by prior BEV. The primary endpoint was PFS. OS, safety, and ORR served as secondary endpoints.Results Among 76 evaluable patients who received IXA + BEV (n = 39) compared to IXA (n = 37), the ORR was 33% (n = 13) versus 8% (n = 3)(P = 0.004), durable at 6 months in 37% (n = 14) and 3% (n = 1) (P < 0.001). BEV significantly improved PFS (median:5.5 vs 2.2 months, HR = 0.33, 95%CI 0.19–0.55, P < 0.001) and OS (median:10.0 vs 6.0 months, HR = 0.52, 95%CI 0.31–0.87, P = 0.006). Both regimens were well-tolerated. TUBB3 expression did not predict response. Subgroup analyses revealed minimal effect of prior BEV or taxane resistant/refractory status on response to IXA + BEV.Conclusions IXA + BEV is a well-tolerated, effective combination for platinum/taxane-resistant ovarian cancer that extends PFS and likely OS relative to IXA monotherapy. Prior receipt of BEV should not preclude the use of IXA + BEV. TUBB3 is not a predictive biomarker.Clinical trial registration NCT3093155.Subject terms: Translational research, Phase II trials |
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