Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer
Document Type
Article
Publication Title
British journal of cancer
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/m 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.
First Page
1695
Last Page
1703
DOI
10.1038/s41416-022-01717-6
Publication Date
6-1-2022
Recommended Citation
Roque, Dana M.; Siegel, Eric R.; Buza, Natalia; Bellone, Stefania; Silasi, Dan-Arin; Huang, Gloria S.; Andikyan, Vaagn; Clark, Mitchell; Azodi, Masoud; Schwartz, Peter E.; Rao, Gautam G.; Reader, Jocelyn C.; Hui, Pei; Tymon-Rosario, Joan R.; Harold, Justin; Mauricio, Dennis; Zeybek, Burak; Menderes, Gulden; Altwerger, Gary; Ratner, Elena; and Santin, Alessandro D., "Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer" (2022). Randomized Controlled Trials. 52.
https://scholar.bridgeporthospital.org/randomized_trial/52
Identifier
35149854 (pubmed); PMC8853032 (pmc); 10.1038/s41416-022-01717-6 (doi); 10.1038/s41416-022-01717-6 (pii)