Randomised phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer.

Autor: 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
Zdroj: British Journal of Cancer; Jun2022, Vol. 126 Issue 12, p1695-1703, 9p
Abstrakt: 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. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index
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