Dataset Information

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

SUBMITTER: Roque DM

PROVIDER: S-EPMC8853032 | biostudies-literature | 2022 Jun

REPOSITORIES: biostudies-literature

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Publications

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

Roque Dana M DM Siegel Eric R ER Buza Natalia N Bellone Stefania S Silasi Dan-Arin DA Huang Gloria S GS Andikyan Vaagn V Clark Mitchell M Azodi Masoud M Schwartz Peter E PE Rao Gautam G GG Reader Jocelyn C JC Hui Pei P Tymon-Rosario Joan R JR Harold Justin J Mauricio Dennis D Zeybek Burak B Menderes Gulden G Altwerger Gary G Ratner Elena E Santin Alessandro D AD

British journal of cancer 20220211 12

<h4>Background</h4>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.<h4>Methods</h4>Participants were randomised to receive ixabepilone 20 mg/m<sup>2</sup> days 1, 8, 15 with (IXA + BEV) or without (IXA) bevacizum ...[more]

PMID: 35149854

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Dataset Information

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

Background

Methods

Results

Conclusions

Clinical trial registration

Publications

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

Similar Datasets

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