Evidence map›Paper›PMID 39516558›Full record

ArticleBJC reports2024

Randomized phase II trial of weekly ixabepilone ± biweekly bevacizumab for platinum-resistant or refractory ovarian/fallopian tube/primary peritoneal cancer (NCT03093155): Updated survival and subgroup analyses.

Dana M Roque, Eric R Siegel, Natalia Buza, Stefania Bellone, Gloria S Huang, Gary Altwerger, Vaagn Andikyan, Mitchell Clark, Masoud Azodi, Peter E Schwartz and 3 more

Registry-linked trialAbstract read
In one paragraph

Article in BJC reports, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03093155 (A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03093155 phase2completednot on this map

A Randomized Phase II Evaluation of Weekly Ixabepilone With or Without Biweekly Bevacizumab in Recurrent or Persistent Platinum-resistant/Refractory Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers

TypeinterventionalSponsorYale UniversityRan2017 to 2022Enrolled78ConditionsEpithelial Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal CancerArmsIxabepilone, Bevacizumab
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

13 authors.

Dana M RoqueDivision of Gynecologic Oncology, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Eric R SiegelDepartment of Biostatistics, University of Arkansas for Medical Sciences, Little Rock, AR, USA.
Natalia BuzaDepartment of Pathology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Stefania BelloneDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Gloria S HuangDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Gary AltwergerDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Vaagn AndikyanDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Mitchell ClarkDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Masoud AzodiDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Peter E SchwartzDivision of Gynecologic Oncology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Gautam G RaoDivision of Gynecologic Oncology, Marlene and Stewart Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine, Baltimore, MD, USA.
Elena RatnerDepartment of Pathology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA.
Alessandro D SantinDepartment of Pathology, Smilow Comprehensive Cancer Center, Yale School of Medicine, New Haven, CT, USA. alessandro.santin@yale.edu.

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundIxabepilone may retain activity in paclitaxel-resistant disease. We previously reported improved response rates (ORR), progression-free (PFS), and overall survival (OS) conferred by ixabepilone+bevacizumab (IXA + BEV) compared to monotherapy (IXA) in heavily pre-treated ovarian cancers. We now describe a mature data set. Subset analyses were performed in patients with different taxane sensitivities and dose modifications.

methodsPatients previously treated with paclitaxel were stratified by prior BEV and randomized to receive IXA 20 mg/m

resultsThirty-seven patients were randomized to IXA and 39 patients to IXA + BEV. At the final data cutoff (05/27/2023), ORR was higher in the IXA + BEV arm (38.4% vs. 8.1%, p = 0.003). Dose reductions were necessary in most participants but did not diminish PFS/OS benefits. Most patients were paclitaxel-refractory/-resistant (51%, n = 19/37;67%, n = 26/39); the remainder were taxane-sensitive. The addition of BEV to IXA conferred benefit in PFS (5.5 vs. 2.2 mo; HR 0.31, 90%CI 0.20-0.49, p < 0.001) and OS (10.3 vs. 6.0 mo; HR 0.56, 90%CI 0.38-0.84, p = 0.02) that persisted after adjusting for prior taxane response.

conclusionsIXA + BEV has activity in heavily pre-treated ovarian cancers and offers significant improvement in ORR and PFS/OS compared to IXA, despite prior taxane response and dose reductions. CLINICAL

trial registrationNCT03093155.

Identifiers

PMID39516558
PMCPMC11523995

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.