Evidence map›Paper›PMID 24637997›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2014

Bevacizumab combined with chemotherapy for platinum-resistant recurrent ovarian cancer: The AURELIA open-label randomized phase III trial.

Eric Pujade-Lauraine, Felix Hilpert, Béatrice Weber, Alexander Reuss, Andres Poveda, Gunnar Kristensen, Roberto Sorio, Ignace Vergote, Petronella Witteveen, Aristotelis Bamias and 7 more

Erratum issued 4 registry-linked trialsAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 763 papers, 13 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
763citing papers in PubMed, 13 pooled it
–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.

NCT02545010 phase1unknown statusnot on this mapstarted 2015, after this paper: background citation

Phase I Study of Low Dose Whole Abdominal Radiation Therapy (LDWART) in Combination With Weekly Paclitaxel for Platinum Resistant Ovarian Cancer With Predominant Non-visceral Abdominal Disease

TypeinterventionalSponsorNational University Hospital, SingaporeRan2015 to 2018Enrolled24ConditionsOvarian CancerArmsPaclitaxel, LDWART (Low Dose Whole Abdominal Radiation Therapy)
NCT03462212 phase1 / phase2unknown statusnot on this mapstarted 2021, after this paper: background citation

A Randomized, Molecular Driven Phase II Trial of Carboplatin-Paclitaxel-Bevacizumab vs Carboplatin-Paclitaxel-Bevacizumab-Rucaparib vs Carboplatin-Paclitaxel-Rucaparib, Selected According to HRD Status, in Patients With Advanced (Stage III B-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube Cancer Preceded by a Phase I Dose Escalation Study on Rucaparib-Bevacizumab Combination

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2021 to 2025Enrolled290ConditionsAdvanced (Stage IIIB-C-IV) Ovarian, Primary Peritoneal and Fallopian Tube CancerArmsCarboplatin, Paclitaxel, Bevacizumab, Rucaparib
NCT03587129 phase2terminatednot on this mapstarted 2018, after this paper: background citation

Clinical Study of Apatinib in the Treatment of Platinum Resistant Recurrent Ovarian Cancer

TypeinterventionalSponsorFirst Affiliated Hospital of Harbin Medical UniversityRan2018 to 2020Enrolled1ConditionsOvarian CancerArmsApatinib
NCT04421547 phase3terminatednot on this mapstarted 2020, after this paper: background citation

Phase III Randomized Control Case Study of Letrozole in Women With Heavily Pretreated Ovarian Cancer (MITO32)

TypeinterventionalSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCSRan2020 to 2024Enrolled86ConditionsEpithelial Ovarian CancerArmsLetrozole 2.5mg, Standard single agent chemotherapy
3 · Its place in the literature

Who cites it

763 citing papers in PubMed, 13 syntheses or guidelines pooled it.

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703 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors.

Eric Pujade-LauraineEric Pujade-Lauraine, Group d'Investigateurs Nationaux pour l'Etude des Cancers Ovariens (GINECO) and Université Paris Descartes, Assistance Publique-Hôpitaux de Paris, Paris; Béatrice Weber, GINECO and Centre Alexis Vautrin, Vandoeuvre-les-Nancy; Philippe Follana, GINECO and Centre Antoine-Lacassagne, Nice; Isabelle Ray-Coquard, GINECO and Centre Léon Bérard, Lyon, France; Felix Hilpert, Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) and Klinik für Gynäkologie und Geburtshilfe, Kiel; Alexander Reuss, AGO and Coordinating Center for Clinical Trials, Marburg; Pauline Wimberger, AGO and University of Duisburg-Essen, Essen, Germany; Andres Poveda, Grupo Español de Investigación en Cáncer de Ovario (GEICO) and Instituto Valenciano de Oncologia, Valencia; Ana Oaknin, GEICO and Vall d'Hebron University Hospital, Barcelona, Spain; Gunnar Kristensen, Nordic Society of Gynaecological Oncology (NSGO) and Norwegian Radium Hospital, Oslo, Norway; Roberto Sorio, Multicenter Italian Trials in Ovarian Cancer and Istituto di Ricovero e Cura a Carattere Scientifico, Aviano, Italy; Ignace Vergote, Belgian Gynaecological Oncology Group and University Hospital Leuven, Leuven, Belgium; Petronella Witteveen, Dutch Gynecological Oncology Group and University Medical Center Utrecht, Utrecht, the Netherlands; Aristotelis Bamias, Hellenic Cooperative Oncology Group and University of Athens, Athens, Greece; Deolinda Pereira, GINECO and Instituto Português de Oncologia do Porto, Porto, Portugal; Mansoor Raza Mirza, NSGO and Rigshospitalet, Copenhagen, Denmark; and David Bollag, F. Hoffmann-La Roche, Basel, Switzerland.
Felix Hilpert
Béatrice Weber
Alexander Reuss
Andres Poveda
Gunnar Kristensen
Roberto Sorio
Ignace Vergote
Petronella Witteveen
Aristotelis Bamias
Deolinda Pereira
Pauline Wimberger
Ana Oaknin
Mansoor Raza Mirza
Philippe Follana
David Bollag
Isabelle Ray-Coquard

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeIn platinum-resistant ovarian cancer (OC), single-agent chemotherapy is standard. Bevacizumab is active alone and in combination. AURELIA is the first randomized phase III trial to our knowledge combining bevacizumab with chemotherapy in platinum-resistant OC. PATIENTS AND

methodsEligible patients had measurable/assessable OC that had progressed < 6 months after completing platinum-based therapy. Patients with refractory disease, history of bowel obstruction, or > two prior anticancer regimens were ineligible. After investigators selected chemotherapy (pegylated liposomal doxorubicin, weekly paclitaxel, or topotecan), patients were randomly assigned to single-agent chemotherapy alone or with bevacizumab (10 mg/kg every 2 weeks or 15 mg/kg every 3 weeks) until progression, unacceptable toxicity, or consent withdrawal. Crossover to single-agent bevacizumab was permitted after progression with chemotherapy alone. The primary end point was progression-free survival (PFS) by RECIST. Secondary end points included objective response rate (ORR), overall survival (OS), safety, and patient-reported outcomes.

resultsThe PFS hazard ratio (HR) after PFS events in 301 of 361 patients was 0.48 (95% CI, 0.38 to 0.60; unstratified log-rank P < .001). Median PFS was 3.4 months with chemotherapy alone versus 6.7 months with bevacizumab-containing therapy. RECIST ORR was 11.8% versus 27.3%, respectively (P = .001). The OS HR was 0.85 (95% CI, 0.66 to 1.08; P < .174; median OS, 13.3 v 16.6 months, respectively). Grade ≥ 2 hypertension and proteinuria were more common with bevacizumab. GI perforation occurred in 2.2% of bevacizumab-treated patients.

conclusionAdding bevacizumab to chemotherapy statistically significantly improved PFS and ORR; the OS trend was not significant. No new safety signals were observed.

Indexed as

AdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabDisease-Free SurvivalDoxorubicinDrug Administration ScheduleDrug Resistance, NeoplasmFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOrganoplatinum CompoundsOvarian NeoplasmsAntibodies, Monoclonal, HumanizedBevacizumabDoxorubicinliposomal doxorubicinOrganoplatinum CompoundsPaclitaxelPolyethylene GlycolsTopotecan

Identifiers

PMID24637997

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.