Evidence map›Paper›PMID 36759720›Full record

Trial reportBritish journal of cancer2023

INOVATYON/ ENGOT-ov5 study: Randomized phase III international study comparing trabectedin/pegylated liposomal doxorubicin (PLD) followed by platinum at progression vs carboplatin/PLD in patients with recurrent ovarian cancer progressing within 6-12 months after last platinum line.

N Colombo, A Gadducci, J Sehouli, E Rulli, J Mäenpää, C Sessa, A Montes, N B Ottevanger, R Berger, I Vergote and 32 more

Registry-linked trialOpen access · hybridAbstract readRandomized Controlled TrialClinical Trial, Phase III
In one paragraph

Trial report in British journal of cancer, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01379989 (Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin), which is not on this map. Cited by 17 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 2 pooled it
5.2field-weighted citation impact, top 4% of its field
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.

NCT01379989 phase3completednot on this map

Phase III International, Randomized Study of Trabectedin Plus Pegylated Liposomal Doxorubicin (PLD) Versus Carboplatin Plus PLD in Patients With Ovarian Cancer Progressing Within 6-12 Months of Last Platinum

TypeinterventionalSponsorMario Negri Institute for Pharmacological ResearchRan2011 to 2020Enrolled617ConditionsOvarian CancerArmsCarboplatin, Pegylated Lipoxomal Doxorubicin (PLD), Trabectedin
3 · Its place in the literature

Who cites it

17 citing papers in PubMed, 2 syntheses or guidelines pooled it, 25 citations in OpenAlex.

  1. SEOM-GEICO clinical guideline on epithelial ovarian cancer (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024
    Guideline
  2. Pooled it
  3. Trial
  4. Article
  5. Review
  6. Review
  7. Article
  8. Pegylated liposomal doxorubicin combined with trabectedin as a treatment option in uterine sarcomas: a single-institution retrospective analysis.International journal of gynecological cancer : official journal of the International Gynecological Cancer Society · 2024
    Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Predicting Response to Anthracyclines in Ovarian Cancer.International journal of environmental research and public health · 2022
    Review
  15. Article
  16. Treatment of Recurrent Epithelial Ovarian Cancer.Geburtshilfe und Frauenheilkunde · 2020
    Article
  17. 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

42 authors at 20 institutions in 11 countries.

N ColomboGynecologic Cancer Program, European Institute of Oncology IRCCS and University of Milan-Bicocca, Milan, Italy.
A GadducciClinical and Experimental Medicine, Division of Gynecology and Obstetrics, University of Pisa, Pisa, Italy.
J SehouliNorth Eastern German Society of Gynecological Oncology (NOGGO) Study group and Gynecology with Center for Oncological Surgery, European Competence Center for Ovarian Cancer, Charité-Berlin University of Medicine, Berlin, Germany.
E RulliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
J MäenpääNordic Society of Gynecologic Oncology Clinical Trial Unit (NSGO-CTU) & Department of Obstetrics and Gynaecology and Tays Cancer Centre Tampere University and University Hospital, Tampere, Finland.
C SessaIstituto Oncologico della Svizzera Italiana, IOSI and Swiss Group for Clinical Cancer Research (SAKK), Bellinzona, Switzerland.
A MontesGuys and St Thomas' NHS Foundation Trust, London, UK.
N B OttevangerMedical Oncology, Radboud University Medical Center, Nijmegen, Netherlands.ORCID http://orcid.org/0000-0001-8209-487X
R BergerMedical University of Innsbruck, Department for Gynecology and Obstetrics, Innsbruck, Austria, and AGO, Innsbruck, Austria.
I VergoteGynecologic Oncology, University Hospitals Leuven, Leuven Cancer Institute, and Belgian Gynaecological Oncology Group (BGOG), European Union, Leuven, Belgium.
M D'IncalciIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.ORCID http://orcid.org/0000-0001-8784-1360
C Churruca GalazHospital de Donosti San Sebastián and Grupo Español de Cáncer de Ovario (GEICO), de Donosti San, Spain.
R ChekerovNorth Eastern German Society of Gynecological Oncology (NOGGO) Study group and Gynecology with Center for Oncological Surgery, European Competence Center for Ovarian Cancer, Charité-Berlin University of Medicine, Berlin, Germany.
G B NyvangNordic Society of Gynecologic Oncology Clinical Trial Unit (NSGO-CTU) & Department of Oncology, Odense University Hospital, Odense, Denmark.
S RinikerOncology, Kantonsspital St. Gallen and Swiss Group for Clinical Cancer Research (SAKK), St. Gallen, Switzerland.
R HerbertsonBrighton and Sussex University Hospitals NHS Trust, Brighton, UK.
R FossatiIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
M P Barretina-GinestaInstitut Catalá de Oncología de Girona and Grupo Español de Cáncer de Ovario (GEICO), de Donosti San, Spain.
M DeryalNorth Eastern German Society of Gynecological Oncology (NOGGO) Study group and CaritasKlinikum St. Theresia-Saarbruecken, Saarbruecken, Germany.
M R MirzaNordic Society of Gynecologic Oncology Clinical Trial Unit (NSGO-CTU) & Department of Cancer Treatment, Copenhagen University Hospital, Copenhagen, Denmark.
E BiagioliIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy. elena.biagioli@marionegri.it.ORCID http://orcid.org/0000-0002-2066-3827
M IglesiasHospital Son Llázter and Grupo Español de Cáncer de Ovario (GEICO), Palma, Spain.
G FunariIstituto di Ricerche Farmacologiche Mario Negri IRCCS, Milan, Italy.
M RomeoInstitut Catalá de Oncología de Badalona and Grupo Español de Cáncer de Ovario (GEICO), de Donosti San, Spain.
G TascaOncologia 2, Istituto Oncologico Veneto, Padua, Italy.
B PardoInstitut Catalá de Oncología de Hospitalet and Grupo Español de Cáncer de Ovario (GEICO), Barcelona, Spain.
G TognonObstetrics and Gynaecology, ASST Spedali Civili-Università degli Studi di Brescia, Brescia, Italy.
M J Rubio-PérezHospital Reina Sofía Córdoba and Grupo Español de Cáncer de Ovario (GEICO), de Donosti San, Spain.
A DeCensiS.C. Oncologia Medica, E.O. Ospedali Galliera, Genoa, Italy.
U De GiorgiIRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola, Italy.ORCID http://orcid.org/0000-0001-7520-2908
P ZolaAOU Città della Salute e della Scienza - OIRM S. Anna, Torino, Italy.
P Benedetti PaniciAOU Policlinico Umberto I di Roma, Rome, Italy.
M AgliettaIstituto di Candiolo, FPO-IRCCS and University of Torino, Torino, Italy.
V ArcangeliOspedale Infermi, Rimini, Italy.
C ZamagniIRCCS Azienda Ospedaliero-Universitaria di Bologna, Bologna, Italy.
A BolognaAzienda Unità Sanitaria Locale di Reggio Emilia IRCCS, Reggio Emilia, Italy.
A WestermannAmsterdam UMC, Amsterdam, Netherlands.
V Heinzelmann-SchwarzUniversitätsspital Basel, USB andSwiss Group for Clinical Cancer Research (SAKK), Basel, Switzerland.
I TsibulakMedical University of Innsbruck, Department for Gynecology and Obstetrics, Innsbruck, Austria, and AGO, Innsbruck, Austria.
P WimbergerNorth Eastern German Society of Gynecological Oncology (NOGGO) Study group and Department of Gynecology and Obstetrics, Technische Universität Dresden, Fetscherstr, Dresden, Germany.
A PovedaInitia Oncologia and Grupo Español de Cáncer de Ovario (GEICO), Valencia, Spain.
INOVATYON study group
Spanish Ovarian Cancer Research Group · ESMario Negri Institute for Pharmacological Research · ITInnsbruck Medical University · ATPoliclinico Umberto I · ITHospital General Universitario Morales Meseguer · ESSantissima Trinità · ITUniversità degli Studi del Piemonte Orientale “Amedeo Avogadro” · ITAzienda Sanitaria Unità Locale di Reggio Emilia · ITEnte Ospedaliero Ospedali Galliera · ITEuropean Union · BEGuy's and St Thomas' NHS Foundation Trust · GBIstituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori · ITRadboud University Nijmegen · NLSwiss Group For Clinical Cancer Research · CHUniversity Hospital of Basel · CHUniversity of Milan · ITUniversity of Pisa · ITAlessandro Manzoni Hospital · ITAlthaia · ESAzienda Ospedaliera di Valtellina e Valchiavenna · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThis trial investigated the hypothesis that the treatment with trabectedin/PLD (TP) to extend the platinum-free interval (TFIp) can improve overall survival (OS) in patients with recurrent ovarian cancer (OC).

methodsPatients with OC (up to two previous platinum-based lines), with a TFIp of 6-12 months, were randomised to receive carboplatin/PLD (CP) or TP followed by platinum therapy at relapse. The primary endpoint was OS (HR: 0.75).

resultsThe study enrolled 617 patients. The median TFIp was 8.3 months and 30.3% of patients had received two previous platinum lines. 74% and 73.9% of patients, respectively, received a subsequent therapy (ST) in the CP and TP arm; in the latter TP arm 87.2% of ST was platinum-based, as per protocol. The median OS was 21.4 for CP and 21.9 months for TP (HR 1.13; 95% CI: 0.94-1.35; p = 0.197). Grade 3-5 adverse reactions occurred in 37.1% of patients in the CP arm and 69.7% of patients in the TP arm, and the most frequent were neutropenia (22.8% CP, 39.5% TP), gastrointestinal (7.1% CP, 17.4% TP), hepatic (0.7% CP, 19.1% TP).

conclusionsThis study did not meet the primary endpoint. CP combination remains the standard for patients with recurrent OC and a 6-12 months TFIp; TP is an effective treatment in patients suffering from persistent platinum toxicities. CLINICAL

trial registrationClinicalTrials.gov, number NCT01379989.

Indexed as

Ovarian NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Ovarian EpithelialDoxorubicinFemaleHumansNeoplasm Recurrence, LocalPlatinumPolyethylene GlycolsTrabectedinCarboplatinDoxorubicinliposomal doxorubicinPlatinumPolyethylene GlycolsTrabectedin

Identifiers

PMID36759720
PMCPMC10070417
OpenAlexW4319770241

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.