Evidence map›Paper›PMID 29623421›Full record

Observational studyJournal of cancer research and clinical oncology2018

Trabectedin plus pegylated liposomal doxorubicin (PLD) for patients with platinum-sensitive recurrent ovarian cancer: a prospective, observational, multicenter study.

Ingo B Runnebaum, Dietmar Reichert, Uta Ringsdorf, Markus Kuther, Tobias Hesse, Jalid Sehouli, Pauline Wimberger

Open access · hybridAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Journal of cancer research and clinical oncology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
1.2field-weighted citation impact, top 19% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed, 12 citations in OpenAlex.

  1. Trial
  2. Article
  3. Observational
  4. Review
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

7 authors at 5 institutions in 1 country.

Ingo B RunnebaumDepartment of Gynecology and Reproductive Medicine and ESGO Training Center for Gynecologic Oncology, Jena University Hospital, University Women's Hospital, Am Klinikum 1, 07747, Jena, Germany. ingo.runnebaum@med.uni-jena.de.
Dietmar ReichertMedizinische Studiengesellschaft NORD-WEST GmbH, Medical oncology, Kuhlenstraße 53d, 26655, Westerstede, Germany.
Uta RingsdorfLahn-Dill-Kliniken GmbH, Gynecology and Obstetrics, Forsthausstraße 1, 35578, Wetzlar, Germany.
Markus KutherMunicipal Hospital Kiel, Medical oncology, Chemnitzstraße 33, 24116, Kiel, Germany.
Tobias HesseDepartment of Gynecology and Obstetrics, Agaplesion Diakonieklinikum Rotenburg GmbH, Elise-Averdieck-Strasse 17, 27356, Rotenburg (Wümme), Germany.
Jalid SehouliDepartment of Gynecology with Center for Oncological Surgery, Campus Virchow Klinikum, Benjamin Franklin Charité Comprehensive Cancer Center and European Competence Center for Ovarian Cancer, Medical University of Berlin, Augustenburger Platz 1, 13353, Berlin, Germany.
Pauline WimbergerMedical Faculty and University Hospital Carl Gustav Carus, Gynecology and Obstetrics, TU Dresden, Fetscherstr. 74, 01397, Dresden, Germany.
Agaplesion Diakonieklinikum Rotenburg · DECharité - Universitätsmedizin Berlin · DEJena University Hospital · DEPathologie Hamburg-West · DEUniversity Hospital Carl Gustav Carus · DE

Funding

PharmaMar ET-D-022-11
6 · The paper itself

Abstract

purposeThe OVA-YOND study is the first prospective, non-interventional trial designed to evaluate trabectedin (1.1 mg/m

methodsEligible patients were adults with platinum-sensitive ROC, pretreated with ≥ 1 platinum-containing regimen/s. The primary endpoint was to assess safety/tolerability of the combination.

resultsSeventy-seven patients with platinum-sensitive relapse from 31 sites were evaluated. Patients received a median of 6 cycles (range 1-21) with 39 patients (50.6%) receiving ≥ 6 cycles. Median treatment duration was 4.2 months (range 0.7-18.8), mostly on an outpatient basis (88.3% of patients). Most common grade 3/4 trabectedin-related adverse events (AEs) were leukopenia (18.2%), neutropenia (15.6%), thrombocytopenia (9.1%), alanine (7.8%) and aspartate aminotransferase (6.5%) increase, and nausea/vomiting (5.2% each). Neutropenia (18.2%), leukopenia (15.6%), thrombocytopenia (10.4%), and nausea/vomiting (5.2% each) were the most frequent grade 3/4 PLD-related AEs. No deaths attributed to drug-related AEs or unexpected AEs occurred. Five patients (6.5%) had a complete response and 19 patients (24.7%) achieved a partial response for an objective response rate of 31.2% with median response duration of 6.25 months. Sixteen patients (20.8%) had disease stabilization for a disease control rate of 51.9%. Median progression-free survival was 6.3 months and median overall survival was 16.4 months.

conclusionTrabectedin plus PLD confer clinically meaningful benefit to pre-treated patients with platinum-sensitive ROC, being comparable to those previously observed in selected populations from clinical trials and with a manageable safety profile.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsDioxolesDisease-Free SurvivalDoxorubicinFemaleHumansMiddle AgedNeoplasm Recurrence, LocalOrganoplatinum CompoundsOvarian NeoplasmsPolyethylene GlycolsProspective StudiesTetrahydroisoquinolinesTrabectedinDioxolesDoxorubicinliposomal doxorubicinOrganoplatinum CompoundsPolyethylene GlycolsTetrahydroisoquinolinesTrabectedinObservational trialPegylated liposomal doxorubicin (PLD)Trabectedin

Identifiers

PMID29623421
PMCPMC5948298
OpenAlexW2795503148

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.