Evidence map›Paper›PMID 20643863›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2011

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer delays third-line chemotherapy and prolongs the platinum-free interval.

S B Kaye, N Colombo, B J Monk, S Tjulandin, B Kong, M Roy, S Chan, E Filipczyk-Cisarz, H Hagberg, I Vergote and 6 more

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 16 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 2 pooled it
8.4field-weighted citation impact, top 3% 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

16 citing papers in PubMed, 2 syntheses or guidelines pooled it, 58 citations in OpenAlex.

  1. CA125-related tumor cell kinetics variables after chemotherapy in advanced ovarian cancer: a systematic review.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2016
    Pooled it
  2. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2013
    Pooled it
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  5. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 10 institutions in 7 countries.

S B KayeSection of Medicine, Institute of Cancer Research, The Royal Marsden Hospital, Sutton, Surrey, UK. Electronic address: stan.kaye@rmh.nhs.uk.
N ColomboMedical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.
B J MonkDivision of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.
S TjulandinDepartment of Clinical Pharmacology and Chemotherapy, Russian Cancer Research Center, Moscow, Russia.
B KongDepartment of Obstetrics and Gynecology, Qilu Hospital, Shandong University, Ji'nan, Shandong, China.
M RoyDepartment of Gynecologic Oncology, University Hospital Center, Quebec, Canada.
S ChanDepartment of Clinical Oncology, Nottingham University Hospital, Nottingham, UK.
E Filipczyk-CisarzChemotherapy Department, Oncology Center, Wroclaw, Poland.
H HagbergDepartment of Oncology, Akademiska Sjukhuset, Uppsala, Sweden.
I VergoteDivision of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.
C LebedinskyClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
T ParekhJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
P SantabárbaraClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
Y C ParkJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ, USA.
A NietoClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
A PovedaDepartment of Medical Oncology, Valencian Institute of Oncology, Valencia, Spain.
PharmaMar (Spain) · ESJohnson & Johnson (United States) · USEuropean Institute of Oncology · ITFundación Instituto Valenciano de Oncología · ESQilu Hospital of Shandong University · CNRoyal Marsden NHS Foundation Trust · GBRussian Cancer Research Center NN Blokhin · RUUniversity of California, Irvine Medical Center · USUniversity of Nottingham · GBUppsala University Hospital · SE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOVA-301 is a large randomized trial that showed superiority of trabectedin plus pegylated liposomal doxorubicin (PLD; CentoCor Ortho Biotech Products L.P., Raritan, NJ, USA). over single-agent PLD in 672 patients with relapsed ovarian cancer, particularly in the partially platinum-sensitive subgroup [platinum-free interval (PFI) of 6-12 months]. This superiority has been suggested to be due to the differential impact of subsequent (platinum) therapy. PATIENTS AND

methodsa detailed analysis of subsequent therapies and survival outcomes in the overall population and in the subsets according to platinum sensitivity was therefore conducted.

resultssimilar proportions of patients received subsequent therapy in each arm (76% versus 77%), including further platinum-based regimens (49% versus 55%). Patients in the trabectedin/PLD arm received subsequent chemotherapy at a later time (median delay 2.5 months versus PLD arm). Overall survival from subsequent platinum was significantly prolonged in the partially platinum-sensitive disease subset (hazard ratio = 0.63; P = 0.0357).

conclusionthe superiority of trabectedin/PLD over single-agent PLD in OVA-301 cannot be explained by differences in the extent or nature of subsequent therapies administered to these patients. On the other hand, these exploratory analyses support the hypothesis that the enhanced survival benefits in the partially platinum-sensitive subset might be due to an extended PFI leading to longer survival with subsequent platinum.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDioxolesDoxorubicinDrug Administration ScheduleFemaleHumansMiddle AgedOrganoplatinum CompoundsOvarian NeoplasmsPolyethylene GlycolsRecurrenceTetrahydroisoquinolinesTrabectedinDioxolesDoxorubicinliposomal doxorubicinOrganoplatinum CompoundsPolyethylene GlycolsTetrahydroisoquinolinesTrabectedin

Identifiers

PMID20643863
PMCPMC3003617
OpenAlexW2139171257

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Registered trials

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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.