Evidence map›Paper›PMID 20643862›Full record

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

Trabectedin plus pegylated liposomal doxorubicin in relapsed ovarian cancer: outcomes in the partially platinum-sensitive (platinum-free interval 6-12 months) subpopulation of OVA-301 phase III randomized trial.

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

Open access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
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 49 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
49citing papers in PubMed, 5 pooled it
14.9field-weighted citation impact, top 1% 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

49 citing papers in PubMed, 5 syntheses or guidelines pooled it, 168 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. SEOM guideline in ovarian cancer 2014.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2014
    Guideline
  4. Pooled it
  5. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2013
    Pooled it
  6. Trial
  7. Trial
  8. Trial
  9. Trial
  10. Article
  11. Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Review
  17. Review
  18. Article
  19. Research progress in the treatment of partial platinum-sensitive recurrent ovarian cancer.Zhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2021
    Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

16 authors at 9 institutions in 7 countries.

A PovedaArea of Gynecologic Oncology, Valencian Institute of Oncology, Valencia, Spain. Electronic address: apoveda@fivo.org.
I VergoteDivision of Gynecological Oncology, Department of Obstetrics and Gynecology, University Hospital, Leuven, Belgium.
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.
S B KayeDepartment of Cancer Medicine, The Royal Mardsen Hospital, Sutton, Surrey, UK.
N ColomboMedical Gynecologic Oncology Unit, European Institute of Oncology, Milan, Italy.
C LebedinskyClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
T ParekhJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.
J GómezClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
Y C ParkJohnson & Johnson Pharmaceutical Research & Development, L.L.C., Raritan, NJ.
V AlfaroClinical R&D and Medical Affairs Department, Pharma Mar, Madrid, Spain.
B J MonkDivision of Gynecological Oncology, Department of Obstetrics and Gynecology, University of California Irvine Medical Center, Orange, CA, USA.
PharmaMar (Spain) · ESJohnson & Johnson (United States) · USEuropean Institute of Oncology · ITFundación Instituto Valenciano de Oncología · ESQilu Hospital of Shandong University · CNRussian 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) over PLD alone in relapsed ovarian cancer. The optimal management of patients with partially platinum-sensitive relapse [6-12 months platinum-free interval (PFI)] is unclear. PATIENTS AND

methodswithin OVA-301, we therefore now report on the outcomes for the 214 cases in this subgroup.

resultsTrabectedin/PLD resulted in a 35% risk reduction of disease progression (DP) or death [hazard ratio (HR) = 0.65, 95% confidence interval (CI), 0.45-0.92; P = 0.0152; median progression-free survival (PFS) 7.4 versus 5.5 months], and a significant 41% decrease in the risk of death (HR = 0.59; 95% CI, 0.43-0.82; P = 0.0015; median survival 23.0 versus 17.1 months). The safety of trabectedin/PLD in this subset mimicked that of the overall population. Similar proportions of patients received subsequent therapy in each arm (76% versus 77%), although patients in the trabectedin/PLD arm had a slightly lower proportion of further platinum (49% versus 55%). Importantly, patients in the trabectedin/PLD arm survived significantly longer after subsequent platinum (HR = 0.63; P = 0.0357; median 13.3 versus 9.8 months).

conclusionThis hypothesis-generating analysis demonstrates that superior benefits with trabectedin/PLD in terms of PFS and survival in the overall population appear particularly enhanced in patients with partially sensitive disease (PFI 6-12 months).

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsDioxolesDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleHumansMiddle AgedMultivariate AnalysisOrganoplatinum CompoundsOvarian NeoplasmsPolyethylene GlycolsRecurrenceDioxolesDoxorubicinliposomal doxorubicinOrganoplatinum CompoundsPolyethylene GlycolsTetrahydroisoquinolinesTrabectedin

Identifiers

PMID20643862
PMCPMC3003616
OpenAlexW2171318838

What OpenQuestion holds

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LicenceCC BY-NC
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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.