Evidence map›Paper›PMID 30591028›Full record

Trial reportBMC cancer2018

Randomized phase II study of the PDGFRα antibody olaratumab plus liposomal doxorubicin versus liposomal doxorubicin alone in patients with platinum-refractory or platinum-resistant advanced ovarian cancer.

William P McGuire, Richard T Penson, Martin Gore, Antonio Casado Herraez, Patrick Peterson, Ashwin Shahir, Robert Ilaria

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIComparative StudyMulticenter Study
In one paragraph

Trial report in BMC cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00913835 (Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha), which is not on this map. Cited by 18 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
18citing papers in PubMed, 4 pooled it
5.0field-weighted citation impact, top 5% 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.

NCT00913835 phase2completednot on this map

Randomized Phase 2 Trial Investigating Liposomal Doxorubicin With or Without Anti-Platelet Derived Growth Factor Receptor-Alpha (PDGFRα) Monoclonal Antibody IMC-3G3 in Patients With Platinum-Refractory or Platinum-Resistant Advanced Ovarian Cancer

TypeinterventionalSponsorEli Lilly and CompanyRan2009 to 2014Enrolled125ConditionsOvarian NeoplasmsArmsOlaratumab, liposomal doxorubicin
3 · Its place in the literature

Who cites it

18 citing papers in PubMed, 4 syntheses or guidelines pooled it, 32 citations in OpenAlex.

  1. Pooled it
  2. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Pooled it
  3. Pooled it
  4. Pooled it
  5. Review
  6. Article
  7. Review
  8. Article
  9. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer.The Cochrane database of systematic reviews · 2023
    Review
  10. Review
  11. Review
  12. Article
  13. Article
  14. Article
  15. Article
  16. Article
  17. Article
  18. 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

7 authors at 6 institutions in 3 countries.

William P McGuireVirginia Commonwealth University, 1201 E Marshall St, Room 11-210, Richmond, VA, 23298, USA. william.mcguire@vcuhealth.org.
Richard T PensonMassachusetts General Hospital, Yawkey 9-064, 32 Fruit St, Boston, MA, 02114, USA.
Martin GoreThe Royal Marsden Hospital, Fulham Road, London, SW3 6JJ, UK.
Antonio Casado HerraezHospital Clinico, San Carlos Servicio de Oncologia Medica, Madrid, Spain.
Patrick PetersonEli Lilly and Company, Indianapolis, IN, USA.
Ashwin ShahirEli Lilly and Company, Lilly UK, EMC Building, Erl Wood Manor, Windlesham, Surrey, GU20 6PH, UK.
Robert IlariaEli Lilly and Company, Indianapolis, IN, USA.
Eli Lilly (United States) · USEli Lilly (United Kingdom) · GBHospital Clínico San Carlos · ESMassachusetts General Hospital · USRoyal Marsden Hospital · GBVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOlaratumab is a platelet-derived growth factor receptor-α (PDGFRα)-targeting monoclonal antibody blocking PDGFRα signaling. PDGFRα expression is associated with a more aggressive phenotype and poor ovarian cancer outcomes. This randomized, open label phase II study evaluated olaratumab plus liposomal doxorubicin compared with liposomal doxorubicin alone in advanced ovarian cancer patients.

methodsPatients with platinum-refractory or platinum-resistant advanced ovarian cancer were randomized 1:1 to receive liposomal doxorubicin (40 mg/m

resultsA total of 123 patients were treated (62 olaratumab+liposomal doxorubicin; 61 liposomal doxorubicin). Median PFS was 4.2 months for olaratumab+liposomal doxorubicin and 4.0 months for liposomal doxorubicin (stratified hazard ratio [HR] = 1.043; 95% confidence interval [CI] 0.698-1.558; p = 0.837). Median OS was 16.6 months and 16.2 months in the olaratumab+liposomal doxorubicin and liposomal doxorubicin arms, respectively (HR = 1.098; 95% CI 0.71-1.71). In the platinum-refractory subgroup, median PFS was 5.5 months (95% CI 1.6-9.2) and 3.7 months (95% CI 1.9-9.2) in the olaratumab+liposomal doxorubicin (n = 15) and liposomal doxorubicin arms (n = 16), respectively (HR = 0.85; 95% CI 0.38-1.91). Overall, 59.7% (olaratumab+liposomal doxorubicin) and 65.6% (liposomal doxorubicin) of patients reported grade ≥ 3 adverse events regardless of causality. The most common treatment-emergent adverse events (all grades) regardless of causality were fatigue related (61%), nausea (57%), and constipation (52%) with olaratumab+liposomal doxorubicin and nausea (64%), fatigue related (62%), and mucositis (46%) with liposomal doxorubicin.

conclusionsThe addition of olaratumab to liposomal doxorubicin did not result in significant prolongation of PFS or OS in platinum-resistant or platinum-refractory ovarian cancer.

trial registrationClinicalTrials.gov identifier: NCT00913835 ; registered June 2, 2009.

Indexed as

Drug Resistance, NeoplasmAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Ovarian EpithelialCisplatinConstipationDoxorubicinFatigueFemaleHumansMiddle AgedMucositisNauseaAntibodies, MonoclonalCisplatinDoxorubicinliposomal doxorubicinolaratumabPolyethylene GlycolsReceptor, Platelet-Derived Growth Factor alphaLiposomal doxorubicinOlaratumabOvarian cancerPlatinum refractoryPlatinum resistant

Identifiers

PMID30591028
PMCPMC6307114
OpenAlexW2906919625

What OpenQuestion holds

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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.