Evidence map›Paper›PMID 30406840›Full record

Trial reportCancer chemotherapy and pharmacology2019

Exposure-response relationship of olaratumab for survival outcomes and safety when combined with doxorubicin in patients with soft tissue sarcoma.

Robin L Jones, Gary Mo, John R Baldwin, Patrick M Peterson, Robert L Ilaria, Ilaria Conti, Damien M Cronier, William D Tap

Abstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Cancer chemotherapy and pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
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

7 citing papers in PubMed.

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

8 authors.

Robin L JonesUniversity of Washington and Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N, Seattle, WA, 98109, USA. robin.Jones@rmh.nhs.uk.
Gary MoEli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.
John R BaldwinEli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.
Patrick M PetersonEli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.
Robert L IlariaEli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.
Ilaria ContiEli Lilly and Company, Lilly Corporate Center, 46285, Indianapolis, IN, USA.
Damien M CronierEli Lilly and Company, Lilly Research Centre, Erl Wood Manor Sunninghill Road, Windlesham, Surrey, GU20 6PH, UK.
William D TapMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, 1275 York Ave, New York, NY, 10065, USA.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
Targeting Oncogenic Pathways in Genetically Complex SarcomasP50CA217694 · NCI · SLOAN-KETTERING INST CAN RESEARCH · PI Marc Ladanyi · 2018 to 2026
$21.5M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

purposeOlaratumab is a recombinant human IgG1 monoclonal antibody against PGDFRα. Olaratumab plus doxorubicin improved survivalversus doxorubicin in an open-label, randomised phase 2 soft tissue sarcoma (STS) trial. We characterised the olaratumab exposure-response relationship for progression-free survival (PFS), overall survival (OS), and safety.

methodsPFS and OS data from the 133 patients enrolled in the phase 2 study were analysed using time-to-event modelling. The effect of olaratumab on PFS/OS was explored using the trough serum concentration after cycle 1 (C

resultsPFS and OS were described by models with an exponential hazard function and inhibitory E

conclusionsPFS/OS benefits occurred without a rate change in TEAEs across quartiles. Maximum benefit in OS was achieved in the upper three quartiles and a potential of early disease progression in the lower quartile of olaratumab serum exposure. These results prompted a loading dose strategy in the ongoing phase 3 STS trial.

Indexed as

Antibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsDoxorubicinFollow-Up StudiesHumansPrognosisSarcomaSurvival RateAntibodies, MonoclonalDoxorubicinolaratumabDoxorubicinExposure responseOlaratumabOutcomeSoft tissue sarcomas

Identifiers

PMID30406840
PMCPMC6373189

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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.