Evidence map›Paper›PMID 28426120›Full record

Trial reportAnnals of oncology : official journal of the European Society for Medical Oncology2017

A phase II study of a human anti-PDGFRα monoclonal antibody (olaratumab, IMC-3G3) in previously treated patients with metastatic gastrointestinal stromal tumors.

A J Wagner, H Kindler, H Gelderblom, P Schöffski, S Bauer, P Hohenberger, H-G Kopp, J A Lopez-Martin, M Peeters, P Reichardt and 4 more

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Annals of oncology : official journal of the European Society for Medical Oncology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01316263 (A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody), which is not on this map. Cited by 31 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
31citing papers in PubMed, 1 pooled it
6.8field-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.

NCT01316263 phase2terminatednot on this map

A Phase 2 Study of a Human Anti-PDGFRα Monoclonal Antibody (IMC-3G3) in Previously Treated Patients With Unresectable and/or Metastatic Gastrointestinal Stromal Tumors (GIST)

TypeinterventionalSponsorEli Lilly and CompanyRan2011 to 2012Enrolled21ConditionsGastrointestinal Stromal Tumor (GIST)ArmsOlaratumab
3 · Its place in the literature

Who cites it

31 citing papers in PubMed, 1 synthesis or guideline pooled it, 47 citations in OpenAlex.

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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

14 authors at 13 institutions in 6 countries.

A J WagnerCenter for Sarcoma and Bone Oncology, Dana-Farber Cancer Institute, Boston.
H KindlerUniversity of Chicago Medical School, Chicago, USA.
H GelderblomLeids Universitair Medisch Centrum, Leiden, Netherlands.
P SchöffskiLeuven Cancer Institute, University Hospitals Leuven, KU Leuven, Leuven, Belgium.
S BauerWest German Cancer Center, University of Duisburg-Essen, Essen, and German Cancer Consortium, Heidelberg.
P HohenbergerDivision of Surgical Oncology and Thoracic Surgery, Medical Faculty Mannheim, University of Heidelberg, Mannheim.
H-G KoppDepartment of Oncology and Hematology, Tuebingen University Medical Center, Tuebingen, Germany.
J A Lopez-Martin12 de Octubre University Hospital and Research Institute, Madrid, Spain.
M PeetersUniversitair Ziekenhuis Antwerpen, Antwerp, Belgium.
P ReichardtHELIOS Klinikum Berlin-Buch, Berlin, Germany.
A QinEli Lilly and Company, Indianapolis, USA.
J NippgenMerck KGaA (Formerly ImClone Medical), Darmstadt, Germany.
R L IlariaEli Lilly and Company, Indianapolis, USA.
P RutkowskiMaria Sklodowska-Curie Memorial Cancer Center and Institute of Oncology, Warsaw, Poland.
Eli Lilly (United States) · USAntwerp University Hospital · BEDana-Farber Cancer Institute · USGerman Cancer Research Center · DEHelios Hospital Berlin-Buch · DEKU Leuven · BELeiden University Medical Center · NLMerck (Germany) · DEResearch Institute Hospital 12 de Octubre · ESThe Maria Sklodowska-Curie National Research Institute of Oncology · PLUniversity Medical Centre Mannheim · DEUniversity of Chicago · USUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Background: This study evaluated tumor response to olaratumab (an anti-PDGFRα monoclonal antibody) in previously treated patients with metastatic gastrointestinal stromal tumor (GIST) with or without PDGFRα mutations (cohorts 1 and 2, respectively). Patients and methods: Patients received olaratumab 20 mg/kg intravenously every 14 days until disease progression, death, or intolerable toxicity occurred. Outcome measures were 12-week tumor response, progression-free survival (PFS), overall survival (OS), and safety. Results: Of 30 patients enrolled, 21 patients received ≥1 dose of olaratumab. In the evaluable population (cohort 1, n = 6; cohort 2, n = 14), no complete response (CR) or partial response (PR) was observed. Stable disease (SD) was observed in 3 patients (50.0%) in cohort 1 and 2 patients (14.3%) in cohort 2. Progressive disease (PD) was observed in 3 patients (50.0%) in cohort 1 and 12 patients (85.7%) in cohort 2. The 12-week clinical benefit rate (CR + PR + SD) (90% CI) was 50.0% (15.3-84.7%) in cohort 1 and 14.3% (2.6-38.5%) in cohort 2. SD lasted beyond 12 weeks in 5 patients (cohort 1, n = 3; cohort 2, n = 2). Median PFS (90% CI) was 32.1 (5.0-35.9) weeks in cohort 1 and 6.1 (5.7-6.3) weeks in cohort 2. Median OS was not reached in cohort 1 and was 24.9 (14.4-49.1) weeks in cohort 2. All patients in cohort 1 and 9 (64.3%) in cohort 2 experienced an olaratumab-related adverse event (AE), most commonly fatigue (38.1%), nausea (19.0%), and peripheral edema (14.3%). Two grade ≥3 olaratumab-related events were reported (cohort 1, syncope; cohort 2, hypertension). Conclusions: Olaratumab had an acceptable AE profile in patients with GIST. While there was no apparent effect on PFS in patients without PDGFRα mutations, patients with PDGFRα-mutant GIST (all with D842V mutations) treated with olaratumab had longer disease control compared with historical data for this genotype. ClinicalTrials.gov Identifier: NCT01316263.

Indexed as

AgedAntibodies, MonoclonalCohort StudiesDisease-Free SurvivalDrug-Related Side Effects and Adverse ReactionsFemaleGastrointestinal Stromal TumorsGenotypeHumansKaplan-Meier EstimateMaleMiddle AgedMutationNeoplasm MetastasisReceptor, Platelet-Derived Growth Factor alphaAntibodies, MonoclonalolaratumabReceptor, Platelet-Derived Growth Factor alphagastrointestinal stromal tumorIMC-3G3monoclonal antibodymutationplatelet-derived growth factor receptor α

Identifiers

PMID28426120
PMCPMC5391707
OpenAlexW2588850652

What OpenQuestion holds

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LicenceCC BY-NC
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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.