Evidence map›Paper›PMID 36709663›Full record

Trial reportGynecologic oncology2023

Results of TRIO-15, a multicenter, open-label, phase II study of the efficacy and safety of ganitumab in patients with recurrent platinum-sensitive ovarian cancer.

T M Davidson, C L Lebreton, A E Wahner Hendricksen, H J Atkinson, M C Larson, A L Oberg, D M Provencher, J A Glaspy, B Y Karlan, D J Slamon and 2 more

Open access · greenAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.8field-weighted citation impact, top 26% 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

2 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Review
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

12 authors at 7 institutions in 3 countries.

T M DavidsonDivision of Oncology, Mayo Clinic, Rochester, MN, USA.
C L LebretonCentre Léon Bérard, Lyon, France.
A E Wahner HendricksenDivision of Oncology, Mayo Clinic, Rochester, MN, USA.
H J AtkinsonDivision of Clinical Trials and Biostatistics, Department of Quantitative Health Science, Mayo Clinic, Rochester, MN, USA.
M C LarsonDivision of Clinical Trials and Biostatistics, Department of Quantitative Health Science, Mayo Clinic, Rochester, MN, USA.
A L ObergDivision of Computational Biology, Department of Quantitative Health Science, Mayo Clinic, Rochester, MN, USA.
D M ProvencherCHUM - Pavillon Notre-Dame, Montréal, QC, Canada.
J A GlaspyDivision of Hematology/Oncology, University of California Los Angeles, Los Angeles, CA, USA.
B Y KarlanDivision of Gynecologic Oncology, University of California Los Angeles, Los Angeles, CA, USA.
D J SlamonDivision of Hematology/Oncology, University of California Los Angeles, Los Angeles, CA, USA.
G E KonecnyDivision of Hematology/Oncology, University of California Los Angeles, Los Angeles, CA, USA; Division of Gynecologic Oncology, University of California Los Angeles, Los Angeles, CA, USA. Electronic address: gkonecny@mednet.ucla.edu.
I L Ray-CoquardCentre Léon Bérard, Lyon, France; Health Services and Performance Research Lab (EA 7425 HESPER), University Claude Bernard Lyon 1, 69008 Lyon, France.
University of California, Los Angeles · USMayo Clinic in Arizona · USMayo Clinic in Florida · USCentre Léon Bérard · FRHôpital Notre-Dame · CAMayo Clinic · USUniversité Claude Bernard Lyon 1 · FR

Funding

Use of microfluidic tumor cultures to enable clinical trials of therapies for ovarian cancerP50CA136393 · NCI · MAYO CLINIC ROCHESTER · PI Zhenkun Lou · 2009 to 2026
$37.0M
NCI NIH HHS P50 CA136393
6 · The paper itself

Abstract

backgroundIGF signaling has been implicated in the pathogenesis and progression of ovarian carcinoma (OC). Single agent activity and safety of ganitumab (AMG 479), a fully human monoclonal antibody against IGF1R that blocks binding of IGF1 and IGF2, were evaluated in patients with platinum-sensitive recurrent OC.

methodsPatients with CA125 progression (GCIG criteria) or measurable disease per RECIST following primary platinum-based therapy received 18 mg/kg of ganitumab q3w. The primary endpoint was objective response rate (ORR) assessed per RECIST 1.1 by an independent radiology review committee (IRC) and/or GCIG CA125 criteria. Secondary endpoints included clinical benefit rate (CBR), progression free survival (PFS) and overall survival (OS).

results61 pts. were accrued. Objective responses were seen in 5/61 patients (ORR 8.2%, 95% CI, 3.1-18.8) with 1 partial response (PR) by RECIST and 2 complete responses (CR) as well as 2 PR by CA125 criteria. CBR was 80.3% (95% CI, 67.8-89.0%). The median PFS according to RECIST by IRC was 2.1 months (95% CI, 2.0-3.1). The median PFS per RECIST IRC and/or CA125 was 2.0 months (95% CI, 1.8-2.2). The median OS was 21 months (95% CI, 19.5-NA). The most common overall adverse events were fatigue (36.1%) and hypertension (34.4%). Grade 1/2 hyperglycemia occurred in 30.4% of patients. Hypertension (11.5%) and hypersensitivity (8.2%) were the most frequent grade 3 adverse events.

conclusionsIGF1R inhibition with ganitumab was well-tolerated, however, our results do not support further study of ganitumab as a single agent in unselected OC patients.

Indexed as

Antibodies, Monoclonal, HumanizedOvarian NeoplasmsAntibodies, MonoclonalFemaleHumansAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedganitumabAMG 479GanitumabIGFR1 inhibitorInsulin-like growth factorOvarian cancerTargeted therapy

Identifiers

PMID36709663
PMCPMC10425916
OpenAlexW4318262272

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.