Evidence map›Paper›PMID 22138373›Full record

Trial reportGynecologic oncology2012

A phase II study single agent of aflibercept (VEGF Trap) in patients with recurrent or metastatic gynecologic carcinosarcomas and uterine leiomyosarcoma. A trial of the Princess Margaret Hospital, Chicago and California Cancer Phase II Consortia.

H J Mackay, R J Buckanovich, H Hirte, R Correa, P Hoskins, J Biagi, L P Martin, G F Fleming, R Morgan, L Wang and 2 more

Abstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gynecologic oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
5.8field-weighted citation impact, top 4% 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

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Hemorrhagic events in cancer patients treated with aflibercept: a meta-analysis.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
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  10. Should MMMT still be treated with adjuvant taxane-based combination chemotherapy?Journal of cancer research and clinical oncology · 2020
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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

12 authors at 7 institutions in 2 countries.

H J MackayPrincess Margaret Hospital, Ontario, Canada.
R J Buckanovich
H Hirte
R Correa
P Hoskins
J Biagi
L P Martin
G F Fleming
R Morgan
L Wang
R Polintan
A M Oza
Princess Margaret Cancer Centre · CABC Cancer Agency · CACity of Hope · USFox Chase Cancer Center · USJuravinski Cancer Centre · CAUniversity of Chicago · USUniversity of Michigan–Ann Arbor · US

Funding

Univ.of Calif., Irvine Cancer Center Support GrantP30CA062203 · NCI · UNIVERSITY OF CALIFORNIA-IRVINE · PI Melanie Funes · 1994 to 2026
$57.9M
REGULATION OF RADIATION-INDUCED APOPTOTIC CELL DEATHR29CA062209 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI STORY, MICHAEL D · 1994 to 1998
–
NCI NIH HHS N01 CM007003NCI NIH HHS N01 CM062203NCI NIH HHS N01 CM062209NCI NIH HHS N01-CM-62203NCI NIH HHS N01-CM-62209PHS HHS N01-CCM-07003-74
6 · The paper itself

Abstract

objectiveThe aim of this multi-institutional non randomized phase II trial was to determine the efficacy and safety of single agent aflibercept (VEGF Trap), a recombinant fusion protein that blocks multiple vascular endothelial growth factor isoforms, in women with gynecologic soft tissue sarcoma.

methodsPatients were enrolled in two cohorts each with Simon two stage designs: uterine leiomyosarcoma and carcinosarcoma of endometrial, ovarian or fallopian tube origin. Eligibility criteria included ≤2 prior lines of chemotherapy for metastatic disease and ECOG performance status of ≤2. Aflibercept 4mg/kg was administered intravenously on day 1 of a 14 day cycle. Primary endpoints were objective response and disease stabilization (Progression Free Survival (PFS) at 6 months).

results41 patients with uterine leiomyosarcoma and 22 patients with carcinosarcoma (19 uterine, 3 ovarian) were enrolled on study. In the leiomyosarcoma cohort, eleven (27%) patients had stable disease (SD), 4 with SD lasting at least 24 weeks. The 6 month PFS was 17%, with median time to progression (TTP) of 1.8 (95% CI:1.6-2.1) months. In the carcinosarcoma cohort, two (9%) patients had SD, one lasting >24 weeks, median TTP was 1.6 months (95%CI: 1.1-1.7) No partial responses were observed in patients from either cohort. Grade 3 or more aflibercept related toxicity was uncommon and included hypertension, fatigue, headache and abdominal pain.

conclusionsSingle agent aflibercept has modest activity in patients with uterine leiomyosarcoma and minimal activity in women with carcinosarcoma.

Indexed as

AdultAgedAntineoplastic AgentsCaliforniaCarcinosarcomaChicagoDisease-Free SurvivalDrug Administration ScheduleFemaleGenital Neoplasms, FemaleHumansKaplan-Meier EstimateLeiomyosarcomaMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptAntineoplastic AgentsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID22138373
PMCPMC3303987
OpenAlexW2055183928

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.