Evidence map›Paper›PMID 21750555›Full record

Trial reportBritish journal of cancer2011

A randomised, phase II study of intetumumab, an anti-αv-integrin mAb, alone and with dacarbazine in stage IV melanoma.

S O'Day, A Pavlick, C Loquai, D Lawson, R Gutzmer, J Richards, D Schadendorf, J A Thompson, R Gonzalez, U Trefzer and 12 more

Open access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
In one paragraph

Trial report in British journal of cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 63 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed, 3 pooled it
5.0field-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

63 citing papers in PubMed, 3 syntheses or guidelines pooled it, 117 citations in OpenAlex.

  1. Systemic treatments for metastatic cutaneous melanoma.The Cochrane database of systematic reviews · 2018
    Pooled it
  2. Pooled it
  3. Pooled it
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Integrins in cancer stem cells.Frontiers in cell and developmental biology · 2024
    Review
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  10. Review
  11. Review
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  15. Inhibition of angiogenesis and tumor progression of MK-0429, an integrin αvβJournal of cancer research and clinical oncology · 2022
    Article
  16. Article
  17. Thy-1-Integrin Interactions inFrontiers in cell and developmental biology · 2022
    Review
  18. Review
  19. Targeting Integrins for Cancer Therapy - Disappointments and Opportunities.Frontiers in cell and developmental biology · 2022
    Review
  20. Article

3 more citing papers are in PubMed but not listed here.

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

22 authors at 12 institutions in 3 countries.

S O'DayThe Angeles Clinic and Research Institute, 2001 Santa Monica Boulevard, Suite 560W, Santa Monica, CA, USA. soday@theangelesclinic.org
A Pavlick
C Loquai
D Lawson
R Gutzmer
J Richards
D Schadendorf
J A Thompson
R Gonzalez
U Trefzer
P Mohr
C Ottensmeier
D Chao
B Zhong
C J de Boer
C Uhlar
D Marshall
M E Gore
Z Lang
W Hait
P Ho
CNTO 95 Investigators
Angeles Clinic and Research Institute · USEmory University · USReaction Biology Corporation (United States) · USRoyal Marsden Hospital · GBSeattle Cancer Care Alliance · USThe Royal Free Hospital · GBCancer Research UK · GBCharité - Universitätsmedizin Berlin · DEElbe Kliniken Stade-Buxtehude · DEEssen University Hospital · DEHeidelberg University · DEMedizinische Hochschule Hannover · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundα(v) integrins are involved in angiogenesis and melanoma tumourigenesis. Intetumumab (CNTO 95) is a fully human anti-α(v)-integrin monoclonal antibody.

methodsIn a multicentre, randomised, phase II study, stage IV melanoma patients were randomised 1:1:1:1 to 1000 mg m(-2) dacarbazine+placebo (n=32), 1000 mg m(-2) dacarbazine+10 mg kg(-1) intetumumab (n=32), 10 mg kg(-1) intetumumab (n=33), or 5 mg kg(-1) intetumumab (n=32) q3w. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), adverse events, and pharmacokinetics.

resultsNo statistically significant differences in efficacy were observed between groups. In the dacarbazine+placebo, dacarbazine+intetumumab, 10 mg kg(-1) intetumumab, and 5 mg kg(-1) intetumumab groups, median PFS was 1.8, 2.5, 1.4, and 1.4 months; median OS was 8, 11, 15, and 9.8 months; and ORR of complete+partial response was 10, 3, 6, and 0%. Nonlinear intetumumab pharmacokinetics and potential intetumumab-dacarbazine interactions were observed. Transient, asymptomatic, nonrecurring, grade 1-2, uveitic reactions that resolved spontaneously or with topical steroids were seen in 22-30% of intetumumab-treated patients. Low-grade infusion-reaction symptoms (headache, fatigue, nausea, vomiting, fever, chills) were observed, as expected, in 16-73% of dacarbazine-treated patients. No intetumumab-related myelosuppression, laboratory/electrocardiogram abnormalities, or deaths occurred.

conclusionWith its favourable safety profile and a nonsignificant trend towards improved OS, intetumumab merits further investigation in advanced melanoma.

Indexed as

AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsDacarbazineDisease-Free SurvivalFemaleHumansIntegrin alphaVMaleMelanomaMiddle AgedSkin NeoplasmsUveitisAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedDacarbazineIntegrin alphaVintetumumab

Identifiers

PMID21750555
PMCPMC3172894
OpenAlexW1963936920

What OpenQuestion holds

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LicenceCC BY
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.