Evidence map›Paper›PMID 20717115›Full record

Trial reportBritish journal of cancer2010

Activity and safety of NGR-hTNF, a selective vascular-targeting agent, in previously treated patients with advanced hepatocellular carcinoma.

A Santoro, T Pressiani, G Citterio, G Rossoni, G Donadoni, F Pozzi, L Rimassa, N Personeni, S Bozzarelli, G Rossoni and 5 more

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in British journal of cancer, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00484211 (NGR008), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 1 pooled it
2.3field-weighted citation impact, top 12% 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.

NCT00484211 phase2completednot on this map

NGR008: A Phase II Study of NGR-hTNF Administered as Single Agent Every 3 Weeks or Weekly in Patients Affected by Advanced or Metastatic Hepatocellular Carcinoma (HCC) Previously Treated With no More Than One Systemic Therapeutic Regimen

TypeinterventionalSponsorAGC Biologics S.p.A.Ran2006 to 2013Enrolled40ConditionsHepatocellular CarcinomaArmsNGR-hTNF
3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 1 synthesis or guideline pooled it, 30 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Review
  4. Review
  5. Article
  6. Review
  7. Article
  8. Article
  9. Article
  10. Peptide-mediated targeting of cytokines to tumor vasculature: the NGR-hTNF example.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2013
    Review
  11. Article
  12. Tumor-targeted TNFα stabilizes tumor vessels and enhances active immunotherapy.Proceedings of the National Academy of Sciences of the United States of America · 2012
    Article
  13. Review
  14. Enhanced expression of CD13 in vessels of inflammatory and neoplastic tissues.The journal of histochemistry and cytochemistry : official journal of the Histochemistry Society · 2011
    Article
  15. 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

15 authors at 4 institutions in 1 country.

A SantoroDepartment of Oncology, Istituto Clinico Humanitas, Rozzano, Italy.
T Pressiani
G Citterio
G Rossoni
G Donadoni
F Pozzi
L Rimassa
N Personeni
S Bozzarelli
G Rossoni
S Colombi
F G De Braud
F Caligaris-Cappio
A Lambiase
C Bordignon
Fondazione Humanitas per la Ricerca · ITSan Raffaele University of Rome · ITVita-Salute San Raffaele University · ITMolMed (Italy) · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundHepatocellular carcinoma (HCC) is a highly vascularised and poor-prognosis tumour. NGR-hTNF is a vascular-targeting agent consisting of human tumour necrosis factor-alpha fused to the tumour-homing peptide NGR, which is able to selectively bind an aminopeptidase N overexpressed on tumour blood vessels.

methodsTwenty-seven patients with advanced-stage disease resistant to either locoregional (59%; range, 1-3), systemic treatments (52%; range, 1-3) or both (33%) received NGR-hTNF 0.8 microg m(-2) once every 3 weeks. The primary aim of the study was progression-free survival (PFS).

resultsNo grade 3-4 treatment-related toxicities were noted. Common toxicity included mild-to-moderate, short-lived chills (63%). Median PFS was 2.3 months (95% CI: 1.7-2.9). A complete response ongoing after 20 months was observed in a sorafenib-refractory patient and a partial response in a Child-Pugh class-B patient, yielding a response rate of 7%. Six patients (22%) experienced stable disease. The disease control rate (DCR) was 30% and was maintained for a median PFS time of 4.3 months. Median survival was 8.9 months (95% CI: 7.5-10.2). In a subset of 12 sorafenib-resistant patients, the response rate was 8% and the median survival was 9.5 months.

conclusionNGR-hTNF was well tolerated and showed single-agent activity in HCC. Further investigation in HCC is of interest.

Indexed as

AdultAgedAngiogenesis InhibitorsCarcinoma, HepatocellularFemaleHumansLiver NeoplasmsMaleMiddle AgedNeovascularization, PathologicOligopeptidesTumor Necrosis Factor-alphaAngiogenesis InhibitorsNGR peptideOligopeptidesTumor Necrosis Factor-alpha

Identifiers

PMID20717115
PMCPMC2966632
OpenAlexW1967670790

What OpenQuestion holds

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LicenceCC BY-NC-SA
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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.