Evidence map›Paper›PMID 22644293›Full record

Trial reportBritish journal of cancer2012

Phase II study of NGR-hTNF in combination with doxorubicin in relapsed ovarian cancer patients.

D Lorusso, G Scambia, G Amadio, A di Legge, A Pietragalla, R De Vincenzo, V Masciullo, M Di Stefano, G Mangili, G Citterio and 3 more

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

Trial report in British journal of cancer, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00484432 (NGR012), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
4.5field-weighted citation impact, top 7% 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.

NCT00484432 phase2completednot on this map

NGR012: A Phase II Study of NGR-hTNF Administered in Combination With Doxorubicin Every 3 Weeks in Patients Affected by Advanced or Metastatic Ovarian Cancer

TypeinterventionalSponsorAGC Biologics S.p.A.Ran2008 to 2016Enrolled37ConditionsOvarian Cancer Metastatic RecurrentArmsNGR-hTNF, doxorubicin
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 48 citations in OpenAlex.

  1. Review
  2. Article
  3. Review
  4. Review
  5. Synthesis ofPharmaceutics · 2021
    Article
  6. Article
  7. Review
  8. Homing Peptides for Cancer Therapy.Advances in experimental medicine and biology · 2021
    Review
  9. Review
  10. Review
  11. A ligand motif enables differential vascular targeting of endothelial junctions between brain and retina.Proceedings of the National Academy of Sciences of the United States of America · 2019
    Article
  12. Article
  13. Article
  14. Article
  15. From amino acid sequence to bioactivity: The biomedical potential of antitumor peptides.Protein science : a publication of the Protein Society · 2016
    Review
  16. Article
  17. Article
  18. Immunotherapy for ovarian cancer.Current treatment options in oncology · 2015
    Review
  19. Peptide-mediated targeting of cytokines to tumor vasculature: the NGR-hTNF example.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2013
    Review
  20. 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

13 authors at 3 institutions in 1 country.

D LorussoDepartment of Gynecologic Oncology, Catholic University of Rome, Rome, Italy.
G Scambia
G Amadio
A di Legge
A Pietragalla
R De Vincenzo
V Masciullo
M Di Stefano
G Mangili
G Citterio
M Mantori
A Lambiase
C Bordignon
Università Cattolica del Sacro Cuore · ITMolMed (Italy) · ITSan Raffaele University of Rome · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe NGR-hTNF (asparagine-glycine-arginine-human tumour necrosis factor) is able to promote antitumour immune responses and to improve the intratumoural doxorubicin uptake by selectively damaging tumour blood vessels.

methodsPatients progressing after ≥ 1 platinum/taxane-based regimen received NGR-hTNF 0.8 μg m(-2) and doxorubicin 60 mg m(-2) every 3 weeks. Primary endpoint was a Response Evaluation Criteria in Solid Tumors-defined response rate with a target of more than 6 out of 37 responding patients.

resultsA total of 37 patients with platinum-free interval lower than 6 months (PFI<6; n=25), or between 6 and 12 months (PFI=6-12; n=12) were enrolled. Median baseline peripheral blood lymphocyte count (PBLC) was 1.6 per ml (interquartile range, 1.2-2.1). In all, 18 patients (49%) received more than 6 cycles. Febrile neutropaenia was registered in one patient (3%). Among 35 assessable patients, 8 (23%; 95% CI 12-39%) had partial response (2 with PFI<6; 6 with PFI=6-12) and 15 (43%) had stable disease (10 with PFI<6; 5 with PFI=6-12). Median progression-free survival (PFS) was 5.0 months for all patients, 3.8 months for patients with PFI<6, and 7.8 months for patients with PFI=6-12. Median overall survival (OS) was 17.0 months. Patients with baseline PBLC higher than the first quartile had improved PFS (P=0.01) and OS (P=0.001).

conclusionTolerability and activity of this combination warrant further randomised testing in patients with PFI<6. The role of PBLC as a blood-based biomarker deserves further investigation.

Indexed as

AdultAgedAntineoplastic Combined Chemotherapy ProtocolsBridged-Ring CompoundsDisease-Free SurvivalDoxorubicinDrug Administration ScheduleFemaleHumansMiddle AgedOvarian NeoplasmsPlatinum CompoundsRecombinant Fusion ProteinsTaxoidsTreatment FailureTumor Necrosis Factor-alphaBridged-Ring CompoundsDoxorubicinPlatinum CompoundsRecombinant Fusion ProteinstaxaneTaxoidsTumor Necrosis Factor-alphatumor necrosis factor-alpha, CNGRC fusion protein, human

Identifiers

PMID22644293
PMCPMC3389423
OpenAlexW2074107776

What OpenQuestion holds

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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.