Evidence map›Paper›PMID 20653948›Full record

Trial reportJournal of translational medicine2010

First-line chemoimmunotherapy in metastatic breast carcinoma: combination of paclitaxel and IMP321 (LAG-3Ig) enhances immune responses and antitumor activity.

Chrystelle Brignone, Maya Gutierrez, Fawzia Mefti, Etienne Brain, Rosana Jarcau, Frédérique Cvitkovic, Nabil Bousetta, Jacques Medioni, Joseph Gligorov, Caroline Grygar and 2 more

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

Trial report in Journal of translational medicine, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00349934 (IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel), which is not on this map. Cited by 124 papers.

0numbers the graph read from it
0cells of the map it votes in
124citing papers in PubMed
2.1field-weighted citation impact, top 13% 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.

NCT00349934 phase1completednot on this map

IMP321 Phase I Study in Metastatic Breast Carcinoma Patients Receiving First-line Paclitaxel

TypeinterventionalSponsorImmutep S.A.S.Ran2006 to 2010Enrolled33ConditionsMetastatic Breast CancerArmsIMP321
3 · Its place in the literature

Who cites it

124 citing papers in PubMed, 254 citations in OpenAlex.

  1. Trial
  2. Trial
  3. Review
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  5. Article
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  8. Article
  9. Review
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  11. Article
  12. Review
  13. Article
  14. Article
  15. LAG-3-An incompletely understood target in cancer therapy.FASEB journal : official publication of the Federation of American Societies for Experimental Biology · 2024
    Review
  16. Identification of Functional Immune Biomarkers in Breast Cancer Patients.International journal of molecular sciences · 2024
    Article
  17. Review
  18. Review
  19. Review
  20. Review

64 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

12 authors at 3 institutions in 1 country.

Chrystelle BrignoneImmutep SA, 2 rue Jean Rostand, Orsay 91893, France.
Maya Gutierrez
Fawzia Mefti
Etienne Brain
Rosana Jarcau
Frédérique Cvitkovic
Nabil Bousetta
Jacques Medioni
Joseph Gligorov
Caroline Grygar
Manon Marcu
Frédéric Triebel
Hôpital René Huguenin · FRHôpital Européen Georges-Pompidou · FRSorbonne Université · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIMP321 is a recombinant soluble LAG-3Ig fusion protein that binds to MHC class II with high avidity and mediates APC and then antigen-experienced memory CD8+ T cell activation. We report clinical and biological results of a phase I/II in patients with metastatic breast carcinoma (MBC) receiving first-line paclitaxel weekly, 3 weeks out of 4.

methodsMBC patients were administered one dose of IMP321 s.c. every two weeks for a total of 24 weeks (12 injections). The repeated single doses were administered the day after chemotherapy at D2 and D16 of the 28-day cycles of paclitaxel (80 mg/m2 at D1, D8 and D15, for 6 cycles). Blood samples were taken 13 days after the sixth and the twelfth IMP321 injections to determine sustained APC, NK and memory CD8 T cell responses.

resultsThirty MBC patients received IMP321 in three cohorts (doses: 0.25, 1.25 and 6.25 mg). IMP321 induced both a sustained increase in the number and activation of APC (monocytes and dendritic cells) and an increase in the percentage of NK and long-lived cytotoxic effector-memory CD8 T cells. Clinical benefit was observed for 90% of patients with only 3 progressors at 6 months. Also, the objective tumor response rate of 50% compared favorably to the 25% rate reported in the historical control group.

conclusionsThe absence of toxicity and the demonstration of activity strongly support the future development of this agent for clinical use in combined first-line regimens.

trial registrationClinicalTrials.gov NCT00349934.

Indexed as

ImmunotherapyAgedAntibodies, NeoplasmAntigens, CDAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBreast NeoplasmsCell CountDrug Administration ScheduleFemaleHumansImmunityLymphocyte ActivationLymphocyte Activation Gene 3 ProteinMiddle AgedMonocytesAntibodies, NeoplasmAntigens, CDAntineoplastic AgentsLag3 protein, humanLymphocyte Activation Gene 3 ProteinPaclitaxelsoluble LAG-3 protein, human

Identifiers

PMID20653948
PMCPMC2920252
OpenAlexW2101477183

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.