Evidence map›Paper›PMID 25669986›Full record

Trial reportOncotarget2015

Immunological response and overall survival in a subset of advanced renal cell carcinoma patients from a randomized phase 2/3 study of naptumomab estafenatox plus IFN-α versus IFN-α.

Eyad Elkord, Deborah J Burt, Anette Sundstedt, Örjan Nordle, Gunnar Hedlund, Robert E Hawkins

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIClinical Trial, Phase IIIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Oncotarget, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00420888 (A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
1.3field-weighted citation impact, top 18% 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.

NCT00420888 phase2 / phase3completednot on this map

A Randomized, Open-label, Multi-center, Phase II/III Study on Treatment With ABR-217620/Naptumomab Estafenatox Combined With IFN-alpha vs. IFN-alpha Alone in Patients With Advanced Renal Cell Carcinoma.

TypeinterventionalSponsorActive Biotech ABRan2007 to 2013Enrolled526ConditionsRenal Cell CarcinomaArmsABR-217620/naptumomab estafenatox, IFN-alpha
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it, 20 citations in OpenAlex.

  1. Pooled it
  2. Immunotherapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2017
    Pooled it
  3. Review
  4. Emerging new therapeutic antibody derivatives for cancer treatment.Signal transduction and targeted therapy · 2022
    Review
  5. Review
  6. Review
  7. Evolution ofInternational journal of molecular sciences · 2020
    Review
  8. Review
  9. Article
  10. Article
  11. Review
  12. Review
  13. 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

6 authors at 4 institutions in 3 countries.

Eyad ElkordDepartment of Medical Oncology, Institute of Cancer Sciences, The University of Manchester, Manchester, UK.
Deborah J BurtDepartment of Medical Oncology, Institute of Cancer Sciences, The University of Manchester, Manchester, UK.
Anette SundstedtActive Biotech AB, Lund, Sweden.
Örjan NordleActive Biotech AB, Lund, Sweden.
Gunnar HedlundActive Biotech AB, Lund, Sweden.
Robert E HawkinsDepartment of Medical Oncology, Institute of Cancer Sciences, The University of Manchester, Manchester, UK.
Active Biotech (Sweden) · SECancer Research UK Manchester Institute · GBUnited Arab Emirates University · AEUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Naptumomab estafenatox/ABR-217620/ANYARA (Nap) has been evaluated in clinical phase 1 and 2/3 studies. RCC patients in the phase 2/3 trial were randomized 1:1 in an open label study to receive Nap+IFN-α or IFN-α. In this study, we analyzed the UK patients for their immunological response in relation to prolonged overall survival (OS). We found that Nap-specific T cells were reduced after 3 treatment days in patients' peripheral blood. Levels of both Nap-specific CD4+ and CD8+ T cells were significantly higher 8 days after the first treatment. Patients with such pattern of reduction and expansion of Nap-binding T cells also showed increased levels of IL-2 and IFN-γ in plasma 3 hours after the first Nap treatment. In addition, Nap caused an increase of IL-6, IL-10 and TNF-α. The patients in the UK subset showed a tendency of OS benefit after Nap treatment. Most Nap treated patients with long OS had low baseline IL-6 and normal levels of anti-SEA/E-120 antibodies. Furthermore, patients with pronounced Nap induced IL-2 and T cell expansion had long OS. In conclusion, patients with low baseline IL-6 and normal anti-SEA/E-120 may respond well to Nap by T cell activation and expansion paving the way for anti-tumour effects.

Indexed as

AdolescentAdultAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Renal CellEnterotoxinsFemaleFlow CytometryHumansImmunoconjugatesInterferon-alphaInterleukin-6Kaplan-Meier EstimateKidney NeoplasmsAntibodies, MonoclonalAntineoplastic AgentsEnterotoxinsIL6 protein, humanImmunoconjugatesInterferon-alphaInterleukin-6naptumomab estafenatox

Identifiers

PMID25669986
PMCPMC4414201
OpenAlexW1910489037

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.