Evidence map›Paper›PMID 20808314›Full record

Trial reportBritish journal of cancer2010

A phase I/II study of siltuximab (CNTO 328), an anti-interleukin-6 monoclonal antibody, in metastatic renal cell cancer.

J-F Rossi, S Négrier, N D James, I Kocak, R Hawkins, H Davis, U Prabhakar, X Qin, P Mulders, B Berns

Open access · hybridAbstract readClinical Trial, Phase IClinical Trial, Phase IIRandomized Controlled Trial
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. Cited by 107 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
107citing papers in PubMed, 3 pooled it
10.3field-weighted citation impact, top 1% 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

107 citing papers in PubMed, 3 syntheses or guidelines pooled it, 185 citations in OpenAlex.

  1. Pooled it
  2. Prognostic role of interleukin-6 in renal cell carcinoma: a meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2020
    Pooled it
  3. Immunotherapy for metastatic renal cell carcinoma.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Trial
  5. Review
  6. Progress in Designing Cytokine Antagonist Antibodies for Cancer Therapy.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Review
  12. Targeting inflammation as cancer therapy.Journal of hematology & oncology · 2024
    Review
  13. Unraveling the complexity of STAT3 in cancer: molecular understanding and drug discovery.Journal of experimental & clinical cancer research : CR · 2024
    Review
  14. Review
  15. Article
  16. Article
  17. Review
  18. Article
  19. Review
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 6 institutions in 4 countries.

J-F RossiService d'Hématologie et d'Oncologie Médicale, CHU Saint-Eloi, BT 509-INSERM U847, CHRU Montpellier et Université Montpelllier I, Montpellier, France.
S Négrier
N D James
I Kocak
R Hawkins
H Davis
U Prabhakar
X Qin
P Mulders
B Berns
Centre Léon Bérard · FRInserm · FRMasaryk Memorial Cancer Institute · CZQueen Elizabeth Hospital · GBRadboud University Nijmegen · NLUniversity of Manchester · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundSerum interleukin (IL)-6 levels correlate with disease outcomes in renal cell carcinoma (RCC) patients. Siltuximab, a chimeric, murine-human mAb against IL-6, was evaluated in a three-part phase I/II study in patients with progressive metastatic RCC.

methodsIn part 1, 11 patients received 1, 3, 6, or 12mgkg-¹ at weeks 1, 4 and q2w × 2 thereafter; in part 2, 37 patients randomly received 3 or 6 mgkg-¹ q3w × 4; in part 3, 20 low-risk patients received 6mgkg-¹ q2w × 6. Modified WHO response criteria were assessed at weeks 7, 11, the 6-week follow-up, and when clinically indicated.

resultsSiltuximab was well tolerated overall, with no maximum tolerated dose or immune response observed. In all, 5 out of 11, 17 out of 37, and 9 out of 20 patients in parts 1, 2, and 3, respectively, received extended treatment beyond 4-6 initial infusions. In part 2, stable disease (SD) (≥11weeks) or better was achieved by 11 out of 17 (65%) 3 mgkg-¹ treated patients (one partial response (PR) ~8 months, 10 SD) and 10 out of 20 (50%) 6mgkg-¹ treated patients (10 SD). In part 3, documented complete or PR was not observed, but 13 out of 20 (65%) patients achieved SD.

conclusionSiltuximab stabilised disease in >50% of progressive metastatic RCC patients. One PR was observed. Given the favourable safety profile of siltuximab and poor correlation of tumour shrinkage with clinical benefit demonstrated for other non-cytotoxic therapies, further evaluation of dose-escalation strategies and/or combination therapy may be considered for patients with RCC.

Indexed as

AdultAgedAged, 80 and overAlgorithmsAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Renal CellDouble-Blind MethodFemaleHumansImmunotherapyInterleukin-6Interleukin-6 InhibitorsKidney NeoplasmsMaleMiddle AgedAntibodies, MonoclonalAntineoplastic AgentsInterleukin-6Interleukin-6 Inhibitorssiltuximab

Identifiers

PMID20808314
PMCPMC2967052
OpenAlexW2097926940

What OpenQuestion holds

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LicenceCC BY
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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.