Evidence map›Paper›PMID 20484019›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2010

Clinical and correlative results of SWOG S0354: a phase II trial of CNTO328 (siltuximab), a monoclonal antibody against interleukin-6, in chemotherapy-pretreated patients with castration-resistant prostate cancer.

Tanya B Dorff, Bryan Goldman, Jacek K Pinski, Philip C Mack, Primo N Lara, Peter J Van Veldhuizen, David I Quinn, Nicholas J Vogelzang, Ian M Thompson, Maha H A Hussain

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00433446 (A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6), which is not on this map. Cited by 115 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
115citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT00433446 phase2completednot on this map

A Phase II Study of CNTO 328, A Monoclonal Antibody Against Interleukin-6 (IL-6), in Patients With Hormone Refractory Prostate Cancer

TypeinterventionalSponsorSWOG Cancer Research NetworkRan2007 to 2011Enrolled62ConditionsProstate CancerArmsCNTO 328
3 · Its place in the literature

Who cites it

115 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
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  5. Interleukin-6 as a therapeutic target in human ovarian cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2011
    Trial
  6. Progress in Designing Cytokine Antagonist Antibodies for Cancer Therapy.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
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55 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

10 authors.

Tanya B DorffUniversity of Southern California, Norris Comprehensive Cancer Center, Los Angeles, California 90033, USA. dorff@usc.edu
Bryan Goldman
Jacek K Pinski
Philip C Mack
Primo N Lara
Peter J Van Veldhuizen
David I Quinn
Nicholas J Vogelzang
Ian M Thompson
Maha H A Hussain

Funding

SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
Staff InvestigatorsP30CA093373 · NCI · UNIVERSITY OF CALIFORNIA DAVIS · PI Gina M Dayton · 2002 to 2026
$84.9M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
SOUTHEAST CANCER CONTROL COSORTIUM, INCU10CA045808 · NCI · SOUTHEAST CLINICAL ONCOL RES CONSORTIUM · PI ATKINS, JAMES NORMAN · 1987 to 2013
$26.6M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035431 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 1985 to 2014
$24.0M
UPSTATE CAROLINA COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA035119 · NCI · SPARTANBURG REGIONAL MEDICAL CENTER · PI BEARDEN, JAMES D · 1985 to 2013
$21.5M
MICHIGAN CANCER RESEARCH CONSORTIUM CCOPU10CA063848 · NCI · SAINT JOSEPH MERCY HEALTH SYSTEM · PI STELLA, PHILIP J · 1994 to 2014
$17.2M
WESTERN ONCOLOGY RESEARCH CONSORTIUMU10CA045377 · NCI · PROVIDENCE PORTLAND MEDICAL CENTER · PI CONLIN, ALISON K · 1987 to 2013
$9.9M
National Community Oncology Research ProjectUG1CA189808 · NCI · VIA CHRISTI REGIONAL MEDICAL CENTER · PI DAKHIL, SHAKER R · 2014 to 2018
$8.6M
OZARKS REGIONAL COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045560 · NCI · ST. JOHN'S REGIONAL HEALTH CENTER · PI CARLSON, JAY W · 1987 to 2014
$8.2M
Montana Cancer Consortium CCOPU10CA067575 · NCI · MONTANA CANCER CONSORTIUM · PI MARCHELLO, BENJAMIN T. · 1995 to 2013
$6.5M
LSU MEDICAL CENTER MINORITY CCOPU10CA063845 · NCI · LSU HEALTH SCIENCES CENTER · PI VEITH, ROBERT W · 1994 to 2014
$6.4M
NCI NIH HHS CA11083NCI NIH HHS CA12644NCI NIH HHS CA14028NCI NIH HHS CA20319NCI NIH HHS CA22433NCI NIH HHS CA3981NCI NIH HHS CA42777NCI NIH HHS CA45377NCI NIH HHS CA45441NCI NIH HHS CA45808NCI NIH HHS CA46282NCI NIH HHS CA58723NCI NIH HHS CA58882NCI NIH HHS CA63845NCI NIH HHS CA63848NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA067575NCI NIH HHS P30 CA093373NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA012644NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA022433NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063845NCI NIH HHS U10 CA063848NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA180835NCI NIH HHS UG1 CA189808
6 · The paper itself

Abstract

purposeInterleukin-6 (IL-6) facilitates cancer cell survival via pleotrophic effects. We conducted a multicenter phase II study of CNTO328 (siltuximab) as second-line therapy for men with castration-resistant prostate cancer. EXPERIMENTAL

designEligible men had castration-resistant prostate cancer treated with one prior chemotherapy. Subjects were treated with 6 mg/kg CNTO328 i.v. every 2 weeks for 12 cycles. Response was assessed after every three cycles. Primary end point was prostate-specific antigen (PSA) response rate defined as a 50% reduction. Accrual was planned in two stages, with 20 eligible patients in the first stage and 40 overall. Plasma cytokines and growth factors were measured by Luminex.

resultsFifty-three eligible subjects had all received prior taxane therapy. Two (3.8%; 95% CI, 0.5-13.0%) had PSA response. None of the 31 patients with measurable disease had a RECIST (Response Evaluation Criteria in Solid Tumors) response but 7 (23%) had stable disease. With median follow-up of 14.8 months, median progression-free survival was 1.6 months (95% CI, 1.6-1.7) and median overall survival was 11.6 months (95% CI, 7.5-19.0). Grade 3/4 toxicities included disseminated intravascular coagulation (1), central nervous system ischemia (1), elevated aspartate aminotransferase (1), gastritis/esophagitis (2), thrombocytopenia (2), pain (2), leukopenia (1), and neuropathy (2). Median baseline IL-6 levels were 12.5 pg/mL (interquartile range, 2.5-41.5). Patients with IL-6 >12.5 pg/mL had worse survival than those with levels <12.5 pg/mL (53% versus 94%; P = 0.02). After treatment, IL-6 levels were >250-fold higher. Thirty-two of 38 patients had a decline in C-reactive protein plasma levels at 6 weeks.

conclusionsCNTO328 resulted in a PSA response rate of 3.8% and a RECIST stable disease rate of 23%. Declining C-reactive protein levels during treatment may reflect biological activity. Despite evidence of CNTO-mediated IL-6 inhibition, elevated baseline IL-6 levels portended a poor prognosis.

Indexed as

AgedAged, 80 and overAntibodies, MonoclonalAntineoplastic Combined Chemotherapy ProtocolsCastrationDrug Resistance, NeoplasmHumansInterleukin-6 InhibitorsMaleMiddle AgedProstatic NeoplasmsRetreatmentAntibodies, MonoclonalInterleukin-6 Inhibitorssiltuximab

Identifiers

PMID20484019
PMCPMC2898710

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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.