Evidence map›Paper›PMID 20606093›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2010

Phase III study comparing gemcitabine plus cetuximab versus gemcitabine in patients with advanced pancreatic adenocarcinoma: Southwest Oncology Group-directed intergroup trial S0205.

Philip A Philip, Jacqueline Benedetti, Christopher L Corless, Ralph Wong, Eileen M O'Reilly, Patrick J Flynn, Kendrith M Rowland, James N Atkins, Barry C Mirtsching, Saul E Rivkin and 5 more

Open access · greenAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 316 papers, 15 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
316citing papers in PubMed, 15 pooled it
28.5field-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

316 citing papers in PubMed, 15 syntheses or guidelines pooled it, 623 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
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  6. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
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  14. Electrolyte disorders assessment in solid tumor patients treated with anti-EGFR monoclonal antibodies: a pooled analysis of 25 randomized clinical trials.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2015
    Pooled it
  15. Outcome of gemcitabine plus molecular targeted agent for treatment of pancreatic cancer: a meta-analysis of prospective phase III studies.Tumour biology : the journal of the International Society for Oncodevelopmental Biology and Medicine · 2014
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256 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

Philip A PhilipWayne State University, Karmanos Cancer Institute, GI Oncology, Detroit, MI 48201, USA. philipp@karmanos.org
Jacqueline Benedetti
Christopher L Corless
Ralph Wong
Eileen M O'Reilly
Patrick J Flynn
Kendrith M Rowland
James N Atkins
Barry C Mirtsching
Saul E Rivkin
Alok A Khorana
Bryan Goldman
Cecilia M Fenoglio-Preiser
James L Abbruzzese
Charles D Blanke
Southeast Clinical Oncology Research Consortium · US

Funding

CANCER AND LEUKEMIA GROUP B MINORITY SATELLITE SUPPLEMENU10CA031946 · NCI · UNIVERSITY OF CHICAGO · PI BERTAGNOLLI, MONICA M · 1985 to 2013
$158.4M
SWOG - Foreign Accrual under UMiU10CA032102 · NCI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BLANKE, CHARLES D. · 1985 to 2013
$141.3M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
TRANSLATIONAL RESEARCHU10CA025224 · NCI · MAYO CLINIC ROCHESTER · PI BUCKNER, JAN C · 1985 to 2013
$85.0M
SOUTHWEST ONCOLOGY GROUP--STATISTICAL CENTERU10CA038926 · NCI · FRED HUTCHINSON CANCER RESEARCH CENTER · PI LEBLANC, MICHAEL L. · 1985 to 2013
$69.8M
CANCER &LEUKEMIA GROUP B STATISTICAL CENTERU10CA033601 · NCI · UNIVERSITY OF NEBRASKA MEDICAL CENTER · PI SARGENT, DANIEL J. · 1985 to 2013
$69.4M
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
GRAND RAPIDS CLINICAL ONCOLOGY PROGRAMU10CA035178 · NCI · SPECTRUM HEALTH HOSPITALS · PI PADULA, GILBERT DARIN ANTHONY · 1985 to 2014
$16.2M
COMMUNITY CLINICAL ONCOLOGY PROGRAMU10CA045807 · NCI · VOLUNTARY HOSPITALS OF AMERICA-ILLINOIS · PI WADE, JAMES L · 1987 to 2014
$16.0M
NCIC Foreign AccrualsU10CA077202 · NCI · QUEEN'S UNIVERSITY AT KINGSTON · PI EISENHAUER, ELIZABETH · 1998 to 2013
$14.6M
NCI NIH HHS N01 CA004919NCI NIH HHS N01 CA027057NCI NIH HHS N01 CA032102NCI NIH HHS N01 CA035119NCI NIH HHS N01 CA035176NCI NIH HHS N01 CA035178NCI NIH HHS N01 CA035431NCI NIH HHS N01 CA038926NCI NIH HHS N01 CA045560NCI NIH HHS N01 CA045807NCI NIH HHS N01 CA046441NCI NIH HHS N01 CA063844NCI NIH HHS N01 CA067575NCI NIH HHS U10 CA004919NCI NIH HHS U10 CA011083NCI NIH HHS U10 CA014028NCI NIH HHS U10 CA020319NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA025224NCI NIH HHS U10 CA027057NCI NIH HHS U10 CA031946NCI NIH HHS U10 CA032102NCI NIH HHS U10 CA033601NCI NIH HHS U10 CA035090NCI NIH HHS U10 CA035119NCI NIH HHS U10 CA035128NCI NIH HHS U10 CA035176NCI NIH HHS U10 CA035178NCI NIH HHS U10 CA035192NCI NIH HHS U10 CA035195NCI NIH HHS U10 CA035261NCI NIH HHS U10 CA035262NCI NIH HHS U10 CA035281NCI NIH HHS U10 CA035431NCI NIH HHS U10 CA038926NCI NIH HHS U10 CA042777NCI NIH HHS U10 CA045377NCI NIH HHS U10 CA045450NCI NIH HHS U10 CA045461NCI NIH HHS U10 CA045560NCI NIH HHS U10 CA045807NCI NIH HHS U10 CA045808NCI NIH HHS U10 CA046282NCI NIH HHS U10 CA046368NCI NIH HHS U10 CA046441NCI NIH HHS U10 CA052654NCI NIH HHS U10 CA058861NCI NIH HHS U10 CA058882NCI NIH HHS U10 CA063844NCI NIH HHS U10 CA067575NCI NIH HHS U10 CA067663NCI NIH HHS U10 CA077202NCI NIH HHS U10 CA077651NCI NIH HHS U10 CA086780NCI NIH HHS U10 CA091105NCI NIH HHS U10 CA095860NCI NIH HHS U10 CA105409
6 · The paper itself

Abstract

purposePatients with advanced pancreas cancer present with disease that is poorly responsive to conventional therapies. Preclinical and early clinical evidence has supported targeting the epidermal growth factor receptor (EGFR) signaling pathway in patients with pancreas cancer. This trial was conducted to evaluate the contribution of an EGFR-targeted agent to standard gemcitabine therapy. Cetuximab is a monoclonal antibody against the ligand-binding domain of the receptor. PATIENTS AND

methodsPatients with unresectable locally advanced or metastatic pancreatic adenocarcinoma were randomly assigned to receive gemcitabine alone or gemcitabine plus cetuximab. The primary end point was overall survival. Secondary end points included progression-free survival, time to treatment failure, objective response, and toxicity.

resultsA total of 745 eligible patients were accrued. No significant difference was seen between the two arms of the study with respect to the median survival time (6.3 months for the gemcitabine plus cetuximab arm v 5.9 months for the gemcitabine alone arm; hazard ratio = 1.06; 95% CI, 0.91 to 1.23; P = .23, one-sided). Objective responses and progression-free survival were similar in both arms of the study. Although time to treatment failure was longer in patients on gemcitabine plus cetuximab (P = .006), the difference in length of treatment was only 2 weeks longer in the combination arm. Among patients who were studied for tumoral EGFR expression, 90% were positive, with no treatment benefit detected in this patient subset.

conclusionIn patients with advanced pancreas cancer, the anti-EGFR monoclonal antibody cetuximab did not improve the outcome compared with patients treated with gemcitabine alone. Alternate targets other than EGFR should be evaluated for new drug development.

Indexed as

AdenocarcinomaAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDeoxycytidineDisease-Free SurvivalFemaleGemcitabineHumansMaleMiddle AgedPancreatic NeoplasmsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedCetuximabDeoxycytidineGemcitabine

Identifiers

PMID20606093
PMCPMC2917315
OpenAlexW2144025124

What OpenQuestion holds

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Registered trials

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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.