Evidence map›Paper›PMID 21629990›Full record

Trial reportInvestigational new drugs2012

A phase II randomized study of cetuximab and bevacizumab alone or in combination with gemcitabine as first-line therapy for metastatic pancreatic adenocarcinoma.

Andrew H Ko, Hagop Youssoufian, Jayne Gurtler, Karel Dicke, Omar Kayaleh, Heinz-Josef Lenz, Mark Keaton, Terry Katz, Shaila Ballal, Eric K Rowinsky

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in Investigational new drugs, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00326911 (A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas), which is not on this map. Cited by 23 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 3 pooled it
3.5field-weighted citation impact, top 6% 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.

NCT00326911 phase2terminatednot on this map

A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas

TypeinterventionalSponsorEli Lilly and CompanyRan2006 to 2008Enrolled61ConditionsMetastatic Pancreatic CancerArmscetuximab, bevacizumab, gemcitabine
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 3 syntheses or guidelines pooled it, 60 citations in OpenAlex.

  1. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Pooled it
  3. Chemotherapy and radiotherapy for advanced pancreatic cancer.The Cochrane database of systematic reviews · 2018
    Pooled it
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  18. Dysphonia induced by anti-angiogenic compounds.Investigational new drugs · 2014
    Review
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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 at 7 institutions in 1 country.

Andrew H KoHelen Diller Family Comprehensive Cancer Center, University of California at San Francisco, 1600 Divisadero Street, 4th Floor, Box 1705, San Francisco, CA 94115, USA. andrewko@medicine.ucsf.edu
Hagop Youssoufian
Jayne Gurtler
Karel Dicke
Omar Kayaleh
Heinz-Josef Lenz
Mark Keaton
Terry Katz
Shaila Ballal
Eric K Rowinsky
Eli Lilly (United States) · USLittoral Research Group (United States) · USOncoceutics (United States) · USRegional Cancer Center · USThe University of Texas MD Anderson Cancer Center · USUCSF Helen Diller Family Comprehensive Cancer Center · USUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The purpose of this study was to assess the efficacy and safety of bevacizumab plus cetuximab with or without gemcitabine in patients with advanced pancreatic adenocarcinoma. Patients with locally advanced or metastatic pancreatic adenocarcinoma, previously untreated, were randomized to bevacizumab (10 mg/kg q2w) plus cetuximab (400/250 mg/m(2) initial/weekly), either with (Arm A) or without (Arm B) gemcitabine (1000 mg/m(2) weekly × 3 of 4 weeks). Tumor assessments were performed q8w. Primary study endpoint was progression-free survival (PFS). Sixty-one patients were randomized to Arm A (n = 30) or Arm B (n = 31). Median treatment duration was 9 weeks in Arm A and 8 weeks in Arm B (range, 2.0-40.4). Patients in Arm A had median PFS and overall survival values of 3.55 months and 5.41 months, respectively, compared to 1.91 months and 4.17 months in Arm B. The study closed early due to lack of sufficient efficacy in both treatment arms. Although both regimens were well tolerated, patients treated with gemcitabine experienced more grade 3-4 toxicities, including proteinuria and thromboembolic events. The combination of cetuximab and bevacizumab did not result in promising activity with or without gemcitabine, suggesting that a strategy of dual EGFR/VEGF inhibition in pancreatic cancer does not warrant further development. To our knowledge, this is one of the first trials to evaluate a completely noncytotoxic regimen in the first-line treatment of advanced pancreatic cancer. (ClinicalTrials.gov number, NCT00326911).

Indexed as

AdenocarcinomaAdultAgedAged, 80 and overAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCetuximabDeoxycytidineFemaleGemcitabineHumansMaleMiddle AgedAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBevacizumabCetuximabDeoxycytidineGemcitabine

Identifiers

PMID21629990
OpenAlexW2094037194

What OpenQuestion holds

Textmetadata
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.