Evidence map›Paper›PMID 22665541›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Multicenter, double-blind, placebo-controlled, randomized phase II trial of gemcitabine/cisplatin plus bevacizumab or placebo in patients with malignant mesothelioma.

Hedy L Kindler, Theodore G Karrison, David R Gandara, Charles Lu, Lee M Krug, James P Stevenson, Pasi A Jänne, David I Quinn, Marianna N Koczywas, Julie R Brahmer and 7 more

Open access · bronzeAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 75 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
75citing papers in PubMed, 7 pooled it
21.0field-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

75 citing papers in PubMed, 7 syntheses or guidelines pooled it, 256 citations in OpenAlex.

  1. Treatment of Malignant Pleural Mesothelioma: American Society of Clinical Oncology Clinical Practice Guideline.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2018
    Guideline
  2. Pooled it
  3. NCCN Guidelines Insights: Malignant Pleural Mesothelioma, Version 3.2016.Journal of the National Comprehensive Cancer Network : JNCCN · 2016
    Guideline
  4. Pooled it
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. Trial
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  16. Review
  17. Article
  18. Target Therapy in Malignant Pleural Mesothelioma: Hope or Mirage?International journal of molecular sciences · 2023
    Review
  19. Novel and Promising Systemic Treatment Approaches in Mesothelioma.Current treatment options in oncology · 2021
    Review
  20. Review

15 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

17 authors at 1 institution in 1 country.

Hedy L KindlerUniversity of Chicago ComprehensiveCancer Center, Chicago, IL, USA. hkindler@medicine.bsd.uchicago.edu
Theodore G Karrison
David R Gandara
Charles Lu
Lee M Krug
James P Stevenson
Pasi A Jänne
David I Quinn
Marianna N Koczywas
Julie R Brahmer
Kathy S Albain
David A Taber
Samuel G Armato
Nicholas J Vogelzang
Helen X Chen
Walter M Stadler
Everett E Vokes
University of California, Davis · US

Funding

REGULATION OF RADIATION-INDUCED APOPTOTIC CELL DEATHR29CA062209 · NCI · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · PI STORY, MICHAEL D · 1994 to 1998
–
NCI NIH HHS N01 CM062209
6 · The paper itself

Abstract

purposeGemcitabine plus cisplatin is active in malignant mesothelioma (MM), although single-arm phase II trials have reported variable outcomes. Vascular endothelial growth factor (VEGF) inhibitors have activity against MM in preclinical models. We added the anti-VEGF antibody bevacizumab to gemcitabine/cisplatin in a multicenter, double-blind, placebo-controlled randomized phase II trial in patients with previously untreated, unresectable MM. PATIENTS AND

methodsEligible patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 and no thrombosis, bleeding, or major blood vessel invasion. The primary end point was progression-free survival (PFS). Patients were stratified by ECOG performance status (0 v 1) and histologic subtype (epithelial v other). Patients received gemcitabine 1,250 mg/m(2) on days 1 and 8 every 21 days, cisplatin 75 mg/m(2) every 21 days, and bevacizumab 15 mg/kg or placebo every 21 days for six cycles, and then bevacizumab or placebo every 21 days until progression.

resultsOne hundred fifteen patients were enrolled at 11 sites; 108 patients were evaluable. Median PFS time was 6.9 months for the bevacizumab arm and 6.0 months for the placebo arm (P = .88). Median overall survival (OS) times were 15.6 and 14.7 months in the bevacizumab and placebo arms, respectively (P = .91). Partial response rates were similar (24.5% for bevacizumab v 21.8% for placebo; P = .74). A higher pretreatment plasma VEGF concentration (n = 56) was associated with shorter PFS (P = .02) and OS (P = .0066), independent of treatment arm. There were no statistically significant differences in toxicity of grade 3 or greater.

conclusionThe addition of bevacizumab to gemcitabine/cisplatin in this trial did not significantly improve PFS or OS in patients with advanced MM.

Indexed as

AdultAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsBevacizumabCisplatinDeoxycytidineDisease-Free SurvivalDouble-Blind MethodFemaleGemcitabineHumansMaleMesotheliomaMiddle AgedPeritoneal NeoplasmsAntibodies, Monoclonal, HumanizedBevacizumabCisplatinDeoxycytidineGemcitabinePlacebos

Identifiers

PMID22665541
PMCPMC3397785
OpenAlexW2167527173

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.