Evidence map›Paper›PMID 18829515›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2008

Fluorescence in situ hybridization subgroup analysis of TRIBUTE, a phase III trial of erlotinib plus carboplatin and paclitaxel in non-small cell lung cancer.

Fred R Hirsch, Marileila Varella-Garcia, Rafal Dziadziuszko, Yun Xiao, Sujatha Gajapathy, Margaret Skokan, Ming Lin, Vincent O'Neill, Paul A Bunn

Registry-linked trialOpen access · bronzeAbstract readClinical Trial, Phase III
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00047736 (A Phase III, Randomized, Double Blind, Multicenter Trial of Tarceva), which is not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
10.6field-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.

NCT00047736 phase3completednot on this map

A Phase III, Randomized, Double Blind, Multicenter Trial of Tarceva (Erlotinib) Plus Chemotherapy (Carboplatin and Paclitaxel) Versus Chemotherapy Alone in Patients With Advanced (Stage IIIb or IV) Non-Small Cell Lung Cancer Who Have Not Received Prior Chemotherapy

TypeinterventionalSponsorGenentech, Inc.Ran2001 to 2003ConditionsLung CancerArmsTarceva (erlotinib HCl)
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it, 59 citations in OpenAlex.

  1. American Society of Clinical Oncology Clinical Practice Guideline update on chemotherapy for stage IV non-small-cell lung cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
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  17. Genetic abnormalities of the EGFR pathway in African American Patients with non-small-cell lung cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2009
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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

9 authors at 2 institutions in 1 country.

Fred R HirschUniversity of Colorado Cancer Center, Aurora, CO 80045, USA. Fred.Hirsch@UCHSC.edu
Marileila Varella-Garcia
Rafal Dziadziuszko
Yun Xiao
Sujatha Gajapathy
Margaret Skokan
Ming Lin
Vincent O'Neill
Paul A Bunn
University of Colorado Cancer Center · USUniversity of Colorado Denver · US

Funding

Tissue Bank and Biomarkers CoreP50CA058187 · NCI · UNIVERSITY OF COLORADO DENVER · PI MILLER, YORK E · 1992 to 2018
$43.8M
NCI NIH HHS P01 CA 58187NCI NIH HHS P50 CA058187
6 · The paper itself

Abstract

purposeTRIBUTE was a phase III trial evaluating the addition of erlotinib to carboplatin and paclitaxel as a first-line treatment for advanced non-small cell lung cancer that did not meet its primary end point of improving overall survival. Here, we assess the value of using epidermal growth factor receptor (EGFR) gene copy number in tumor biopsy samples, as determined by fluorescence in situ hybridization (FISH), as a predictor of treatment outcome.

methodsEGFR FISH analysis was done using LSI EGFR SpectrumOrange/CEP7 SpectrumGreen probe.

resultsOf 275 samples, 245 (89.1%) were successfully analyzed by FISH. One hundred (40.8%) of patients were EGFR FISH(+). Median overall survival was not different between FISH(+) and FISH(-) patients in either the chemotherapy+erlotinib arm or the chemotherapy+placebo arm. In FISH(+) patients, median time to progression (TTP) was 6.3 months in the erlotinib arm versus 5.8 months in the placebo arm (hazard ratio, 0.59; 95% confidence interval, 0.35-0.99; P = 0.0430); in FISH(-) patients, median TTP was 4.6 months versus 6.0 months (hazard ratio, 1.42; 95% confidence interval, 0.95-2.14; P = 0.0895; treatment interaction test, P = 0.007). After 6 months of treatment, a notable separation of the TTP curves in favor of erlotinib emerged. Objective response rates were 11.6% versus 29.8% in FISH(+) patients (chemotherapy+erlotinib arm versus chemotherapy+placebo arm; P = 0.0495) and 21.8% versus 25.4%, respectively, for FISH(-) patients (P = 0.6954).

conclusionsEGFR gene copy number by FISH did not predict survival benefit. However, among EGFR FISH(+) patients, TTP was longer in patients who received erlotinib and continued to receive it after completing first-line therapy.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarboplatinCarcinoma, Non-Small-Cell LungErbB ReceptorsErlotinib HydrochlorideFemaleGene Expression Regulation, NeoplasticHumansIn Situ Hybridization, FluorescenceLung NeoplasmsMaleMiddle AgedPaclitaxelCarboplatinErbB ReceptorsErlotinib HydrochloridePaclitaxelQuinazolines

Identifiers

PMID18829515
PMCPMC3368373
OpenAlexW2120953374

What OpenQuestion holds

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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.