Evidence map›Paper›PMID 23690416›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2013

Randomized international phase III trial of ERCC1 and RRM1 expression-based chemotherapy versus gemcitabine/carboplatin in advanced non-small-cell lung cancer.

Gerold Bepler, Charles Williams, Michael J Schell, Wei Chen, Zhong Zheng, George Simon, Shirish Gadgeel, Xiuhua Zhao, Fred Schreiber, Julie Brahmer and 7 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01977209 (A Randomized, Double Blind, Placebo-controlled Multiple-center Phase III Trial of Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression), which is not on this map. Cited by 77 papers.

0numbers the graph read from it
0cells of the map it votes in
77citing papers in PubMed
20.1field-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.

NCT01977209 phase3unknown statusnot on this map

A Randomized, Double Blind, Placebo-controlled Multiple-center Phase III Trial of Gossypol Combined With Docetaxel and Cisplatin Scheme in Advanced Non Small-cell Lung Cancers With APE1 High Expression

TypeinterventionalSponsorThird Military Medical UniversityRan2013 to 2016Enrolled204ConditionsNon-small Cell Lung CancerArmsGossypol, Placebo
3 · Its place in the literature

Who cites it

77 citing papers in PubMed, 143 citations in OpenAlex.

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  17. Molecular biomarkers in early stage lung cancer.Translational lung cancer research · 2021
    Review
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17 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.

Gerold BeplerKarmanos Cancer Institute, Detroit, MI 48201, USA. beplerg@karmanos.org
Charles Williams
Michael J Schell
Wei Chen
Zhong Zheng
George Simon
Shirish Gadgeel
Xiuhua Zhao
Fred Schreiber
Julie Brahmer
Alberto Chiappori
Tawee Tanvetyanon
Mary Pinder-Schenck
Jhanelle Gray
Eric Haura
Scott Antonia
Juergen R Fischer
Moffitt Cancer Center · US

Funding

TRANSLATIONAL RESEARCHP30CA076292 · NCI · UNIVERSITY OF SOUTH FLORIDA · PI KENNETH Lynn WRIGHT · 1998 to 2026
$93.5M
Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
RRM1 in the Management of Lung CancerR01CA129343 · NCI · WAYNE STATE UNIVERSITY · PI BEPLER, GEROLD · 2008 to 2013
$2.8M
Enhancing neoadjuvant chemotherpay responses with targeted T cellsR01CA140314 · NCI · WAYNE STATE UNIVERSITY · PI BEPLER, GEROLD · 2010 to 2015
$2.5M
NCI NIH HHS CA129343NCI NIH HHS R01 CA129343
6 · The paper itself

Abstract

purposeWe assessed whether chemotherapy selection based on in situ ERCC1 and RRM1 protein levels would improve survival in patients with advanced non-small-cell lung cancer (NSCLC). PATIENTS AND

methodsEligible patients were randomly assigned 2:1 to the trial's experimental arm, which consisted of gemcitabine/carboplatin if RRM1 and ERCC1 were low, docetaxel/carboplatin if RRM1 was high and ERCC1 was low, gemcitabine/docetaxel if RRM1 was low and ERCC1 was high, and docetaxel/vinorelbine if both were high. In the control arm, patients received gemcitabine/carboplatin. The trial was powered for a 32% improvement in 6-month progression-free survival (PFS).

resultsOf 331 patients registered, 275 were eligible. The median number of cycles given was four in both arms. A tumor rebiopsy specifically for expression analysis was required in 17% of patients. The median time from informed consent to expression analysis was 11 days. We found no statistically significant differences between the experimental arm and the control arm in PFS (6.1 months v 6.9 months) or overall survival (11.0 months v 11.3 months). A subset analysis revealed that patients with low levels for both proteins who received the same treatment in both treatment arms had a statistically better PFS (P = .02) in the control arm (8.1 months) compared with the experimental arm (5.0 months).

conclusionThis demonstrates that protein expression analysis for therapeutic decision making is feasible in newly diagnosed patients with advanced-stage NSCLC. A tumor rebiopsy is safe, required in 17%, and acceptable to 89% (47 of 53) of patients.

Indexed as

AdultAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsBiomarkers, TumorCarboplatinCarcinoma, Non-Small-Cell LungDeoxycytidineDisease ProgressionDNA-Binding ProteinsDocetaxelEndonucleasesFeasibility StudiesFemaleFollow-Up StudiesGemcitabineBiomarkers, TumorCarboplatinDeoxycytidineDNA-Binding ProteinsDocetaxelEndonucleasesERCC1 protein, humanGemcitabineRibonucleoside Diphosphate ReductaseRNA, MessengerRRM1 protein, humanTaxoidsTumor Suppressor Proteins

Identifiers

PMID23690416
PMCPMC3691357
OpenAlexW2165963900

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.