Evidence map›Paper›PMID 24246704›Full record

Trial reportEuropean journal of cancer (Oxford, England : 1990)2014

Dosing to rash: a phase II trial of the first-line erlotinib for patients with advanced non-small-cell lung cancer an Eastern Cooperative Oncology Group Study (E3503).

J R Brahmer, J W Lee, A M Traynor, M M Hidalgo, J M Kolesar, J M Siegfried, P P Guaglianone, J D Patel, M D Keppen, J H Schiller

Open access · greenAbstract readClinical Trial, Phase II
In one paragraph

Trial report in European journal of cancer (Oxford, England : 1990), 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed, 2 pooled it
3.1field-weighted citation impact, top 8% 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

11 citing papers in PubMed, 2 syntheses or guidelines pooled it, 26 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Trial
  4. Trial
  5. Article
  6. Article
  7. Review
  8. Article
  9. Review
  10. Article
  11. Observational
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 8 institutions in 2 countries.

J R BrahmerSidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD, United States. Electronic address: brahmju@jhmi.edu.
J W LeeDana-Farber Cancer Institute, Boston, MA, United States.
A M TraynorUniversity of Wisconsin, Madison, WI, United States.
M M HidalgoHospital Madrid Sanchinarro, Madrid, Spain.
J M KolesarUniversity of Wisconsin, Madison, WI, United States.
J M SiegfriedUniversity of Pittsburgh, Pittsburgh, PA, United States.
P P GuaglianoneDecatur Memorial Hospital, Decatur, IL, United States.
J D PatelNorthwestern University, Chicago, IL, United States.
M D KeppenSanford Cancer Center, Sioux Falls, SD, United States.
J H SchillerUniversity of Texas Southwestern Medical Center, Dallas, TX, United States.
University of Wisconsin–Madison · USDana-Farber Cancer Institute · USDecatur Memorial Hospital · USHospital Universitario HM Sanchinarro · ESJohns Hopkins University · USNorthwestern University · USThe University of Texas Southwestern Medical Center · USUniversity of Pittsburgh · US

Funding

Translational Research Central ServicesP30CA006973 · NCI · JOHNS HOPKINS UNIVERSITY · PI Rosalie Wollett · 1985 to 2026
$208.6M
Tumor Environment and Metastasis (TEAM) Research ProgramP30CA060553 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI Daniela E Matei · 1993 to 2026
$153.9M
ECOG OPERATIONS OFFICE (IBCSG)U10CA021115 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2013
$132.6M
ECOG Statistical Office Data Management GrantU10CA066636 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI GRAY, ROBERT J · 1994 to 2013
$39.5M
Foreign Accrual - ECOGU10CA037403 · NCI · UNIVERSITY OF WISCONSIN MADISON · PI COMIS, ROBERT L · 1985 to 2014
$34.6M
PROVIDE STATISTICAL SERVICESU10CA023318 · NCI · DANA-FARBER CANCER INSTITUTE · PI GRAY, ROBERT J · 1985 to 2013
$33.4M
ECOG Specimen BankingU24CA114737 · NCI · FRONTIER SCI &TECHNOLOGY RSCH FDN, INC · PI COMIS, ROBERT L · 2005 to 2014
$9.3M
EASTERN COOPERATIVE ONCOLOGY GROUP--WISCONSIN STUDIESU10CA021076 · NCI · UNIVERSITY OF WISCONSIN-MADISON · PI KAHL, BRAD · 1985 to 2013
$8.2M
ECOG Clinical TrialsU10CA017145 · NCI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI BENSON, AL B · 1985 to 2013
$6.1M
NCTN LAPS at Johns HopkinsUG1CA233196 · NCI · JOHNS HOPKINS UNIVERSITY · PI DEBORAH K ARMSTRONG, Julie Renee Brahmer · 2019 to 2026
$4.6M
EASTERN COOPERATIVE ONCOLOGY GROUPU10CA016116 · NCI · JOHNS HOPKINS UNIVERSITY · PI FORASTIERE, ARLENE ANN · 1985 to 2013
$4.0M
ONCOLOGYU10CA039229 · NCI · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · PI KIRKWOOD, JOHN MUNN · 1985 to 2013
$3.3M
NCI NIH HHS CA16116NCI NIH HHS CA17145NCI NIH HHS CA21076NCI NIH HHS CA21115NCI NIH HHS CA23318NCI NIH HHS CA39229NCI NIH HHS CA66636NCI NIH HHS P30 CA006973NCI NIH HHS P30 CA060553NCI NIH HHS U10 CA016116NCI NIH HHS U10 CA017145NCI NIH HHS U10 CA021076NCI NIH HHS U10 CA021115NCI NIH HHS U10 CA023318NCI NIH HHS U10 CA037403NCI NIH HHS U10 CA039229NCI NIH HHS U10 CA066636NCI NIH HHS U10 CA180802NCI NIH HHS U24 CA114737NCI NIH HHS UG1 CA233196
6 · The paper itself

Abstract

backgroundThe development of a rash has been retrospectively associated with increased response and improved survival when treated with erlotinib at the standard dose of 150 mg per day. The objective of this trial was to evaluate the association of the activity of erlotinib in the first-line setting in patients with advanced non-small-cell lung cancer (NSCLC) with the development of a tolerable rash via dose escalation of erlotinib or tumour characteristics.

methodsPatients, with advanced NSCLC without prior systemic therapy, were treated with erlotinib 150 mg orally per day. The dose was increased by 25mg every two weeks until the development of grade 2/tolerable rash or other dose limiting toxicity. Tumour biopsy specimens were required for inclusion.

resultsThe study enrolled 137 patients, 135 were evaluable for safety and 124 were eligible and evaluable for response. Only 73 tumour samples were available for analysis. Erlotinib dose escalation occurred in 69/124 patients. Erlotinib was well tolerated with 70% of patients developing a grade 1/2 rash and 10% developing grade 3 rash. Response rate and disease control rate were 6.5% and 41.1% respectively. Median overall survival was 7.7 months. Toxicity and tumour markers were not associated with response. Grade 2 or greater skin rash and low phosphorylated mitogen-activated protein kinase (pMAPK) were associated with improved survival.

conclusionsOverall survival was similar in this trial compared to first-line chemotherapy in this unselected patient population. Dose escalation to the development of grade 2 skin rash was associated with improved survival in this patient population.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungDose-Response Relationship, DrugDrug Administration ScheduleErlotinib HydrochlorideExanthemaFatigueFemaleHumansLung NeoplasmsMaleMiddle AgedProtein Kinase InhibitorsQuinazolinesErlotinib HydrochlorideProtein Kinase InhibitorsQuinazolinesErlotinibNSCLCPhase II

Identifiers

PMID24246704
PMCPMC3991133
OpenAlexW2045432173

What OpenQuestion holds

Textmetadata
LicenceTDM
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.