Evidence map›Paper›PMID 21558399›Full record

Trial reportClinical cancer research : an official journal of the American Association for Cancer Research2011

Molecular characteristics predict clinical outcomes: prospective trial correlating response to the EGFR tyrosine kinase inhibitor gefitinib with the presence of sensitizing mutations in the tyrosine binding domain of the EGFR gene.

Naiyer A Rizvi, Valerie Rusch, William Pao, Jamie E Chaft, Marc Ladanyi, Vincent A Miller, Lee M Krug, Christopher G Azzoli, Manjit Bains, Robert Downey and 7 more

2 registry-linked trialsAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Clinical cancer research : an official journal of the American Association for Cancer Research, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 34 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT01407822 phase2 / phase3unknown statusnot on this map

A National, Multi Center, Randomized, Open-label, Phase II Trial of Erlotinib Versus Combination of GC as (Neo)Adjuvant Treatment in Stage IIIA-N2 NSCLC With Sensitizing EGFR Mutation in Exon 19 or 21(EMERGING)

TypeinterventionalSponsorGuangdong Association of Clinical TrialsRan2011 to 2022Enrolled72ConditionsNon-small Cell Lung CancerArmsErlotinib, Gemcitabine/cisplatin
NCT01833572 phase2completednot on this mapstarted 2013, after this paper: background citation

A Single-arm, Phase II Study of Preoperative Gefitinib for Stage II-IIIa NSCLC With Activating EGFR Mutation

TypeinterventionalSponsorFudan UniversityRan2013 to 2015Enrolled36ConditionsNon-small-cell Lung CancerArmsGefitinib
3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Guideline
  4. Guideline
  5. Trial
  6. Effectiveness of gefitinib against non-small-cell lung cancer with the uncommon EGFR mutations G719X and L861Q.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2014
    Trial
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Cancers · 2022
    Review
  14. Preoperative and Postoperative Systemic Therapy for Operable Non-Small-Cell Lung Cancer.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2022
    Review
  15. Review
  16. Article
  17. Review
  18. Review
  19. Article
  20. IASLC Multidisciplinary Recommendations for Pathologic Assessment of Lung Cancer Resection Specimens After Neoadjuvant Therapy.Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer · 2020
    Review
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.

Naiyer A RizviThoracic Oncology Service, Division of Solid Tumor Oncology, Department of Medicine, Memorial Sloan-Kettering Cancer Center and Weill Medical College of Cornell University, New York, New York 10021, USA. rizvin@mskcc.org
Valerie Rusch
William Pao
Jamie E Chaft
Marc Ladanyi
Vincent A Miller
Lee M Krug
Christopher G Azzoli
Manjit Bains
Robert Downey
Raja Flores
Bernard Park
Bhuvanesh Singh
Maureen Zakowski
Robert T Heelan
Ronglai Shen
Mark G Kris

Funding

Investigational Cancer Therapeutics Training Program (ICTTP)T32CA009207 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Omar Abdel-Wahab, Alexander Drilon · 1985 to 2026
$13.7M
SOLID TUMORP01CA005826 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI SPRIGGS, DAVID R · 1985 to 2005
$8.1M
Summer research experiences for medical students supervised by faculty mentorsR25CA020449 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Charlotte Eielson Ariyan · 1985 to 2026
$6.2M
Correlation of EGFR Mutations and Response to GefitinibR21CA113653 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI RIZVI, NAIYER A · 2005 to 2006
$243k
NCI NIH HHS P01 CA005826NCI NIH HHS P01 CA-05836NCI NIH HHS R21 CA113653NCI NIH HHS R25 CA020449NCI NIH HHS T32 CA009207
6 · The paper itself

Abstract

purposeTo determine if tumor regression following treatment with gefitinib correlates with the presence of sensitizing mutations in epidermal growth factor receptor (EGFR). PATIENTS AND

methodsPatients with resectable stage I and II non-small cell lung cancer (NSCLC) enriched for the likelihood of EGFR mutation (≤ 15 pack-year cigarette smoking history and/or a component of bronchioloalveolar carcinoma) received preoperative gefitinib for 21 days. Tumor specimens were analyzed for EGFR and KRAS mutations and EGFR protein expression and amplification. Patients with 25% or more reduction in tumor size measured bidimensionally at 3 weeks and/or patients with an EGFR mutation received adjuvant gefitinib for 2 years postoperatively.

resultsFifty patients with stage I/II NSCLC were treated. After 21 days of preoperative gefitinib a response of 25% or more was observed in 21 of 50 (42%) patients. Seventeen of 21 patients with a response had an EGFR mutation and 4 of 21 patients with a response did not (P = 0.0001). Twenty-five of 50 patients were eligible to receive adjuvant gefitinib. With a median follow-up of 44.1 months, 2-year disease free survival for EGFR mutant patients and for those who received adjuvant gefitinib was not statistically different than those who were EGFR wild-type and those who did not receive adjuvant gefitinib. The median disease free and overall survivals have not been reached.

conclusionsThe presence of sensitizing EGFR mutations correlates with radiographic response. A short course of preoperative treatment serves a platform for evaluating activity of new agents and assures sufficient tumor availability for correlative analyses.

Indexed as

AdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungCatalytic DomainDrug Resistance, NeoplasmErbB ReceptorsFemaleGefitinibGenes, erbB-1HumansLung NeoplasmsMaleMiddle AgedMutationPrognosisErbB ReceptorsGefitinibProtein Kinase InhibitorsQuinazolinesTyrosine

Identifiers

PMID21558399
PMCPMC3261615

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.