Evidence map›Paper›PMID 24501009›Full record

Trial reportCancer2014

A phase 2 trial of dacomitinib (PF-00299804), an oral, irreversible pan-HER (human epidermal growth factor receptor) inhibitor, in patients with advanced non-small cell lung cancer after failure of prior chemotherapy and erlotinib.

Karen L Reckamp, Giuseppe Giaccone, D Ross Camidge, Shirish M Gadgeel, Fadlo R Khuri, Jeff A Engelman, Marianna Koczywas, Arun Rajan, Alicyn K Campbell, Diana Gernhardt and 6 more

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Cancer, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00548093 (A PHASE 2, OPEN-LABEL, TWO ARM TRIAL TO EVALUATE THE EFFICACY OF PF-00299804 IN PATIENTS WITH ADVANCED NSCLC AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN AND FAILURE OF PRIOR TREATMENT WITH ERLOTINIB), which is not on this map. Cited by 62 papers.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed
–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.

NCT00548093 phase2completednot on this map

A phase 2, open-label, two arm trial to evaluate the efficacy of pf-00299804 in patients with advanced nsclc after failure of at least one prior chemotherapy regimen and failure of prior treatment with erlotinib

TypeinterventionalSponsorPfizerRan2008 to 2012Enrolled66ConditionsCarcinoma, Non Small Cell LungArmsPF-00299804
3 · Its place in the literature

Who cites it

62 citing papers in PubMed.

  1. Trial
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  4. Exploring tyrosine kinase inhibitors for HER2-positive breast cancer: comprehensive review on a complete pharmacology-molecular mechanisms, safety profiles, and insights from preclinical and clinical studies.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2026
    Review
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  12. Discovery of novel thiazolyl-pyrazolines as dual EGFR and VEGFR-2 inhibitors endowed withJournal of enzyme inhibition and medicinal chemistry · 2022
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2 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

16 authors.

Karen L ReckampCity of Hope, Duarte, California.
Giuseppe Giaccone
D Ross Camidge
Shirish M Gadgeel
Fadlo R Khuri
Jeff A Engelman
Marianna Koczywas
Arun Rajan
Alicyn K Campbell
Diana Gernhardt
Ana Ruiz-Garcia
Stephen Letrent
Jane Liang
Ian Taylor
Joseph P O'Connell
Pasi A Jänne

Funding

Thoracic and Gastrointestinal Oncology Branch Medical Clinical CoreZIDBC011540 · NCI · DIVISION OF BASIC SCIENCES - NCI · PI HASSAN, RAFFIT · 2014 to 2025
$17.7M
6 · The paper itself

Abstract

backgroundThis phase 2 trial (ClinicalTrials.gov identifier NCT00548093) assessed the efficacy, safety, and impact on health-related quality of life of dacomitinib (PF-00299804), an irreversible tyrosine kinase inhibitor (TKI) of human epidermal growth factor receptors (EGFR)/HER1, HER2, and HER4, in patients with KRAS wild-type non-small cell lung cancer (NSCLC).

methodsPatients with advanced NSCLC, progression on 1 or 2 regimens of chemotherapy and erlotinib, KRAS wild-type or known EGFR-sensitizing mutant tumor, and Eastern Cooperative Oncology Group performance status of 0 to 2 received 45 mg of dacomitinib once daily continuously in 21-day cycles.

resultsA total of 66 patients enrolled (adenocarcinoma, n = 50; those without adenocarcinoma [nonadenocarcinoma], n = 16). The objective response rate (ORR) for patients with adenocarcinoma (primary endpoint) was 5% (2 partial responses; 1-sided P = .372 for null hypothesis [H0 ]: ORR ≤ 5%) and 6% (1 partial response) for patients with nonadenocarcinoma. Responders included: 2 of 25 EGFR mutation-positive tumors; 1 of 3 EGFR wild-type with HER2 amplification. Median progression-free survival was 12 weeks overall (n = 66) and 18 weeks (n = 26) for patients with EGFR mutation-positive tumors. Common treatment-related adverse events were of grade 1 or 2 severity, manageable with standard supportive care, and included diarrhea (grade 3 [G3], 12%), acneiform dermatitis (G3, 6%), exfoliative rash (G3, 3%), dry skin (G3, 0%), fatigue (G3, 3%), and stomatitis (G3, 2%). Six patients (9%) discontinued due to treatment-related adverse events. By patient report, NSCLC symptoms of dyspnea, cough, and pain (chest, arm/shoulder) showed improvement first observed after 3 weeks on therapy.

conclusionsDacomitinib demonstrated preliminary activity and acceptable tolerability in heavily pretreated patients, and may offer benefit in molecularly defined patient subsets.

Indexed as

AdenocarcinomaAdministration, OralAdultAgedAged, 80 and overCarcinoma, Non-Small-Cell LungDisease-Free SurvivalErbB ReceptorsErlotinib HydrochlorideFemaleHumansLung NeoplasmsMaleMiddle AgedMutationQuinazolinesdacomitinibErbB ReceptorsErlotinib HydrochlorideQuinazolinesQuinazolinonesadenocarcinomadacomitiniberlotinibnonadenocarcinomanon-small cell lung cancerPF-00299804

Identifiers

PMID24501009
PMCPMC4164026

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.