Cited by 148Lung Cancer Treatments and MutationsHER2/EGFR in Cancer ResearchLung Cancer Diagnosis and Treatment

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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

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Reckamp, Karen L., Giaccone, Giuseppe, Camidge, D. Ross, Gadgeel, Shirish M., Khuri, Fadlo R., Engelman, Jeff A., Koczywas, Marianna, Rajan, Arun, Campbell, Alicyn K., Gernhardt, Diana, Ruiz‐Garcia, Ana, Letrent, Stephen, Liang, Jane, Taylor, Ian, O'Connell, Joseph P., Jänne, Pasi A.·2014·Cancer

DOI 10.1002/cncr.28561PMC PMC4164026

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Abstract

BACKGROUND: This 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). METHODS: Patients 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. RESULTS: A 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. CONCLUSIONS: Dacomitinib demonstrated preliminary activity and acceptable tolerability in heavily pretreated patients, and may offer benefit in molecularly defined patient subsets.

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Figure 1 Study flow diagram shows patient disposition and analysis populations.CC BY-NC-ND · PubMed Central

Figure 2 Maximum percentage change is shown in target lesions per RECIST (Response Evaluation Criteria in Solid Tumors) in 56 patients with both a baseline and at least one on‐study measurement reflected in the database. Six patients had no change in the size of their tumor; of these, 1 had EGFR mutation, 1 had EGFR of unknown status, and 4 had EGFR wild‐type tumors.CC BY-NC-ND · PubMed Central

Figure 3 Kaplan‐Meier curves show (A) progression‐free survival and (B) overall survival by arm (all patients). CI indicates confidence interval.CC BY-NC-ND · PubMed Central

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Authors: Reckamp, K. L., Giaccone, G., Camidge, D. R., Gadgeel, S. M., Khuri, F. R., Engelman, J. A., Koczywas, M., Rajan, A., Campbell, A. K., Gernhardt, D., Ruiz‐Garcia, A., Letrent, S., Liang, J., Taylor, I., O'Connell, J. P., & Jänne, P. A.
Affiliations: City Of Hope National Medical Center (US)
National Cancer Institute (US)
University of Colorado Denver (US)
Wayne State University (US)
Winship Cancer Institute (US)
Massachusetts General Hospital (US)
Pfizer (United States) (US)
Pfizer Oncology La Jolla California
Dana‐Farber Cancer Institute Boston Massachusetts
Corresponding author: Reckamp, Karen L.
ORCID: Reckamp, Karen L.
Giaccone, Giuseppe
Camidge, D. Ross
Gadgeel, Shirish M.
Khuri, Fadlo R.
Koczywas, Marianna
Rajan, Arun
Venue: Cancer
Publisher: Wiley
Published: 2014-02-05
Volume: 120
Issue: 8
Pages: 1145-1154
ISSN: 0008-543X (ISSN-L)
1097-0142
DOI: 10.1002/cncr.28561
PMC: PMC4164026
OpenAlex: W2113508099
Cited by: 144
References: 23
Citations by year: 2026: 3 · 2025: 3 · 2024: 5 · 2023: 5 · 2022: 14 · 2021: 11 · 2020: 5 · 2019: 13 · 2018: 15 · 2017: 14 · 2016: 13 · 2015: 30 · 2014: 13
FWCI: 18.99
Type: journal article
Language: en
Open access: hybrid
doi.org
Licence: cc-by-nc-nd
creativecommons.org/licenses/by-nc-nd/3.0/ (vor)
Locations: Cancer (publishedVersion, cc-by-nc-nd)
PubMed Central (publishedVersion, cc-by-nc-nd)
PubMed (publishedVersion)
Funders: Pfizer
Topics: Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Treatments and Mutations
Health Sciences › Medicine › Oncology › HER2/EGFR in Cancer Research
Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Lung Cancer Diagnosis and Treatment
Keywords: dacomitinib, pan-HER inhibitor, non-small cell lung cancer, EGFR tyrosine kinase inhibitors, KRAS wild-type, EGFR mutation, HER2 amplification, objective response rate, progression-free survival, treatment-related adverse events, health-related quality of life, adenocarcinoma, tyrosine kinase inhibitors
MeSH terms: Erlotinib Hydrochloride, Adenocarcinoma, Administration, Oral, Adult, Aged, Aged, 80 and over, Carcinoma, Non-Small-Cell Lung, Female, Humans, Lung Neoplasms, Male, Middle Aged, Mutation, Quinazolines, Treatment Failure, Disease-Free Survival, Quinazolinones, ErbB Receptors

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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

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