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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
Open accessAbstract
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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Metadata
- 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
- Venue
- Cancer
- Publisher
- Wiley
- Published
- 2014-02-05
- Volume
- 120
- Issue
- 8
- Pages
- 1145-1154
- ISSN
- 0008-543X (ISSN-L)
- 1097-0142
- 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
- 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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