The DOI matches its Crossref record; 21 of the 21 references it cites were found in a registry or an index.
Randomized Phase II Study of Dacomitinib (PF-00299804), an Irreversible Pan–Human Epidermal Growth Factor Receptor Inhibitor, Versus Erlotinib in Patients With Advanced Non–Small-Cell Lung Cancer
Open accessAbstract
Purpose: This randomized, open-label trial compared dacomitinib (PF-00299804), an irreversible inhibitor of human epidermal growth factor receptors (EGFR)/HER1, HER2, and HER4, with erlotinib, a reversible EGFR inhibitor, in patients with advanced non–small-cell lung cancer (NSCLC). Patients and Methods: Patients with NSCLC, Eastern Cooperative Oncology Group performance status 0 to 2, no prior HER-directed therapy, and one/two prior chemotherapy regimens received dacomitinib 45 mg or erlotinib 150 mg once daily. Results: One hundred eighty-eight patients were randomly assigned. Treatment arms were balanced for most clinical and molecular characteristics. Median progression-free survival (PFS; primary end point) was 2.86 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (hazard ratio [HR] = 0.66; 95% CI, 0.47 to 0.91; two-sided P = .012); in patients with KRAS wild-type tumors, median PFS was 3.71 months for patients treated with dacomitinib and 1.91 months for patients treated with erlotinib (HR = 0.55; 95% CI, 0.35 to 0.85; two-sided P = .006); and in patients with KRAS wild-type/EGFR wild-type tumors, median PFS was 2.21 months for patients treated with dacomitinib and 1.84 months for patients treated with erlotinib (HR = 0.61; 95% CI, 0.37 to 0.99; two-sided P = .043). Median overall survival was 9.53 months for patients treated with dacomitinib and 7.44 months for patients treated with erlotinib (HR = 0.80; 95% CI, 0.56 to 1.13; two-sided P = .205). Adverse event-related discontinuations were uncommon in both arms. Common treatment-related adverse events were dermatologic and gastrointestinal, predominantly grade 1 to 2, and more frequent with dacomitinib. Conclusion: Dacomitinib demonstrated significantly improved PFS versus erlotinib, with acceptable toxicity. PFS benefit was observed in most clinical and molecular subsets, notably KRAS wild-type/EGFR any status, KRAS wild-type/EGFR wild-type, and EGFR mutants.
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Metadata
- Authors
- Ramalingam, S. S., Blackhall, F., Krzakowski, M., Barrios, C. H., Park, K., Bover, I., Seog Heo, D., Rosell, R., Talbot, D. C., Frank, R., Letrent, S. P., Ruiz-Garcia, A., Taylor, I., Liang, J. Q., Campbell, A. K., O'Connell, J., & Boyer, M.
- Venue
- Journal of Clinical Oncology
- Published
- 2012-09-20
- Volume
- 30
- Issue
- 27
- Pages
- 3337-3344
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2102743085
- Cited by
- 264
- References
- 21
- FWCI
- 35.34
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Ramalingam, S. S., Blackhall, F., Krzakowski, M., Barrios, C. H., Park, K., Bover, I., Seog Heo, D., Rosell, R., Talbot, D. C., Frank, R., Letrent, S. P., Ruiz-Garcia, A., Taylor, I., Liang, J. Q., Campbell, A. K., O'Connell, J., & Boyer, M. (2012). Randomized Phase II Study of Dacomitinib (PF-00299804), an Irreversible Pan–Human Epidermal Growth Factor Receptor Inhibitor, Versus Erlotinib in Patients With Advanced Non–Small-Cell Lung Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2011.40.9433
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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