The DOI matches its Crossref record; 23 of the 23 references it cites were found in a registry or an index.
Neratinib, an Irreversible ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Advanced ErbB2-Positive Breast Cancer
Open accessAbstract
Purpose: Neratinib is an oral, irreversible pan-ErbB receptor tyrosine kinase inhibitor. The efficacy and safety of neratinib were evaluated in two cohorts of patients with advanced ErbB2-positive breast cancer—those with and those without prior trastuzumab treatment—in an open-label, multicenter, phase II trial. Patients and Methods: Patients in the two cohorts (prior trastuzumab, n = 66; no prior trastuzumab, n = 70) received oral neratinib 240 mg once daily. The primary end point was the 16-week progression-free survival (PFS) rate for the evaluable population (prior trastuzumab, n = 63; no prior trastuzumab, n = 64), as assessed by independent review. Results: The 16-week PFS rates were 59% for patients with prior trastuzumab treatment and 78% for patients with no prior trastuzumab treatment. Median PFS was 22.3 and 39.6 weeks, respectively. Objective response rates were 24% among patients with prior trastuzumab treatment and 56% in the trastuzumab-naïve cohort. The most common adverse events were diarrhea, nausea, vomiting, and fatigue. Diarrhea was the most frequent grades 3 to 4 adverse event, occurring in 30% of patients with prior trastuzumab treatment and in 13% of patients with no prior trastuzumab treatment, which prompted dose reductions in 29% and 4% of patients, respectively, but treatment discontinuation in only one patient. No neratinib-related, grades 3 or 4 cardiotoxicity was reported. Conclusion: Oral neratinib showed substantial clinical activity and was reasonably well tolerated among both heavily pretreated and trastuzumab-naïve patients who had advanced, ErbB2-positive breast cancer. Diarrhea was the most common adverse effect but was manageable with antidiarrheal agents and dose modification.
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“Afatinib (Minkovsky and Berezov, 2008) andneratinib (Burstein et al., 2010) are irreversible, covalent HER2/EGFR TKIs with activity against HER2, HER4, EGFR, and some HER2 insertion mutants (Bose et al., 2013).”
Background
Metadata
- Authors
- Burstein, H. J., Sun, Y., Dirix, L. Y., Jiang, Z., Paridaens, R., Tan, A. R., Awada, A., Ranade, A., Jiao, S., Schwartz, G., Abbas, R., Powell, C., Turnbull, K., Vermette, J., Zacharchuk, C., & Badwe, R.
- Venue
- Journal of Clinical Oncology
- Published
- 2010-03-10
- Volume
- 28
- Issue
- 8
- Pages
- 1301-1307
- ISSN
- 0732-183X (ISSN-L)
- 1527-7755
- OpenAlex
- W2154246971
- Cited by
- 522
- References
- 23
- FWCI
- 27.35
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Burstein, H. J., Sun, Y., Dirix, L. Y., Jiang, Z., Paridaens, R., Tan, A. R., Awada, A., Ranade, A., Jiao, S., Schwartz, G., Abbas, R., Powell, C., Turnbull, K., Vermette, J., Zacharchuk, C., & Badwe, R. (2010). Neratinib, an Irreversible ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Advanced ErbB2-Positive Breast Cancer. Journal of Clinical Oncology. https://doi.org/10.1200/jco.2009.25.8707
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