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Article: Final Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial

TitleFinal Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial
Authors
KeywordsAdjuvant therapy
Disease-free survival
Distant disease-free survival
Neoadjuvant therapy
Overall survival
Issue Date2021
Citation
Clinical Breast Cancer, 2021, v. 21, n. 1, p. 80-91.e7 How to Cite?
AbstractBackground: The ExteNET trial demonstrated improved invasive disease-free survival (iDFS) with neratinib, an irreversible pan-HER tyrosine kinase inhibitor, versus placebo in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) early-stage breast cancer (eBC). Patients and Methods: ExteNET was a multicenter, randomized, double-blind, phase III trial of 2840 patients with HER2+ eBC after neoadjuvant/adjuvant trastuzumab-based therapy. Patients were stratified by HR status and randomly assigned 1-year oral neratinib 240 mg/day or placebo. The primary endpoint was iDFS. Descriptive analyses were performed in patients with HR+ eBC who initiated treatment ≤ 1 year (HR+/≤ 1-year) and > 1 year (HR+/> 1-year) post-trastuzumab. Results: HR+/≤ 1-year and HR+/> 1-year populations comprised 1334 (neratinib, n = 670; placebo, n = 664) and 297 (neratinib, n = 146; placebo, n = 151) patients, respectively. Absolute iDFS benefits at 5 years were 5.1% in HR+/≤ 1-year (hazard ratio, 0.58; 95% confidence interval [CI], 0.41-0.82) and 1.3% in HR+/>1-year (hazard ratio, 0.74; 95% CI, 0.29-1.84). In HR+/≤ 1-year, neratinib was associated with a numerical improvement in overall survival (OS) at 8 years (absolute benefit, 2.1%; hazard ratio, 0.79; 95% CI, 0.55-1.13). Of 354 patients in the HR+/≤ 1-year group who received neoadjuvant therapy, 295 had residual disease, and results showed absolute benefits of 7.4% at 5-year iDFS (hazard ratio, 0.60; 95% CI, 0.33-1.07) and 9.1% at 8-year OS (hazard ratio, 0.47; 95% CI, 0.23-0.92). There were fewer central nervous system events with neratinib. Adverse events were similar to those previously reported. Conclusion: Neratinib significantly improved iDFS in the HER2+/HR+/≤ 1-year population, and a similar trend was observed in patients with residual disease following neoadjuvant treatment. Numerical improvements in central nervous system events and OS were consistent with iDFS benefits and suggest long-term benefit for neratinib in this population. In the patient population with early-stage human epidermal growth factor receptor 2-positive/hormone receptor-positive breast cancer who initiate neratinib within 1 year of trastuzumab-based therapy, the absolute 5-year invasive disease-free survival benefit versus placebo is 5.1%, and absolute 8-year overall survival benefit is 2.1%. Among those with residual disease after neoadjuvant therapy (non-pathologic complete response), absolute gains with neratinib are 7.4% and 9.1%, respectively.
Persistent Identifierhttp://hdl.handle.net/10722/326500
ISSN
2023 Impact Factor: 2.9
2023 SCImago Journal Rankings: 0.942
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorChan, Arlene-
dc.contributor.authorMoy, Beverly-
dc.contributor.authorMansi, Janine-
dc.contributor.authorEjlertsen, Bent-
dc.contributor.authorHolmes, Frankie Ann-
dc.contributor.authorChia, Stephen-
dc.contributor.authorIwata, Hiroji-
dc.contributor.authorGnant, Michael-
dc.contributor.authorLoibl, Sibylle-
dc.contributor.authorBarrios, Carlos H.-
dc.contributor.authorSomali, Isil-
dc.contributor.authorSmichkoska, Snezhana-
dc.contributor.authorMartinez, Noelia-
dc.contributor.authorAlonso, Mirta Garcia-
dc.contributor.authorLink, John S.-
dc.contributor.authorMayer, Ingrid A.-
dc.contributor.authorCold, Søren-
dc.contributor.authorMurillo, Serafin Morales-
dc.contributor.authorSenecal, Francis-
dc.contributor.authorInoue, Kenichi-
dc.contributor.authorRuiz-Borrego, Manuel-
dc.contributor.authorHui, Rina-
dc.contributor.authorDenduluri, Neelima-
dc.contributor.authorPatt, Debra-
dc.contributor.authorRugo, Hope S.-
dc.contributor.authorJohnston, Stephen R.D.-
dc.contributor.authorBryce, Richard-
dc.contributor.authorZhang, Bo-
dc.contributor.authorXu, Feng-
dc.contributor.authorWong, Alvin-
dc.contributor.authorMartin, Miguel-
dc.date.accessioned2023-03-10T02:19:43Z-
dc.date.available2023-03-10T02:19:43Z-
dc.date.issued2021-
dc.identifier.citationClinical Breast Cancer, 2021, v. 21, n. 1, p. 80-91.e7-
dc.identifier.issn1526-8209-
dc.identifier.urihttp://hdl.handle.net/10722/326500-
dc.description.abstractBackground: The ExteNET trial demonstrated improved invasive disease-free survival (iDFS) with neratinib, an irreversible pan-HER tyrosine kinase inhibitor, versus placebo in patients with human epidermal growth factor receptor 2-positive (HER2+)/hormone receptor-positive (HR+) early-stage breast cancer (eBC). Patients and Methods: ExteNET was a multicenter, randomized, double-blind, phase III trial of 2840 patients with HER2+ eBC after neoadjuvant/adjuvant trastuzumab-based therapy. Patients were stratified by HR status and randomly assigned 1-year oral neratinib 240 mg/day or placebo. The primary endpoint was iDFS. Descriptive analyses were performed in patients with HR+ eBC who initiated treatment ≤ 1 year (HR+/≤ 1-year) and > 1 year (HR+/> 1-year) post-trastuzumab. Results: HR+/≤ 1-year and HR+/> 1-year populations comprised 1334 (neratinib, n = 670; placebo, n = 664) and 297 (neratinib, n = 146; placebo, n = 151) patients, respectively. Absolute iDFS benefits at 5 years were 5.1% in HR+/≤ 1-year (hazard ratio, 0.58; 95% confidence interval [CI], 0.41-0.82) and 1.3% in HR+/>1-year (hazard ratio, 0.74; 95% CI, 0.29-1.84). In HR+/≤ 1-year, neratinib was associated with a numerical improvement in overall survival (OS) at 8 years (absolute benefit, 2.1%; hazard ratio, 0.79; 95% CI, 0.55-1.13). Of 354 patients in the HR+/≤ 1-year group who received neoadjuvant therapy, 295 had residual disease, and results showed absolute benefits of 7.4% at 5-year iDFS (hazard ratio, 0.60; 95% CI, 0.33-1.07) and 9.1% at 8-year OS (hazard ratio, 0.47; 95% CI, 0.23-0.92). There were fewer central nervous system events with neratinib. Adverse events were similar to those previously reported. Conclusion: Neratinib significantly improved iDFS in the HER2+/HR+/≤ 1-year population, and a similar trend was observed in patients with residual disease following neoadjuvant treatment. Numerical improvements in central nervous system events and OS were consistent with iDFS benefits and suggest long-term benefit for neratinib in this population. In the patient population with early-stage human epidermal growth factor receptor 2-positive/hormone receptor-positive breast cancer who initiate neratinib within 1 year of trastuzumab-based therapy, the absolute 5-year invasive disease-free survival benefit versus placebo is 5.1%, and absolute 8-year overall survival benefit is 2.1%. Among those with residual disease after neoadjuvant therapy (non-pathologic complete response), absolute gains with neratinib are 7.4% and 9.1%, respectively.-
dc.languageeng-
dc.relation.ispartofClinical Breast Cancer-
dc.subjectAdjuvant therapy-
dc.subjectDisease-free survival-
dc.subjectDistant disease-free survival-
dc.subjectNeoadjuvant therapy-
dc.subjectOverall survival-
dc.titleFinal Efficacy Results of Neratinib in HER2-positive Hormone Receptor-positive Early-stage Breast Cancer From the Phase III ExteNET Trial-
dc.typeArticle-
dc.description.naturelink_to_subscribed_fulltext-
dc.identifier.doi10.1016/j.clbc.2020.09.014-
dc.identifier.pmid33183970-
dc.identifier.scopuseid_2-s2.0-85095826918-
dc.identifier.volume21-
dc.identifier.issue1-
dc.identifier.spage80-
dc.identifier.epage91.e7-
dc.identifier.eissn1938-0666-
dc.identifier.isiWOS:000641314800025-

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