Neratinib after trastuzumab-based adjuvant therapy in patients from Asia with early stage HER2-positive breast cancer
Journal
Future Oncology
Journal Volume
15
Journal Issue
21
Pages
2489-2501
Date Issued
2019
Author(s)
Iwata H
Masuda N
Kim S.-B
Inoue K
Rai Y
Fujita T
Chiu J
Ohtani S
Takahashi M
Miyaki T
Xu B
Yap Y.S
Bustam A
Yao B
Zhang B
Bryce R
Chan A.
Abstract
Aim: To evaluate the efficacy and safety of neratinib as extended adjuvant therapy in patients from Asia based on exploratory analyses of the Phase III ExteNET trial. Patients & methods: A total of 2840 women with early stage HER2-positive breast cancer were randomly assigned to neratinib 240 mg/day or placebo for 1 year after trastuzumab-based adjuvant therapy. Results: A total of 341 patients were from Asia (neratinib, n = 165; placebo, n = 176). 2-year invasive disease-free survival rates were 92.8 and 90.8% with neratinib and placebo, respectively (HR: 0.70; 95% CI: 0.31-1.55), and 5-year rates were 91.9 and 87.2%, respectively (HR: 0.57; 95% CI: 0.27-1.13). Diarrhea was the most common adverse event with neratinib. Conclusion: Extended adjuvant therapy with neratinib reduces disease recurrences in Asian women with HER2-positive breast cancer. Trial registration: Clinicaltrials.gov NCT00878709. ? 2019 Future Medicine Ltd.
Subjects
Asia; early stage breast cancer; efficacy; extended adjuvant therapy; HER2; neratinib; safety; tyrosine kinase inhibitor
SDGs
Other Subjects
anthracycline; antiestrogen; aromatase inhibitor; neratinib; placebo; taxane derivative; trastuzumab; antineoplastic agent; epidermal growth factor receptor 2; neratinib; protein kinase inhibitor; quinoline derivative; trastuzumab; abdominal pain; adult; aged; Article; Asian; body weight loss; cancer adjuvant therapy; cancer hormone therapy; cancer patient; cancer radiotherapy; cancer recurrence; cancer survival; controlled study; decreased appetite; diarrhea; disease free survival; disease severity; dizziness; double blind procedure; drug dose reduction; drug efficacy; drug safety; early cancer; exploratory research; fatigue; female; fever; flu like syndrome; hand foot syndrome; headache; human; human epidermal growth factor receptor 2 positive breast cancer; lumpectomy; major clinical study; mastectomy; middle aged; multicenter study; nausea; paronychia; patient compliance; phase 3 clinical trial; priority journal; randomized controlled trial; rash; rhinopharyngitis; stomatitis; treatment duration; tumor invasion; upper abdominal pain; very elderly; vomiting; adjuvant chemotherapy; breast tumor; cancer staging; clinical trial; Kaplan Meier method; metabolism; pathology; prognosis; proportional hazards model; retreatment; treatment outcome; Aged; Aged, 80 and over; Antineoplastic Agents; Antineoplastic Combined Chemotherapy Protocols; Breast Neoplasms; Chemotherapy, Adjuvant; Female; Humans; Kaplan-Meier Estimate; Middle Aged; Neoplasm Staging; Prognosis; Proportional Hazards Models; Protein Kinase Inhibitors; Quinolines; Receptor, ErbB-2; Retreatment; Trastuzumab; Treatment Outcome
Publisher
Future Medicine Ltd.
Type
journal article