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.
Keywords:
Asia; HER2; early stage breast cancer; efficacy; extended adjuvant therapy; neratinib; safety; tyrosine kinase inhibitor.
Publication types
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Clinical Trial, Phase III
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Aged
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Aged, 80 and over
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Antineoplastic Agents / administration & dosage
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Antineoplastic Agents / adverse effects
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Antineoplastic Agents / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / adverse effects
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Antineoplastic Combined Chemotherapy Protocols / therapeutic use
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Breast Neoplasms / drug therapy*
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Breast Neoplasms / metabolism*
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Breast Neoplasms / pathology
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Chemotherapy, Adjuvant
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Female
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Humans
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Kaplan-Meier Estimate
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Middle Aged
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Neoplasm Staging
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Prognosis
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Proportional Hazards Models
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Protein Kinase Inhibitors / administration & dosage
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Protein Kinase Inhibitors / adverse effects
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Protein Kinase Inhibitors / therapeutic use*
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Quinolines / administration & dosage
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Quinolines / adverse effects
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Quinolines / therapeutic use*
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Receptor, ErbB-2 / metabolism*
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Retreatment
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Trastuzumab / administration & dosage
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Treatment Outcome
Substances
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Antineoplastic Agents
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Protein Kinase Inhibitors
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Quinolines
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Receptor, ErbB-2
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neratinib
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Trastuzumab
Associated data
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ClinicalTrials.gov/NCT00878709