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Longitudinal evaluation of health-related quality of life in Chinese patients with early-stage HER2-positive breast cancer undergoing neratinib extended adjuvant therapy: a real-world prospective cohort study
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DOI：10.3389/fonc.2026.1828599.png)
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Abstract
En 中文
BackgroundNeratinib; an irreversible pan-HER tyrosine kinase inhibitor; is a well-established extended adjuvant therapy for early-stage human epidermal growth factor receptor 2-positive (HER2+) breast cancer. However; its clinical application is often constrained by the high incidence of treatment-related diarrhea. This study sought to assess the dynamic changes in health-related quality of life (HRQoL) and the tolerability of neratinib; with a particular focus on dose escalation strategies and anti-diarrheal prophylaxis; within a real-world Chinese patient cohort.MethodsThis single-center; prospective observational study included 31 female patients diagnosed with stage I-III HER2-positive breast cancer who initiated neratinib therapy following the completion of trastuzumab-based adjuvant treatment between October 2022 and January 2024. Patients were administered either non–dose-escalation group (240 mg/day) or dose-escalation group (120 mg/160 mg daily during Week 1; 160 mg/200 mg daily during Week 2; and 240 mg daily from Week 3 onward). Diarrhea management was conducted using prophylactic or on-demand loperamide. HRQoL was evaluated longitudinally through the EQ-5D-5L (health utility index and EQ visual analog scale [EQ VAS]) and Functional Assessment of Chronic Illness Therapy-Diarrhea (FACIT-D) questionnaires at predefined time points: baseline (D1); D30; D60; D90; D180; and D360. Diarrhea severity was graded according to Common Terminology Criteria for Adverse Events v5.0 (CTCAE v5.0) criteria. Statistical analyses encompassed descriptive statistics and Wilcoxon signed-rank tests.ResultsThe median age of the patients was 48 years (range: 37–65 years); with 58.1% and 41.9% classified as pathological stage II and III; respectively. A total of 64 diarrhea events were recorded (grade 1; 48.4%; grade 2; 50.0%; grade 3; 1.6%); with no grade 4 events or fatalities. Permanent discontinuation of treatment due to diarrhea occurred in 16.1% of patients; 23.5% in the dose-escalation group vs. 7.1% in the non-dose-escalation group. HRQoL temporarily declined during the early treatment phase; as evidenced by a reduction in the EQ-5D-5L health utility index from 0.96 ± 0.07 at baseline to 0.89 ± 0.15 at D30 (p=0.011) and a decrease in the EQ VAS score from 89.94 ± 9.92 to 84.16 ± 12.64 at D30 (p=0.018). However; HRQoL demonstrated progressive recovery from D90 onward; with scores surpassing baseline levels by D180 (EQ-5D-5L utility index: 0.96 ± 0.07; EQ VAS: 89.92 ± 7.74) and D360 (utility index: 0.97 ± 0.06; EQ VAS: 92.84 ± 7.19). The FACIT-D score showed an initial improvement (baseline: 58.81 ± 7.95 vs. D30: 66.90 ± 11.39; p=0.002); followed by stabilization at baseline levels from D180 onward. Notably; no disease recurrence or distant metastasis was observed in patients who completed the treatment.ConclusionsNeratinib-associated HRQoL impairment is transient; with initial declines primarily due to diarrhea; which typically resolves within 3–6 months of treatment. With the implementation of appropriate supportive measures; such as loperamide prophylaxis and dose modifications; the majority of patients experience sustained HRQoL recovery; and even improvement; over a 12-month period.
Keywords:
quality of life
diarrhea
patient-reported outcomes
HER2-positive breast cancer
neratinib
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