Breast (Edinburgh, Scotland) · 2026
Real-world use of neratinib as extended adjuvant therapy in HER2-positive early-stage breast cancer: a multicentre study in mainland China and Hong Kong.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Abudureheiyimu Nilupai, Jia Yueran, Peng Zexi, Shi Yanxia, Liu Qiang, Wang Haibo, Zhou Yidong, Wang Hao, Wang Kun, Hu Hai, Liu Zhao, Chen Wenlin, Ng Ting Ying, Guo Ziyu, Ren Zhuoqiong, Zhen Huanying, Fan Ying, Xu Binghe
Аннотация
BACKGROUND: Neratinib, an oral irreversible pan-HER tyrosine kinase inhibitor, was approved in China in 2020 for extended adjuvant treatment of early-stage HER2-positive breast cancer (BC) after completion of trastuzumab-based adjuvant therapy. With rising neoadjuvant therapy use, treatment landscape for HER2+ early breast cancer (EBC) is evolving.
METHODS: This multicentre, real-world study included patients with HER2+ EBC who received ≥1 dose of neratinib as extended adjuvant treatment and completed treatment before 26 September 2024. The primary objective was to characterise patient demographics and clinical features at neratinib initiation. Secondary objectives included describing BC treatment patterns, neratinib use, and safety.
RESULTS: A total of 508 patients from 11 centres were included. Median age was 48.0 years, and 64.8% had HER2+/HR+ tumours. At diagnosis, 52.8% had stage I-II disease and 46.1% had stage III disease. Most patients had clinical T1 (31.9%) or T2 (54.1%) tumours, and 86.7% were lymph node positive. Neoadjuvant therapy was administered in 141 patients (27.8%), of whom 49.6% did not achieve pathological complete response (pCR). Nearly all patients (99.6%) received adjuvant therapy, most commonly trastuzumab plus pertuzumab (88.7%). The median interval from prior adjuvant therapy completion to neratinib initiation was 52 days. Most patients (88.4%) started at 240 mg dose. Diarrhoea management strategies were used in 54.5% of patients; neratinib-related diarrhoea occurred in 19.3%, with 5.3% Grade 3 events.
CONCLUSIONS: Patient characteristics reflect current Chinese practice. Increasing adoption of diarrhoea prophylaxis in real-world practice reflects growing clinical experience with neratinib and its recognised benefit in preventing diarrhoea.
METHODS: This multicentre, real-world study included patients with HER2+ EBC who received ≥1 dose of neratinib as extended adjuvant treatment and completed treatment before 26 September 2024. The primary objective was to characterise patient demographics and clinical features at neratinib initiation. Secondary objectives included describing BC treatment patterns, neratinib use, and safety.
RESULTS: A total of 508 patients from 11 centres were included. Median age was 48.0 years, and 64.8% had HER2+/HR+ tumours. At diagnosis, 52.8% had stage I-II disease and 46.1% had stage III disease. Most patients had clinical T1 (31.9%) or T2 (54.1%) tumours, and 86.7% were lymph node positive. Neoadjuvant therapy was administered in 141 patients (27.8%), of whom 49.6% did not achieve pathological complete response (pCR). Nearly all patients (99.6%) received adjuvant therapy, most commonly trastuzumab plus pertuzumab (88.7%). The median interval from prior adjuvant therapy completion to neratinib initiation was 52 days. Most patients (88.4%) started at 240 mg dose. Diarrhoea management strategies were used in 54.5% of patients; neratinib-related diarrhoea occurred in 19.3%, with 5.3% Grade 3 events.
CONCLUSIONS: Patient characteristics reflect current Chinese practice. Increasing adoption of diarrhoea prophylaxis in real-world practice reflects growing clinical experience with neratinib and its recognised benefit in preventing diarrhoea.