| 郝莉,韩兴华,潘跃银.伊尼妥单抗联合方案治疗人表皮生长因子受体 2阳性晚期乳腺癌 113例的疗效及安全性分析[J].安徽医药,2026,30(9):1875-1880. |
| 伊尼妥单抗联合方案治疗人表皮生长因子受体 2阳性晚期乳腺癌 113例的疗效及安全性分析 |
| Efficacy and safety of inetetamab-based combination regimens in the treatment of 113 patients with human epidermal growth factor receptor 2-positive advanced breast cancer |
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| DOI：10.3969/j.issn.1009-6469.2026.09.033 |
| 中文关键词: 乳腺肿瘤 人表皮生长因子受体 2阳性 伊尼妥单抗 疗效 安全性 |
| 英文关键词: Breast neoplasms Human epidermal growth factor receptor 2 positive Inetetamab Efficacy Safety |
| 基金项目:国家自然科学基金面上项目( 82472979)；安徽省卫生健康科研项目( AHWJ2024BAc30076) |
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| 中文摘要: |
| 目的评估伊尼妥单抗联合方案治疗人表皮生长因子受体 2(HER2)阳性晚期乳腺癌的疗效及安全性。方法回顾性研究。选取 2021年 12月至 2025年 5月在中国科学技术大学附属第一医院接受伊尼妥单抗联合方案治疗的 HER2阳性晚期乳腺癌病人 113例。主要研究终点为中位无进展生存期( mPFS)次要终点包括客观缓解率(ORR)、疾病控制率(DCR)和安全性。结果 19例病人因缺乏疗效评价被排除在外，最终 94例病人纳，入疗效分析。总人群的 mPFS为 7.0个月， ORR为 27.7%(26/ 94)DCR为 84.1%(79/94)。伊尼妥单抗联合方案用于晚期一线、二线、 ≥三线治疗时， mPFS分别为 12.2、9.9和 5.1个月( P=0.012。伊尼妥单抗 +抗 HER2酪氨酸激酶抑制剂( TKI)+化疗预后最好， mPFS为 11.1个月，其中伊尼妥单抗 +吡咯替尼 +卡培他滨是最常联合的方案， mPFS为 9.9个月。多因素分析显示，美国东部肿瘤协作组( ECOG)体力状况评分［HR=3.56，95%CI:)，(1.73，7.32)P<0.001］、抗体药物偶联物( ADC)治疗史［HR=3.27，95%CI:(1.61，6.61)P=0.001］是 mPFS的独立预后因素。最常见的 3~4良事件为白细胞减少( 10.6%，10/94)、中性粒细胞减少( 7.4%，7/94)以泻( 4.3%，4/94)。结论伊尼妥单抗级不，及腹，联合方案在 HER2阳性晚期乳腺癌病人中显示出良好的疗效及安全性。 |
| 英文摘要: |
| Objective To evaluate the efficacy and safety of inetetamab-based regimens in patients with human epidermal growth fac. tor receptor 2 (HER2)-positive advanced breast cancer.Methods This retrospective study included 113 patients with HER2-positive advanced breast cancer who received inetetamab-based combination therapy at the First Affiliated Hospital of University of Scienceand Technology of China from December 2021 to May 2025. The primary endpoint was median progression-free survival (mPFS), and the secondary endpoints included objective response rate (ORR), disease control rate (DCR), and safety.Results A total of 19 patientswere excluded due to lack of efficacy evaluation, leaving 94 patients for the efficacy analysis. In the overall population, the mPFS was7.0 months, with an ORR of 27.7% (26/94) and a DCR of 84.1% (79/94). When used as first-line, second-line, and ≥ third-line treat. ment for advanced disease, the respective mPFS values were 12.2, 9.9, and 5.1 months (P=0.012). The combination of inetetamab plus an anti-HER2 tyrosine kinase inhibitor (TKI) and chemotherapy demonstrated the best prognosis, with an mPFS of 11.1 months. Themost frequently used regimen, inetetamab plus pyrotinib and capecitabine, had an mPFS of 9.9 months. Multivariate analysis showedthat Eastern Cooperative Oncology Group (ECOG) performance status score [HR=3.56, 95% CI:(1.73, 7.32), P<0.001] and a history of anti. body-drug conjugate (ADC) treatment [HR=3.27, 95% CI:(1.61, 6.61), P=0.001] were independent prognostic factors for mPFS. The most common grade 3-4 adverse events were leukopenia (10.6%, 10/94), neutropenia (7.4%, 7/94), and diarrhea (4.3%, 4/94).Conclusion In. etetamab-based combination regimens demonstrated good efficacy and safety in patients with HER2-positive advanced breast cancer. |
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