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Abstract：
BACKGROUND: Inetetamab is the first domestically developed innovative anti-HER2 monoclonal antibody in China, proven effective and safe in HER2-positive advanced breast cancer. However, its efficacy and safety in neoadjuvant treatment of HER2-positive locally advanced breast cancer (LABC) remain to be validated.
METHODS: This prospective cohort study aimed to evaluate the efficacy and safety of inetetamab combined with pertuzumab, taxanes, and carboplatin (TCbIP) in neoadjuvant therapy for HER2-positive LABC, comparing it to data from patients treated with the TCbHP regimen (trastuzumab combined with pertuzumab, taxanes, and carboplatin) using propensity score matching (PSM). The primary endpoint was total pathological complete response (tpCR). Adverse events (AEs), objective response rate (ORR), and near-pCR were key secondary endpoints.
RESULTS: Forty-four patients with clinical stage IIA-IIIC HER2-positive LABC were prospectively enrolled and treated with the TCbIP regimen. The tpCR rate among 28 patients who completed surgery was 60.7%, comparable to and slightly higher than the TCbHP group in PSM (60.7% vs. 53.6%, P = 0.510). The ORR was 96.4%, and the DCR reached 100.0%. The most common ≥ grade 3 AE was neutropenia (21.4% vs. 11.9%, P = 0.350). No significant reduction in left ventricular ejection fraction was observed, and no patient withdrew from treatment due to AEs.
CONCLUSIONS: Neoadjuvant therapy with TCbIP showed good efficacy and safety in patients with HER2-positive LABC and might be another promising option for neoadjuvant treatment.
BACKGROUND: NCT05749016 (registration date: Nov 01, 2021).
METHODS: This prospective cohort study aimed to evaluate the efficacy and safety of inetetamab combined with pertuzumab, taxanes, and carboplatin (TCbIP) in neoadjuvant therapy for HER2-positive LABC, comparing it to data from patients treated with the TCbHP regimen (trastuzumab combined with pertuzumab, taxanes, and carboplatin) using propensity score matching (PSM). The primary endpoint was total pathological complete response (tpCR). Adverse events (AEs), objective response rate (ORR), and near-pCR were key secondary endpoints.
RESULTS: Forty-four patients with clinical stage IIA-IIIC HER2-positive LABC were prospectively enrolled and treated with the TCbIP regimen. The tpCR rate among 28 patients who completed surgery was 60.7%, comparable to and slightly higher than the TCbHP group in PSM (60.7% vs. 53.6%, P = 0.510). The ORR was 96.4%, and the DCR reached 100.0%. The most common ≥ grade 3 AE was neutropenia (21.4% vs. 11.9%, P = 0.350). No significant reduction in left ventricular ejection fraction was observed, and no patient withdrew from treatment due to AEs.
CONCLUSIONS: Neoadjuvant therapy with TCbIP showed good efficacy and safety in patients with HER2-positive LABC and might be another promising option for neoadjuvant treatment.
BACKGROUND: NCT05749016 (registration date: Nov 01, 2021).
摘要：
背景：Inetetamab是国内首个研发的创新抗HER2单克隆抗体，在HER2阳性晚期乳腺癌中被证明是有效和安全的。然而,其在HER2阳性局部晚期乳腺癌(LABC)新辅助治疗中的有效性和安全性仍有待验证.
方法：这项前瞻性队列研究旨在评估伊奈他单抗联合帕妥珠单抗的疗效和安全性。紫杉烷,和卡铂（TCbIP）在HER2阳性LABC的新辅助治疗中，将其与接受TCbHP方案治疗的患者的数据进行比较（曲妥珠单抗联合帕妥珠单抗，紫杉烷,和卡铂)使用倾向评分匹配(PSM)。主要终点是总病理完全缓解（tpCR）。不良事件（AE），客观反应率（ORR），接近pCR是关键的次要终点。
结果：44例临床阶段IIA-IIICHER2阳性LABC患者被前瞻性纳入并接受TCbIP方案治疗。28例完成手术的患者的tpCR率为60.7%,与PSM中的TCbHP组相当并稍高(60.7%与53.6%,P=0.510）。ORR为96.4%,DCR达到100.0%。最常见的≥3级AE是中性粒细胞减少症（21.4%与11.9%,P=0.350）。未观察到左心室射血分数显著降低，无患者因不良事件退出治疗。
结论：TCbIP新辅助治疗在HER2阳性LABC患者中显示出良好的疗效和安全性，可能是新辅助治疗的另一种有希望的选择。
背景：NCT05749016（注册日期：2021年11月1日）。
方法：这项前瞻性队列研究旨在评估伊奈他单抗联合帕妥珠单抗的疗效和安全性。紫杉烷,和卡铂（TCbIP）在HER2阳性LABC的新辅助治疗中，将其与接受TCbHP方案治疗的患者的数据进行比较（曲妥珠单抗联合帕妥珠单抗，紫杉烷,和卡铂)使用倾向评分匹配(PSM)。主要终点是总病理完全缓解（tpCR）。不良事件（AE），客观反应率（ORR），接近pCR是关键的次要终点。
结果：44例临床阶段IIA-IIICHER2阳性LABC患者被前瞻性纳入并接受TCbIP方案治疗。28例完成手术的患者的tpCR率为60.7%,与PSM中的TCbHP组相当并稍高(60.7%与53.6%,P=0.510）。ORR为96.4%,DCR达到100.0%。最常见的≥3级AE是中性粒细胞减少症（21.4%与11.9%,P=0.350）。未观察到左心室射血分数显著降低，无患者因不良事件退出治疗。
结论：TCbIP新辅助治疗在HER2阳性LABC患者中显示出良好的疗效和安全性，可能是新辅助治疗的另一种有希望的选择。
背景：NCT05749016（注册日期：2021年11月1日）。
