新辅助吡罗替尼联合曲妥珠单抗、多西他赛和卡铂治疗中国早期或局部晚期人类表皮受体2阳性乳腺癌:一项多中心、随机、双盲、安慰剂对照的2期试验

IF 2 4区 医学 Q3 ONCOLOGY
Yuqin Ding, Wenju Mo, Xiaohong Xie, Ouchen Wang, Xiangming He, Shuai Zhao, Xidong Gu, Chenlu Liang, Chengdong Qin, Kaijing Ding, Hongjian Yang, Xiaowen Ding
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引用次数: 2

摘要

这项多中心、随机、双盲、安慰剂对照的2期试验比较了吡罗替尼联合曲妥珠单抗、多西他赛和卡铂与安慰剂、曲妥珠单抗、多西他赛和卡铂在中国人类表皮受体2 (HER2)阳性早期或局部晚期乳腺癌患者中的疗效和安全性(ClinicalTrials.gov identifier: NCT03756064)。方法:69例her2阳性早期(T1-3、N0-1、M0)或局部晚期乳腺癌(T2-3、N2或N3、M0;T4,任意N, M0)于2019年10月1日至2021年6月1日招募。术前,患者接受6个周期的口服吡罗替尼(400mg / 1次/天)、曲妥珠单抗(8mg /kg负荷剂量和6mg /kg维持剂量)、多西他赛(75mg /m2)、卡铂(AUC = 6mg /mL·min)或每3周口服安慰剂、曲妥珠单抗、多西他赛和卡铂。主要终点是独立审查委员会评估的总病理完全缓解率。采用双侧Cochran-Mantel-Haenszel检验,按年龄、激素受体状态、肿瘤分期、淋巴结分期、cTNM分期和Ki-67水平分层,比较治疗组间的发生率。结果:共有69例女性患者被随机分配(pyrotinib, 36例;安慰剂,33人;中位年龄:53岁[31-69]岁)。在意向治疗人群中,pyrotinib组的总病理完全缓解率为65.5%(19/29),安慰剂组为33.3%(10/30)(差异为32.2%,p = 0.013)。pyrotinib组86.1%的患者(31/36)报告腹泻是最常见的不良事件(ae),安慰剂组为15.2%(5/33)。但未见4级或5级ae的报道。结论:与安慰剂、曲妥珠单抗、多西紫杉醇和卡铂相比,吡罗替尼、曲妥珠单抗、多西紫杉醇和卡铂联合治疗中国早期或局部晚期her2阳性乳腺癌患者的新辅助治疗总病理完全缓解率有统计学意义的改善。安全性数据与已知的pyrotinib安全性一致,并且在治疗组之间具有可比性。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Neoadjuvant Pyrotinib plus Trastuzumab, Docetaxel, and Carboplatin in Early or Locally Advanced Human Epidermal Receptor 2-Positive Breast Cancer in China: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial.

Introduction: This multicenter, randomized, double-blind, placebo-controlled phase 2 trial compared the efficacy, and safety of adding pyrotinib to trastuzumab, docetaxel, and carboplatin versus placebo, trastuzumab, docetaxel, and carboplatin in Chinese patients with human epidermal receptor 2 (HER2)-positive early or locally advanced breast cancer (ClinicalTrials.gov identifier: NCT03756064).

Methods: Sixty-nine women with HER2-positive early (T1-3, N0-1, M0) or locally advanced breast cancer (T2-3, N2 or N3, M0; T4, any N, M0) were recruited from October 1, 2019, to June 1, 2021. Before surgery, patients received 6 cycles of orally pyrotinib (400 mg once per day), trastuzumab (8-mg/kg loading dose and 6-mg/kg maintenance doses), docetaxel (75 mg/m2), and carboplatin (AUC = 6 mg/mL·min) or orally placebo, trastuzumab, and docetaxel, and carboplatin every 3 weeks. The primary end point was independent review committee-assessed total pathologic complete response rate. The 2-sided Cochran-Mantel-Haenszel test, stratified by age, hormone receptor status, tumor stage, nodal status, cTNM stage, and Ki-67 level was used to compare rates between treatment groups.

Results: In total, 69 female patients were randomized (pyrotinib, 36; and placebo, 33; median age, 53 [31-69] years). In the intention-to-treat population, total pathologic complete response rates were 65.5% (19/29) in the pyrotinib group and 33.3% (10/30) in the placebo group (difference, 32.2%, p = 0.013). Diarrhea was been reported in 86.1% of patients (31/36) in the pyrotinib group as the most common adverse events (AEs) and 15.2% of patients (5/33) in the placebo group. But no grade 4 or 5 AEs were reported.

Conclusion: Treatment with pyrotinib, trastuzumab, docetaxel, and carboplatin resulted in a statistically significant improvement in the total pathologic complete response rate versus placebo, trastuzumab, docetaxel, and carboplatin for the neoadjuvant treatment of HER2-positive early or locally advanced breast cancer in Chinese patients. Safety data were in line with the known pyrotinib safety profile and generally comparable between treatment groups.

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来源期刊
CiteScore
3.20
自引率
0.00%
发文量
84
期刊介绍: With the first issue in 2014, the journal ''Onkologie'' has changed its title to ''Oncology Research and Treatment''. By this change, publisher and editor set the scene for the further development of this interdisciplinary journal. The English title makes it clear that the articles are published in English – a logical step for the journal, which is listed in all relevant international databases. For excellent manuscripts, a ''Fast Track'' was introduced: The review is carried out within 2 weeks; after acceptance the papers are published online within 14 days and immediately released as ''Editor’s Choice'' to provide the authors with maximum visibility of their results. Interesting case reports are published in the section ''Novel Insights from Clinical Practice'' which clearly highlights the scientific advances which the report presents.
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