Efficacy of Pyrotinib With/Without Trastuzumab in Treatment-Refractory, HER2-Positive Metastatic Colorectal Cancer: Result From a Prospective Observational Study

IF 4.3 3区材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC

ACS Applied Electronic Materials Pub Date : 2024-03-01 DOI:10.1016/j.clcc.2023.10.008

Haojie Zhou , Minzhi Lv , Wei Li , Yan Wang , Jing Wu , Qing Liu , Tianshu Liu , Yuehong Cui , Qian Li

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Abstract

Background

Human epidermal growth factor receptor 2 (HER2) is a promising therapeutic target in metastatic colorectal cancer (mCRC). This study was to evaluate the efficacy and safety of pyrotinib alone or pyrotinib with trastuzumab in patients with HER2-positive mCRC.

Patients and Methods

In this prospective observational study, patients with HER2 positive, Ras Sarcoma Viral Oncogene Homolog (RAS) wild type mCRC who received at least one standard treatment of palliative chemotherapy were enrolled. Patients were treated with oral pyrotinib alone or pyrotinib with trastuzumab. The primary endpoint was progression free survival (PFS), and the secondary endpoints were overall survival (OS), confirmed objective response rate (ORR), and safety. This trial is registered with chitcr.org, number ChiCTR2100046381.

Results

From February 15, 2021, to January 10, 2023, 32 patients were enrolled in this study. Twenty (62.5%) patients were treated with pyrotinib, while 12 (37.5%) received pyrotinib and trastuzumab. As of June 24, 2023, with a median follow-up of 11.0 months, the median PFS was 5.7 months (95%CI 4.5-10.2), while OS was not evaluable (NE), ORR and disease control rate (DCR were 34.4% and 87.5%. Patients’ PFS in the pyrotinib plus trastuzumab subgroup and pyrotinib monotherapy group were 8.6 and 5.5 months, OS was not evaluable (NE) and 10.9 months, ORR was 50.0% and 25.0%, respectively. Most treatment-related adverse events (TRAEs) were grade 1-2, diarrhea was the most frequent TRAE (81.3%, 26/32). Grade 3 TRAEs occurred in 11 patients: 9 for diarrhea, 1 for nausea, and 1 for oral mucositis.

Conclusion

Pyrotinib with or without trastuzumab showed promising anti-tumor activity and acceptable toxicities in treatment-refractory, HER2-positive mCRC.

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pyrotinib联合/不联合曲妥珠单抗治疗难治性her2阳性转移性结直肠癌的疗效:一项前瞻性观察研究的结果

背景:her2是转移性结直肠癌(mCRC)的一个有前景的治疗靶点。本研究旨在评估单独使用吡罗替尼或吡罗替尼联合曲妥珠单抗治疗HER2阳性mCRC患者的疗效和安全性。患者和方法在这项前瞻性观察性研究中，纳入了接受至少一种姑息性化疗标准治疗的HER2阳性RAS野生型mCRC患者。患者单独口服吡罗替尼或吡罗替尼联合曲妥珠单抗治疗。主要终点是无进展生存期(PFS)，次要终点是总生存期(OS)、确认的客观缓解率(ORR)和安全性。本试验已在chitcr.org注册，注册号为ChiCTR2100046381。结果从2021年2月15日至2023年1月10日，32例患者入组。20例(62.5%)患者接受了吡罗替尼治疗，而12例(37.5%)患者接受了吡罗替尼和曲妥珠单抗治疗。截至2023年6月24日，中位随访11.0个月，中位PFS为5.7个月(95%CI 4.5-10.2)，而OS不可评估(NE)， ORR和DCR分别为34.4%和87.5%。pyrotinib +曲妥珠单抗亚组和pyrotinib单药治疗组患者的PFS分别为8.6和5.5个月，OS不可评估(NE)和10.9个月，ORR分别为50.0%和25.0%。大多数治疗相关不良事件(TRAEs)为1-2级，腹泻是最常见的TRAE(81.3%， 26/32)。11例患者发生3级trae:腹泻9例，恶心1例，口腔黏膜炎1例。结论吡罗替尼联合曲妥珠单抗或不联合曲妥珠单抗治疗难治性her2阳性mCRC具有良好的抗肿瘤活性和可接受的毒性。微摘要:ther2是一种很有前景的mCRC治疗靶点。在这项研究中，HER2阳性难治性mCRC患者联合/不联合曲妥珠单抗接受吡罗替尼治疗。中位PFS和OS为5.7个月，无法评估。ORR和DCR分别为34.4%和87.5%。Pyrotinib +曲妥珠单抗在数值上显示更好的结果。上述治疗在治疗难治性her2阳性mCRC中显示出良好的疗效和可接受的毒性。

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来源期刊

ACS Applied Electronic Materials Multiple-

CiteScore

7.20

自引率

4.30%

发文量

567