免疫疗法时代:曲妥珠单抗耐药的 HER2 阳性晚期或转移性胃癌患者在病情进展后使用曲妥珠单抗的价值。

IF 4.3 3区 材料科学 Q1 ENGINEERING, ELECTRICAL & ELECTRONIC
ACS Applied Electronic Materials Pub Date : 2024-04-11 eCollection Date: 2024-01-01 DOI:10.1177/17562848241245455
Hui Wang, Caiyun Nie, Weifeng Xu, Jing Li, He Gou, Huifang Lv, Beibei Chen, Jianzheng Wang, Yingjun Liu, Yunduan He, Jing Zhao, Xiaobing Chen
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引用次数: 0

摘要

背景:对于经曲妥珠单抗一线治疗后病情进展的人表皮生长因子受体-2(HER2)阳性晚期或转移性胃癌患者,持续使用曲妥珠单抗耐药进展期治疗(TBP)的临床价值尚存争议:本研究旨在评估癌症免疫疗法时代曲妥珠单抗耐药的HER2阳性晚期或转移性胃癌患者使用TBP的疗效并探索新的治疗策略:回顾性分析:回顾性分析2019年6月至2020年12月期间基于曲妥珠单抗靶向治疗的一线治疗失败的HER2阳性晚期或转移性胃癌患者。主要终点是无进展生存期(PFS)。次要终点包括总生存期(OS)、客观反应率(ORR)、疾病控制率(DCR)和安全性。采用 Kaplan-Meier 法估算患者的生存曲线,并用对数秩检验进行比较:共有30名患者在接受TBP治疗的同时接受了化疗、免疫治疗或抗血管生成治疗,另有26名患者接受了医生选择的不含曲妥珠单抗的治疗。TBP和非TBP人群的中位PFS分别为6.0个月[95%置信区间(CI)=3.8-8.2]和3.5个月(95% CI=2.2-4.8)(P=0.038),中位OS分别为12.3个月(95% CI=10.4-14.2)和9.0个月(95% CI=6.6-11.4)(P=0.008)。接受TBP治疗的患者的PFS和OS均优于未接受TBP治疗的患者。在TBP组中,接受曲妥珠单抗联合化疗和免疫治疗的患者的ORR(40.0%对16.7%)和DCR(90.0%对50.0%)均高于单纯化疗的TBP患者,PFS(7.0对1.9个月)也显著改善。亚组分析表明,男性患者、免疫组化评分 3+ 的 HER2 阳性患者和一线治疗 PFS 少于 6 个月的患者从 TBP 中获益更大。TBP组和非TBP组的3-4级不良反应发生率分别为43.3%和38.5%:结论:持续使用TBP可改善曲妥珠单抗耐药的HER2阳性晚期或转移性胃癌患者的PFS和OS,且毒性耐受性良好。在免疫治疗时代,TBP联合化疗和免疫治疗可进一步提高临床疗效,提供一种新的治疗策略:本研究为回顾性研究,无需临床注册。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
In era of immunotherapy: the value of trastuzumab beyond progression in patients with trastuzumab-resistant HER2-positive advanced or metastatic gastric cancer.

Background: For patients with human epidermal growth factor receptor-2 (HER2)-positive advanced or metastatic gastric cancer who have progressed on first-line trastuzumab therapy, the clinical value of the continuous use of trastuzumab beyond progression (TBP) is controversial.

Objectives: The present study was conducted to evaluate the efficacy and explore new treatment strategies of TBP for patients with trastuzumab-resistant HER2-positive advanced or metastatic gastric cancer in the era of cancer immunotherapy.

Design: Retrospective analysis.

Methods: Patients with HER2-positive advanced or metastatic gastric cancer who have failed first-line treatment based on trastuzumab-targeted therapy from June 2019 to December 2020 were retrospectively analyzed. The primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate (ORR), disease control rate (DCR), and safety. Survival curves of patients were estimated by the Kaplan-Meier method and compared using the log-rank test.

Results: In all, 30 patients received TBP with chemotherapy, immunotherapy, or anti-angiogenic therapy, and the other 26 patients received treatment of physician's choice without trastuzumab. The median PFS in the TBP and non-TBP population was 6.0 [95% confidence interval (CI) = 3.8-8.2] and 3.5 (95% CI = 2.2-4.8) months, respectively (p = 0.038), and the median OS was 12.3 (95% CI = 10.4-14.2) and 9.0 (95% CI = 6.6-11.4) months (p = 0.008). The patients who received TBP treatment had more favorable PFS and OS than the non-TBP population. In the TBP group, patients who received trastuzumab plus chemotherapy and immunotherapy had higher ORR (40.0% versus 16.7%), DCR (90.0% versus 50.0%), and showed a significant improvement in PFS (7.0 versus 1.9 m) compared to TBP with chemotherapy alone. Subgroup analysis suggested that patients with male, HER2 positive with immunohistochemistry score 3+ and PFS of first-line treatment less than 6 months had a greater benefit from TBP. The incidence of Grade 3-4 adverse events in the TBP and non-TBP groups was 43.3% and 38.5%.

Conclusion: The continuous use of TBP improves PFS and OS in patients with trastuzumab-resistant HER2-positive advanced or metastatic gastric cancer with well-tolerated toxicity. In the era of immunotherapy, TBP combined with chemotherapy and immunotherapy may further enhance the clinical benefit and provide a new treatment strategy.

Trial registration: This study is a retrospective study, which does not require clinical registration.

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