The FJQR Has Synergistic Effect with Fluoropyrimidine in the Maintenance Treatment for HER-2 Negative Gastric Cancer.

IF 2.5 4区医学 Q3 ONCOLOGY

Recent patents on anti-cancer drug discovery Pub Date : 2024-01-01 DOI:10.2174/1574892818666230522161742

Fanming Kong, Lu Zhao, Na Wang, Dou Zhang, Ziwei Wang, Qingyun Mei, Yongchao Yu, Yingjie Jia

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引用次数: 0

Abstract

Introduction: Maintenance therapy aimed to strengthen the first-line chemotherapy and improve quality of life is needed for gastric cancer (GC). Currently, many clinical studies have confirmed the important role of fluoropyrimidine in the maintenance stage. Our team has created patented prescriptions "Fuzheng jiedu Quyu Method" recipe (FJQR), which was considered as an adjuvant therapeutic scheme (reduce toxicity and increase the efficacy of chemotherapy). This study aimed to evaluate the efficacy and safety of FJQR combined with fluoropyrimidine as a maintenance treatment in HER-2 negative GC patients.

Methods: We performed the analysis of 129 patients with HER-2 negative GC who entered the maintenance stage in our hospital and Tianjin Cancer Hospital between January 2018 and December 2020. Out of the 129 eligible patients, 64 were categorized into the maintenance treatment group with FJQR+fluoropyrimidine, and 65 patients were assigned to the control group if they received fluoropyrimidine alone. Capecitabine was orally 1000mg/m², Qd, half an hour after meals, and FGQR was 15g Bid after capecitabine. The primary endpoint was progression-free survival (PFS). The secondary endpoints were overall survival (OS), overall remission rate (ORR), quality of Life (QOL), TCM syndrome and safety.

Results: The mPFS in the treatment group was significantly prolonged compared with the control group (6.3 vs. 5.0 months, p = 0.03), while the mOS was not substantially improved (11.4 vs. 10.5 months, p = 0.38). Gastrointestinal symptoms and pain became better in the treatment group. The number of distant metastatic organs, first-line chemotherapy cycles, and lymph node metastasis were independent risk predictors for PFS. Blood stasis syndrome may be the protective factor. In terms of safety, treatment-related adverse events (AEs) in the treatment group were relatively lighter, and the incidence of grade III-IV AEs could be significantly reduced.

Conclusion: FJQR and fluoropyrimidine have synergistic effects as maintenance treatment in HER-2 negative GC, with good efficacy and safety.

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FJQR与氟嘧啶协同维持治疗HER-2阴性癌症

胃癌(GC)需要以加强一线化疗和改善生活质量为目的的维持治疗。目前，许多临床研究都证实了氟嘧啶在维持阶段的重要作用。团队独创专利处方“扶正解毒祛郁法”方剂(FJQR)，被认为是一种辅助治疗方案(降低毒副作用，提高化疗疗效)。本研究旨在评价FJQR联合氟嘧啶作为HER-2阴性GC患者维持治疗的有效性和安全性。我们对2018年1月至2020年12月在我院和天津市肿瘤医院就诊的129例进入维持期的HER-2阴性胃癌患者进行分析。在129例符合条件的患者中，64例患者被划分为FJQR+氟嘧啶维持治疗组，65例患者被划分为单独使用氟嘧啶的对照组。卡培他滨口服1000mg/m2, Qd，餐后半小时，卡培他滨后FGQR 15g Bid。主要终点为无进展生存期(PFS)。次要终点为总生存期(OS)、总缓解率(ORR)、生活质量(QOL)、中医证候和安全性。治疗组mPFS较对照组明显延长(6.3个月vs. 5.0个月，P=0.03)，而mOS无明显改善(11.4个月vs. 10.5个月，P=0.38)。治疗组的胃肠道症状和疼痛有所改善。远处转移器官的数量、一线化疗周期和淋巴结转移是PFS的独立危险预测因素。血瘀证可能是保护因素。安全性方面，治疗组治疗相关不良事件(ae)相对较轻，III-IV级ae发生率可显著降低。FJQR与氟嘧啶作为HER-2阴性GC的维持治疗具有协同作用，具有良好的疗效和安全性。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Recent patents on anti-cancer drug discovery 医学-药学

CiteScore

4.50

自引率

7.10%

发文量

审稿时长

3 months

期刊介绍： Aims & Scope Recent Patents on Anti-Cancer Drug Discovery publishes review and research articles that reflect or deal with studies in relation to a patent, application of reported patents in a study, discussion of comparison of results regarding application of a given patent, etc., and also guest edited thematic issues on recent patents in the field of anti-cancer drug discovery e.g. on novel bioactive compounds, analogs, targets & predictive biomarkers & drug efficacy biomarkers. The journal also publishes book reviews of eBooks and books on anti-cancer drug discovery. A selection of important and recent patents on anti-cancer drug discovery is also included in the journal. The journal is essential reading for all researchers involved in anti-cancer drug design and discovery. The journal also covers recent research (where patents have been registered) in fast emerging therapeutic areas/targets & therapeutic agents related to anti-cancer drug discovery.