伏美替尼联合GC化疗方案对非小细胞肺癌患者的疗效观察

doi:10.3760/cma.j.issn.1007-1245.2024.24.016

摘要/Abstract

摘要：

目的　探究伏美替尼联合吉西他滨+顺铂（GC）化疗方案对非小细胞肺癌（NSCLC）患者的临床疗效。方法　前瞻性选取西安大兴医院2021年4月至2022年8月收治的92例NSCLC患者，用电脑随机数字法分为两组，各46例。对照组男21例，女25例，年龄（59.32±6.59）岁，Ⅲ期34例、Ⅳ期12例，鳞癌26例、腺癌20例；观察组男24例，女22例，年龄（58.41±6.37）岁，Ⅲ期31例、Ⅳ期15例，鳞癌23例、腺癌23例。对照组予以GC化疗方案：第1～3天，25 mg/m²顺铂与250 ml生理盐水混合进行静脉滴注，每天1次；第1、8天，1 000 mg/m²吉西他滨与250 ml生理盐水混合进行静脉滴注；以21 d为一个化疗周期，共用药2个周期。观察组予以伏美替尼联合GC化疗方案：GC化疗方案同对照组，同时从化疗第1天开始增加伏美替尼口服，每次40 mg，每天2次，共用药2个周期。比较两组疗效、肿瘤标志物、血管生成相关因子、用药安全性。对患者进行1年的随访，比较两组生存率。采用χ²检验、t检验、Log-rank检验进行统计学分析。结果　观察组客观缓解率（ORR）［52.18%（24/46）比28.26%（13/46）］、疾病控制率（DCR）［93.48%（43/46）比78.26%（36/46）］均高于对照组（均P<0.05）。观察组治疗后癌胚抗原（CEA）［（10.33±1.47）μg/L比（11.49±1.64）μg/L］、神经元特异性烯醇化酶（NSE）［（13.52±1.93）μg/L比（14.76±2.11）μg/L］、细胞角蛋白19片段（CYFRA21-1）［（2.18±0.39）μg/L比（2.43±0.44）μg/L］、糖类抗原125（CA125）［（36.25±4.53）U/ml比（39.47±4.93）U/ml］、血管内皮生长因子（VEGF）［（365.48±45.69）ng/L比（395.47±49.43）ng/L］、基质金属蛋白酶9（MMP-9）［（101.21±11.25）mg/L比（107.68±11.96）mg/L］、血小板衍生生长因子（PDGF）［（1 511.62±167.95）ng/L比（1 623.40±180.38）ng/L］水平均低于对照组（均P<0.05）。两组总不良反应发生率比较差异无统计学意义（P>0.05）。观察组生存率高于对照组［89.13%（41/46）比69.56%（32/46）］（P<0.05）。结论　对NSCLC患者予以伏美替尼联合GC化疗方案可降低肿瘤标志物及血管生成相关因子水平，抑制肿瘤增殖，提升疗效，且用药安全，生存率较高。

关键词:

非小细胞肺癌, 伏美替尼, 吉西他滨+顺铂化疗方案, 肿瘤标志物, 生存分析

Abstract:

Objective　To explore the clinical efficacy of the combination of furmonertinib and gemcitabine plus cisplatin (GC) chemotherapy regimen in patients with non-small cell lung cancer (NSCLC). Methods　A total of 92 patients with NSCLC admitted to Xi'an Daxing Hospital from April 2021 to August 2022 were prospectively selected and were divided into two groups with 46 cases in each group by computer random number method. In the control group, there were 21 males and 25 females, aged (59.32±6.59) years, 34 cases of stage Ⅲ and 12 cases of stage Ⅳ, 26 cases of squamous cell carcinoma and 20 cases of adenocarcinoma. In the observation group, there were 24 males and 22 females, aged (58.41±6.37) years, 31 cases of stage Ⅲ and 15 cases of stage Ⅳ, 23 cases of squamous cell carcinoma and 23 cases of adenocarcinoma. The control group was given GC chemotherapy regimen: on day 1 to day 3, 25 mg/m² of cisplatin was mixed with 250 ml of normal saline for intravenous infusion, once a day; on day 1 and 8, 1 000 mg/m² of gemcitabine was mixed with 250 ml of normal saline for intravenous infusion, 21 days as a chemotherapy cycle, for a total of 2 cycles. The observation group was given furmonertinib combined with GC chemotherapy regimen: GC chemotherapy regimen was the same as the control group, and oral furmonertinib was added since the first day of chemotherapy, 40 mg each time, twice a day, for a total of 2 cycles. The efficacy, tumor markers, angiogenesis related factors, and drug safety were compared between the two groups. The patients were followed up for 1 year and the survival rates of the two groups were compared. χ² test, t test, and Log-rank test were used for statistical analysis. Results　The objective remission rate (ORR) [52.18% (24/46) vs. 28.26% (13/46)] and disease control rate (DCR) [93.48% (43/46) vs. 78.26% (36/46)] in the observation group were higher than those in the control group (both P<0.05). In the observation group, the levels of carcinoembryonic antigen (CEA) [(10.33±1.47) μg/L vs. (11.49±1.64) μg/L], neuron-specific enolase (NSE) [(13.52±1.93) μg/L vs. (14.76±2.11) μg/L], cytokeratin 19 fragment (CYFRA21-1) [(2.18±0.39) μg/L vs. (2.43±0.44) μg/L], carbohydrate antigen 125 (CA125) [(36.25±4.53) U/ml vs. (39.47±4.93) U/ml], vascular endothelial growth factor (VEGF) [(365.48±45.69) ng/L vs. (395.47±49.43) ng/L], matrix metalloproteinase 9 (MMP-9) [(101.21±11.25) mg/L vs. (107.68±11.96) mg/L], platelet-derived growth factor (PDGF) [(1 511.62±167.95) ng/L vs. (1 623.40±180.38) ng/L] were lower than those in the control group (all P<0.05). There was no statistically significant difference in the total incidence of adverse reactions between the two groups (P>0.05). The survival rate of the observation group was higher than that of the control group [89.13% (41/46) vs. 69.56% (32/46)] (P<0.05). Conclusion　The combination of furmonertinib and GC chemotherapy regimen for NSCLC patients can reduce the levels of tumor markers and angiogenesis related factors, inhibit tumor proliferation, improve efficacy, and has high drug safety and survival rate.

Key words:

Non-small cell lung cancer, Furmonertinib, Gemcitabine plus cisplatin chemotherapy regimen, Tumor markers, Survival analysis

王淑红常英张莉霞.

伏美替尼联合GC化疗方案对非小细胞肺癌患者的疗效观察 [J]. 国际医药卫生导报, 2024, 30(24): 4141-4145.

Wang Shuhong, Chang Ying, Zhang Lixia.

Observation on the efficacy of furmonertinib combined with GC chemotherapy in patients with non-small cell lung cancer [J]. International Medicine and Health Guidance News, 2024, 30(24): 4141-4145.

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