| 侯自立,刘博.帕博利珠单抗联合吉非替尼治疗表皮生长因子受体突变非小细胞肺癌的临床获益分析[J].安徽医药,2026,30(6):1241-1247. |
| 帕博利珠单抗联合吉非替尼治疗表皮生长因子受体突变非小细胞肺癌的临床获益分析 |
| Clinical benefit analysis of pabolizumab combined with gefitinib in treatment of epidermal growth factor receptor-mutated non-small cell lung cancer |
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| DOI：10.3969/j.issn.1009-6469.2026.06.036 |
| 中文关键词: 癌，非小细胞肺 帕博利珠单抗 吉非替尼 表皮生长因子受体突变 T细胞功能 |
| 英文关键词: Carcinoma, non-small-cell lung Pabolizumab Gefitinib Epidermal growth factor receptor mutation T cell function |
| 基金项目:河北省重点研发计划项目( 20201012907D) |
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| 摘要点击次数: 51 |
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| 中文摘要: |
| 目的分析帕博利珠单抗联合吉非替尼治疗表皮生长因子受体( EGFR)突变非小细胞肺癌( NSCLC)临床获益情况。方法前瞻性随机对照试验。采用随机数字表法和 1∶1原则将 2021年 1月至 2023年 1月邢台市人民医院收治的 102例 EGFR突变 NSCLC病人分为两组，各 51例。两组均予以化疗，在此基础上，吉非替尼组口服吉非替尼片 250毫克 /次， 1次/天， 3周为 1个疗程；联合组基于吉非替尼组加用帕博利珠单抗 200 mg静脉滴注，每 3周 1次， 3周为 1个疗程。两组均持续治疗 4个疗程。对比两组近期疗效、肿瘤标志物［癌胚抗原( CEA)、神经元特异性烯醇化酶( NSE)、细胞角蛋白 19片段( CYFRA21-1)、糖类抗原 125(CA125)］、 T细胞功能［ T细胞 /干细胞样中央记忆性 T细胞( SCM)百分率、记忆性 T细胞百分率、 CD4+、CD4+/CD8+］、促癌因子［基质金属蛋白酶 -9(MMP-9)、 POK红细胞髓性致癌因子(pokemon)、抗菌肽人类阳离子抗菌蛋白 18(hCAP18)］、无进展生存期及不良反应。结果治疗 4个疗程后，联合组客观缓解率为 76.47%(39/51)疾病控制率为 94.12%(48/51)高于吉非替尼组的 45.10%(23/51)、 74.51%(38/51)(P<0.05)；治疗 1、4个疗程后联合组 NSE、C，EA、CA125、CYFRA21-1低于吉，非替尼组( P< 0.05)；治疗 1、4个疗程后联合组 T细胞 /SCM百分率、记忆性 T细胞百分率、 CD4+CD4+/CD8+高于吉非替尼组( P<0.05)；治疗 1、4个疗程后联合组 MMP-9、Pokemon、hCAP18低于吉非替尼组( P<0.05)；联合组 9个、月无进展生存率为 68.63%(35/51)高于吉非替尼组的 48.00%(24/50)(P<0.05)；联合组胃肠道反应、肝损害、骨髓抑制、肾损害发生率分别为 68.63%(35/51)、 17.65%(9/ 51)、 54.90%(28/51)、 11.76%(6/51)与吉非替尼组的 60.78%(31/51)、 11.76%(6/51)、 47.06%(24/51)、7.84%(4/51)比较，差异无统计学意义( P>0.05)。结论帕博利，珠单抗联合吉非替尼治疗 EGFR突变 NSCLC可调节 T细胞功能，改善机体免疫反应，增强抗肿瘤效果，且耐受性较好，从而能提高无进展生存率。 |
| 英文摘要: |
| Objective To analyze the clinical benefit of palilizumab combined with gefitinib in the treatment of epidermal growth fac.tor receptor (EGFR) mutated non-small cell lung cancer (NSCLC).Methods A prospective randomized controlled trial was used in this study. A total of 102 patients with EGFR-mutated NSCLC admitted to Xingtai People's Hospital from January 2021 to January2023, and they were divided into two groups with 51 cases in each group according to the random number table method and 1:1 princi.ple. Both groups were given chemotherapy. On this basis, gefitinib group was given oral gefitinib tablets 250 mg per time, once a day,with 3 weeks as one treatment course. The combined group received additional intravenous infusion of pembrolizumab 200 mg once ev.ery 3 weeks on the basis of the gefitinib regimen, with 3 weeks as one treatment course. Both groups were continuously treated for 4courses. The short-term efficacy, tumor markers [carcinoembryonic antigen (CEA), neuron-specific enolase (NSE), cytokeratin 19 frag. ment (CYFRA21-1), carbohydrate antigen 125 (CA125)], T-cell function [T cell/stem cell-like central memory T cells (SCM) percent. age, percentage of memory T cells, CD4+, CD4+/CD8+], cancer promoting factors [matrix metalloproteinase-9 (MMP-9), POK erythroid myeloid oncogenic factor (pokemon), human cationic antimicrobial protein 18 (hCAP18)], progression-free survival and adverse reac. tions were compared between the two groups.Results After 4 courses of treatment, the objective remission rate and disease controlrate in combination group were 76.47% (39/51) and 94.12% (48/51), which were higher than 45.10% (23/51) and 74.51% (38/51) in ge.fitinib group (P<0.05). After 1 course of treatment and 4 courses of treatment, NSE, CEA, CA125 and CYFRA21-1 in combination group were lower than those in gefitinib group (P<0.05). After 1 course of treatment and 4 courses of treatment, the percentage of T cell/ SCM, percentages of memory T cells, CD4+, CD4+/CD8+ in combination group were higher than those in gefitinib group (P<0.05). After 1 course of treatment and 4 courses of treatment, MMP-9, Pokemon and hCAP18 in combination group were lower than those in gefi. tinib group (P<0.05). The 9-month progression-free survival rate of the combined group was 68.63% (35/51), which was higher than 48.00% (24/50) of the gefitinib group (P<0.05). The incidence rates of gastrointestinal reaction, liver damage, myelosuppression and re.nal damage in combination group were 68.63% (35/51), 17.65% (9/51), 54.90% (28/51) and 11.76% (6/51), respectively, which had nostatistical significance compared with 60.78% (31/51), 11.76% (6/51), 47.06% (24/51) and 7.84% (4/51) in gefitinib group (P > 0.05). Conclusion Palilizumab combined with gefitinib in the treatment of EGFR-mutated NSCLC can regulate T cell function, improve im. mune response, enhance anti-tumor effect, and be well tolerated, thus improving progression-free survival rate. |
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