中国临床药理学杂志2026，Vol.42Issue(12)：1665-1672,8.DOI:10.13699/j.cnki.1001-6821.2026.12.003
替雷利珠单抗联合PC方案治疗晚期非鳞非小细胞肺癌患者的临床研究
Clinical trial of tislelizumab combined with PC regimen in the treatment of advanced non-squamous non-small cell lung cancer patients
摘要
Abstract
Objective To assess the clinical outcomes and safety of tislelizumab injection combined with pemetrexed disodium for injection and platinum chemotherapy(carboplatin for injection or cisplatin for injection)(PC)in advanced non-squamous non-small cell lung cancer(nsq-NSCLC)patients.Methods Patients with advanced nsq-NSCLC were divided into the control group and the treatment group according to the treatment plan.The control group was treated with intravenous infusion of pemetrexed for injection 500 mg·m-2 and platinum-based therapy on the first day,carboplatin for injection was administered at a dose of 5 under the curve at the time of administration,cisplatin for injection was given at a dose of 75 mg·m-2,with 21 days as one cycle and the treatment group.On the basis of the control group,treatment group was intravenously infused 200 mg of tislelizumab injection on the first day;each infusion lasted for 30 to 60 minutes,and 21 days was one cycle.Two group were treated for 4 cycles.The clinical efficacy,immune function indicators,tumor-related markers,quality of life and safety of the two groups of patients were compared.Results A total of 92 patients were enrolled,with 44 cases in control group and 48 cases in treatment group.After treatment,the objective response rate(ORR)in the treatment group and the control group were 68.75％(33 cases/48 cases)and 47.73％(21 cases/44 cases),respectively;the disease control rate(DCR)were 85.42％(41 cases/48 cases)and 65.91％(29 cases/44 cases),respectively.The cluster of differentiation(CD)3+levels were(34.29±5.49)％and(31.37±5.37)％,respectively;the CD4+/CD8+ratios were(1.09±0.31)and(0.92±0.18),respectively;the serum levels of carcinoembryonic antigen(CEA)were(24.68±6.28)and(28.46±6.57)ng·mL-1,respectively;the levels of thymidine kinase 1(TK-1)were(1.58±0.32)and(1.79±0.35)pmol·L-1,respectively;the levels of matrix metalloproteinase-9(MMP-9)were(27.14±5.47)and(31.06±7.24)ng·mL-1,respectively;the levels of vascular endothelial growth factor(VEGF)were(321.53±62.15)and(355.76±68.19)ng·L-1,respectively;the levels of basic fibroblast growth factor(bFGF)were(15.72±2.94)and(17.38±3.12)pg·mL-1,respectively.Median follow-up 33 months,median progress free survival(PFS)was 15.0 and 10.0 months and median overall survival(OS)27.0 and 17.0 months.Statistically significant difference was found for all of the above indicators when comparing the two groups(P＜0.05,P＜0.01).A total of 27 adverse reactions occurred in the treatment group(56.25％),including 3 cases of rash,3 cases of hypothyroidism,3 cases of abnormal liver function,2 cases of abnormal renal function,4 cases of fatigue,2 cases of anemia,6 cases of myelosuppression,and 4 cases of gastrointestinal reactions.A total of 20 adverse reactions occurred in the control group(45.45％),including 1 case of rash,2 cases of hypothyroidism,3 cases of abnormal liver function,3 cases of abnormal renal function,2 cases of fatigue,2 cases of anemia,5 cases of myelosuppression,and 2 cases of gastrointestinal reactions.There was no statistically significant difference in the overall incidence of adverse durg reactions between the two groups(P＞0.05).Conclusion Compared with the PC regimen alone,the tislelizumab injection combined with PC regimen was associated with higher ORR and DCR in the real world,and showed certain advantages in immune function and quality of life indicators,and no significant increase in the overall risk of adverse drug reactions was observed.This combination regimen offers an effective and well-tolerated treatment option for patients with advanced nsq-NSCLC.关键词
替雷利珠单抗注射液/注射用培美曲塞二钠/注射用顺铂/注射用卡铂/免疫治疗/晚期非鳞型非小细胞肺癌Key words
tislelizumab injection/pemetrexed disodium for injection/cisplatin for injection/carboplatin for injection/immunotherapy/advanced non-squamous non-small cell lung carcinoma分类
医药卫生引用本文复制引用
林洁桓,马骏,王宏进,陈福楠..替雷利珠单抗联合PC方案治疗晚期非鳞非小细胞肺癌患者的临床研究[J].中国临床药理学杂志,2026,42(12):1665-1672,8.基金项目
福建省自然科学基金资助项目(2025J011683) （2025J011683）
