Therapeutic efficacy analysis of sintilimab combined with paclitaxel and docetaxel for advanced non-small cell lung cancer
蔚晓勇 1李晓凤 2史婉婷 2杜家乐 2张俊伟 吕晶丽
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作者信息
1. 包头医学院研究生院，包头 014060
2. 包头市肿瘤医院胸部肿瘤科，包头 014030
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摘要
目的 探讨信迪利单抗联合紫杉醇、多西他赛二线治疗晚期非小细胞肺癌（NSCLC）的效果。 方法 前瞻性队列研究。前瞻性选取包头市肿瘤医院2019年10月至2022年10月收治的90例二线治疗晚期NSCLC患者，采用随机数字表法分为研究组（信迪利单抗联合紫杉醇或多西他赛二线治疗，45例）和对照组（单纯紫杉醇或多西他赛二线治疗，45例）。比较两组患者的近期疗效、血清细胞因子水平、生命质量和T细胞亚群等；获取随访6个月内患者生存情况，采用Kaplan-Meier法分析两组总生存（OS），组间比较行log-rank检验。 结果 研究组和对照组患者年龄分别为（63±5）岁、（65±6）岁，分别有男性25例（55.56%）、28例（62.22%），两组性别、年龄、美国东部肿瘤协作组评分、体质量差异均无统计学意义（均P>0.05），具有可比性。研究组总有效率为88.89%（40/45），对照组为71.11%（32/45），差异有统计学意义（χ2＝4.44，P＝0.035）。两组治疗后血清血管内皮生长因子（VEGF）、糖类抗原125（CA125）水平均低于治疗前（均P<0.001），且治疗后研究组均低于对照组[VEGF：（223±15）pg/ml比（289±15）pg/ml，t＝20.82，P<0.001；CA125：（23±6）ng/ml比（75±4）ng/ml，t＝51.28，P<0.001]；两组治疗后生命质量量表评分、Karnofsky评分均高于治疗前（均P<0.05），且治疗后研究组均高于对照组[生命质量量表评分：（63±6）分比（51±5）分，t＝10.29，P<0.001；Karnofsky评分：（80.5±5.7）分比（78.8±3.7）分，t＝1.70，P＝0.041]；两组治疗后T细胞亚群相关指标均高于治疗前（均P<0.001），且治疗后研究组均高于对照组[CD3+细胞比例：（68±5）%比（65±5）%，t＝2.52，P＝0.014；CD4+细胞比例：（42.5±1.7）%比（36.5±3.7）%，t＝9.91，P<0.001；CD4+/CD8+：1.78±0.54比1.46±0.27，t＝3.56，P<0.001]。研究组和对照组不良反应总发生率差异无统计学意义[11.11%（5/45）比15.55%（7/45），χ2＝0.39，P＝0.534]。随访6个月，研究组OS优于对照组（χ2＝3.86，P＝0.044）。 结论 信迪利单抗联合紫杉类药物二线治疗晚期NSCLC有效，可改善患者免疫功能，安全性良好。 Objective To investigate the efficacy of sintilimab combined with paclitaxel and docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Prospective cohort study was performed. A total of 90 patients with advanced NSCLC receiving second-line treatment in Baotou Cancer Hospital from October 2019 to October 2022 were prospectively selected. All patients were divided into the study group (sintilimab combined with paclitaxel and docetaxel as second-line treatment, 45 cases) and the control group (paclitaxel or docetaxel alone, 45 cases) according to random number table method. The short-term efficacy, serum cytokine levels, quality of life and T-cell subsets of the two groups were compared. The survival of patients within 6 months was followed up. Kaplan-Meier method was used to analyze the overall survival (OS) of both groups, and log-rank test was used to make comparison among groups. Results There were 25 males (55.56%) in the study group with the age of (63±5) years and 28 males (62.22%) in the control group with the age of (65±6) years. There were no statistically significant differences in the gender, age, Eastern Cooperative Oncology Group scores, the body mass (all P>0.05). The total effective rate was 88.89% (40/45) in the study group and 71.11% (32/45) in the control group, and the difference was statistically significant (χ2 = 4.44, P = 0.035). The levels of serum vascular endothelial growth factor (VEGF) and carbohydrate antigen 125 (CA125) of both groups after treatment were lower than those before treatment (all P<0.001) the levels of VEGF and CA125 in the study group after treatment were lower than those in the control group [VEGF: (223±15) pg/ml vs. (289±15) pg/ml,t=20.82, P<0.001 CA125: (23±6) ng/ml vs. (75±4) ng/ml,t=51.28, P<0.001].Quality of life scale score, Karnofsky score of both groups after treatment were higher than those before treatment (allP<0.05) quality of life scale score and Karnofsky score in the study group after treatment were higher than those in the control group [quality of life scale score: (63±6) scores vs. (51±5) scores,t=10.29, P<0.001 Karnofsky score: (80.5±5.7) scores vs.(78.8±3.7) scores,t=1.70,P=0.041]. T-cell subsets indicators of both groups after treatment were higher than those before treatment (all P<0.001). T-cell subsets indicators in the study group after treatment were higher than those in the control group [CD3+ cell proportion: (68±5)% vs. (65±5)%, t=2.52, P = 0.014 CD4+ cell proportion:(42.5±1.7)% vs. (36.5±3.7)%, t=9.91, P<0.001 CD4+/CD8+: 1.78±0.54 vs. 1.46±0.27, t=3.56, P<0.001]. There was no significant difference in the incidence of adverse reactions between the two groups [11.11% (5/45) vs. 15.55% (7/45),χ2=0.39,P=0.534]. The follow-up time was 6 months. The OS in the study group was better than that in the control group (χ2=3.86, P = 0.044). Conclusions Sintilimab combined with taxoid chemotherapy drugs is effective in the second-line treatment of advanced NSCLC, and it improves immune function and shows a favorable safety.
Abstract
Objective To investigate the efficacy of sintilimab combined with paclitaxel and docetaxel in the treatment of advanced non-small cell lung cancer (NSCLC). Methods Prospective cohort study was performed. A total of 90 patients with advanced NSCLC receiving second-line treatment in Baotou Cancer Hospital from October 2019 to October 2022 were prospectively selected. All patients were divided into the study group (sintilimab combined with paclitaxel and docetaxel as second-line treatment, 45 cases) and the control group (paclitaxel or docetaxel alone, 45 cases) according to random number table method. The short-term efficacy, serum cytokine levels, quality of life and T-cell subsets of the two groups were compared. The survival of patients within 6 months was followed up. Kaplan-Meier method was used to analyze the overall survival (OS) of both groups, and log-rank test was used to make comparison among groups. Results There were 25 males (55.56%) in the study group with the age of (63±5) years and 28 males (62.22%) in the control group with the age of (65±6) years. There were no statistically significant differences in the gender, age, Eastern Cooperative Oncology Group scores, the body mass (all P>0.05). The total effective rate was 88.89% (40/45) in the study group and 71.11% (32/45) in the control group, and the difference was statistically significant (χ2 = 4.44, P = 0.035). The levels of serum vascular endothelial growth factor (VEGF) and carbohydrate antigen 125 (CA125) of both groups after treatment were lower than those before treatment (all P<0.001) the levels of VEGF and CA125 in the study group after treatment were lower than those in the control group [VEGF: (223±15) pg/ml vs. (289±15) pg/ml,t=20.82, P<0.001 CA125: (23±6) ng/ml vs. (75±4) ng/ml,t=51.28, P<0.001].Quality of life scale score, Karnofsky score of both groups after treatment were higher than those before treatment (allP<0.05) quality of life scale score and Karnofsky score in the study group after treatment were higher than those in the control group [quality of life scale score: (63±6) scores vs. (51±5) scores,t=10.29, P<0.001 Karnofsky score: (80.5±5.7) scores vs.(78.8±3.7) scores,t=1.70,P=0.041]. T-cell subsets indicators of both groups after treatment were higher than those before treatment (all P<0.001). T-cell subsets indicators in the study group after treatment were higher than those in the control group [CD3+ cell proportion: (68±5)% vs. (65±5)%, t=2.52, P = 0.014 CD4+ cell proportion:(42.5±1.7)% vs. (36.5±3.7)%, t=9.91, P<0.001 CD4+/CD8+: 1.78±0.54 vs. 1.46±0.27, t=3.56, P<0.001]. There was no significant difference in the incidence of adverse reactions between the two groups [11.11% (5/45) vs. 15.55% (7/45),χ2=0.39,P=0.534]. The follow-up time was 6 months. The OS in the study group was better than that in the control group (χ2=3.86, P = 0.044). Conclusions Sintilimab combined with taxoid chemotherapy drugs is effective in the second-line treatment of advanced NSCLC, and it improves immune function and shows a favorable safety.
万方数据