贝伐珠单抗注射液辅助治疗老年局部非小细胞肺癌的临床研究

Clinical trial of bevacizumab injection on assisted treatment of elderly patients with locally advanced non-small cell lung cancer

目的观察贝伐珠单抗注射液辅助治疗老年局部晚期非小细胞肺癌(NSCLC)患者的临床疗效及机制。方法 58例老年局部晚期NSCLC患者随机分为试验组29例与对照组29例。对照组用放疗联合同步化疗,化疗方案:第1,8,15天,静脉滴注紫杉醇注射液60 mg·m-2,第1,15天,静脉滴注卡铂AUC2~4 mg·m-2,每个周期21 d,同步化疗2个周期,放疗结束后继续化疗2个周期;试验组在对照组治疗的基础上,第1天,静脉滴注贝伐珠单抗7.5 mg·kg-1,每个周期21 d,辅助化疗4个周期。比较2组患者的总有效率、生活质量改善情况、血管内皮生长因子(VEGF)、碱性纤维细胞生长因子(b FGF)水平变化及药物不良反应发生情况。结果试验组总有效率为75.86%(22/29例),对照组为62.07%(18/29例),差异有统计学意义(P<0.05)。试验组生活质量提高率为58.62%(17/29例),对照组为34.48%(10/29例,P<0.05)。试验组VEGF为(258.81±74.41)ng·L^(-1),b FGF为(13.02±8.72)ng·L^(-1);对照组VEGF为(310.34±100.24)ng·L^(-1),b FGF为(19.81±10.73)ng·L^(-1)(P<0.05)。2组药物不良反应主要表现为肺、食管、骨髓、皮肤等药物不良反应,2组药物不良反应发生率差异无统计学意义(P>0.05)。结论贝伐珠单抗辅助治疗能有效降低患者血清VEGF和b FGF水平,在改善患者生活质量方面有更加积极的作用。

Objective To investigate the clinical efficacy and mechanism of bevacizumab - assisted treatment of elderly patients with locally ad- vanced non- small cell lung cancer（NSCLC）. Methods Totally 59 el- derly patients with locally advanced NSCLC were randomly divided into treatment group（n = 29） and control group （ n = 29）. Control group was treated with actinotheraphy combined with concurrent chemotherapy, chemotherapy regimens： 60 mg m-2 of paclitaxel injection were given by intravenous drop on 1, 8, 15 d, and AUC 2 -4 mg m-2 of carboplatin were given by intravenous drop on 1,5 d, each cycle was 21 d, two cycles of concurrent chemotherapy, and continue to received two cycles of chemo- therapy at the end of radiotherapy. Treatment group was given bevacizumab 7. 5 mg kg-1 by intravenous drop on first day, each cycle was 21 d with 4 cycles of chemotherapy - assisted on the basis of control group. The total efficiency and quality of life, changes of serum vascular endothelial growth factor（VEGF） and basic fibroblast growth factor （bFGF） and incidence of adverse drug reactions in two groups were observed. Results Total effective rate in treatment group was 75.86% （22/29）, and was 62. 07% （18/29） in control group, with statistical significance （P 〈 0. 05 ）. The increasing rate of quality of life in treatment group was 58.62% （17/29）, which had significant difference with 34. 48% （10/29） in control group（P 〈0. 05 ）. The serum VEGF in treatment group was（258.81 ±74. 41 ） ng L-1 , and the bFGF was（ 13.02 ± 8.72） ng L-1 , the VEGF in control group was（310. 34 ± 100. 24） ng L-1 , bFGF was（ 19. 81 ± 10. 73） ng L-1 （P 〈0. 05）. The main adverse drug reactions were lung, esophageal, marrow and skin, the incidence of adverse drug reactions in two groups had no significant difference （P 〉 0. 05 ）. Conclusion Bevacizumab can effectively reduce the serum VEGF and bFGF levels and improve the quality of life in the treatment of elderly patients with NSCLC.