培美曲塞注射剂联合卡铂注射液治疗表皮生长因子受体-酪氨酸激酶抑制药耐药后晚期肺腺癌患者的临床研究
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摘要
目的观察培美曲塞注射剂联合卡铂注射液治疗表皮生长因子受体-酪氨酸激酶抑制药(EGFR-TKI)耐药后晚期肺腺癌患者的临床疗效及安全性。方法将84例对EGFR-TKI耐药后晚期肺腺癌患者随机分为对照组和试验组,每组42例。对照组予以培美曲塞每次500 mg·m~(-2),静脉滴注,第1天;试验组在对照组治疗的基础上,予以卡铂每次300 mg·m~(-2),静脉滴注,第1天。2组患者均治疗2个周期以上,每个周期21 d。比较2组患者的临床疗效,血清癌胚抗原(CEA)、神经元特异性烯酶(NSE)和细胞角蛋白抗原19片段(CYFRA21-1)水平,以及药物不良反应的发生情况。结果治疗后,试验组和对照组的总有效率分别为52.38%(22例/42例)和42.86%(18例/42例),差异无统计学意义(P>0.05)。治疗后,试验组和对照组血清CEA分别为(37.53±6.28)和(39.15±5.80)ng·mL~(-1),NSE分别为(22.12±2.62)和(21.61±4.00)ng·mL~(-1),CYFRA21-1分别为(6.31±0.97)和(5.66±1.00)ng·mL~(-1),差异均无统计学意义(均P>0.05)。2组患者的药物不良反应均以恶心呕吐、骨髓抑制、肝功能损伤、皮疹和发热为主,试验组和对照组的总药物不良反应发生率分别为69.05%和64.29%,差异无统计学意义(P>0.05)。结论培美曲塞注射剂联合卡铂注射液治疗EGFR-TKI耐药后晚期肺腺癌患者的临床疗效和安全性与单用培美曲塞注射剂相当,两者均能显著抑制CEA、NSE及CYFRA21-1表达。
Objective To observe the clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with epidermal growth factor receptor-tyrosine kinase inhibitor( EGFR-TKI) resistance. Methods Eighty-four patients of advanced lung adenocarcinoma after EGFR-TKI resistance were divided into control and treatment groups with 42 cases per group. Control group received 500 mg·m~(-2) pemetrexed per time,intravenous drip,day 1. Treatment group was given 300 mg·m~(-2) carboplatin per time,intravenous drip,day 1,on the basis of control group. Two groups were treated for more than 2 cycles with 21 days per cycle. The clinical efficacy,serum levels of carcino embryonic antigen( CEA),neuron-specific enolase( NSE) and cytokeratin antigen 19( CYFRA21-1),and adverse drug reactions were compared between two groups. Results After treatment,total effective rates of treatment and control groups were 52. 38%( 22 cases/42 cases) and 42. 86%( 18 cases/42 cases) without significant difference( P > 0. 05). After treatment,the main indexes of treatment and control groups were compared: CEA were( 37. 53 ± 6. 28) and( 39. 15 ± 5. 80)ng·mL~(-1),NSE were( 22. 12 ± 2. 62) and( 21. 61 ± 4. 00) ng·mL~(-1),CYFRA21-1 were( 6. 31 ± 0. 97) and( 5. 66 ± 1. 00) ng·mL~(-1),the differences were not statistically significant( all P > 0. 05). The adverse drug reactions of two groups were nausea,vomiting,myelosuppression,liver function damage,rash and fever. The total incidences of adverse drug reactions in treatment and control groups were 69. 05% and 64. 29% without significant difference( P > 0. 05). Conclusion The clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with EGFR-TKI resistance were equal to pemetrexed injection alone,and both could significantly inhibit the expressions of CEA,NSE and CYFRA21-1.
Objective To observe the clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with epidermal growth factor receptor-tyrosine kinase inhibitor( EGFR-TKI) resistance. Methods Eighty-four patients of advanced lung adenocarcinoma after EGFR-TKI resistance were divided into control and treatment groups with 42 cases per group. Control group received 500 mg·m~(-2) pemetrexed per time,intravenous drip,day 1. Treatment group was given 300 mg·m~(-2) carboplatin per time,intravenous drip,day 1,on the basis of control group. Two groups were treated for more than 2 cycles with 21 days per cycle. The clinical efficacy,serum levels of carcino embryonic antigen( CEA),neuron-specific enolase( NSE) and cytokeratin antigen 19( CYFRA21-1),and adverse drug reactions were compared between two groups. Results After treatment,total effective rates of treatment and control groups were 52. 38%( 22 cases/42 cases) and 42. 86%( 18 cases/42 cases) without significant difference( P > 0. 05). After treatment,the main indexes of treatment and control groups were compared: CEA were( 37. 53 ± 6. 28) and( 39. 15 ± 5. 80)ng·mL~(-1),NSE were( 22. 12 ± 2. 62) and( 21. 61 ± 4. 00) ng·mL~(-1),CYFRA21-1 were( 6. 31 ± 0. 97) and( 5. 66 ± 1. 00) ng·mL~(-1),the differences were not statistically significant( all P > 0. 05). The adverse drug reactions of two groups were nausea,vomiting,myelosuppression,liver function damage,rash and fever. The total incidences of adverse drug reactions in treatment and control groups were 69. 05% and 64. 29% without significant difference( P > 0. 05). Conclusion The clinical efficacy and safety of pemetrexed injection combined with carboplatin injection in the treatment of advanced lung adenocarcinoma with EGFR-TKI resistance were equal to pemetrexed injection alone,and both could significantly inhibit the expressions of CEA,NSE and CYFRA21-1.
引文
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[7]张云江.培美曲塞联合顺铂和吉非替尼治疗晚期肺腺癌的临床疗效和毒副反应[J].实用临床医药杂志,2016,20(17):145-146.
[8]KUMAR R,DUBASHI B,KAYAL S,et al.Study of gefitinib maintenance in unselected patients with metastatic primary lung adenocarcinoma:A descriptive study[J].Indian J Cancer,2017,54(1):188-192.
[2]刘思文,于韶荣,冯继锋.肺癌EGFR-TKI继发耐药的主要机制与应对策略[J].国际肿瘤学杂志,2015,42(1):56-59.
[3]黄韵坚,庄武,吴标,等.老年晚期非小细胞肺癌表皮生长因子受体-酪氨酸激酶抑制剂一线治疗获得性耐药后培美曲塞化疗的疗效和安全性观察[J].临床和实验医学杂志,2016,15(18):1764-1766.
[4]吴一龙,廖美琳,蒋国膊,等.局部晚期非小细胞肺癌诊断治疗之共识[J].中华肿瘤杂志,2002,24(6):576-578.
[5]鲍云华,李俭杰.介绍新的实体瘤治疗反应评价标准(RECIST)[J].中国肺癌杂志,2010,8(1):77-78.
[6]黄芳,姜达,李颖,等.晚期肺腺癌化疗方案的优化[J].肿瘤防治研究,2015,42(7):687-692.
[7]张云江.培美曲塞联合顺铂和吉非替尼治疗晚期肺腺癌的临床疗效和毒副反应[J].实用临床医药杂志,2016,20(17):145-146.
[8]KUMAR R,DUBASHI B,KAYAL S,et al.Study of gefitinib maintenance in unselected patients with metastatic primary lung adenocarcinoma:A descriptive study[J].Indian J Cancer,2017,54(1):188-192.