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目的观察贝伐珠单抗联合化疗在晚期肺腺癌一线治疗方面的疗效和安全性。方法 94例初治晚期肺腺癌患者随机分为贝伐珠单抗联合化疗组(联合化疗组,n=44)和单纯化疗组(n=50)。联合化疗组给予贝伐珠单抗(7.5 mg·kg-1)+培美曲塞(500 mg·m-2)+卡铂(300 mg·m-2)治疗,单纯化疗组给予培美曲塞(500 mg·m-2)+卡铂(300 mg·m-2)治疗,两组患者均以21 d为一个周期,用药6个周期,均为化疗第1日静脉给药。比较两组的疗效、不良反应及肿瘤标志物肿瘤特异性生长因子(TSGF)、癌胚抗原(CEA)和细胞角蛋白19片段(CK-19)的变化。结果联合化疗组与单纯化疗组的缓解率分别为57%和34%,疾病控制率分别为86%和64%(P<0.05);中位无进展生存期分别为8.4个月和6.1个月,中位总生存期分别为15.1个月和11.9个月(P<0.01),一年生存率分别为55%和34%(P<0.05)。联合化疗组治疗后的TSGF、CEA和CK-19水平均显著低于单纯化疗组(P<0.01)。联合化疗组较单纯化疗组增加的不良反应主要是高血压,但均为Ⅰ~Ⅱ度,经治疗后均可控制。结论贝伐珠单抗联合化疗在晚期肺腺癌一线治疗中疗效明显,且未增加严重不良反应,具有很好的临床应用前景。
Objective To observe the efficacy and safety of bevacizumab combined with chemotherapy in first-line treatment of advanced lung adenocarcinoma. Methods Ninety-four patients with newly diagnosed advanced lung adenocarcinoma were randomly divided into bevacizumab combined chemotherapy group (combination chemotherapy group, n = 44) and chemotherapy alone group (n = 50). The combination chemotherapy group was treated with bevacizumab (7.5 mg · kg-1) + pemetrexed (500 mg · m-2) + carboplatin (300 mg · m-2) (500 mg · m-2) and carboplatin (300 mg · m-2). Both groups were given 21 cycles of one cycle for 6 cycles, all of which were intravenously administered on the first day of chemotherapy. The curative effect, side effects and tumor markers such as tumor specific growth factor (TSGF), carcinoembryonic antigen (CEA) and cytokeratin 19 (CK-19) were compared between the two groups. Results The remission rate was 57% and 34% in the combination chemotherapy group and the chemotherapy alone group, and the disease control rates were 86% and 64% respectively (P <0.05). The median progression-free survival rates were 8.4 months and 6.1 months The median overall survival was 15.1 months and 11.9 months, respectively (P <0.01). The one-year survival rates were 55% and 34%, respectively (P <0.05). The levels of TSGF, CEA and CK-19 in the combined chemotherapy group were significantly lower than those in the chemotherapy alone group (P <0.01). Adverse reactions of combined chemotherapy group than chemotherapy group were mainly hypertension, but all were grade Ⅰ ~ Ⅱ, which could be controlled after treatment. Conclusion Bevacizumab combined with chemotherapy has obvious curative effect in first-line treatment of advanced lung adenocarcinoma without any serious side effects and has good clinical application prospect.