贝伐珠单抗联合卡培他滨治疗晚期乳腺癌的有效性及安全性

Efficacy and safety of bevacizumab combined with capecitabine in the treatment of advanced breast cancer

目的探讨晚期乳腺癌应用贝伐珠单抗联合卡培他滨治疗的有效性及安全性。方法选择2019年8月至2021年5月于中国人民解放军海军安庆医院肿瘤中心收治确诊的76例晚期乳腺癌患者,根据治疗方案不同,将患者分为对照组(采用单药卡培他滨治疗)和试验组(采用贝伐珠单抗联合卡培他滨治疗),每组38例。治疗4个周期后对比两组患者的临床疗效、无进展生存期(PFS)、总生存期(OS)和不良反应,比较治疗前后患者血管内皮生长因子(VEGF)-121、VEGF-145、VEGF-165水平、生命质量。结果试验组的客观缓解率[57.89%(22/38)]虽高于对照组[42.11%(16/38)],但差异无统计学意义(χ^(2)=1.89,P=0.169);试验组的疾病控制率[81.58%(31/38)]优于对照组[55.26%(21/38)],差异有统计学意义(χ^(2)=6.09,P=0.014)。试验组患者中位PFS(6.3个月)长于对照组(4.2个月),差异有统计学意义(χ^(2)=0.48,P=0.003);试验组患者中位OS(14.8个月)与对照组(13.2个月)比较,差异无统计学意义(χ^(2)=0.15,P=0.704)。治疗后试验组患者血清VEGF-121[(201.25±18.37)ng/L比(276.83±20.26)ng/L]、VEGF-145[(102.24±12.16)ng/L比(170.39±15.28)ng/L]、VEGF-165[(135.08±14.32)ng/L比(210.53±16.09)ng/L]水平比对照组低,差异均有统计学意义(t=17.03,P<0.001;t=21.51,P<0.001;t=21.59,P<0.001)。治疗后试验组健康调查简表(SF-36)生理功能[(80.18±13.96)分比(71.72±16.12)分]、生理职能[(67.19±30.62)分比(53.12±9.86)分]、躯体疼痛[(70.01±17.97)分比(61.06±17.57)分]、总体健康[(68.67±18.92)分比(57.96±20.97)分]、活力[(78.39±19.37)分比(68.26±18.52)分]、社会功能[(82.24±19.73)分比(70.92±20.31)分]、情感职能[(73.81±28.86)分比(60.23±29.19)分]、精神健康[(76.19±12.82)分比(70.31±12.54)分]评分均高于对照组,差异均有统计学意义(t=2.45,P=0.017;t=2.03,P=0.046;t=2.19,P=0.031;t=2.34,P=0.022;t=2.33,P=0.023;t=2.46,P=0.016;t=2.04,P=0.045;t=2.02,P=0.047)。试验组患者不良反应发生率[18.42%(7/38)]低于对照组[76.32%(29/38)],差异有统计学意义(χ^(2)=25.54,P<0.001)。结论贝伐珠单抗联合卡培他滨化疗对晚期乳腺癌具有较好的疗效,可显著降低患者VEGF水平,提高患者的生命质量,且不良反应小,具有较高的安全性。

Objective To investigate the efficacy and safety of bevacizumab combined with capecitabine in the treatment of advanced breast cancer.Methods Seventy-six patients with advanced breast cancer who were diagnosed in the Cancer Center of the People's Liberation Army Navy Anqing Hospital from August 2019 to May 2021 were selected.According to different treatment schemes,the patients were divided into the control group(using single drug capecitabine)and the test group(using bevacizumab combined with capecitabine),with 38 cases in each group.After 4 cycles of treatment,the clinical efficacy,progression-free survival(PFS),overall survival(OS)and adverse reactions were compared between the two groups,and the levels of vascular endothelial growth factor(VEGF)-121,VEGF-145,VEGF-165 and quality of life before and after treatment were compared.Results The objective remission rate of the test group[57.89%(22/38)]was higher than that of the control group[42.11%(16/38)],but there was no statistically significant difference(χ^(2)=1.89,P=0.169);The disease control rate of the test group[81.58%(31/38)]was better than that of the control group[55.26%(21/38)],there was a statistically significant difference(χ^(2)=6.09,P=0.014).The median PFS of patients in the test group(6.3 months)was longer than that in the control group(4.2 months),there was a statistically significant difference(χ^(2)=0.48,P=0.003);The median OS of patients in the test group(14.8 months)was not significantly different from that in the control group(13.2 months)(χ^(2)=0.15,P=0.704).After treatment,the expression level of serum VEGF-121[(201.25±18.37)ng/L vs.(276.83±20.26)ng/L],VEGF-145[(102.24±12.16)ng/L vs.(170.39±15.28)ng/L],VEGF-165[(135.08±14.32)ng/L vs.(210.53±16.09)ng/L]in the test group was lower than that in the control group,there were statistically significant differences(t=17.03,P<0.001;t=21.51,P<0.001;t=21.59,P<0.001).After treatment,patients in the test group were assessed according to 36-item Short-Form(SF-36)physiological function[(80.18±13.96)score vs.(71.72±16.12)score],physiological function[(67.19±30.62)score vs.(53.12±9.86)score],physical pain[(70.01±17.97)score vs.(61.06±17.57)score],overall health[(68.67±18.92)score vs.(57.96±20.97)score],vitality[(78.39±19.37)score vs.(68.26±18.52)score],social function[(82.24±19.73)score vs.(70.92±20.31)score],the scores of emotional function[(73.81±28.86)score vs.(60.23±29.19)score]and mental health[(76.19±12.82)score vs.(70.31±12.54)score]were higher than those of the control group,there were statistically significant differences(t=2.45,P=0.017;t=2.03,P=0.046;t=2.19,P=0.031;t=2.34,P=0.022;t=2.33,P=0.023;t=2.46,P=0.016;t=2.04,P=0.045;t=2.02,P=0.047).The incidence of adverse reactions in the test group[18.42%(7/38)]was lower than that in the control group[76.32%(29/38)],there was a statistically significant difference(χ^(2)=25.54,P<0.001).Conclusion The combination of bevacizumab and capecitabine chemotherapy has a higher clinical effect on advanced breast cancer,which can significantly reduce the level of VEGF in patients,improve the quality of life of patients,with mild adverse reactions and high safety.