复发转移三阴性乳腺癌卡培他滨维持治疗的临床观察

Clinical observation of capecitabine maintenance treatment for recurrent triple-negativebreast cancer patients

目的：评价应用卡培他滨对一线化疗后未进展的复发转移三阴性乳腺癌进行维持治疗的疗效及安全性。方法将该院93例接受一线化疗有效的复发转移的雌激素受体（ER）、孕激素受体（PR）及人类表皮生长因子受体2（HER2）全阴性的乳腺癌按随机数字表法分为卡培他滨维持观察组和对照组，观察组47例口服卡培他滨，疾病进展或者不良反应不能耐受则停止治疗；对照组46例予以定期随访观察。比较两组疗效、无进展生存期和不良反应。结果观察组中位无进展生存期（MPFS）为8个月（3～18月），高于对照组的4．5个月（2．5～12个月），生存率的差异有统计学意义（χ2＝27．74，P ＜0．01）。观察组客观缓解率（ORR）和肿瘤控制率（DCR）分别为55．32％和87．23％，均显著高于对照组。主要不良反应为骨髓抑制、胃肠道反应、肝功能损害及手足综合征，均可耐受。结论卡培他滨维持治疗对一线化疗有效的复发转移三阴性乳腺癌疗效好，可明显延长患者的无进展生存期，不良反应轻且可耐受。

Objective To evaluate the efficacy and safety of capecitabine maintenance chemotherapy for recurrent triple -negative breast cancer patients without progress post -chemotherapy of first line.Methods A total of 93 recurrent metastatic breast cancer pa-tients,who were negative for ER,PR and HER2,had been evaluated as CR/PR/SD after first -line chemotherapy,were randomly divid-ed into capecitabine maintenance treating group and control group.The treating group（47 cases）took capecitabine orally,and stopped treatment when disease progressing or being intolerant to adverse reaction.The control group（46 cases）were given follow -up regular-ly.The efficacy,progression free survival（PFS）,and adverse reaction were compared.Results Themedian PFS of treating group was 8 months（3 ~18 months）,higher than that of control group which was 4.5 months（2.5 ~12 months）,and the difference of survival was statistically significant（χ2 =27.74,P 〈0.01）.The ORRand DCR of treating group were 55.32% and 87.23% respectively,obviously higher than those of control group.The main adverse reactions were myelosuppression,gastrointestinal reaction,liver function lesion and hand -foot syndrome,which were all tolerable.Conclusions Maintenance chemotherapy with capecitabine can achieve fine efficacy for recurrent triple -negative breast cancer patients without progression post -chemotherapy,and can prolong obviously the progression free survival.The adverse reactions were light and tolerable.