GP或NX方案在复发转移性三阴性乳腺癌患者中的临床疗效与毒副反应评价

Evaluation of clinical efficacy and toxicities of GP or NX regimen in patients with recurrent metastatic triple negative breast cancer

目的观察GP方案与NX方案在复发转移性三阴性乳腺癌患者中的临床疗效以及毒副反应。方法选取新疆医科大学附属医院乳腺内科2015年1月1日—2017年12月31日收治的96例既往接受蒽环类或紫杉类药物治疗后复发转移的三阴性乳腺癌患者,按照数字随机分组法分为GP组(48例)和NX组(48例)。GP组给予GP方案(吉西他滨+顺铂),NX组给予NX方案(长春瑞滨+卡培他滨),共治疗6个周期。主要研究终点为客观缓解率(ORR)和疾病控制率(DCR),次要研究终点为肿瘤进展时间(TTP)和药物毒副反应。结果 NX组ORR、DCR虽高于GP组,但差异无统计学意义(P>0.05);GP组TTP略高于NX组,但差异无统计学意义(P>0.05);GP组患者血小板减少、胃肠道反应、肾功能损害的发生率高于NX组,差异有统计学意义(P<0.05);NX组手足综合征的发生率高于GP组,差异有统计学意义(P<0.05)。结论 GP方案与NX方案对复发转移性三阴性乳腺癌患者的疗效相当,值得肯定,不良反应可耐受,安全性高,可根据患者对不同治疗方案的耐受程度来选择合适的个体化治疗方案。

Objective To observe the clinical efficacy and toxic and side effects of GP regimen or NX regimen in patients with recurrent metastatic triple negative breast cancer.Methods Between January 1, 2015 and December 31,2017, 96 patients with recurrent and metastatic triple negative breast cancer who had previously received anthracycline or taxane treatment were selected from our hospital. They were randomly divided into two groups: 48 patients in the GP group and 48 in the NX group. The GP group was given the GP regimen(gemcitabine plus cisplatin);and the NX group was given the NX regimen(vinorelbine plus capecitabine). All patients had treatment for a total of 6 cycles. The primary study endpoint was objective response rate(ORR) and disease control rate(DCR), and the secondary study endpoint was time to tumor progression(TTP) and drug toxicity.Results The ORR and DCR in the NX group were higher than in the GP group, but there was no significant difference(P>0.05). The TTP in the GP group was slightly higher than in the NX group, but the difference was not statistically significant(P>0.05). The incidence rates of thrombocytopenia, gastrointestinal reactions and renal impairment were higher in the GP group than in the NX group(P<0.05). The incidence rate of hand-foot syndrome in the NX group was higher than in the GP group(P<0.05).Conclusion The GP or NX regimen had the same effects on the recurrent metastatic triple negative breast cancer. Both had tolerated adverse reactions and high safety. Both can be selected individually according to the tolerance of patients.