卡培他滨联合顺铂与卡培他滨联合多西他赛治疗三阴性复发转移性乳腺癌的临床研究

Comparison of Capecitabine plus Cisplatin with Capecitabine plus Docetaxel for treatment of recurrent metastatic triple negative breast cancer

摘要:

比较卡培他滨联合顺铂与卡培他滨联合多西他赛治疗三阴性复发转移性乳腺癌的临床疗效及其安全性。方法 将 58 例三阴性复发转移性乳腺癌病例随机分为 A 组和 B 组，A 组进行卡培他滨联合顺铂方案化疗，B 组进行卡培他滨联合多西他赛方案化疗，21 d 为 1 个周期，至少应用 2 个周期。结果 A 组 26 例，B 组 32 例，可评价疗效 A 组 22 例，B 组 30 例，两组患者基线情况无统计学差异。A、B 两组的完全缓解率（9.1%vs 3.3%， =0.781）差异无统计学意义，A 组的疾病控制率（86.4% vs 53.3%， =0.012）和客观缓解率（50.0% vs23.3%， =0.046）均较 B 组高，差异具有统计学意义。A、B 两组的中位无进展生存期（PFS）分别为 7.5 和 5.5 个月，差异具有统计学意义（ =0.015）；中位总生存期（OS）两组分别为 19.7 个月和 13.3 个月，差异具有统计学意义（ =0.037）。A、B 两组常见的Ⅲ～Ⅳ度不良反应为白细胞减少和粒细胞减少。其他常见的不良反应多为Ⅰ～Ⅱ度，其中脱发发生率 A 组 0.05）。结论 卡培他滨联合顺铂方案的疗效较卡培他滨联合多西他赛方案有优势，其不良反应可耐受，在临床实践中可作为复发转移性三阴性乳腺癌解救治疗的有效选择之一。

Abstract:

To compare the efficacy and safety of Capecitabine plus Cisplatin (XP)and Capecitabine plus Docetaxel(TX)in treatment of recurrent metastatic triple negative breast cancer(TNBC).Methods In this study 58 patients with recurrent metastatic TNBC were randomly distributed togroup A (26 cases)and group B (32 cases).The patientsin the group A were treated with XP regimen and those in the group B were treated with TX regimen for21 days as a cycle,atleasttwo cycles were applied.Results The group A and the group B had consistent baseline.Therewere 22 casesin thegroup A and 30 casesin thegroup B evaluable for their clinical responses.No significant difference was found in the complete remission rate between the two groups(9.1% vs3.3% ， = 0.781).The disease controlrate(86.4% vs53.3% ， = 0.012)and the objective remission rate (50.0% vs23.3% ， = 0.046)of the group A were significantly higherthan those of the group B.There were significant differences in the median PFS (7.5 monthsvs5.5 months, = 0.015)and the median OS (19.7 monthsvs13.3 months, = 0.037)between the groups A and B.The common degree Ⅲ and Ⅳ adverse reactions in the two groups were leucopenia and granulono significant differences in the incidences of adverse reactions except for alopecia(15.4% vs56.3% , = 0.001).Conclusions The clinicalefficacy of XP regimen is significantly superior to that of TX regimen.Its adverse reactions are tolerable. The XP regimen can be one of the effective options for the treatment of recurrent metastasis TNBC in clinical practice.penia.Other common adverse reactionsin the two groupswere of degreeⅠ and Ⅱ.The two groups showed no significant differencesin theincidences of adverse reactions except for alopecia(15.4% vs56.3% , = 0.001).Conclusions The clinicalefficacy of XP regimen is significantly superior to that of TX regimen.Its adverse reactions are tolerable. The XP regimen can be one of the effective options for the treatment of recurrent metastas is TNBC in clinical practice.