多西紫杉醇联合卡培他滨治疗转移性乳腺癌的临床研究

背景与目的:对于既往使用过含蒽环、紫杉醇药物方案化疗失败的复发转移性乳腺癌,可用的药物不多.多西紫杉醇(docetaxel)联合卡培他滨(capecitabine)是近年来治疗转移性乳腺癌一个较新的方案,本研究初步探讨多西紫杉醇联合卡培他滨(DC)治疗转移性乳腺癌的近期疗效和安全性情况.方法:31例女性转移性乳腺癌患者接受多西紫杉醇联合卡培他滨方案化疗.卡培他滨2 500 mg·(m2·d)-1,第1～14天,分2次饭后30 min口服;多西紫杉醇75 mg/m2静滴1 h,第1天.方案21天重复循环.在多西紫杉醇用药前1天,开始口服地塞米松8 mg,每天2次,连用3天.结果:31例患者使用DC方案化疗共116疗程,中位疗程数为3.7个.总有效率(response rate,RR)为41.9%(13/31),完全缓解(complete remission,CR)3例(9.6%).主要不良反应为乏力、骨髓抑制、胃肠道反应、手足综合征、粘膜炎等.中位随访时间10.8个月(2～23个月),死亡2例(均死于肿瘤进展),中位无进展生存期(progression-free survival,PFS)5.7个月(2～12个月).结论:多西紫杉醇与卡培他滨联合治疗转移性乳腺癌,有效率高、疗效肯定、不良反应可以耐受,为治疗转移性乳腺癌的有效方案.

Efficacy of docetaxel combined capecitabine on metastatic breast cancer

BACKGROUND & OBJECTIVE: Few treatment options are available for metastatic breast cancer with resistance to both anthracycline- and taxane-based chemotherapy regimens. Docetaxel combined capecitabine (DC regimen) is approved as a new active regimen for metastatic breast cancer. This study was to explore the efficacy of DC regimen on metastatic breast cancer, and evaluate its safety. METHODS: A total of 31 metastatic breast cancer patients received DC regimen during each 3-week chemotherapy cycle. All patients received oral administration of capecitabine (1250 mg/m2) twice daily, within 30 min after meal on day 1 to Day 14, and infusion of docetaxel (75 mg/m2) on the first day of each 3-week cycle. All patients received prophylactic therapy with oral dexamethasone (8 mg) twice daily on 3 successive days. RESULTS: A total of 116 cycles of DC regimen were administered, with a median of 3.7 cycles. The objective response rate was 41.9%, with a complete remission (CR) rate of 9.6%. The most frequent treatment-related adverse events were fatigue, leukopenia, nausea, vomiting, hand-foot syndrome, and stomatitis. The median follow-up was 10.8 months (range 2-23 months). Two patients were died of tumor progression. CONCLUSION: The combination of docetaxel and capecitabine provides a well-tolerated and active chemotherapy regimen for metastatic breast cancer.