含脂质体阿霉素方案在乳腺癌术后辅助化疗中的安全性评价

Safety analysis of liposomal doxorubicin-based adjuvant chemotherapy in breast cancer

目的评价含脂质体阿霉素方案在乳腺癌术后辅助化疗中的安全性。方法收集2014年9月至2016年8月接受术后辅助化疗的乳腺癌患者29例。化疗方案分别为:3周FAC方案(5-FU 500 mg/m^2,脂质体阿霉素30 mg/m^2,环磷酰胺500 mg/m^2,每21天重复,共3个周期)14例;2周AC方案(脂质体阿霉素30 mg/m^2,环磷酰胺600 mg/m^2;每14天重复,共4个周期)11例;3周AC方案(脂质体阿霉素30 mg/m^2,环磷酰胺600 mg/m^2;每21天重复,共4个周期)4例。毒副反应按照NCI CTCAE 4.0.3版本分为1~5级。心脏毒性的评估包括定期检查心电图、心脏超声等。结果所有患者中最显著的毒副反应为中性粒细胞减少,发生率为79.3%(23/29);其次为手足综合征和口腔炎,发生率分别为51.7%(15/29)、27.6%(8/29)。AC方案组患者3级手足综合征的发生率为26.7%(4/15),高于FAC方案组的0(0/14)。本组中无1例左心室射血分数降低10%以上;无1例出现充血性心力衰竭。结论含脂质体阿霉素方案在乳腺癌术后辅助化疗中是安全的。

Objective To evaluate the safety of liposomal doxorubicin-based regimen in postoperative adjuvant chemotherapy for breast cancer. Methods From September 2014 to August 2016,29 breast cancer patients were treated with liposomal doxorubicinbased adjuvant chemotherapy in our department. Fourteen patients were treated with 3 cycles of FAC（ 5-FU 500 mg/m^2,liposomal doxorubicin 30 mg/m^2,CTX 500 mg/m^2,every 3 weeks）; Eleven patients received 4 cycles of AC by a two-week program（ liposomal doxorubicin 30 mg/m^2,CTX 600 mg/m^2,every 2 weeks）; Four patients were treated with 4 cycles of AC by a three-week program（ liposomal doxorubicin 30 mg/m^2,CTX 600 mg/m^2,every 3 weeks）. The adverse events estimated by NCI CTCAE 4. 0. 3 criterion were divided into 1-5 levels. The cardiotoxicity was evaluated by examination of electrocardiogram and echocardiography periodically,and so on. Results The major hematological toxicity of 29 patients was neutropenia,and the incidence was about 79. 3%（ 23/29）. Most common nonhematologic toxicities were hand-foot syndrome and oral mucotitis,and the incidence was about 51. 7%（ 15/29）,27. 6%（ 8/29） respectively. The incidence of severe hand-foot syndrome（ grade 3） in AC group was 26. 7%（ 4/15）,higher than 0（ 0/14）in FAC group（ P〈0. 05）. There was no patient whose left ventricular ejection fraction（ LVEF） deceased more than ten percent,and no patient with signs and symptoms of congestive heart failure during chemotherapy. Conclusion Liposomal doxorubicin-based adjuvant chemotherapy can be safe in the treatment of breast cancer.