卡培他滨对比替吉奥治疗转移性乳腺癌的临床观察

Clinical observation of capecitabine vs. S-1 on patients with metastatic breast cancer

目的探讨卡培他滨对比替吉奥治疗转移性乳腺癌的疗效及安全性。方法收集2011年4月至2013年4月转移性乳腺癌患者100例,其中50例接受卡培他滨方案(2500 mg/m^2分2次口服,d_1～d_(14)),余50例患者接受S-1方案[40 mg(体表面积≤1.25 m^2)、50 mg(1.25 m^2<体表面积<1.5 m^2)或60 mg(体表面积≥1.5 m^2时)口服,d_1～d_(14)],两方案均以21天为1个周期。两个周期后采用RECIST 1.1版标准评价近期疗效,采用NCI CTC 4.0版标准评价不良反应,同时随访患者的生存情况。结果全组100例患者均可评价疗效,其中替吉奥组获CR 5例、PR 10例、SD 18例和PD 17例,有效率(RR)和疾病控制率(DCR)分别为30.0%(15/50)和66.0%(33/50);卡培他滨组获CR 10例、PR 7例,SD 18例和PD 15例,RR和DCR分别为34.0%(17/50)和70.0%(35/50),两组RR和DCR的差异无统计学意义(P>0.05)。卡培他滨组和替吉奥组的中位无进展生存期分别为4.3个月和5.1个月,中位总生存期分别为32.1个月和33.6个月,差异均无统计学意义(P>0.05)。两组的主要不良反应为高胆红素血症、食欲不佳、骨髓抑制、疲劳和手足综合征,其中替吉奥组高胆红素血症的发生率高于卡培他滨组,而手足综合征的发生率低于卡培他滨组,以上差异均有统计学意义(P<0.05);两组食欲不佳、骨髓抑制和疲劳发生率的差异无统计学意义(P>0.05)。结论卡培他滨与替吉奥二、三线治疗转移性乳腺癌在控制疾病进展和延长生存方面疗效相当;替吉奥可降低手足综合征的发生风险,提高日常生活质量,但需注意在治疗过程中监测血清胆红素水平。

Objective To investigate the efficacy and safety of capecitabine vs. S-1 in the treatment of metastatic breast cancer. Methods One hundred patients with metastatic breast cancer were enrolled from April 2011 to April 2013 and assigned into capecitabine group ( n = 50) and S-1 group ( n = 50). All patients in capecitabine group were orally given 2500 mg/m^ 2 of capecitabine daily from day 1 to day 14. All patients in S-1 group orally received S-1 twice every day from day 1 to 14. The dose of S-1 was determined according to the body surface area as follows:<1.25 m^ 2, 40 mg;1.25 to <1.5 m^ 2, 50 mg;and≥1.5 m ^2, 60 mg. Twenty-one days was a cycle for two regimens. Response to chemoradiotherapy was assessed by RECIST criteria 1.1 after 2 cycles. Toxicity was evaluated according to NCI CTC 4.0 criteria. Patients were followed up for survival. Results All the patients were evaluable for response. In capecitabine group, there were 5 cases of CR, 10 cases of PR, 18 cases of SD and 17 cases of PD with the response rate (RR) and disease control rate (DCR) of 30.0%(15/50) and 66.0%(33/50). In S-1 group, there were 10 cases of CR, 7 cases of PR, 18 cases of SD and 15 cases of PD with RR and DCR of 34.0%(17/50) and 70.0%(35/50). No significant difference was observed on RR and DCR between both groups ( P > 0.05). The median progression-free survival were 4.3 months and 5.1 months in capecitabine group and S-1 group ( P > 0.05). The median overall survival were 32.1 months and 33.6 months in capecitabine group and S-1 group ( P > 0.05). The main side effects of both groups were hyperbilirubinemia, poor appetite, bone marrow depression, fatigue and hand-foot syndrome. The incidence of hyperbilirubinemia in S-1 group was significantly higher than that in capecitabine group, while the incidence of hand-foot syndrome was lower than that in capecitabine group ( P < 0.05). There was no significant difference in the incidence of poor appetite, bone marrow depression and fatigue between the two groups ( P > 0.05). Conclusion Capecitabine and S-1 as second-and third-line chemotherapy for metastatic breast cancer possess similar effects on controlling disease progression and prolonging survival time. S-1 application can efficiently reduce the risk of hand-foot syndrome, improve the quality of daily life, but need to pay attention to monitoring the serum bilirubin level in the course of treatment.