替吉奥联合奥沙利铂一线治疗晚期结直肠癌的疗效及安全性研究

目的 观察替吉奥联合奥沙利铂一线治疗晚期结直肠癌的疗效及安全性.方法 选取确诊为晚期结直肠癌患者58例,按随机数字表法分为替吉奥联合奥沙利铂(SOX)组29例及mFOLFOX6组29例,SOX组:奥沙利铂130 mg·m-2,静脉滴注2 h,第1天.根据体表面积选择替吉奥给药剂量(体表面积<1.25 m2,40 mg,每日2次;1.25~1.5 m2,50 mg,每日2次;>1.5 m2,60 mg,每日2次),早晚餐后口服,连续给药14 d,停药7 d;每3周重复.mFOLFOX6组:奥沙利铂85 mg·m-2,静滴2 h,第1天;亚叶酸钙400 mg·m-2,使用奥沙利铂后静滴2 h,第1天;5-氟尿嘧啶 400 mg·m-2静推,第1天,随后2 400 mg·m-2持续静滴46 h,每2周重复.SOX组及mFOLFOX6组均每6周进行疗效评价,每周期进行安全性评价,两组患者均接受随访评估一线治疗无进展生存时间(PFS).结果 SOX组客观反应率(ORR)率为31%,疾病控制率(DCR)率为82.8%,中位PFS为6.1个月;mFOLFOX6组ORR率34.5%,DCR率86.2%,中位PFS为6.8个月,两组比较差异无统计学意义(P>0.05).两组不良反应发生率相当,多为Ⅰ~Ⅱ级,可耐受.但SOX组Ⅲ~Ⅳ级血小板减少发生率明显高于mFOLFOX6组,差异有统计学意义(P<0.05).结论 SOX方案治疗晚期结直肠癌患者与mFOLFOX6方案相比,疗效相当,且口服便捷,可院外给药,有利于提高生活质量.但其Ⅲ~Ⅳ级血小板减少发生率高于mFOLFOX6组,长程给药需注意监测血常规.

Efficacy and safety of s-1 and oxaliplatin(SOX) as first-line chemotherapyfor metastatic colorectal cancerNING Jie,JIAO Yang,LI Min,LIU Pingping,MA Tai,XIONG Fuxing,GU Kangsheng (Department of Oncology,The First Affiliated Hospital of Anhui Medical University,Hefei,Anhui 230022,China) Abstract:Objective

Objective To compare the efficacy and safety of s-1 and oxaliplatin(SOX) as the first-line chemotherapy in patients with advanced colorectal cancer(ACC).Methods Patients with ACC and no prior chemotherapy were randomly assigned into SOX group(n=29) and mFOLFOX6 group(n=29).In SOX group oxaliplatin (130 mg·m-2) was administered on day 1,iv 2 h,plus postprandial oral administration of S-1(40-60mg twice daily according to body surface area(40 mg twice daily if BSA < 1.25 m2;50 mg twice daily if 1.25 m2≤BSA≤1.5 m2;and 60 mg twice daily if BSA>1.5 m2) ,on days 1-14 ,repeated every 3 weeks.In mFOLFOX6 group oxaliplatin 85 mg·m-2 was administered on day 1,iv 2 h,plus a 2-hour infusion of LV (400 mg·m-2) followed by a 5-fluorouracil(400 mg·m-2) on day 1 and 5-fluorouracil 46-hour infusion (2 400 mg·m-2),repeated every 2 weeks.Response assessment was done every 6 weeks in both groups,and safety assessment was done every cycle.All patients received follow-up to assess the first-line progression-free survival(PFS).Results The objective response rates,disease control rates and median PFS were 31% vs 34.5%,82.8% vs 86.2%,and 6.1 months vs 6.8 months in SOX group and mFOLFOX6 group respectively.There were no significant differences between the two groups(P>0.05).Major treatment-related adverse events were gradeⅠ-Ⅱin intensity in the two groups,both well-tolerated and the difference was not statistically significant.However,grade Ⅲ-Ⅳ thrombocytopenia(P<0.05)were more frequent in SOX group.The difference was statistically significant (P<0.05).Conclusions This study demonstrates that SOX is as effective as mFOLFOX6 in treating patients with ACC.Oral administration of SOX can improve the patients′ quality of life.However,because of the high incidence rate of thrombocytopenia,blood routine examination monitoring is recommended during SOX treatment.