替吉奥单药治疗胆管细胞癌根治术患者的临床疗效

Effects of S1 single agent chemotherapy in the radical resection of cholangiocarcinoma

  • 摘要: 目的:探讨替吉奥单药治疗胆管细胞癌根治术患者的临床疗效。
    方法:回顾性分析2011年11月至2013年12月浙江大学医学院附属第二医院收治的51例行胆管细胞癌根治术患者的临床资料。25例患者术后未行化疗,设为未化疗组;26例患者术后行替吉奥单药化疗,设为化疗组。未化疗组患者行胆管细胞癌根治术后无特殊处理。化疗组患者术后给予替吉奥单药化疗,用法:口服,2次/d,分别为早、晚餐后;用量:体表面积<1.25 m2的患者为40 mg/次,1.25 m2≤体表面积<1.50 m2的患者为50 mg/次,体表面积≥1.50 m2的患者为60 mg/次。连续用药14 d后停药7 d,为1个疗程。常规给予6~8个疗程。采用门诊和电话方式进行随访,随访时间截至2014年12月1日。计数资料比较采用χ2检验。符合正态分布的计量资料以±s表示,采用t检验进行比较。采用KaplanMeier法绘制生存曲线,Logrank检验进行生存分析。
    结果:化疗组26例患者均完成化疗疗程,无化疗相关死亡患者。14例患者出现化疗不良反应,停药后均明显缓解。51例患者均获得随访,随访时间为5~37个月,中位随访时间为19个月。未化疗组患者总体中位生存时间为22个月(18~27个月),1、3年总体生存率分别为72.3%和42.9%;无瘤中位生存时间为21个月(16~26个月),1、3年无瘤生存率分别为60.0%和55.0%。化疗组患者总体中位生存时间为32个月(29~35个月),1、3年总体生存率分别为84.6%和44.4%;无瘤中位生存时间为26个月(21~31个月),1、3年无瘤生存率分别为76.9%和61.9%。两组患者总体生存情况比较,差异有统计学意义(χ2=6.032,P<0.05);两组患者无瘤生存情况比较,差异无统计学意义(χ2=0.498,P>0.05)。
    结论:胆管细胞癌患者行根治术后给予替吉奥化疗,能取得明显的生存获益,但在抑制胆管细胞癌复发方面,无明显优势。

     

    Abstract: Objective:To explore the clinical effects of S1 single agent chemotherapy for the patients undergoing radical resection of cholangiocarcinoma.
    Methods:The clinical data of 51 patients receiving radical resection of cholangiocarcinoma who were admitted to the Second Affiliated Hospital of Zhejiang University from November 2011 to December 2013 were retrospectively analyzed. After radical resection of cholangiocarcinoma, 25 patients receiving nonspecial treatment and 26 patients receiving S1 single agent chemotherapy were divided into the operation group and chemotherapy group, respectively. S1 was taken orally twice per day. Forty mg/once of S1 was applied to patients with the body surface area<1.25 m2, 50 mg/once of S1 was applied to patients with the body surface area ≥1.25 m2 and <1.50 m2, and 60 mg/once of S1 was applied to patients with the body surface area ≥1.50 m2.  The 14 days usage and 7 days withdrawal of S1 were used as one course of treatment. The standard usage of S1 was 6-8 courses of treatment. All the patients were followed up by outpatient examination and telephone interview till December 1, 2014.  Count data were analyzed using the chisquare test. Measurement data with normal distribution were presented as ±s and analyzed using the t test. Survival curve was drawn by the KaplanMeier method, and survival analysis was done using the Logrank test.
    Results:Twentysix patients in the chemotherapy group finished the courses of chemotherapy without chemotherapyrelated death, and 14 patients had chemotherapy adverse reactions with remission after discontinuation of S1. All the 51 patients were followed up for 5-37 months with a median time of 19 months. The median overall survival time, 1, 3year overall survival rates, tumorfree median survival time and 1 , 3year tumorfree survival rates were 22 months (range, 18-27 months), 72.3%, 42.9%, 21 months (range, 16-26 months), 60.0%, 55.0% in the operation group and 32 months (range, 29-35 months), 84.6%, 44.4%, 26 months (range, 21-31 months), 76.9%, 61.9% in the chemotherapy group, respectively. There was a significant difference in the overall survival between the 2 groups (χ2=6.032, P<0.05). There was no significant difference in the tumorfree survival between the 2 groups (χ2=0.498,  P>0.05).
    Conclusion:S1 single agent chemotherapy after radical resection of cholangiocarcinoma could improve the survival of patients, while no obvious advantages of inhibiting tumor recurrence is observed.

     

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