羟基喜树碱联合卡培他滨和亚叶酸钙治疗晚期结直肠癌的临床研究

Preliminary clinical study on HCPT combined with capecitabine and calcium folinate in treating patients with advanced colorectal carcinoma

目的:观察羟基喜树碱(HCPT)联合卡培他滨(Xeloda)和亚叶酸钙(CF)治疗晚期结直肠癌的有效性及安全性。方法:全组共44例,入组后给予HLX方案化疗,HCPT6mg/m2,加入0.9%氯化钠注射液500ml中静脉滴注,第1～5天;希罗达1250mg/m2,分2次口服,第1～14天;亚叶酸钙片50mg口服,每日2次,第1～14天,每3周重复,2周期后按照RE-CIST标准评价近期客观疗效,按照NCI-CTC评价毒性反应。结果:全组共接受了242个周期化疗,平均每例5.6个周期(2～8个周期)。43例可评价疗效,44例可评价毒副反应。获得CR2例(4.7%),PR9例(20.9%),有效率(RR)为25.6%,疾病控制率(DCR)62.8%。中位疾病进展时间(TTP)6.0个月(95%CI:4.8～7.2个月)。毒副反应主要为骨髓抑制,以Ⅰ～Ⅱ度为主,出现Ⅲ度白细胞下降2例,Ⅲ度血小板下降4例;Ⅲ度口腔溃疡1例,Ⅲ度手足综合征2例。结论:HLX方案治疗晚期结直肠癌有较确切的疗效,并且毒性可以耐受,值得临床进一步应用。

Objective：To observe the availability and the safety of the therapy of HCPT combine with capecitabine （xeloda） and calcium folinate tablets in colorectal cancer. Methods：A total of 44 patients with colorectal cancer were included in the study, which were received HLX chemotherapy regimen to the patients, that＇s 6mg per square meter of HCPT parenteral solution, added to 500ml of 0. 9% sodium chloride injection, intervenous drop infusion days 1-14, and xeloda 1 250mg/m^2 and calcium folinate tablets 50 mg p. o twice daily, oral application on days 1-14. To evaluate the near future therapeutic effect according to the RECIST standard and to evaluate the toxic reaction according to the NCI-CTC standard two weeks later. Results： Overall 242 cycles were administrated to the 44 patients （average 5-6 cycles per patients, range 2-8 cycles）. Forty three patients could evaluate the near future therapeutic effect, 44 patients could evaluate toxic reaction. The overall response rate （RR） was 25.6% , the disease control rate （DCR） was 62. 8%. Two patients got clinic comphed relief, 9 patients got partial relief. The TTP was 6 months（95% CI, 4. 8-7.2 months） , the common toxic reaction was bone marrow depression. Conclusion ：The therapy of colorectal cancer with HLX chemotherapy regimen had indeed better therapeutic effect, moreover the toxic reaction was tolerant, further clinic application has more worthy.