紫杉醇和卡培他滨联合恩度治疗晚期胃癌腹膜转移的临床观察

Clinical observation of paclitaxel combined with capecitabine plus endostar in the treatment of advanced gastric cancer with peritoneal metastasis

目的:评价周剂量紫杉醇/卡培他滨(TX)加恩度方案治疗腹膜转移晚期胃癌的疗效和不良反应。方法:43例经病理学或组织细胞学确诊为腹膜转移的晚期胃癌患者分为试验组和对照组。试验组:TX方案加恩度,紫杉醇80mg/(m2.d),静脉滴入,d1、d8;卡培他滨2 000mg/(m2.d),分早晚2次口服,d1～d14;恩度7.5mg/(m2.d),静脉滴入,d1～d14;每21d重复。对照组:TX方案,紫杉醇80mg/(m2.d),静脉滴入,d1、d8;卡培他滨2 000mg/(m2.d),分早晚2次口服,d1～d14;每21d重复。观察有效率(RR)、疾病控制率(DCR)、1年生存率、中位生存时间(MST)以及安全性。结果:43例患者中,23例患者加用恩度(试验组),其余20例患者未加用恩度(对照组)。试验组17例有可评价靶病灶,对照组12例有可评价靶病灶,RR分别为58.8%(10/17)和41.7%(5/12),χ2=3.948,P=0.039;DCR分别为88.2%(15/17)和83.4%(10/12),χ2=0.882,P=0.365;1年生存率分别为69.7%和54.9%,MST分别为16.5和12.5个月。两组生存曲线比较,试验组优于对照组,P=0.042;两组在血液学毒性及非血液学毒性反应方面差异均无统计学意义,P>0.05。结论:周剂量紫杉醇联合卡培他滨加恩度方案能提高腹膜转移晚期胃癌的疗效和生存,且毒副作用可耐受,值得临床进一步研究。

OBJECTIVE： To evaluate the efficacy and adverse events of weekly paclitaxel combined with capecitabine plus endostar in advanced gastric cancer patients with peritoneal metastasis. METHODS： Forty-three histologically or cy- tologically confirmed advanced gastric cancer patients with peritoneal metastasis were enrolled in trial group [TX plus en- dostar：Paclitaxel was administered i. v. at 80 mg/（m2 · d） on days 1 and 8. Capecitabine was administered at 2 000 mg/m2 for 14 consecutive days. Endostar was administered i.v. at 7.5 mg/（m2 · d） on days 1-14, repeat every 21 days] or control group[TX： Paclitaxel was administered i. v. at 80 mg/（m2 · d） on days 1 and 8. Capecitabine was ad- ministered at 2 000 mg/m2. for 14 consecutive days repeat every 21 days]. The trial endpoints included response rate （RR）,disease control rate（DCR）, 1 year survival rate,median survival time（MST） and safety. RESULTS： Of forty-three patients ,23 patients were in the trial group and 20 patients were in the control group. Seventeen patients in the trial group were evaluable for efficacy and twelve patients in the control group were evaluable for efficacy. Response rate（RR） was 58.8 % （10/17） in the trial group and 41.7 % （5 / 12） in the control group （ X2= 3.948, P = 0.039）. The disease control rate （DCR） was 88.2%（15/17） in the trial group and 83.4%（10/12） in the control group（3C =0. 882,P=0. 365）. One year survival rate was 69.70%in the trial group and 54.9% in the control group. The median survival time（MST） was 16.5 months in the trial group and 12.5 months in the control group, respectively. The comparison of survival curve between two groups showed that the trial group was associated with better survival（P= 0. 042）. There were no significant differ- ence of hematologic and non hematologic toxicity between two groups. CONCLUSIONS： Endostar in combined with week- ly paclitaxel and capecitabine shows a better efficacy, survival time and is well tolerated in gastric cancer patients with per- itoneal metastasis. It is worthy of further clinical studies.