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目的评价海王替吉奥片联合顺铂一线治疗晚期胃癌的有效性、安全性。方法采用多中心、随机、开放,与顺铂联合氟尿嘧啶、亚叶酸钙的常规方案阳性对照研究,将177例患者按2:1分别入选试验组和对照组。试验组122例患者给予替吉奥片40mg/m2,2次/d,连续口服21d;顺铂60mg/m2,静脉滴注,于化疗第8天开始使用;每35天为1个周期,共2～6周期。对照组55例患者给予亚叶酸钙200mg/d,静脉滴注,于化疗第1～5天使用;氟尿嘧啶400mg/m2,静脉滴注4～6h,于化疗第1～5天使用;顺铂60mg/m2,静脉滴注,于化疗第1天开始使用;每28天为1个周期,共2～6周期。结果入组177例患者中,进入全分析集(FAS分析)试验组122例,对照组55例;符合方案集(PPS分析)试验组99例,对照组44例;安全性分析试验组122例,对照组55例。作为主要疗效指标的两组中位至肿瘤进展时间(mTTP),按FAS分析,试验组为21.0周(9.0～33.0周),对照组为9.0周(6.0～21.0周),差异有统计学意义(P=0.001);按PPS分析,试验组为22.0周(13.0～34.0周),对照组为12.5周(8.0～24.0周),差异有统计学意义(P=0.002)。不良反应主要是恶心呕吐(试验组63.93%,对照组67.27%)、腹泻(试验组19.67%,对照组7.27%)、便秘(试验组13.93%,对照组5.45%)、食欲不振(试验组1.64%,对照组5.45%)等消化道症状及脱发(试验组9.02%,对照组10.91%)、口腔炎(试验组5.74%,对照组7.27%);除试验组腹泻发生率相对高(P=0.0446)外,差异均无统计学意义(P>0.05)。其中Ⅲ或Ⅳ度临床症状不良反应主要为恶心呕吐(试验组8.20%,对照组10.91%)、腹泻(试验组4.10%,对照组1.82%),两组Ⅲ或Ⅳ度临床症状不良反应发生率比较,差异均无统计学意义(P>0.05)。结论国产海王替吉奥片联合顺铂用于晚期胃癌的一线治疗,疗效优于传统氟尿嘧啶联合顺铂方案,其耐受性好,使用方便,具有广阔的临床应用前景。
Objective To evaluate the effectiveness and safety of neptunian tiotropium combined with cisplatin in the treatment of advanced gastric cancer. METHODS: A multicenter, randomized, open-label, positive control study of conventional regimens with cisplatin plus fluorouracil and leucovorin was conducted. 177 patients were enrolled in the test and control groups, respectively, at a 2: 1 ratio. In the experimental group, 122 patients were treated with tiotropium 40mg / m2,2 times / d for 21 days continuously; cisplatin 60mg / m2 was given intravenously on the 8th day of chemotherapy; every 35 days was 1 cycle 2 to 6 cycles. 55 patients in the control group were given leucovorin 200mg / d, intravenous infusion, in the first to fifth days of chemotherapy; fluorouracil 400mg / m2, intravenous infusion of 4 ~ 6h, 1 to 5 days of chemotherapy; cisplatin 60mg / m2, intravenous infusion, started on the first day of chemotherapy; every 28 days for a cycle, a total of 2 to 6 cycles. Results Among the 177 patients enrolled in the study, 122 patients in the FAS analysis group and 55 patients in the control group were enrolled in the study. Among them, 99 were in the experimental group (PPS analysis), 44 in the control group, 122 in the safety analysis test group , Control group of 55 cases. The median time to tumor progression (mTTP) as the primary efficacy index was 21.0 weeks (9.0-33.0 weeks) in the test group and 9.0 weeks (6.0-21.0 weeks) in the control group according to FAS analysis, with a statistically significant difference (P = 0.001). According to PPS analysis, the test group was 22.0 weeks (range, 13.0-34.0 weeks) and the control group was 12.5 weeks (8.0-24.0 weeks), the difference was statistically significant (P = 0.002). Adverse reactions were mainly nausea and vomiting (63.93% in the test group and 67.27% in the control group), diarrhea (19.67% in the test group and 7.27% in the control group), constipation (13.93% in the test group and 5.45% in the control group), poor appetite (Control group 9.02%, control group 10.91%), stomatitis (experimental group 5.74%, control group 7.27%); except for the incidence of diarrhea in the experimental group was relatively high (P = 0.0446), the differences were not statistically significant (P> 0.05). The clinical symptoms of grade Ⅲ or Ⅳ were mainly nausea and vomiting (8.20% in the trial group and 10.91% in the control group), diarrhea (4.10% in the trial group and 1.82% in the control group), and the incidence of clinical symptoms in both groups There was no significant difference between the two groups (P> 0.05). Conclusion The combination of domestic Neptunin and tiotropium combined with cisplatin for the first-line treatment of advanced gastric cancer is superior to the traditional fluorouracil and cisplatin regimen in that it is well tolerated, easy to use and has broad clinical application prospects.