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目的研究羟甲戊二酰辅酶A还原酶(HMG-CoA)抑制剂辛伐他汀联合卡培他滨顺铂(XP)治疗非手术晚期胃癌(AGC)患者的临床疗效。方法对2009年2月—2014年11月间244例患者进行双盲安慰剂对照临床研究。患者年龄≥18岁,组织学或细胞学证实胃或胃食管交界处腺癌(GEJ)。患者按疾病可测性随机分为2组,治疗组120例,安慰剂组124例。治疗组:第1~14天卡培他滨1 000 mg/m~2,2次/d,加辛伐他汀40 mg,1次/d,同时第1天,加顺铂80 mg/m~2,每3周为一个周期;安慰剂组:第1~14天卡培他滨1 000 mg/m~2,2次/d,加安慰剂40 mg,1次/d,同时第1天,加顺铂80 mg/m~2,每3周为一个周期。顺铂治疗8周期;卡培他滨和辛伐他汀给予直至疾病进展或出现不可受毒性。结果治疗组中位无进展生存期(PFS)5.2个月(95%CI 4.3~6.1);安慰剂组中位无进展生存期(FPS)4.63个月(95%CI 3.5~5.7),危险比0.930,95%CI 0.684~1.264;P=0.642。治疗组整体缓解率为27.5%,安慰剂组整体缓解率为29.0%,二者相比较差异无统计学意义(χ~2=0.08,P>0.05)。治疗组63例(52.5%)和安慰剂组70例(56.4%)出现3级以上药物不良反应。结论治疗组药物毒性虽不增加,但未延长PFS。化疗方案加入低剂量的辛伐他汀(40 mg),并不适合AGC人群。
Objective To investigate the clinical efficacy of simvastatin combined with capecitabine and cisplatin (HMG-CoA) inhibitor in the treatment of patients with advanced non-surgical gastric cancer (AGC). Methods 244 double-blind, placebo-controlled, controlled trials between February 2009 and November 2014 were performed. Patients were ≥18 years of age and histologically or cytologically confirmed gastric or gastroesophageal junction adenocarcinoma (GEJ). The patients were randomly divided into two groups according to disease predictability: 120 cases in the treatment group and 124 cases in the placebo group. The treatment group: capecitabine 1 000 mg / m ~ 2, 2 times / d on the 1st to 14th, simvastatin 40 mg, 1 / d, on the 1st day, plus cisplatin 80 mg / m ~ 2 every 3 weeks for one cycle; placebo group: capecitabine 1 to 14 days 1 000 mg / m to 2, 2 times / d, plus placebo 40 mg, 1 / d, while the first day , Plus cisplatin 80 mg / m ~ 2 every 3 weeks for a cycle. Cisplatin is administered for 8 cycles; capecitabine and simvastatin are administered until the disease progresses or appears unacceptable. Results The median progression-free survival (PFS) was 5.2 months (95% CI 4.3 to 6.1) in the treatment group and 4.63 months (95% CI 3.5 to 5.7) in the placebo group. The hazard ratio 0.930, 95% CI 0.684-1.264; P = 0.642. The overall response rate was 27.5% in the treatment group and 29.0% in the placebo group. There was no significant difference between the two groups (χ ~ 2 = 0.08, P> 0.05). Sixty-three (52.5%) patients in the treatment group and 70 patients (56.4%) in the placebo group experienced adverse drug reactions of grade 3 or higher. Conclusions The drug toxicity of the treatment group did not increase, but did not prolong the PFS. Chemotherapy regimen with low-dose simvastatin (40 mg) is not suitable for AGC populations.