低剂量卡培他滨联合奥沙利铂治疗高龄晚期贲门癌的临床研究

目的观察低剂量卡培他滨(Capecitabine,CAPE)联合奥沙利铂(Oxaliplatin,L-OHP)治疗高龄晚期贲门癌(Gastric cardiac adenocarcinoma,GCA)的疗效和安全性。方法 76例75岁以上晚期GCA患者随机分为低剂量组38例和对照组38例,均采用XELOX方案化疗,即低剂量组CAPE 650 mg/m2口服,对照组第1～14天CAPE 1 000 mg/m2口服,2次/d,两组第1、8天均联合L-OHP 65 mg/m2静脉滴注2 h,21 d为1周期,连续4～6个周期。化疗2个周期后评价肿瘤化疗敏感性和吞咽困难改善情况;化疗结束4周后进行近期疗效和不良反应评价。结果低剂量组和对照组比较,肿瘤化疗敏感性分别为73.7%(28/38)和76.3%(29/38),差异无统计学意义(χ2=0.070,P=0.791);吞咽困难改善率分别为84.2%(32/38)和86.8.0%(33/38),差异无统计学意义(χ2=0.106,P=0.744);近期疗效分别为81.6%(31/38)和78.9%(30/38),差异无统计学意义(χ2=0.083,P=0.773);中位无疾病进展生存期(Progression-Free survival,PFS)分别为5.80个月(95%可信区间5.69～5.91)和5.70个月(95%可信区间5.46～5.94),差异无统计学意义(P=0.4445);中位总体生存期(Overall survival,OS)分别为10.90个月(95%可信区间9.31-12.59)和11.00个月(95%可信区间10.55～11.45),差异无统计学意义(P=0.7815);两组不良反应均为可逆性,患者基本耐受,低剂量组手足综合征不良反应为34.2%(13/38),明显低于对照组63.2%(24/38)(χ2=6.373,P=0.012)。结论低剂量CAPE联合L-OHP治疗高龄晚期贲门癌患者有效率无明显下降,手足综合征不良反应发生率低。

Therapeutic Effect of Combination of Low-dose Capecitabine with Oxaliplatin on Elderly Patients with Advanced Gastric Cardiac Adenocarcinoma

Objective The effectiveness and safety of combination chemotherapy,using low-dose capecitabine(CAPE) with oxaliplatin(L-OHP),were evaluated in elderly patients with advanced gastric cardiac adenocarcinoma(GCA).The combination chemotherapy regimen was based on the XELOX regimen. Methods Seventy-six older patients(≥75 years old) with advanced GCA were divided into a low-dose group(CAPE 650 mg/m2,n=36) and a control group(CAPE 1 000 mg/m2,n=36).A 21-day cycle of the XELOX regimen was administered to the two groups as follows: CAPE(650 or 1 000 mg/m2,p.o.,b.i.d.) on days 1 to 14,followed by an off period of 7 days.L-OHP(65 mg/m2,i.v.,given over 2 h) was administered on days 1 and 8.This regimen was repeated for four to six cycles.Response and swallowing status were assessed after two treatment cycles(6 weeks).Effectiveness and toxicity were evaluated four weeks after chemotherapy was completed. Results The response rate was 73.7%(28/38) in the low-dose group and 76.3%(29/38) in the control group(χ2=0.070,P=0.791).Improvement in swallowing was 84.2%(32 /38) in the low-dose group and 86.8%(33 /38) in the control group(χ2 = 0.106,P = 0.744).Efficacy was 81.6%(31 /38) in the low-dose group and 78.9%(30 /38) in the control group(χ2 = 0.083,P = 0.773).Median time of progression-free survival(PFS) was 5.80 months(95% CI5.69 ～ 5.91) in the low-dose group and 5.70 months(95% CI5.46 ～ 5.94) in the control group(P = 0.445).The median overall survival(OS) was 10.90 months(95% CI9.31 ～ 12.59) in the low-dose group and 11.00 months(95% CI 10.55 ～ 11.45) in the control group(P = 0.782).Toxicities were reversible and well tolerated in both groups.Hand-foot syndrome was 34.2%(13 /38) in the low dose group.This was significantly lower than in the control group,which was 63.2%(24 /38)(χ 2 = 6.373,P = 0.012).Conclusion Combination chemotherapy using low-dose CAPE with L-OHP(XELOX regimen) in older patients with advanced GCA shows no obvious decline in effectiveness,and the incidence of Hand-foot syndrome is significantly reduced.