卡培他滨和奥沙利铂治疗进展期食管癌和胃癌
Capecitabine and Oxaliplatin for Advanced Esophagogastric CancerABSTRACT
摘要
Background We evaluated capecitabine (an oral fluoropyrimidine) and oxaliplatin (a platinum compound) as alternatives to infused fluorouracil and cisplatin, respectively, for untreated advanced esophagogastric cancer.
背景：我们对卡培他滨（一种口服的氟嘧啶）和奥沙利铂（一种铂化合物）分别作为注射用氟尿嘧啶和顺铂的替代药物用于未经治疗的进展期食管癌和胃癌进行了评估。
Methods In a two-by-two design, we randomly assigned 1002 patients to receive triplet therapy with epirubicin and cisplatin plus either fluorouracil (ECF) or capecitabine (ECX) or triplet therapy with epirubicin and oxaliplatin plus either fluorouracil (EOF) or capecitabine (EOX). The primary end point was noninferiority in overall survival for the triplet therapies containing capecitabine as compared with fluorouracil and for those containing oxaliplatin as compared with cisplatin.
方法：在一个2×2的设计中，我们随机安排1002名患者接受如下三联疗法：表柔比星、顺铂加氟尿嘧啶（ECF方案）或卡培他滨（ECX方案），或表柔比星、奥沙利铂加氟尿嘧啶（EOF方案）或卡培他滨（EOX方案）。主要终点是卡培他滨与氟尿嘧啶作对比的三联疗法以及奥沙利铂与顺铂作对比的三联疗法各自的总体生存率的非劣效性检验。
Results For the capecitabine–fluorouracil comparison, the hazard ratio for death in the capecitabine group was 0.86 (95% confidence interval , 0.80 to 0.99); for the oxaliplatin–cisplatin comparison, the hazard ratio for the oxaliplatin group was 0.92 (95% CI, 0.80 to 1.10). The upper limit of the confidence intervals for both hazard ratios excluded the predefined noninferiority margin of 1.23. Median survival times in the ECF, ECX, EOF, and EOX groups were 9.9 months, 9.9 months, 9.3 months, and 11.2 months, respectively; survival rates at 1 year were 37.7%, 40.8%, 40.4%, and 46.8%, respectively. In the secondary analysis, overall survival was longer with EOX than with ECF, with a hazard ratio for death of 0.80 in the EOX group (95% CI, 0.66 to 0.97; P=0.02). Progression-free survival and response rates did not differ significantly among the regimens. Toxic effects of capecitabine and fluorouracil were similar. As compared with cisplatin, oxaliplatin was associated with lower incidences of grade 3 or 4 neutropenia, alopecia, renal toxicity, and thromboembolism but with slightly higher incidences of grade 3 or 4 diarrhea and neuropathy.
结果：在卡培他滨—氟尿嘧啶对照试验中，卡培他滨组的死亡风险比为0.86（95%的可信区间，0.80－0.99）；在奥沙利铂—顺铂对照试验中，奥沙利铂组的死亡风险比为0.92（95%的可信区间，0.80－1.10）。两组风险比可信区间的上限值不包括预定的非劣效性检验界限值1.23。ECF，ECX，EOF及EOX各方案组的中位生存时间分别为9.9个月，9.9个月，9.3个月及11.2个月；一年生存率分别为37.7%，40.8%，40.4%和46.8%。二级分析显示，EOX方案组的总体生存时间比ECF方案组更长，其中EOX方案组的死亡风险比为0.80（95%的可信区间，0.66－0.97;P=0.02）。不同方案之间无进展生存率和有效率无显著性差异。卡培他滨和氟尿嘧啶的毒副作用相似。与顺铂相比较，奥沙利铂3级或4级粒细胞减少、脱发、肾毒性以及血栓栓塞的发生率更低，而3级或4级腹泻及神经病变发生率略高。
Conclusions Capecitabine and oxaliplatin are as effective as fluorouracil and cisplatin, respectively, in patients with previously untreated esophagogastric cancer.
结论：卡培他滨和奥沙利铂用于先前未经治疗的食管癌和胃癌患者，效果分别与氟尿嘧啶和顺铂相同。
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