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发布者:鑫达医学翻译公司 发布时间:2011-06-18 8:50:52 阅读:

原文:
    Subgroup analyses indicated that the benefit of adding cetuximab to platinum–fluorouracil chemotherapy was evident in most of the subgroups. The hazard ratios for progression-free survival showed a uniformly positive effect of adding cetuximab in all subgroups, with hazard ratios ranging from 0.34 to 0.80. There was a significant interaction with the primary tumor site, but because of repeated testing, this result could be due to chance. Such subgroup analyses must be interpreted cautiously; the results do not allow us to state with certainty that some groups did not benefit or to speculate on the degree of benefit.
    Compliance with cetuximab was good: a relative dose intensity of 80% or more was achieved in 84% of the patients who received cetuximab after the initial dose of 400 mg per square meter and in 82% of the patients who received cetuximab as maintenance therapy. Compliance with chemotherapy was similar in the two groups, indicating that the addition of cetuximab did not affect the tolerability of the standard treatment.
    The adverse-event profile in the chemotherapy-alone group was typical of that for the combination of platinum plus fluorouracil and was not affected by the addition of cetuximab, except that there were 9 cases of sepsis in the cetuximab group, as compared with 1 case in the chemotherapy-alone group. The main additional grade 3 or 4 adverse events, including skin reactions, were consistent with the side-effect profile of cetuximab.

译文:
    亚组分析表明多数亚组的铂-氟尿嘧啶联合西妥昔单抗获益显著。所有亚组加用西妥昔单抗后无进展生存期危害比(0.34-0.80)均有所改善。其与原发肿瘤位点显著相关,但由于是重复检测,该结果可能是偶发性的。需对该亚组分析进行谨慎分析,结果并不表明有些治疗组无治疗获益,也不能对获益程度进行推测。
    西妥昔单抗患者顺应性良好:西妥昔单抗初始剂量(400mg/m2)后84%的患者相对剂量强度≥80%,服用西妥昔单抗作为维持治疗的患者中82%的患者相对剂量强度≥80%。两治疗组化疗顺应性类似,表明添加西妥昔单抗不影响标准治疗的耐受性。
    单纯化疗组不良事件发生率与常规铂-氟尿嘧啶化疗一致。除败血病病例数不一致外(西妥昔单抗组出现9例,单纯化疗出现1例),加用西妥昔单抗无影响。主要3级与4级不良皮肤反应与西妥昔单抗副作用一致。
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