Oxford Outcomes Ltd, Canada.
Curr Med Res Opin. 2011 Dec;27(12):2253-9. doi: 10.1185/03007995.2011.633989. Epub 2011 Nov 14.
Cetuximab (Erbitux*) is the only new medical therapy for locally and regionally advanced SCCHN to be licensed in industrialized countries in the past 15 years and presents an alternative to cisplatin which is the current therapeutic standard. In the absence of a published head-to-head trial, we estimated the relative benefit of cetuximab and cisplatin using an indirect comparison methodology.
We performed a systematic review of the Medline and Embase databases between 1998 and 2008 to find published trials of cisplatin plus radiotherapy vs. radiotherapy alone and synthesized the information with meta-analysis. Those results were combined with trial-based results of cetuximab plus radiotherapy vs. radiotherapy alone. Inclusion criteria stipulated that cisplatin be administered concurrently with radiation, the radiation protocol be comparable to the registration trial for cisplatin (once-daily, twice-daily, or concomitant boost) and cisplatin dosing be comparable to that in common use (i.e. day 1, 22 and 43 of treatment). Endpoints were locoregional control and overall survival. Two reviewers examined 269 abstracts which yielded four trials meeting the inclusion criteria.
There was little evidence of superiority of either platinum-based radiotherapy or cetuximab-based radiotherapy. All estimated hazard ratios were near 1.0 (equivalence), all confidence intervals spanned the null value (1.0), and no consistent pattern was observed regarding the direction of the effect. The results remained robust in sensitivity analysis.
This is the first quantitative analysis allowing formal comparison between cetuximab and radiotherapy versus cisplatin and radiotherapy. Based on state-of-the-art methodology for indirect comparisons, it was not possible to identify either treatment regimen as superior in prolonging either locoregional control or overall survival. Until the publication of more studies, and particularly a head-to-head comparison, the two treatments may be considered equally efficacious when given alongside radiotherapy. The choice of treatment may focus on the toxicity profile of the medications.
西妥昔单抗（爱必妥*）是过去 15 年中在工业化国家获得批准的唯一用于局部和区域性晚期头颈部鳞癌的新型医学疗法，是目前治疗标准顺铂的替代疗法。由于没有发表头对头试验，我们使用间接比较方法来估计西妥昔单抗和顺铂的相对益处。
我们在 1998 年至 2008 年期间对 Medline 和 Embase 数据库进行了系统回顾，以查找顺铂联合放疗与单纯放疗的已发表试验，并通过荟萃分析综合了这些信息。这些结果与西妥昔单抗联合放疗与单纯放疗的试验结果相结合。纳入标准规定，顺铂应与放疗同时进行，放射方案应与顺铂的注册试验相当（每日一次、每日两次或同时加量），且顺铂剂量应与常规使用剂量相当（即治疗的第 1、22 和 43 天）。终点为局部区域控制和总生存。两名审查员检查了 269 份摘要，其中有四项试验符合纳入标准。
铂类为基础的放疗或西妥昔单抗为基础的放疗均无明显优势。所有估计的危险比都接近 1.0（等效），置信区间均跨越零值（1.0），并且没有观察到效应方向的一致模式。敏感性分析结果仍然稳健。
这是首次对西妥昔单抗与放疗相比顺铂与放疗进行定量分析。基于间接比较的最新方法，无法确定任何一种治疗方案在延长局部区域控制或总生存方面具有优势。在更多研究发表，特别是头对头比较之前，当与放疗联合使用时，这两种治疗方法可能被认为同样有效。治疗选择可能集中在药物的毒性特征上。
