Stell P M, Rawson N S
Department of Otorhinolaryngology, University of Liverpool, UK.
Br J Cancer. 1990 May;61(5):779-87. doi: 10.1038/bjc.1990.175.
An overview is presented of 23 trials of adjuvant chemotherapy in squamous cell carcinoma of the head and neck. These were reviewed from the point of view of design of the trial, analysis of survival, response rates, meta-analysis, site of failure, toxicity and cost. The minimal increase in survival that could be detected ranged from 11 to 51%, with a median of 25%. No trial was big enough to detect the likely increase of survival, which is 5%. Many trials excluded some eligible patients before randomisation, the proportion being 21% in those series with details. A further 9% of treated patients were excluded from analysis. A response rate in four induction studies of 47% equated with a 6% increase in cancer mortality. Meta-analysis showed an insignificant overall improvement in cancer mortality of 0.5%. Induction chemotherapy, synchronous chemotherapy and induction/maintenance chemotherapy did not affect cancer mortality whereas synchronous/maintenance therapy did. Cisplatinum, methotrexate, bleomycin, 5-FU and a variety of other regimens did not affect the death rate from cancer, but the combination of VBM significantly increased it. Neither single agent nor combination chemotherapy produced a significant reduction of cancer deaths. The rate of locoregional failure was significantly lower in the treated arms, whereas the metastatic rate was similar in both arms. Only three papers gave full details of toxicity with grading: these showed a high toxicity rate. The mortality rate from chemotherapy in nine series averaged 6.5%.
本文综述了23项头颈部鳞状细胞癌辅助化疗试验。从试验设计、生存率分析、缓解率、荟萃分析、失败部位、毒性和成本等角度对这些试验进行了回顾。能够检测到的生存率最小增幅在11%至51%之间，中位数为25%。没有一项试验规模大到足以检测出可能的5%的生存率增幅。许多试验在随机分组前排除了一些符合条件的患者，在有详细信息的系列中这一比例为21%。另有9%的接受治疗的患者被排除在分析之外。四项诱导研究中的缓解率为47%，相当于癌症死亡率增加6%。荟萃分析显示癌症死亡率总体改善不显著，为0.5%。诱导化疗、同步化疗和诱导/维持化疗不影响癌症死亡率，而同步/维持治疗则有影响。顺铂、甲氨蝶呤、博来霉素、5-氟尿嘧啶和其他各种方案均不影响癌症死亡率，但VBM联合方案显著增加了死亡率。单药化疗或联合化疗均未显著降低癌症死亡率。治疗组的局部区域失败率显著较低，而两组的转移率相似。只有三篇论文给出了毒性分级的详细信息：这些显示出高毒性率。九个系列中化疗的死亡率平均为6.5%。
