Institut Gustave Roussy, Villejuif Cedex, France.
J Clin Oncol. 2013 Aug 10;31(23):2854-60. doi: 10.1200/JCO.2012.47.7802. Epub 2013 Jul 8.
PURPOSE Cisplatin plus fluorouracil (PF) induction chemotherapy has been compared with taxane (docetaxel or paclitaxel), cisplatin, and fluorouracil (Tax-PF) in randomized trials in locoregionally advanced head and neck cancers (LAHNCs). The aim of this meta-analysis was to study the efficacy and toxicity of Tax-PF and PF and identify differences in outcomes in subsets of patients. METHODS Five randomized trials representing 1,772 patients were identified. Updated individual patient data (IPD) were retrieved for all trials. The log-rank test, stratified by trial, was used for comparison. Interaction or trend tests were used to study the interaction between covariates and treatment. Results Median follow-up was 4.9 years. The hazard ratio (HR) of death was 0.79 (95% CI, 0.70 to 0.89; P < .001; absolute benefit at 5 years: 7.4%) in favor of Tax-PF. Heterogeneity was significant (P = .08, I(2) = 51%) and related to one trial. There was no more heterogeneity after exclusion of this trial (P = .99, I(2) = 0%), and HR of death was 0.72 (95% CI, 0.63 to 0.83) in favor of Tax-PF. There was no interaction between treatment effect and the following patient covariates: age, sex, performance status, tumor stage, or site. Tax-PF was associated with significant reductions of progression, locoregional failure, and distant failure compared with PF, with HRs of 0.78 (95% CI, 0.69 to 0.87; P < .001), 0.79 (95% CI, 0.66 to 0.94; P = .007), and 0.63 (95% CI, 0.45 to 0.89; P = .009) respectively. CONCLUSION This IPD meta-analysis shows the superiority of Tax-PF over PF as induction chemotherapy. Its precise role in the management of LAHNC remains to be determined.
顺铂联合氟尿嘧啶(PF)诱导化疗已在局部晚期头颈部癌症(LAHNCs)的随机试验中与紫杉烷(多西紫杉醇或紫杉醇)、顺铂和氟尿嘧啶(Tax-PF)进行了比较。本荟萃分析的目的是研究 Tax-PF 和 PF 的疗效和毒性,并确定患者亚组结果的差异。
确定了 5 项代表 1772 名患者的随机试验。检索了所有试验的更新个体患者数据(IPD)。采用对数秩检验,按试验分层,进行比较。交互或趋势检验用于研究协变量与治疗之间的相互作用。
中位随访时间为 4.9 年。死亡风险比(HR)为 0.79(95%CI,0.70 至 0.89;P<0.001;5 年绝对获益:7.4%)有利于 Tax-PF。异质性显著(P=0.08,I²=51%),与一项试验相关。排除该试验后,异质性不再显著(P=0.99,I²=0%),死亡 HR 有利于 Tax-PF,为 0.72(95%CI,0.63 至 0.83)。治疗效果与以下患者协变量之间无交互作用:年龄、性别、表现状态、肿瘤分期或部位。Tax-PF 与 PF 相比,显著降低了进展、局部区域失败和远处失败的风险,HR 分别为 0.78(95%CI,0.69 至 0.87;P<0.001)、0.79(95%CI,0.66 至 0.94;P=0.007)和 0.63(95%CI,0.45 至 0.89;P=0.009)。
这项 IPD 荟萃分析表明,Tax-PF 作为诱导化疗优于 PF。它在 LAHNC 管理中的精确作用仍有待确定。