Pignon Jean-Pierre, le Maître Aurélie, Maillard Emilie, Bourhis Jean
Department of Biostatistics and Epidemiology, Institut Gustave-Roussy, Villejuif, France.
Radiother Oncol. 2009 Jul;92(1):4-14. doi: 10.1016/j.radonc.2009.04.014. Epub 2009 May 14.
Our previous individual patient data (IPD) meta-analysis showed that chemotherapy improved survival in patients curatively treated for non-metastatic head and neck squamous cell carcinoma (HNSCC), with a higher benefit with concomitant chemotherapy. However the heterogeneity of the results limited the conclusions and prompted us to confirm the results on a more complete database by adding the randomised trials conducted between 1994 and 2000.
The updated IPD meta-analysis included trials comparing loco-regional treatment to loco-regional treatment+chemotherapy in HNSCC patients and conducted between 1965 and 2000. The log-rank-test, stratified by trial, was used to compare treatments. The hazard ratios of death were calculated.
Twenty-four new trials, most of them of concomitant chemotherapy, were included with a total of 87 trials and 16,485 patients. The hazard ratio of death was 0.88 (p<0.0001) with an absolute benefit for chemotherapy of 4.5% at 5 years, and a significant interaction (p<0.0001) between chemotherapy timing (adjuvant, induction or concomitant) and treatment. Both direct (6 trials) and indirect comparisons showed a more pronounced benefit of the concomitant chemotherapy as compared to induction chemotherapy. For the 50 concomitant trials, the hazard ratio was 0.81 (p<0.0001) and the absolute benefit 6.5% at 5 years. There was a decreasing effect of chemotherapy with age (p=0.003, test for trend).
The benefit of concomitant chemotherapy was confirmed and was greater than the benefit of induction chemotherapy.
我们之前的个体患者数据（IPD）荟萃分析表明，化疗可改善非转移性头颈部鳞状细胞癌（HNSCC）根治性治疗患者的生存率，同步化疗的获益更高。然而，结果的异质性限制了结论，促使我们通过纳入1994年至2000年间进行的随机试验，在更完整的数据库上证实结果。
更新后的IPD荟萃分析纳入了1965年至2000年间在HNSCC患者中比较局部区域治疗与局部区域治疗+化疗的试验。采用按试验分层的对数秩检验来比较治疗方法。计算死亡风险比。
纳入了24项新试验，其中大多数为同步化疗试验，总共87项试验和16485例患者。死亡风险比为0.88（p<0.0001），化疗在5年时的绝对获益为4.5%，化疗时机（辅助、诱导或同步）与治疗之间存在显著交互作用（p<0.0001）。直接比较（6项试验）和间接比较均显示，与诱导化疗相比，同步化疗的获益更显著。对于50项同步试验，风险比为0.81（p<0.0001），5年时的绝对获益为6.5%。化疗效果随年龄降低（p=0.003，趋势检验）。
同步化疗的获益得到证实，且大于诱导化疗的获益。
