Identification of surrogate endpoints in patients with locoregionally advanced nasopharyngeal carcinoma receiving neoadjuvant chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone.
Identification of surrogate endpoints in patients with locoregionally advanced nasopharyngeal carcinoma receiving neoadjuvant chemotherapy plus concurrent chemoradiotherapy versus concurrent chemoradiotherapy alone.
复制标题
接受新辅助化疗联合同步放化疗与单独同步放化疗的局部晚期鼻咽癌患者替代终点的确定
DOI：
10.1186/s12885-015-1816-6
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发表时间：
2015-11-24
期刊：
影响因子：
3.8
通讯作者：
Ma J
中科院分区：
文献类型：
--
作者：
Chen YP;Zhang WN;Tang LL;Mao YP;Liu X;Chen L;Zhou GQ;Mai HQ;Shao JY;Jia WH;Kang TB;Zeng MS;Sun Y;Ma J
背景在调强放疗(IMRT)时代，新辅助化疗(NACT)与同期放化疗(CCRT)对局部晚期鼻咽癌(NPC)的疗效目前正在进行试验研究。总生存期(OS)是鼻咽癌试验的金标准终点。我们进行这项分析是为了确定OS的替代终点，这可以缩短随访时间并加快疗效评估。方法我们回顾分析了208例区域晚期鼻咽癌患者接受NACT+CCRT或CCRT治疗的配对病例。按Prentice标准评价2年和3年的无进展生存期(PFS)、无失败生存期(FFS)、无远处失败生存期(D-FFS)和局部无失败生存期(LR-FFS)。用Spearman‘s等级相关系数评估相关性的强度。结果两年时，任何替代终点的治疗组之间没有显著差异，这拒绝了Prentice的第二个标准。而3年的LR-FFS、PFS、FFS和D-FFS均符合Prentice的四项标准；3年的PFS与5年的OS的等级相关系数最高(0.730)。结论3年的PFS、FFS和D-FFS可以作为5年OS的有效替代终点，3年的PFS可能是最准确的。
BackgroundIn the era of intensity-modulated radiotherapy (IMRT), the efficacy of additional neoadjuvant chemotherapy (NACT) to concurrent chemoradiotherapy (CCRT) in locoregionally advanced nasopharyngeal carcinoma (NPC) is currently being investigated in ongoing trials. Overall survival (OS) is the gold standard endpoint in NPC trials. We performed this analysis to identify surrogate endpoints for OS, which could shorten follow-up duration and speed up assessment of treatment effects.MethodsWe retrospectively analysed 208 matched-pair patients with locoregionally advanced NPC receiving NACT+CCRT or CCRT. Progression-free survival (PFS), failure-free survival (FFS), distant failure-free survival (D-FFS) and locoregional failure-free survival (LR-FFS) at 2 and 3 years were assessed as surrogates for 5-year OS according to Prentice’s criteria. The strength of the associations were assessed using Spearman’s rank correlation coefficient.ResultsNo significant differences were observed between treatment arms for any surrogate endpoint at 2 years, which rejected Prentice’s second criterion. In contrast, 3-year LR-FFS, PFS, FFS and D-FFS were consistent with all four of Prentice’s criteria; the rank correlation coefficient (0.730) between 3-year PFS and 5-year OS was highest.Conclusions3-year PFS, FFS and D-FFS could be valid surrogate endpoints for 5-year OS; 3-year PFS may be the most accurate.