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首页> 外文期刊>Annals of oncology: official journal of the European Society for Medical Oncology >Identification of potential surrogate end points in randomized clinical trials of aggressive and indolent non-Hodgkin's lymphoma: correlation of complete response, time-to-event and overall survival end points.
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Identification of potential surrogate end points in randomized clinical trials of aggressive and indolent non-Hodgkin's lymphoma: correlation of complete response, time-to-event and overall survival end points.

机译：在侵袭性和惰性非霍奇金淋巴瘤随机临床试验中确定潜在替代终点：完全缓解，事件发生时间和总生存终点的相关性。

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BACKGROUND: The correlation between efficacy end points in randomized controlled trials (RCTs) of systemic therapy for non-Hodgkin's lymphoma (NHL) was investigated to identify an appropriate surrogate end point for overall survival (OS). METHODS: RCTs of previously untreated NHL published from 1990 to 2009 were identified. Associations between absolute differences in efficacy end points were determined using nonparametric Spearman's rank correlation coefficients (r(s)). RESULTS: Thirty-eight RCTs representing 85 treatment arms for aggressive NHL and 20 RCTs representing 42 arms for indolent NHL were included. For aggressive NHL, differences in 3-year progression-free survival (PFS)/event-free survival (EFS) were high correlated with differences in 5-year OS {r(s) of 0.90 [95% confidence interval (CI) 0.73-0.96]} and linear regression determined that a 10% improvement in 3-year EFS or PFS would predict for a 7% +/- 1% improvement in 5-year OS. For indolent histology disease, differences in complete response were strongly correlated with differences in 3-year EFS [r(s) 0.86 (95% CI 0.35-0.97)], but there was no correlation between 3-year time-to-event end points and 5-year OS. CONCLUSIONS: Improvements in 3-year EFS/PFS are highly correlated with improvements in 5-year OS in aggressive NHL and should be explored as a candidate surrogate end point. Definition of these relationships may inform future clinical trial design and interpretation of interim trial data.
机译：背景：系统性非霍奇金淋巴瘤（NHL）治疗的随机对照试验（RCT）的疗效终点之间的相关性进行了研究，以确定总体生存期（OS）的合适替代终点。方法：确定1990年至2009年出版的未经治疗的NHL的RCT。使用非参数Spearman秩相关系数（r（s））确定功效终点的绝对差异之间的关联。结果：包括38个代表侵略性NHL的治疗臂的RCT和20个代表惰性NHL的42个臂的RCT。对于积极的NHL，3年无进展生存期（PFS）/无事件生存期（EFS）的差异与5年OS的差异高度相关{r（s）为0.90 [95％置信区间（CI）0.73 -0.96]}和线性回归确定3年EFS或PFS改善10％可以预测5年OS改善7％+/- 1％。对于惰性的组织学疾病，完全缓解的差异与3年EFS的差异密切相关[r（s）0.86（95％CI 0.35-0.97）]，但3年事件结束时间之间没有相关性点数和5年操作系统。结论：3年EFS / PFS的改善与积极NHL的5年OS的改善高度相关，因此应作为候选替代终点进行探讨。这些关系的定义可能会为将来的临床试验设计和临时试验数据的解释提供依据。

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