Stanford University School of Medicine, Stanford, CA, United States.
SWOG Statistical Center, Seattle, WA Fred Hutchinson Cancer Research Center, Seattle, WA, United States.
Leuk Res. 2019 Mar;78:29-33. doi: 10.1016/j.leukres.2019.01.007. Epub 2019 Jan 17.
To study whether institutional clinical trial accrual volume affects clinical outcomes of younger (age less than 61 years) patients with acute myeloid leukemia.
We investigated the impact of clinical trial accrual on response rates, early mortality and survival in patients with AML enrolled between 2002 and 2009 into two parallel cooperative group clinical trials SWOG S0106/ECOG-ACRIN E1900. Institutions were classified as low- (LAIs) (≤ 9 enrolled patients) or high-accruing institutions (HAIs) (≥10 enrolled patients). Fisher's exact text and logistic regression analysis were used to analyze the response and early mortality rates. The effect of accrual volume on survival was analyzed by log-rank tests and Cox regression models.
A total of 1252 patients from 152 institutions were included in the final analyses. The median clinical trial registrations in HAIs was 19 patients (range, 10 to 92) versus 3 (range, 1 to 9) patients in LAIs. In multivariate analyses, HAIs, as a quantitative covariate, was associated with improved complete remission rates (odds ratio (OR) 1.08, p = 0.0051), but no improvement median overall survival (HR 0.97, p = 0.065) or median event-free (hazard ratio (HR) 0.97, p = 0.05). Early mortality rates were similar between cohorts and academic affiliation had no impact on response rates or survival.
Clinical trial accrual volume, had an independent, albeit modest, impact on complete remission rates, but not on overall survival and event-free in younger patients with AML.
研究机构临床试验入组量是否影响年轻（年龄<61 岁）急性髓系白血病患者的临床结局。
我们调查了临床试验入组对纳入 2002 年至 2009 年两项平行合作组临床试验 SWOG S0106/ECOG-ACRIN E1900 的 AML 患者的反应率、早期死亡率和生存率的影响。机构被分为低入组量机构（LAIs）（≤9 例入组患者）或高入组量机构（HAIs）（≥10 例入组患者）。采用 Fisher 确切检验和逻辑回归分析来分析反应和早期死亡率。采用对数秩检验和 Cox 回归模型分析入组量对生存率的影响。
共有来自 152 个机构的 1252 例患者纳入最终分析。HAIs 的中位临床试验注册数量为 19 例（范围，10 至 92），而 LAIs 为 3 例（范围，1 至 9）。多变量分析中，HAIs 作为一个定量协变量，与完全缓解率的提高相关（比值比（OR）1.08，p=0.0051），但对中位总生存（风险比（HR）0.97，p=0.065）或中位无事件生存（HR 0.97，p=0.05）无改善。两组患者的早期死亡率相似，学术隶属关系对反应率或生存率无影响。
临床试验入组量对年轻 AML 患者的完全缓解率有独立的、但适度的影响，但对总生存和无事件生存没有影响。
