Department of Family Medicine and Center for Clinical Epidemiology and Clinical Statistics, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Faculty of Medicine, Center for Clinical Epidemiology and Clinical Statistics, Chiang Mai University, Chiang Mai, Thailand.
BMC Res Notes. 2021 Jan 6;14(1):3. doi: 10.1186/s13104-020-05423-5.
To examine the presence of the time-dependent effect of metronomic chemotherapy for the treatment of older patients with acute myeloid leukemia (AML) who were unfit for standard chemotherapy and to reanalyze the data using an appropriate statistical approach in the presence of non-proportional hazards, the restricted mean survival time (RMST).
This was a secondary analysis of a multi-center, open-label, randomized controlled trial, which was conducted in seven tertiary care hospitals across Thailand. A total of 81 unfit AML patients were randomized into two treatment groups, metronomic chemotherapy and palliative treatment. The hazard ratio of metronomic chemotherapy over palliative treatment was time-dependent. At three landmark time points of 90, 180, 365 days, the restricted mean survival time differences were 13.3 (95% CI 1.9-24.7) days, 28.9 (95% CI 3.3-54.4) days, and 40.4 (95% CI - 1.3 to 82.0) days, respectively. With non-proportional hazards modeling and RMST analysis, we were able to conclude that metronomic chemotherapy is a potentially effective alternative treatment for elderly AML patients who were medically unfit for intensive chemotherapy. In the future clinical trials, non-proportional hazards should be carefully inspected and properly handled with appropriate statistical methods. Trial registration Randomized clinical trial TCTR20150918001; registration date: 15/09/2015. Retrospectively registered.
探讨节拍化疗治疗不适合标准化疗的老年急性髓系白血病（AML）患者的时间依赖性效应，并在存在非比例风险时使用适当的统计方法重新分析数据，即限制性平均生存时间（RMST）。
这是一项在泰国 7 家三级护理医院进行的多中心、开放标签、随机对照试验的二次分析。共有 81 名不适合 AML 的患者被随机分为节拍化疗组和姑息治疗组。节拍化疗与姑息治疗的风险比随时间变化而变化。在 90、180、365 天三个标志性时间点，RMST 差异分别为 13.3（95%CI 1.9-24.7）天、28.9（95%CI 3.3-54.4）天和 40.4（95%CI -1.3 至 82.0）天。通过非比例风险模型和 RMST 分析，我们得出结论，节拍化疗是一种潜在有效的替代治疗方法，适用于不适合强化化疗的老年 AML 患者。在未来的临床试验中，应仔细检查非比例风险，并使用适当的统计方法进行适当处理。
随机临床试验 TCTR20150918001；注册日期：2015 年 9 月 15 日。回顾性注册。
