Reljic Tea, Sehovic Marina, Lancet Jeffrey, Kim Jongphil, Al Ali Najla, Djulbegovic Benjamin, Extermann Martine
Program for Comparative Effectiveness Research, University of South Florida, Tampa, FL, USA.
Senior Adult Oncology Program, Moffitt Cancer Center, Tampa, FL, USA.
J Geriatr Oncol. 2020 Nov;11(8):1293-1308. doi: 10.1016/j.jgo.2020.06.019. Epub 2020 Jul 12.
The majority of patients with acute myeloid leukemia (AML) are aged 70 and over. However, there is uncertainty about how and whether older patients with AML should receive cytotoxic treatment.
Medline and Cochrane library search was performed for studies in newly diagnosed AML which enrolled at least 20 patients per arm (for randomized controlled trials), or 50 patients (for non-randomized studies) over the age of 70. References were hand searched for additional eligible studies. Study investigators were contacted to maximize relevant data. Dual independent data extraction was done using standardized data collection forms. Data was collected on study and treatment characteristics, baseline patient information, and outcomes. Study methodological quality was assessed. The primary outcome was 1 year overall survival (OS). Impact of treatment [intensive chemotherapy (INT), low-dose chemotherapy (LOW), hypomethylating agents (HMA), or best supportive care (BSC)], cytogenetics, performance status, and comorbidity were assessed.
The search produced 11,846 references of which 38 randomized controlled trials and 30 non-randomized studies met inclusion criteria, representing 13,381 patients, with a worldwide distribution. One-year OS with INT was 37% (31-42%), with LOW 11% (6-18%), with HMA 35% (18-54%) and with BSC 17%(13-21%). Two-year OS was 22% (18-26%), 11% (7-15%), 22% (16-28%), 6% (2-12%), respectively. We present subgroup data based on the studies including cytogenetics, performance status, and comorbidity. Formal direct comparisons with adjustment for all prognostic factors were not possible.
In this largest to date series of AML patients aged 70 and older, we provide benchmarks for treatment efficacy and effectiveness that may be used for decision analysis models and for the future development of clinical trials focusing on these patients.
大多数急性髓系白血病（AML）患者年龄在70岁及以上。然而，对于老年AML患者应如何以及是否接受细胞毒性治疗尚存在不确定性。
对Medline和Cochrane图书馆进行检索，查找新诊断AML的研究，这些研究每组至少纳入20例患者（随机对照试验）或50例患者（非随机研究），年龄在70岁以上。通过手工检索参考文献查找其他符合条件的研究。联系研究调查人员以获取最大量的相关数据。使用标准化数据收集表进行双人独立数据提取。收集有关研究和治疗特征、患者基线信息及结局的数据。评估研究方法的质量。主要结局为1年总生存期（OS）。评估治疗（强化化疗（INT）、低剂量化疗（LOW）、去甲基化药物（HMA）或最佳支持治疗（BSC））、细胞遗传学、体能状态和合并症的影响。
检索产生了11846篇参考文献，其中38项随机对照试验和30项非随机研究符合纳入标准，代表13381例患者，分布于世界各地。INT治疗的1年OS为37%（31%-42%），LOW为11%（6%-18%），HMA为35%（18%-54%），BSC为17%（13%-21%）。2年OS分别为22%（18%-26%）、11%（7%-15%）、22%（16%-28%）、6%（2%-12%）。我们根据包括细胞遗传学、体能状态和合并症的研究呈现亚组数据。无法进行针对所有预后因素调整的正式直接比较。
在这个迄今为止最大的70岁及以上AML患者系列中，我们提供了治疗疗效和有效性的基准，可用于决策分析模型以及未来针对这些患者的临床试验的开展。
