Fred & Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE.
Alliance Statistics and Data Management Center, Mayo Clinic, Rochester, MN.
JCO Oncol Pract. 2023 Jun;19(6):e877-e891. doi: 10.1200/OP.22.00822. Epub 2023 Apr 14.
Clinical trials are important for managing older patients with AML. We investigated differences in outcomes of older patients with AML on the basis of whether patients participated in intensive chemotherapy trials at community versus academic cancer centers.
We used data from the Alliance for Clinical Trials in Oncology phase III trials that enrolled patients age ≥ 60 years with newly diagnosed AML between 1998 and 2002 in the Cancer and Leukemia Group B (CALGB) 9720 trial and between 2004 and 2006 in the CALGB 10201 trial. Centers funded by the NCI Community Oncology Research Program were identified as community cancer centers; others were designated as academic cancer centers. Logistic regression models and Cox proportional hazards models were used to compare 1-month mortality and overall survival (OS) by center type.
Seventeen percent of the 1,170 patients were enrolled in clinical trials in community cancer centers. The study results demonstrated comparable rates of grade ≥3 adverse events (97% 93%), 1-month mortality (19.1% 16.1%), and OS (43.9% 35.7% at 1 year) between community versus academic cancer centers, respectively. After adjusting for covariates, 1-month mortality (odds ratio, 1.40; 95% CI, 0.92 to 2.12; = .11) and OS (hazard ratio, 1.04; 95% CI, 0.88 to 1.22; = .67) were not statistically different among patients treated in community versus academic cancer centers.
An older patient population, who have complex health care needs, can be successfully treated on intensive chemotherapy trials in select community cancer centers with outcomes comparable with that achieved at academic cancer centers.
临床试验对于治疗老年 AML 患者非常重要。我们基于患者在社区癌症中心和学术癌症中心参与强化化疗试验的情况，研究了老年 AML 患者的预后差异。
我们使用了从癌症和白血病组 B（CALGB）9720 试验（1998 年至 2002 年期间招募年龄≥60 岁的新诊断 AML 患者）和 CALGB 10201 试验（2004 年至 2006 年期间招募年龄≥60 岁的新诊断 AML 患者）的肿瘤临床试验联盟（Alliance for Clinical Trials in Oncology）三期临床试验的数据。由 NCI 社区肿瘤学研究计划资助的中心被认定为社区癌症中心；其他中心被指定为学术癌症中心。我们使用逻辑回归模型和 Cox 比例风险模型比较了中心类型与 1 个月死亡率和总生存期（OS）的关系。
1170 名患者中有 17%在社区癌症中心参加了临床试验。研究结果表明，社区癌症中心与学术癌症中心之间的 3 级以上不良事件发生率（分别为 97%和 93%）、1 个月死亡率（分别为 19.1%和 16.1%）和 OS（分别为 1 年时 43.9%和 35.7%）相似。在调整了协变量后，社区癌症中心与学术癌症中心之间 1 个月死亡率（比值比，1.40；95%置信区间，0.92 至 2.12；P=0.11）和 OS（风险比，1.04；95%置信区间，0.88 至 1.22；P=0.67）无统计学差异。
在特定的社区癌症中心中，患有复杂医疗需求的老年患者人群可以成功接受强化化疗试验治疗，其预后与学术癌症中心相当。
