Stanford Cancer Institute, CCSR Building 1136, MC 5151, Stanford, California, 94305, USA.
Fox Chase Cancer Center, Temple University Health System, 333 Cottman Avenue, Philadelphia, PA 19111, USA.
J Geriatr Oncol. 2019 Jul;10(4):540-546. doi: 10.1016/j.jgo.2018.11.001. Epub 2018 Dec 18.
Older patients make up the majority of patients with pancreatic cancer, with a median age of 71 years at diagnosis. However, older patients are underrepresented in clinical trials in pancreatic cancer. This study investigates trends in age distribution of patients enrolled in clinical trials for advanced pancreatic cancer over time, and examines outcomes and toxicity in older patient subgroups from two studies conducted by Eastern Cooperative Oncology Group and American College of Radiology Imaging Network (ECOG-ACRIN) in this disease.
16,042 patients from 38 phase III clinical trials for locally advanced or metastatic pancreatic adenocarcinoma published between 1997 and 2016 were identified and included in this analysis. Outcomes and toxicity by age were examined in two of the trials, ECOG-ACRIN trials E2297 and E6201, which included a total of 1146 patients.
The median age across the trials was 62.7 years; median ages for individual trials ranged from 57 years to 66 years. Weighted linear regression showed no significant change in median age over time. Combined analysis of the two ECOG-ACRIN trials demonstrated higher rates of fatigue, thrombocytopenia, and infection in those ≥75 years compared with those <75 years, but despite this showed no difference in overall survival (OS) or progression-free survival (PFS) (OS: 5.7 vs. 5.6 months and PFS: 2.8 vs 3.5 months).
Enrollment of older adults in phase III pancreatic cancer clinical trials has not increased over time, despite increasing number of older patients seen in clinic. Increased efforts are needed to enhance enrollment of older patients in clinical trials, and to promote trials specifically for older patients, in order to improve the evidence base for treating this patient population.
在诊断时，大多数胰腺癌患者年龄在 71 岁左右，属于老年患者。然而，在胰腺癌临床试验中，老年患者的代表性不足。本研究调查了随着时间的推移，入组晚期胰腺癌临床试验的患者年龄分布趋势，并检查了东部合作肿瘤学组和美国放射肿瘤学会影像学网络（ECOG-ACRIN）在该疾病中进行的两项研究中老年患者亚组的结局和毒性。
本分析纳入了 1997 年至 2016 年间发表的 38 项局部晚期或转移性胰腺腺癌 III 期临床试验中的 16042 例患者。在 ECOG-ACRIN 试验 E2297 和 E6201 中检查了两项试验中年龄与结局和毒性的关系，这两项试验共纳入了 1146 例患者。
试验的中位年龄为 62.7 岁；各试验的中位年龄范围为 57 岁至 66 岁。加权线性回归显示中位年龄随时间无显著变化。两项 ECOG-ACRIN 试验的联合分析显示，≥75 岁的患者疲劳、血小板减少和感染的发生率高于<75 岁的患者，但尽管如此，总生存（OS）和无进展生存（PFS）没有差异（OS：5.7 与 5.6 个月和 PFS：2.8 与 3.5 个月）。
尽管临床上看到的老年患者数量不断增加，但在 III 期胰腺癌临床试验中，老年成年人的入组人数并未随时间增加。需要加大努力，增加老年患者的临床试验入组人数，并为老年患者专门开展临床试验，以提高治疗这一患者群体的证据基础。
