Department of Oncology, Cross Cancer Institute, University of Alberta, Edmonton, Alberta, T4G 1Z2, Canada.
Int J Colorectal Dis. 2019 Dec;34(12):2143-2150. doi: 10.1007/s00384-019-03430-y. Epub 2019 Nov 16.
Within the context of metastatic colorectal cancer, patients with Eastern Cooperative Oncology Group (ECOG) performance score 0-1 are usually pooled together in clinical practice guidelines and clinical trials' reports. The current study aims to delineate potential differences in outcomes between metastatic colorectal cancer patients with ECOG score 0 versus 1 who are treated with currently accepted first-line fluorouracil (5FU)-based chemotherapy.
The current study is based on a pooled dataset from five clinical trials of 5FU-based treatment for metastatic colorectal cancer (NCT00272051; NCT00115765; NCT00305188; NCT00364013; and NCT00384176). Patients with metastatic colorectal cancer and ECOG score of 0-1 were eligible for the current study. Multivariable logistic regression analysis was used to assess the relationship between ECOG performance status and the development of different toxicities. Kaplan-Meier survival estimates were used to clarify the impact of the ECOG score on overall and progression-free survivals. Multivariable Cox regression analysis was then used to evaluate the impact of ECOG score on overall and progression-free survivals.
A total of 3143 patients were included in the current analysis. Within multivariable logistic regression analysis, patients with an ECOG score of 0 have a lower probability of serious adverse events (OR 0.678; 95% CI 0.583-0.788; P < 0.001), fatal adverse events (OR 0.552; 95% CI 0.397-0.766; P < 0.001), high-grade anemia (OR 0.426; 95% CI 0.252-0.721; P = 0.001), and high-grade nausea/vomiting (OR 0.697; 95% CI 0.509-0.955; P = 0.024). Through Kaplan-Meier survival analysis, patients with an ECOG score of 0 have better overall and progression-free survivals (P < 0.001 for both endpoints). Median overall survival was 27.63 months among patients with an ECOG score of 0 versus 20.00 months among patients with an ECOG score of 1. Within multivariable Cox regression analysis, patients with ECOG score of 0 were associated with better overall and progression-free survivals (HR for overall survival 0.613; 95% CI 0.556-0.676; P < 0.001); (HR for progression-free survival 0.765; 95% CI 0.705-0.829; P < 0.001).
Compared with patients with ECOG score of 1, patients with ECOG score of 0 have better overall and progression-free survival, and less probability of serious and fatal adverse events. This distinction in outcomes should be noted when choosing appropriate therapeutic strategies and when designing/reporting the results of clinical trials.
在转移性结直肠癌的背景下，ECOG 表现评分为 0-1 的患者通常在临床实践指南和临床试验报告中被汇总在一起。本研究旨在描述接受目前公认的氟尿嘧啶（5FU）为基础的一线化疗的 ECOG 评分为 0 与 1 的转移性结直肠癌患者之间潜在的结局差异。
本研究基于五项氟尿嘧啶为基础的转移性结直肠癌治疗临床试验的汇总数据集（NCT00272051；NCT00115765；NCT00305188；NCT00364013；和 NCT00384176）。ECOG 评分为 0-1 的转移性结直肠癌患者符合本研究条件。多变量逻辑回归分析用于评估 ECOG 表现状态与不同毒性发展之间的关系。Kaplan-Meier 生存估计用于阐明 ECOG 评分对总生存和无进展生存的影响。然后使用多变量 Cox 回归分析评估 ECOG 评分对总生存和无进展生存的影响。
共有 3143 名患者纳入本分析。在多变量逻辑回归分析中，ECOG 评分为 0 的患者发生严重不良事件的概率较低（OR 0.678；95%CI 0.583-0.788；P<0.001）、致命不良事件（OR 0.552；95%CI 0.397-0.766；P<0.001）、高级别贫血（OR 0.426；95%CI 0.252-0.721；P=0.001）和高级别恶心/呕吐（OR 0.697；95%CI 0.509-0.955；P=0.024）的概率较低。通过 Kaplan-Meier 生存分析，ECOG 评分为 0 的患者具有更好的总生存和无进展生存（两个终点均 P<0.001）。ECOG 评分为 0 的患者的中位总生存时间为 27.63 个月，而 ECOG 评分为 1 的患者为 20.00 个月。在多变量 Cox 回归分析中，ECOG 评分为 0 的患者与更好的总生存和无进展生存相关（总生存的 HR 为 0.613；95%CI 0.556-0.676；P<0.001）；（无进展生存的 HR 为 0.765；95%CI 0.705-0.829；P<0.001）。
与 ECOG 评分为 1 的患者相比，ECOG 评分为 0 的患者具有更好的总生存和无进展生存，且发生严重和致命不良事件的概率较低。在选择适当的治疗策略和设计/报告临床试验结果时，应注意到这些结局差异。
