Department of Medical Oncology, Tom Baker Cancer Center, Calgary, Alberta, Canada; Department of Oncology, University of Calgary, Calgary, Alberta, Canada.
Department of Oncology, University of Calgary, Calgary, Alberta, Canada.
Clin Colorectal Cancer. 2020 Dec;19(4):e226-e234. doi: 10.1016/j.clcc.2020.05.005. Epub 2020 May 26.
The results of adjuvant chemotherapy trials in stage II and III colon cancer are often extrapolated to real-world patients. This study was conducted to determine the proportion of real-world patients with stage II/III colon cancer who would be eligible for adjuvant chemotherapy trials and to compare the outcomes among eligible versus ineligible patients.
We identified all patients diagnosed with stage II/III colon cancer between 2004 and 2015 from a large province in Canada. Patients meeting any one of the following criteria were considered ineligible: age > 75 years, anemia, comorbid conditions (heart disease, uncontrolled diabetes, kidney disease, liver disease), and a history of malignancy or immunosuppression. Cox regression models were constructed to determine the factors predicting overall and cancer-specific survival.
A total of 7841 patients with stage II/III colon cancer were identified, of whom 52.0% were men and median age at diagnosis was 71 years. Approximately 58.6% of patients were deemed trial ineligible; the most common reasons for ineligibility included advanced age (36.2%), renal dysfunction (26.9%), and cardiac disease (17.4%). In the real-world setting, 54.0% of eligible patients received adjuvant chemotherapy compared to 23.2% of ineligible patients (odds ratio, 3.89; 95% confidence interval, 3.53-4.28; P < .0001). The 5-year overall and cancer-specific survival of trial-ineligible patients who received adjuvant chemotherapy was significantly better than those treated with surgery alone.
The eligibility criteria of adjuvant chemotherapy trials in colon cancer should be broadened to be more representative of real-world patients.
辅助化疗试验在 II 期和 III 期结肠癌中的结果经常被外推到真实世界的患者中。本研究旨在确定 II 期/III 期结肠癌真实世界患者中有多少比例符合辅助化疗试验的条件，并比较符合条件和不符合条件的患者的结局。
我们从加拿大一个大省确定了所有在 2004 年至 2015 年间被诊断为 II 期/III 期结肠癌的患者。符合以下任何一项标准的患者被认为不符合条件：年龄 > 75 岁、贫血、合并症（心脏病、未控制的糖尿病、肾病、肝病）和恶性肿瘤或免疫抑制病史。构建 Cox 回归模型以确定预测总生存和癌症特异性生存的因素。
共确定了 7841 例 II 期/III 期结肠癌患者，其中 52.0%为男性，中位诊断年龄为 71 岁。约 58.6%的患者被认为不符合试验条件；最常见的不合格原因包括年龄较大（36.2%）、肾功能不全（26.9%）和心脏病（17.4%）。在真实环境中，54.0%的符合条件的患者接受了辅助化疗，而不符合条件的患者中只有 23.2%接受了化疗（优势比，3.89；95%置信区间，3.53-4.28；P <.0001）。接受辅助化疗的不符合条件的患者的 5 年总生存和癌症特异性生存明显优于仅接受手术治疗的患者。
结肠癌辅助化疗试验的入选标准应放宽，以更能代表真实世界的患者。
