Introduction

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.

Patients and Methods

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.

Results

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.

Conclusion

The eligibility criteria of adjuvant chemotherapy trials in colon cancer should be broadened to be more representative of real-world patients.

中文翻译：

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现实世界中 II 期和 III 期结肠癌患者进行辅助化疗试验的资格。

介绍

II 期和 III 期结肠癌辅助化疗试验的结果通常会外推到真实世界的患者中。本研究旨在确定符合辅助化疗试验条件的真实 II/III 期结肠癌患者的比例，并比较符合条件与不符合条件的患者的结果。

患者和方法

我们确定了 2004 年至 2015 年间来自加拿大一个大省的所有诊断为 II/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、肾脏疾病、肝脏疾病）以及恶性肿瘤或免疫抑制病史。构建 Cox 回归模型以确定预测总体生存率和癌症特异性生存率的因素。

结果

共确定了 7841 名 II/III 期结肠癌患者，其中 52.0% 为男性，诊断时的中位年龄为 71 岁。大约 58.6% 的患者被认为不符合试验条件；不合格的最常见原因包括高龄 (36.2%)、肾功能障碍 (26.9%) 和心脏病 (17.4%)。在现实世界中，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为 23.2%（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试验条件的患者的 5 年总体生存率和癌症特异性生存率显着优于仅接受手术治疗的患者。

结论

结肠癌辅助化疗试验的资格标准应扩大，以更能代表真实世界的患者。