Purpose: There is a need to improve current risk stratification of stage II colorectal cancer (CRC) to better inform risk of recurrence and guide adjuvant chemotherapy. We sought to examine whether integration of QuantCRC, a digital pathology biomarker utilizing hematoxylin and eosin-stained slides, provides improved risk stratification over current American Society of Clinical Oncology (ASCO) guidelines. Experimental Design: ASCO and QuantCRC-integrated schemes were applied to a cohort of 398 mismatch repair proficient (MMRP) stage II CRCs from three large academic medical centers. The ASCO stage II scheme was taken from recent guidelines. The QuantCRC-integrated scheme utilized pT3 vs. pT4 and a QuantCRC-derived risk classification. Evaluation of recurrence free survival (RFS) according to these risk schemes was compared using the log-rank test and hazard ratios. Results: Integration of QuantCRC provides improved risk stratification compared to the ASCO scheme for stage II MMRP CRCs. The QuantCRC-integrated scheme placed more stage II tumors in the low-risk group compared to the ASCO scheme (62.5% vs. 42.2%) without compromising excellent 3-year RFS. The QuantCRC-integrated scheme provided larger hazard ratios (HR) for both intermediate-risk (2.27, 95%CI 1.32-3.91, P=0.003) and high-risk (3.27, 95%CI 1.42-7.55, P=0.006) groups compared to ASCO intermediate-risk (1.58, 95%CI 0.87-2.87, P=0.1) and high-risk (2.24, 95%CI 1.09-4.62, P=0.03) groups. The QuantCRC-integrated risk groups remained prognostic in the subgroup of patients that did not receive any adjuvant chemotherapy. Conclusions: Incorporation of QuantCRC into risk stratification provides a powerful predictor of RFS that has potential to guide subsequent treatment and surveillance for stage II MMRP CRCs.

中文翻译：

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使用数字病理生物标志物 QuantCRC 改进错配修复熟练的 II 期结直肠癌的风险分层方案

目的：需要改进当前 II 期结直肠癌 (CRC) 的风险分层，以更好地告知复发风险并指导辅助化疗。我们试图研究 QuantCRC（一种利用苏木精和伊红染色载玻片的数字病理学生物标记物）的整合是否能够比当前美国临床肿瘤学会 (ASCO) 指南提供更好的风险分层。实验设计：ASCO 和 QuantCRC 集成方案应用于来自三个大型学术医疗中心的 398 名错配修复熟练 (MMRP) II 期 CRC 患者队列。ASCO 第二阶段计划取自最近的指南。QuantCRC 集成方案利用 pT3 与 pT4 以及 QuantCRC 衍生的风险分类。使用对数秩检验和风险比对根据这些风险方案的无复发生存（RFS）评估进行比较。结果：与 II 期 MMRP CRC 的 ASCO 方案相比，QuantCRC 的集成提供了改进的风险分层。与 ASCO 方案相比，QuantCRC 整合方案将更多 II 期肿瘤置于低风险组中（62.5% 对比 42.2%），且不影响出色的 3 年 RFS。QuantCRC 集成方案为中风险组（2.27，95%CI 1.32-3.91，P=0.003）和高风险组（3.27，95%CI 1.42-7.55，P=0.006）提供了更大的风险比（HR）与ASCO中危组（1.58，95%CI 0.87-2.87，P=0.1）和高危组（2.24，95%CI 1.09-4.62，P=0.03）相比。QuantCRC 整合的风险组在未接受任何辅助化疗的患者亚组中仍然具有预后作用。结论：将 QuantCRC 纳入风险分层可为 RFS 提供强大的预测因子，有可能指导 II 期 MMRP CRC 的后续治疗和监测。