Yothers Greg, Venook Alan P, Oki Eiji, Niedzwiecki Donna, Lin Yan, Crager Michael R, Chao Calvin, Baehner Frederick L, Wolmark Norman, Yoshino Takayuki
NSABP, NRG Oncology, University of Pittsburgh, Pittsburgh, PA, USA.
Helen Diller Family Comprehensive Cancer Center, University of California at San Francisco, San Francisco, CA, USA.
J Gastrointest Oncol. 2022 Feb;13(1):126-136. doi: 10.21037/jgo-21-620.
Individualized estimates of the risk of recurrence in colon cancer patients are needed that reflect current medical practice and available treatment options.
Three validation studies of the 12-gene colon recurrence score assay were used with pre-specified patient-specific meta-analysis (PSMA) methods to integrate the 12-gene Oncotype DX Colon Recurrence Score result (RS) with the clinical and pathology risk factors stage, T-stage, mis-match repair (MMR) status, and number of nodes examined to calculate individualized recurrence risk estimates. Baseline risk estimation used the most recent studies, so the risk estimates reflect current medical practice. The effect of fluorouracil (5FU) was estimated with a meta-analysis of two studies. The effect of oxaliplatin was estimated using one of the RS assay validation studies, in which patients were randomized to 5FU with or without oxaliplatin.
The RS result and each of the clinical-pathologic factors provided independent prognostic information for recurrence. Among stage II, T3, MMR-proficient patients with ≥12 nodes examined (the most common scenario), patients with RS ≤30 (approximately 48%) have estimated 5-year recurrence risk ≤10% with surgery alone. Among stage IIIA/B, T3, MMR-deficient patients with ≥12 nodes examined, patients with RS ≤19 (approximately 14%) have an estimated 5-year recurrence risk ≤10% with surgery alone. Among stage IIIA/B, T3, MMR-proficient patients with ≥12 nodes examined, those with RS ≤14 (approximately 6%) have estimated 5-year recurrence risk ≤10% with 5FU alone.
The PSMA integrates the 12-gene colon RS result with clinical and pathology factors to provide individualized recurrence risk estimates that reflect current medical practice. The risk estimates are in a range that may help inform treatment decisions for a substantial number of stage II and stage III patients.
需要对结肠癌患者的复发风险进行个体化评估，以反映当前的医疗实践和可用的治疗选择。
采用三项12基因结肠癌复发评分检测的验证研究，并使用预先指定的患者特异性荟萃分析（PSMA）方法，将12基因Oncotype DX结肠癌复发评分结果（RS）与临床和病理风险因素分期、T分期、错配修复（MMR）状态以及检查的淋巴结数量相结合，以计算个体化的复发风险估计值。基线风险评估采用最新研究，因此风险估计反映了当前的医疗实践。通过对两项研究的荟萃分析评估氟尿嘧啶（5FU）的效果。使用RS检测验证研究之一评估奥沙利铂的效果，在该研究中，患者被随机分为接受5FU联合或不联合奥沙利铂治疗。
RS结果以及每个临床病理因素都为复发提供了独立的预后信息。在II期、T3、MMR熟练且检查淋巴结≥12个的患者（最常见情况）中，RS≤30的患者（约48%）估计单纯手术的5年复发风险≤10%。在IIIA/B期、T3、MMR缺陷且检查淋巴结≥12个的患者中，RS≤19的患者（约14%）估计单纯手术的5年复发风险≤10%。在IIIA/B期、T3、MMR熟练且检查淋巴结≥12个的患者中，RS≤14的患者（约6%）估计单纯使用5FU的5年复发风险≤10%。
PSMA将12基因结肠癌RS结果与临床和病理因素相结合，以提供反映当前医疗实践的个体化复发风险估计值。风险估计值的范围可能有助于为大量II期和III期患者的治疗决策提供参考。
