Department of Surgery (MSR, PJKK, GJL, CJHvdV) and Department of Medical Statistics (HP), Leiden University Medical Center, Leiden, the Netherlands; Genomic Health Inc., Redwood City, CA (MLe, MLo, HT, KCL, SS).
J Natl Cancer Inst. 2014 Sep 26;106(11). doi: 10.1093/jnci/dju269. Print 2014 Nov.
The 12-gene Recurrence Score assay is a validated predictor of recurrence risk in stage II and III colon cancer patients. We conducted a prospectively designed study to validate this assay for prediction of recurrence risk in stage II and III rectal cancer patients from the Dutch Total Mesorectal Excision (TME) trial.
RNA was extracted from fixed paraffin-embedded primary rectal tumor tissue from stage II and III patients randomized to TME surgery alone, without (neo)adjuvant treatment. Recurrence Score was assessed by quantitative real time-polymerase chain reaction using previously validated colon cancer genes and algorithm. Data were analysed by Cox proportional hazards regression, adjusting for stage and resection margin status. All statistical tests were two-sided.
Recurrence Score predicted risk of recurrence (hazard ratio [HR] = 1.57, 95% confidence interval [CI] = 1.11 to 2.21, P = .01), risk of distant recurrence (HR = 1.50, 95% CI = 1.04 to 2.17, P = .03), and rectal cancer-specific survival (HR = 1.64, 95% CI = 1.15 to 2.34, P = .007). The effect of Recurrence Score was most prominent in stage II patients and attenuated with more advanced stage (P(interaction) ≤ .007 for each endpoint). In stage II, five-year cumulative incidence of recurrence ranged from 11.1% in the predefined low Recurrence Score group (48.5% of patients) to 43.3% in the high Recurrence Score group (23.1% of patients).
The 12-gene Recurrence Score is a predictor of recurrence risk and cancer-specific survival in rectal cancer patients treated with surgery alone, suggesting a similar underlying biology in colon and rectal cancers.
12 基因复发评分检测是 II 期和 III 期结肠癌患者复发风险的有效预测指标。我们进行了一项前瞻性设计的研究，以验证该检测在荷兰全直肠系膜切除术（TME）试验中对 II 期和 III 期直肠癌患者的复发风险预测的有效性。
从接受 TME 手术而未接受（新）辅助治疗的 II 期和 III 期患者的固定石蜡包埋原发直肠肿瘤组织中提取 RNA。通过定量实时聚合酶链反应使用先前验证的结肠癌基因和算法评估复发评分。通过 Cox 比例风险回归进行数据分析，调整分期和切除边缘状态。所有统计检验均为双侧检验。
复发评分预测了复发风险（危险比[HR] = 1.57，95%置信区间[CI] = 1.11 至 2.21，P =.01）、远处复发风险（HR = 1.50，95%CI = 1.04 至 2.17，P =.03）和直肠癌特异性生存（HR = 1.64，95%CI = 1.15 至 2.34，P =.007）。复发评分的作用在 II 期患者中最为明显，并随着分期的进展而减弱（每个终点的 P（交互）≤.007）。在 II 期，低复发评分组（48.5%的患者）五年累积复发率为 11.1%，而高复发评分组（23.1%的患者）为 43.3%。
12 基因复发评分是单独接受手术治疗的直肠癌患者复发风险和癌症特异性生存的预测指标，提示结直肠癌和直肠癌具有相似的潜在生物学特性。
