The Oncotype DX colon cancer assay is a clinically validated predictor of recurrence risk in stage II colon cancer patients. This prospective study evaluated the impact of recurrence score (RS) results on physician recommendations regarding adjuvant chemotherapy in T3, mismatch repair-proficient (MMR-P) stage II colon cancer patients. Patients and Methods. Stage IIA colon cancer patients were enrolled in 17 centers. Patient tumor specimens were assessed by the RS test (quantitative reverse transcription-polymerase chain reaction) and mismatch repair (immunohistochemistry). For each patient, the physician's recommended postoperative treatment plan of observation, fluoropyrimidine monotherapy, or combination therapy with oxaliplatin was recorded before and after the RS and mismatch repair results were provided. Results. Of 221 enrolled patients, 141 patients had T3 MMR-P tumors and were eligible for the primary analysis. Treatment recommendations changed for 63 (45%; 95% confidence interval: 36%-53%) of these 141 T3 MMR-P patients, with intensity decreasing for 47 (33%) and increasing for 16 (11%). Recommendations for chemotherapy decreased from 73 patients (52%) to 42 (30%), following review of RS results by physician and patient. Increased treatment intensity was more often observed at higher RS values, and decreased intensity was observed at lower values (p = .011). Conclusion. Compared with traditional clinicopathological assessment, incorporation of the RS result into clinical decision making was associated with treatment recommendation changes for 45% of T3 MMR-P stage II colon cancer patients in this prospective multicenter study. Use of the RS assay may lead to overall reduction in adjuvant chemotherapy use in this subgroup of stage II colon cancer patients.
摘要
目的 Oncotype DX 结肠癌测定是一项已通过临床验证的 II 期结肠癌复发风险预测工具。本前瞻性研究评估了复发评分 (RS) 对 T3 期错配修复精巧 (MMR-P) II 期结肠癌患者的辅助化疗治疗建议的影响。
患者与方法 我们在 17 个研究中心进行了 IIA 期结肠癌患者的招募。使用 RS 检测法（定量逆转录聚合酶链反应）和错配修复（免疫组织化学）对患者肿瘤样本进行了评估。我们记录了医生在获得 RS 和错配修复结果前及获得结果后为每一位患者建议的术后治疗方案，包括观察、氟嘧啶单药治疗，或氟嘧啶与奥沙利铂联合治疗。
结果 在 221 名入组患者中，有 141 名存在 T3 MMR-P 肿瘤并有资格被纳入主要分析。在这 141 名 T3 MMR-P 患者中，有 63 名的治疗建议发生了改变（45%；95% 置信区间： 36%–53%），其中 47 (33%) 名的治疗强度被下调，16 (11%) 名的治疗强度被上调。在医生和患者重审 RS 结果后，建议对其施用化疗的患者从 73 名 (52%) 下降至 42 名 (30%)。高 RS 值通常伴随治疗强度的增加，而低 RS 值通常伴随治疗强度的下降 (p = 0.011)。
结论 与传统临床病理评估相比，将 RS 结果纳入临床决策过程中导致了本前瞻性多中心研究中有 45% 的 T3 MMR-P II 期结肠癌患者的治疗建议发生了更改。RS 测定法的使用可能会从整体上降低这一II 期结肠癌患者亚组的辅助化疗使用率。The Oncologist 2014;19:492–497
Keywords: Adjuvant; Chemotherapy; Colon cancer; Decision analysis; Risk assessment.