Srivastava Geetika, Renfro Lindsay A, Behrens Robert J, Lopatin Margarita, Chao Calvin, Soori Gamini S, Dakhil Shaker R, Mowat Rex B, Kuebler J Philip, Kim George, Mazurczak Miroslaw, Lee Mark, Alberts Steven R
Mayo Clinic, Rochester, Minnesota, USA, Medical Oncology and Hematology Associates, Des Moines, Iowa, USA; Genomic Health, Inc., Redwood City, California, USA; Alegent Bergan Mercy Cancer Center, Omaha, Nebraska, USA; Cancer Center of Kansas, Wichita, Kansas, USA; Toledo Clinic, Toledo, Ohio, USA; Columbus Oncology Associates, Columbus, Ohio, USA; Mayo Clinic, Jacksonville, Florida, USA; Sanford Hospital, Sioux Falls, South Dakota, USA.
Oncologist. 2014 May;19(5):492-7. doi: 10.1634/theoncologist.2013-0401. Epub 2014 Apr 7.
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.
Oncotype DX结肠癌检测是II期结肠癌患者复发风险的临床验证预测指标。这项前瞻性研究评估了复发评分（RS）结果对T3、错配修复 proficient（MMR-P）II期结肠癌患者辅助化疗医生建议的影响。患者与方法。IIA期结肠癌患者在17个中心入组。对患者的肿瘤标本进行RS检测（定量逆转录-聚合酶链反应）和错配修复（免疫组织化学）评估。对于每位患者，在提供RS和错配修复结果前后，记录医生推荐的观察、氟嘧啶单药治疗或奥沙利铂联合治疗的术后治疗方案。结果。在221名入组患者中，141名患者患有T3 MMR-P肿瘤，符合初步分析条件。这141名T3 MMR-P患者中有63名（45%；95%置信区间：36%-53%）的治疗建议发生了变化，其中强度降低的有47名（33%），强度增加的有16名（11%）。在医生和患者查看RS结果后，化疗建议从73名患者（52%）降至42名（30%）。在较高RS值时更常观察到治疗强度增加，在较低值时观察到强度降低（p = 0.011）。结论。在这项前瞻性多中心研究中，与传统的临床病理评估相比将RS结果纳入临床决策与45%的T3 MMR-P II期结肠癌患者的治疗建议改变相关。使用RS检测可能会导致该亚组II期结肠癌患者辅助化疗的总体使用减少。
