Renfro Lindsay A, Zhang Nan, Lopatin Margarita, Chao Calvin, Alberts Steven R
Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN.
Genomic Health, Inc, Redwood City, CA.
Clin Colorectal Cancer. 2017 Mar;16(1):23-30. doi: 10.1016/j.clcc.2016.07.016. Epub 2016 Aug 9.
The Oncotype DX colon cancer assay is a validated predictor of recurrence risk in patients with resected stage II colon cancer. We previously reported that Oncotype DX led to a change in treatment recommendations for 45% of patients with T3 mismatch repair proficient (MMR-P) stage II tumors in a prospective study. In the present study, we report the assay's influence on patient treatment decisions, physician confidence, concordance between physicians and patients, and patient decisional conflict.
Consecutive patients with resected stage IIA colon cancer were enrolled. The tumor specimens were assessed using a 12-gene assay (reverse transcription-polymerase chain reaction) and by immunohistochemistry for MMR. Before and after receiving the results, the patients completed surveys that included their treatment preference, their current and preferred roles in treatment decision-making, and indicators of decisional conflict. Physicians completed similar pre- and postassay surveys.
Of 221 patients enrolled, 139 T3 MMR-P patients were evaluable for the patient-reported analyses and 150 patients were evaluable for the physician-reported analyses. Before the assay, 46% of the patients chose observation, 3% 5-fluorouracil, 7% oxaliplatin, 4% other, and 41% were undecided. After the assay, 75% chose observation, 12% 5-fluorouracil, 11% oxaliplatin, and 2% other. After the assay, 94% of the defined treatment decisions were concordant between patients and physicians compared with 60% before the assay. Physicians reported the assay influenced their treatment decisions and increased confidence in their treatment recommendations for 69% and 84% of patients, respectively. Most patients (86%) reported that the assay influenced their treatment decisions. Patient decisional conflict was significantly lower after learning the assay results (P < .001).
In the present prospective study, knowledge of the 12-gene assay results influenced treatment decisions for most patients and physicians, increased physician confidence, improved the concordance between patients and physicians, and decreased patient decisional conflict.
Oncotype DX结肠癌检测是已切除的II期结肠癌患者复发风险的有效预测指标。我们之前在一项前瞻性研究中报告称，Oncotype DX导致45%的T3错配修复 proficient（MMR-P）II期肿瘤患者的治疗建议发生改变。在本研究中，我们报告了该检测对患者治疗决策、医生信心、医患一致性以及患者决策冲突的影响。
纳入连续的已切除IIA期结肠癌患者。使用12基因检测（逆转录-聚合酶链反应）和免疫组织化学检测MMR对肿瘤标本进行评估。在收到结果前后，患者完成了包括治疗偏好、他们在治疗决策中当前和期望的角色以及决策冲突指标的调查。医生完成了类似的检测前和检测后调查。
在纳入的221例患者中，139例T3 MMR-P患者可用于患者报告分析，150例患者可用于医生报告分析。检测前，46%的患者选择观察，3%选择5-氟尿嘧啶，7%选择奥沙利铂，4%选择其他，41%未决定。检测后，75%选择观察，12%选择5-氟尿嘧啶，11%选择奥沙利铂，2%选择其他。检测后，94%的明确治疗决策在患者和医生之间是一致的，而检测前为60%。医生报告称，该检测分别影响了69%和84%患者的治疗决策，并增强了他们对治疗建议的信心。大多数患者（86%）报告称该检测影响了他们的治疗决策。了解检测结果后，患者的决策冲突显著降低（P <.001）。
在本前瞻性研究中，12基因检测结果的知晓影响了大多数患者和医生的治疗决策，增强了医生的信心，改善了医患一致性，并降低了患者的决策冲突。
