Yale University School of Medicine; Yale New Haven Hospital-Smilow Cancer Hospital, New Haven, CT.
J Oncol Pract. 2017 Dec;13(12):e1012-e1020. doi: 10.1200/JOP.2017.022731. Epub 2017 Oct 19.
The 21-gene recurrence score (RS) assay is used to help formulate adjuvant chemotherapy recommendations for patients with estrogen receptor-positive, early-stage breast cancer. Most frequently, medical oncologists order RS after surgery. Results take an additional 2 weeks to return, which can delay decision making. We conducted a prospective quality-improvement project to assess the impact of early guideline-directed RS ordering by surgeons before the first visit with a medical oncologist on adjuvant therapy decision making.
Surgical oncologists ordered RS testing following National Comprehensive Cancer Network guidelines at time of diagnosis or at time of surgery between July 1, 2015 and December 31, 2015. We measured the testing rate of patients eligible for RS, time to chemotherapy decisions, rates of chemotherapy use, accrual to RS-based clinical trials, cost, and physician acceptance of the policy and compared the results to patients who met eligibility criteria for early guideline-directed testing during the 6 months before the project.
Ninety patients met eligibility criteria during the testing period. RS was ordered for 91% of patients in the early testing group compared with 76% of historical controls ( P < .001). Median time to chemotherapy decision was significantly shorter in the early testing group (20 days; 95% CI, 17 to 23 days) compared with historical controls (32 days; 95% CI, 29 to 35 days; P < .001). There were no significant differences in time to chemotherapy initiation, chemotherapy use, RS-based trial enrollment, or calculated costs between the groups.
Early guideline-directed RS testing in selected patients is an effective way to shorten time to treatment decisions.
21 基因复发评分(RS)检测用于帮助制定雌激素受体阳性、早期乳腺癌患者的辅助化疗建议。大多数情况下,肿瘤内科医生在手术后会开具 RS 检测。结果需要额外两周才能返回,这可能会延迟决策。我们开展了一项前瞻性质量改进项目,评估在与肿瘤内科医生首次就诊之前,外科医生根据指南提前开具 RS 检测对辅助治疗决策的影响。
在 2015 年 7 月 1 日至 2015 年 12 月 31 日期间,外科肿瘤医生根据国家综合癌症网络指南在诊断时或手术时开具 RS 检测。我们测量了符合 RS 检测条件的患者的检测率、化疗决策时间、化疗使用率、基于 RS 的临床试验入组率、成本以及医生对该政策的接受程度,并将结果与项目前 6 个月符合早期指南指导检测条件的患者进行比较。
在检测期间,有 90 名患者符合入选标准。在早期检测组中,91%的患者开具了 RS 检测,而历史对照组中为 76%(P <.001)。早期检测组的化疗决策中位时间明显更短(20 天;95%CI,17 至 23 天),而历史对照组为 32 天(95%CI,29 至 35 天;P <.001)。两组间化疗起始时间、化疗使用率、基于 RS 的临床试验入组率或计算成本均无显著差异。
在选定患者中进行早期指南指导的 RS 检测是缩短治疗决策时间的有效方法。