Breast Service, Department of Surgery, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Biostatistics Service, Department of Epidemiology and Biostatistics, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
Ann Surg Oncol. 2019 Oct;26(10):3282-3288. doi: 10.1245/s10434-019-07537-y. Epub 2019 Jul 24.
A ductal carcinoma in situ (DCIS) Nomogram integrating 10 clinicopathologic/treatment factors and a Refined DCIS Score (RDS) that incorporates a genomic assay and three clinicopathologic factors (Oncotype DX DCIS Score) are available to estimate DCIS 10-year local recurrence risk (LRR). This study compared these estimates.
Patients 50 years of age or older with DCIS size 2.5 cm or smaller and a genomic assay available were identified. An RDS within 1-2% of the range of Nomogram LRR estimates obtained by assuming use and non-use of endocrine therapy (Nomogram ± ET) was defined as concordant. Assuming a 10-year risk threshold of 10% for recommending radiation, Nomogram ± ET and RDS estimates were compared, and threshold concordance was determined.
For 54 (92%) of 59 patients, the RDS and Nomogram ± ET LRR estimates were concordant. For the remaining 5 (8%) of the 59 patients, the RDS LRR estimates were lower than the Nomogram + ET estimates, with an absolute difference of 3-8%, and thus were discordant. For these five patients, the RDS estimates of 10-year LRR were lower than 10% (range 5-8%) and the Nomogram + ET estimates were 10% or higher (range 11-14%). These five patients with both discordant and threshold-discordant estimates all had close margins (≤ 2 mm).
Among 92% of women 50 years of age or older with DCIS size 2.5 cm or smaller, free-of-charge online Nomogram 10-year LRR estimates were concordant with those obtained using the commercially available RDS (> $4600). Among the 8% with discordant risk estimates, the RDS appeared to underestimate the LRR and may lead to inappropriate omission of radiotherapy. Unless other data show a clinically significant advantage of the RDS (Oncotype DX DCIS Score), the study data suggest that for women 50 years of age or older with DCIS size 2.5 cm or smaller, its use is not warranted.
目前有一款整合了 10 项临床病理/治疗因素的导管原位癌(DCIS)列线图和一个 Refined DCIS 评分(RDS),该评分纳入了基因组检测和 3 项临床病理因素(Oncotype DX DCIS 评分),可用于评估 DCIS 的 10 年局部复发风险(LRR)。本研究比较了这两种评估方法。
筛选出年龄 50 岁或以上、肿瘤直径 2.5cm 或更小且可进行基因组检测的 DCIS 患者。如果 RDS 评分与列线图假设使用和不使用内分泌治疗(Nomogram±ET)时得到的 LRR 估计值的范围相差 1%至 2%,则定义为一致。如果推荐放疗的 10 年风险阈值为 10%,那么比较列线图±ET 和 RDS 的估计值,并确定阈值一致性。
在 59 例患者中的 54 例(92%)中,RDS 和 Nomogram±ET 的 LRR 估计值一致。在剩余的 5 例(8%)患者中,RDS 的 LRR 估计值低于 Nomogram+ET 的估计值,绝对差值为 3%至 8%,因此不一致。对于这 5 例患者,RDS 评估的 10 年 LRR 低于 10%(范围为 5%至 8%),而 Nomogram+ET 的估计值为 10%或更高(范围为 11%至 14%)。这 5 例具有不一致和阈值不一致估计值的患者,其切缘均较近(≤2mm)。
在 92%年龄 50 岁或以上、肿瘤直径 2.5cm 或更小的 DCIS 患者中,免费在线列线图 10 年 LRR 估计值与使用商业 RDS(>4600 美元)得到的估计值一致。在 8%风险估计不一致的患者中,RDS 似乎低估了 LRR,可能导致放疗的不当遗漏。除非其他数据显示 RDS(Oncotype DX DCIS 评分)具有明显的临床优势,否则研究数据表明,对于年龄 50 岁或以上、肿瘤直径 2.5cm 或更小的 DCIS 患者,其使用并不合理。