Department of Breast Imaging, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Department of Breast Oncology, The University of Texas MD Anderson Cancer Center, Houston, Texas.
Cancer. 2021 Aug 15;127(16):2880-2887. doi: 10.1002/cncr.33604. Epub 2021 Apr 20.
Heterogeneity exists in the response of triple-negative breast cancer (TNBC) to standard anthracycline (AC)/taxane-based neoadjuvant systemic therapy (NAST), with 40% to 50% of patients having a pathologic complete response (pCR) to therapy. Early assessment of the imaging response during NAST may identify a subset of TNBCs that are likely to have a pCR upon completion of treatment. The authors aimed to evaluate the performance of early ultrasound (US) after 2 cycles of neoadjuvant NAST in identifying excellent responders to NAST among patients with TNBC.
Two hundred fifteen patients with TNBC were enrolled in the ongoing ARTEMIS (A Robust TNBC Evaluation Framework to Improve Survival) clinical trial. The patients were divided into a discovery cohort (n = 107) and a validation cohort (n = 108). A receiver operating characteristic analysis with 95% confidence intervals (CIs) and a multivariate logistic regression analysis were performed to model the probability of a pCR on the basis of the tumor volume reduction (TVR) percentage by US from the baseline to after 2 cycles of AC.
Overall, 39.3% of the patients (42 of 107) achieved a pCR. A positive predictive value (PPV) analysis identified a cutoff point of 80% TVR after 2 cycles; the pCR rate was 77% (17 of 22) in patients with a TVR ≥ 80%, and the area under the curve (AUC) was 0.84 (95% CI, 0.77-0.92; P < .0001). In the validation cohort, the pCR rate was 44%. The PPV for pCR with a TVR ≥ 80% after 2 cycles was 76% (95% CI, 55%-91%), and the AUC was 0.79 (95% CI, 0.70-0.87; P < .0001).
The TVR percentage by US evaluation after 2 cycles of NAST may be a cost-effective early imaging biomarker for a pCR to AC/taxane-based NAST.
三阴性乳腺癌（TNBC）对标准蒽环类药物（AC）/紫杉烷类新辅助全身治疗（NAST）的反应存在异质性，约 40%至 50%的患者对治疗有病理完全缓解（pCR）。在 NAST 期间早期评估影像学反应可能可以识别出一部分 TNBC 患者，这些患者在完成治疗后很可能有 pCR。作者旨在评估新辅助 NAST 进行 2 个周期后早期超声（US）在识别 TNBC 患者中对 NAST 有极好反应者方面的表现。
215 例 TNBC 患者入组正在进行的 ARTEMIS（一种提高 TNBC 生存率的稳健框架）临床试验。患者分为发现队列（n=107）和验证队列（n=108）。使用 95%置信区间（CI）的受试者工作特征分析和多变量逻辑回归分析，根据基线至 AC 治疗 2 个周期后 US 测量的肿瘤体积减少（TVR）百分比，建立 pCR 概率模型。
总体而言，39.3%的患者（107 例中有 42 例）达到了 pCR。阳性预测值（PPV）分析确定了 2 个周期后 TVR 为 80%的截断点；TVR≥80%的患者 pCR 率为 77%（17/22），曲线下面积（AUC）为 0.84（95%CI，0.77-0.92；P<.0001）。在验证队列中，pCR 率为 44%。2 个周期后 TVR≥80%的 pCR 的 PPV 为 76%（95%CI，55%-91%），AUC 为 0.79（95%CI，0.70-0.87；P<.0001）。
NAST 进行 2 个周期后 US 评估的 TVR 百分比可能是 AC/紫杉烷类 NAST 获得 pCR 的一种具有成本效益的早期影像学生物标志物。
