Department of Surgical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.
Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Hyderabad, India.
JCO Glob Oncol. 2023 Sep;9:e2300014. doi: 10.1200/GO.23.00014.
With the advent of taxanes and targeted agents in neoadjuvant chemotherapy (NACT) for breast cancer, the rates for pathologic complete response (pCR) have been steadily increasing. Surgery in these women serves as a biopsy to confirm or negate a pCR.
All newly diagnosed patients with nonmetastatic breast cancer, planned for NACT, were screened. Eligible patients with a complete or near-complete response to NACT as seen on a mammogram and ultrasound (US) were recruited. A magnetic resonance imaging was performed for these patients for documentation. US-guided core biopsies of the tumor bed (Core Bx) using a 14G needle was performed (minimum four in number), and the results were compared with the final histopathology report after surgery for standard performance parameters.
This study recruited 65 women of whom 94% were node-positive, and 60% were hormone receptor-negative. The pCR rate was 41.5% and 53.8% for the whole cohort and the hormone receptor-negative subgroup, respectively. The false-negative rate (FNR) for Core Bx was 42.1% (95% CI, 26.3 to 59.2), with a negative predictive value of 59.0% (95% CI, 42.1 to 74.4). Among the hormone receptor-negative tumors, the FNR was 44.4% (95% CI, 21.5 to 69.2) with a negative predictive value of 70.4% (95% CI, 49.8 to 86.2).
The Complete Responders in the Breast study results suggest that ultrasound-guided 14G core needle biopsy of the tumor bed may not be a reliable predictor of pCR in the breast. These results highlight the importance of further research into the omission of surgery in the breast after chemotherapy. This study is registered with Clinical Trials Registry of India (CTRI/2018/01/011122).
随着紫杉烷类药物和靶向药物在乳腺癌新辅助化疗（NACT）中的应用，病理完全缓解（pCR）的比例稳步上升。这些女性的手术是为了活检以确认或否定 pCR。
所有新诊断为非转移性乳腺癌、计划接受 NACT 的患者均进行筛查。招募了在 NACT 后在乳房 X 线照相术和超声（US）上看到完全或近乎完全缓解的合格患者。对这些患者进行磁共振成像（MRI）以进行记录。使用 14G 针进行肿瘤床的超声引导核心活检（Core Bx）（至少 4 个），并将结果与手术后的最终组织病理学报告进行比较，以评估标准性能参数。
这项研究共招募了 65 名女性，其中 94%的患者淋巴结阳性，60%的患者激素受体阴性。整个队列和激素受体阴性亚组的 pCR 率分别为 41.5%和 53.8%。Core Bx 的假阴性率（FNR）为 42.1%（95%CI，26.3 至 59.2），阴性预测值为 59.0%（95%CI，42.1 至 74.4）。在激素受体阴性肿瘤中，FNR 为 44.4%（95%CI，21.5 至 69.2），阴性预测值为 70.4%（95%CI，49.8 至 86.2）。
Breast 研究的完全缓解者结果表明，肿瘤床的超声引导 14G 核心针活检可能不是 pCR 的可靠预测指标。这些结果强调了进一步研究在化疗后是否可以省略乳房手术的重要性。该研究在印度临床试验注册中心（CTRI/2018/01/011122）注册。
