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Abstract：
BACKGROUND: Breast cancer patients with residual disease after neoadjuvant systemic treatment (NAST) have a worse prognosis compared with those achieving a pathologic complete response (pCR). Earlier identification of these patients might allow timely, extended neoadjuvant treatment strategies. We explored the feasibility of a vacuum-assisted biopsy (VAB) after NAST to identify patients with residual disease (ypT+ or ypN+) prior to surgery.
METHODS: We used data from a multicenter trial, collected at 21 study sites (NCT02948764). The trial included women with cT1-3, cN0/+ breast cancer undergoing routine post-neoadjuvant imaging (ultrasound, MRI, mammography) and VAB prior to surgery. We compared the findings of VAB and routine imaging with the histopathologic evaluation of the surgical specimen.
RESULTS: Of 398 patients, 34 patients with missing ypN status and 127 patients with luminal tumors were excluded. Among the remaining 237 patients, tumor cells in the VAB indicated a surgical non-pCR in all patients (73/73, positive predictive value [PPV] 100%), whereas PPV of routine imaging after NAST was 56.0% (75/134). Sensitivity of the VAB was 72.3% (73/101), and 74.3% for sensitivity of imaging (75/101).
CONCLUSIONS: Residual cancer found in a VAB specimen after NAST always corresponds to non-pCR. Residual cancer assumed on routine imaging after NAST corresponds to actual residual cancer in about half of patients. Response assessment by VAB is not safe for the exclusion of residual cancer. Response assessment by biopsies after NAST may allow studying the new concept of extended neoadjuvant treatment for patients with residual disease in future trials.
METHODS: We used data from a multicenter trial, collected at 21 study sites (NCT02948764). The trial included women with cT1-3, cN0/+ breast cancer undergoing routine post-neoadjuvant imaging (ultrasound, MRI, mammography) and VAB prior to surgery. We compared the findings of VAB and routine imaging with the histopathologic evaluation of the surgical specimen.
RESULTS: Of 398 patients, 34 patients with missing ypN status and 127 patients with luminal tumors were excluded. Among the remaining 237 patients, tumor cells in the VAB indicated a surgical non-pCR in all patients (73/73, positive predictive value [PPV] 100%), whereas PPV of routine imaging after NAST was 56.0% (75/134). Sensitivity of the VAB was 72.3% (73/101), and 74.3% for sensitivity of imaging (75/101).
CONCLUSIONS: Residual cancer found in a VAB specimen after NAST always corresponds to non-pCR. Residual cancer assumed on routine imaging after NAST corresponds to actual residual cancer in about half of patients. Response assessment by VAB is not safe for the exclusion of residual cancer. Response assessment by biopsies after NAST may allow studying the new concept of extended neoadjuvant treatment for patients with residual disease in future trials.
摘要：
背景：与获得病理完全缓解（pCR）的乳腺癌患者相比，新辅助系统治疗（NAST）后有残留疾病的乳腺癌患者的预后更差。这些患者的早期识别可能会允许及时，延长新辅助治疗策略。我们探讨了NASH术后真空辅助活检（VAB）的可行性，以在手术前识别残留疾病（ypT或ypN）的患者。
方法：我们使用了来自多中心试验的数据，在21个研究地点收集（NCT02948764）。该试验包括接受常规新辅助成像后cT1-3，cN0/乳腺癌的女性（超声，MRI,乳房X线照相术）和手术前的VAB。我们将VAB和常规影像学检查的结果与手术标本的组织病理学评估进行了比较。
结果：在398名患者中，排除了34例缺失ypN状态的患者和127例管腔肿瘤的患者。在剩下的237名患者中，VAB中的肿瘤细胞表明所有患者的手术非pCR（73/73，阳性预测值[PPV]100％），而NASH后常规成像的PPV为56.0%(75/134)。VAB的灵敏度为72.3%(73/101),成像灵敏度为74.3%(75/101)。
结论：在NAST后的VAB样本中发现的残留癌症总是对应于非pCR。在约一半的患者中,在NAST后常规成像中假定的残余癌症对应于实际的残余癌症。通过VAB的反应评估对于排除残留癌症是不安全的。NAST后活检的反应评估可能允许在未来的试验中研究对残留疾病患者进行扩展新辅助治疗的新概念。
方法：我们使用了来自多中心试验的数据，在21个研究地点收集（NCT02948764）。该试验包括接受常规新辅助成像后cT1-3，cN0/乳腺癌的女性（超声，MRI,乳房X线照相术）和手术前的VAB。我们将VAB和常规影像学检查的结果与手术标本的组织病理学评估进行了比较。
结果：在398名患者中，排除了34例缺失ypN状态的患者和127例管腔肿瘤的患者。在剩下的237名患者中，VAB中的肿瘤细胞表明所有患者的手术非pCR（73/73，阳性预测值[PPV]100％），而NASH后常规成像的PPV为56.0%(75/134)。VAB的灵敏度为72.3%(73/101),成像灵敏度为74.3%(75/101)。
结论：在NAST后的VAB样本中发现的残留癌症总是对应于非pCR。在约一半的患者中,在NAST后常规成像中假定的残余癌症对应于实际的残余癌症。通过VAB的反应评估对于排除残留癌症是不安全的。NAST后活检的反应评估可能允许在未来的试验中研究对残留疾病患者进行扩展新辅助治疗的新概念。
