Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes
Definition and Impact of Pathologic Complete Response on Prognosis After Neoadjuvant Chemotherapy in Various Intrinsic Breast Cancer Subtypes
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DOI：
10.1200/jco.2011.38.8595
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发表时间：
2012-05-20
影响因子：
45.3
通讯作者：
Loibl, Sibylle
中科院分区：
文献类型：
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作者：
von Minckwitz, Gunter;Untch, Michael;Loibl, Sibylle
病理完全缓解（pCR）的确切定义及其对内在型乳腺癌亚型生存率的预后影响尚不确定。我们分析了7项随机试验中377例接受蒽环类-紫杉类新辅助化疗的原发性乳腺癌患者。与仅残留导管原位癌（n = 309）、乳腺无浸润性残留但累及淋巴结的患者（n = 186）相比，在乳腺或淋巴结无浸润性和无原位残留的患者（n = 955）中，仅乳腺局灶性浸润性病变（n = 478）和大体浸润性残留病变（n = 4，449; P <0.001）。当定义为无浸润性和无原位残留（0.446）时，比较有或无pCR患者的DFS风险比最低，当定义中包括原位残留（0.523）、无浸润性乳腺残留但累及淋巴结（0.623）和局灶性浸润性疾病（0.727）时，DFS风险比单调增加。pCR与管腔型B/人表皮生长因子受体2（HER 2）阴性（P = 0.005）、HER 2阳性/非管腔型（P <0.001）和三阴性（P <0.001）乳腺癌的DFS改善相关，但与管腔型A（P = 0.39）或管腔型B/HER 2阳性（P = 0.45）乳腺癌无关。pCR在HER 2阳性（非管腔）和三阴性肿瘤与良好的预后。结论pCR定义为无侵入性和无原位残留在乳腺和淋巴结可以最好地区分患者的有利和不利的结果。存在非侵入性或局灶性侵入性残留物或累及淋巴结的患者不应视为已实现pCR。pCR是管腔型B/HER 2阴性、HER 2阳性（非管腔型）和三阴性疾病患者的合适替代终点，但不适用于管腔型B/HER 2阳性或管腔型A肿瘤患者。J Clin Oncol 30：1796-1804. (c)2012年美国临床肿瘤学会
PurposeThe exact definition of pathologic complete response (pCR) and its prognostic impact on survival in intrinsic breast cancer subtypes is uncertain.MethodsTumor response at surgery and its association with long-term outcome of 6,377 patients with primary breast cancer receiving neoadjuvant anthracycline-taxane-based chemotherapy in seven randomized trials were analyzed.ResultsDisease-free survival (DFS) was significantly superior in patients with no invasive and no in situ residuals in breast or nodes (n = 955) compared with patients with residual ductal carcinoma in situ only (n = 309), no invasive residuals in breast but involved nodes (n = 186), only focal-invasive disease in the breast (n = 478), and gross invasive residual disease (n = 4,449; P < .001). Hazard ratios for DFS comparing patients with or without pCR were lowest when defined as no invasive and no in situ residuals (0.446) and increased monotonously when in situ residuals (0.523), no invasive breast residuals but involved nodes (0.623), and focal-invasive disease (0.727) were included in the definition. pCR was associated with improved DFS in luminal B/human epidermal growth factor receptor 2 (HER2) -negative (P = .005), HER2-positive/nonluminal (P < .001), and triple-negative (P < .001) tumors but not in luminal A (P = .39) or luminal B/HER2-positive (P = .45) breast cancer. pCR in HER2-positive (nonluminal) and triple-negative tumors was associated with excellent prognosis.ConclusionpCR defined as no invasive and no in situ residuals in breast and nodes can best discriminate between patients with favorable and unfavorable outcomes. Patients with noninvasive or focal-invasive residues or involved lymph nodes should not be considered as having achieved pCR. pCR is a suitable surrogate end point for patients with luminal B/HER2-negative, HER2-positive (nonluminal), and triple-negative disease but not for those with luminal B/HER2-positive or luminal A tumors. J Clin Oncol 30:1796-1804. (c) 2012 by American Society of Clinical Oncology