Kuerer H M, Newman L A, Smith T L, Ames F C, Hunt K K, Dhingra K, Theriault R L, Singh G, Binkley S M, Sneige N, Buchholz T A, Ross M I, McNeese M D, Buzdar A U, Hortobagyi G N, Singletary S E
Department of Surgical Oncology, University of Texas M.D. Anderson Cancer Center, Houston 77030, USA.
J Clin Oncol. 1999 Feb;17(2):460-9. doi: 10.1200/JCO.1999.17.2.460.
To assess patient and tumor characteristics associated with a complete pathologic response (pCR) in both the breast and axillary lymph node specimens and the outcome of patients found to have a pCR after neoadjuvant chemotherapy for locally advanced breast cancer (LABC).
Three hundred seventy-two LABC patients received treatment in two prospective neoadjuvant trials using four cycles of doxorubicin-containing chemotherapy. Patients had a total mastectomy with axillary dissection or segmental mastectomy and axillary dissection followed by four or more cycles of additional chemotherapy. Patients then received irradiation treatment of the chest-wall or breast and regional lymphatics. Median follow-up was 58 months (range, 8 to 99 months).
The initial nodal status, age, and stage distribution of patients with a pCR were not significantly different from those of patients with less than a pCR (P>.05). Patients with a pCR had initial tumors that were more likely to be estrogen receptor (ER)-negative (P<.01), and anaplastic (P = .01) but of smaller size (P<.01) than those of patients with less than a pCR. Upon multivariate analysis, the effects of ER status and nuclear grade were independent of initial tumor size. Sixteen percent of the patients in this study (n = 60) had a pathologic complete primary tumor response. Twelve percent of patients (n = 43) had no microscopic evidence of invasive cancer in their breast and axillary specimens. A pathologic complete primary tumor response was predictive of a complete axillary lymph node response (P<.01 ). The 5-year overall and disease-free survival rates were significantly higher in the group who had a pCR (89% and 87%, respectively) than in the group who had less than a pCR (64% and 58%, respectively; P<.01).
Neoadjuvant chemotherapy has the capacity to completely clear the breast and axillary lymph nodes of invasive tumor before surgery. Patients with LABC who have a pCR in the breast and axillary nodes have a significantly improved disease-free survival rate. However, a pCR does not entirely eliminate recurrence. Further efforts should focus on elucidating the molecular mechanisms associated with this response.
评估与乳腺及腋窝淋巴结标本中完全病理缓解（pCR）相关的患者和肿瘤特征，以及局部晚期乳腺癌（LABC）新辅助化疗后达到pCR的患者的预后。
372例LABC患者在两项前瞻性新辅助试验中接受了含阿霉素的化疗，共四个周期。患者接受了全乳切除加腋窝清扫或保乳手术加腋窝清扫，随后进行四个或更多周期的辅助化疗。然后患者接受胸壁或乳腺及区域淋巴结的放射治疗。中位随访时间为58个月（范围8至99个月）。
达到pCR的患者的初始淋巴结状态、年龄和分期分布与未达到pCR的患者相比无显著差异（P>0.05）。达到pCR的患者初始肿瘤更可能为雌激素受体（ER）阴性（P<0.01）、间变（P = 0.01），但比未达到pCR的患者的肿瘤体积小（P<0.01）。多因素分析显示，ER状态和核分级的影响独立于初始肿瘤大小。本研究中16%的患者（n = 60）达到了原发性肿瘤病理完全缓解。12%的患者（n = 43）在乳腺和腋窝标本中无浸润癌的镜下证据。原发性肿瘤病理完全缓解可预测腋窝淋巴结完全缓解（P<0.01）。达到pCR的组的5年总生存率和无病生存率（分别为89%和87%）显著高于未达到pCR的组（分别为64%和58%；P<0.01）。
新辅助化疗有能力在手术前完全清除乳腺和腋窝淋巴结中的浸润性肿瘤。乳腺和腋窝淋巴结达到pCR的LABC患者的无病生存率显著提高。然而，pCR并不能完全消除复发。应进一步努力阐明与这种反应相关的分子机制。
