术前化疗对可手术乳腺癌女性局部区域疾病的影响：来自国家外科辅助乳腺和肠道项目B-18的研究结果

Effect of preoperative chemotherapy on local-regional disease in women with operable breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-18.

作者信息

Fisher B, Brown A, Mamounas E, Wieand S, Robidoux A, Margolese R G, Cruz A B, Fisher E R, Wickerham D L, Wolmark N, DeCillis A, Hoehn J L, Lees A W, Dimitrov N V

机构信息

Department of Biostatistics, Graduate School of Public Health, University of Pittsburgh, Shadyside Hospital, PA, USA.

出版信息

J Clin Oncol. 1997 Jul;15(7):2483-93. doi: 10.1200/JCO.1997.15.7.2483.

DOI:10.1200/JCO.1997.15.7.2483

PMID:9215816

Abstract

PURPOSE

To determine whether preoperative doxorubicin and cyclophosphamide (AC) permits more lumpectomies to be performed and decreases the incidence of positive nodes in women with primary breast cancer.

PATIENTS AND METHODS

Women (n = 1,523) were randomized to National Surgical Adjuvant Breast and Bowel Project (NSABP) B-18; 759 eligible patients received postoperative AC and 747, preoperative AC. The clinical size of breast and axillary tumors was determined before each of four cycles of AC and before surgery. Tumor response to preoperative therapy was clinically complete (cCR), partial (cPR), stable (cSD), or progressive disease (cPD). Tissue from patients with a cCR was evaluated for a pathologic complete response (pCR).

RESULTS

Breast tumor size was reduced in 80% of patients after preoperative therapy; 36% had a cCR. Tumor size and clinical nodal status were independent predictors of cCR. Twenty-six percent of women with a cCR had a pCR. Clinical nodal response occurred in 89% of node-positive patients: 73% had a cCR and 44% of those had a pCR. There was a 37% increase in the incidence of pathologically negative nodes. Before randomization, lumpectomy was proposed for 86% of women with tumors < or = 2 cm, 70% with tumors 2.1 to 5.0 cm, and 3% with tumors > or = 5.1 cm. Clinical tumor size and nodal status influenced the physician's decision. Overall, 12% more lumpectomies were performed in the preoperative group; in women with tumors > or = 5.1 cm, there was a 175% increase.

CONCLUSION

Preoperative therapy reduced the size of most breast tumors and decreased the incidence of positive nodes. The greatest increase in lumpectomy after preoperative therapy occurred in women with tumors > or = 5 cm, since women with tumors less than 5 cm were already lumpectomy candidates. Preoperative therapy should be considered for the initial management of breast tumors judged too large for lumpectomy.

摘要

目的

确定术前使用阿霉素和环磷酰胺（AC）是否能使更多原发性乳腺癌女性患者接受保乳手术，并降低阳性淋巴结的发生率。

患者与方法

1523名女性被随机分配至国家外科辅助乳腺和肠道项目（NSABP）B - 18研究；759名符合条件的患者接受术后AC治疗，747名接受术前AC治疗。在AC的四个疗程中的每一个疗程之前以及手术前，确定乳腺和腋窝肿瘤的临床大小。术前治疗的肿瘤反应分为临床完全缓解（cCR）、部分缓解（cPR）、稳定（cSD）或疾病进展（cPD）。对达到cCR的患者组织进行病理完全缓解（pCR）评估。

结果

术前治疗后80%的患者乳腺肿瘤大小减小；36%达到cCR。肿瘤大小和临床淋巴结状态是cCR的独立预测因素。达到cCR的女性中有26%实现了pCR。89%的淋巴结阳性患者出现临床淋巴结反应：73%达到cCR，其中44%实现了pCR。病理阴性淋巴结的发生率增加了37%。随机分组前，对于肿瘤≤2 cm的女性，86%建议行保乳手术；肿瘤2.1至5.0 cm的女性中，70%建议行保乳手术；肿瘤≥5.1 cm的女性中，3%建议行保乳手术。临床肿瘤大小和淋巴结状态影响医生的决策。总体而言，术前治疗组的保乳手术率提高了12%；在肿瘤≥5.1 cm的女性中，保乳手术率提高了175%。