Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18.
Preoperative chemotherapy in patients with operable breast cancer: nine-year results from National Surgical Adjuvant Breast and Bowel Project B-18.
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DOI：
10.1093/oxfordjournals.jncimonographs.a003469
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发表时间：
2001-12
期刊：
影响因子：
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通讯作者：
N. Wolmark;Jiping Wang;E. Mamounas;J. Bryant;B. Fisher
中科院分区：
文献类型：
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作者：
N. Wolmark;Jiping Wang;E. Mamounas;J. Bryant;B. Fisher
国家手术辅助乳腺和肠项目（NSABP）方案B-18于1988年启动，目的是确定术前给予4个周期的阿霉素/环磷酰胺与术后给予相同的化疗相比，是否能提高生存率和无病生存率（DFS）。次要目的包括评估术前化疗对降低原发性乳腺肿瘤及累及腋窝淋巴结的影响，比较两治疗组的乳房肿瘤切除术率和同侧乳腺肿瘤复发率（IBTR），以及评估原发性肿瘤反应与预后的相关性。最初发表的研究结果是基于5年的随访；本报告更新了9年随访的结果。两组患者的生存期和DFS总体上没有统计学上的显著差异。术后组9年生存率为70%，术前组为69% （P = 0.80）。术后患者DFS为53%，术前患者为55% （P = 0.50）。原发肿瘤反应与预后之间存在统计学上显著的相关性，随着随访时间的延长，这种相关性在统计学上变得更强。术前化疗患者的肿瘤发生率明显高于术后患者，尤其是研究开始时肿瘤大于5cm的患者。虽然术前组IBTR率略高（10.7% vs 7.6%），但差异无统计学意义。在生存率和DFS方面，年龄与治疗之间的相互作用似乎出现了统计学上的显著差异，这表明年轻患者可能受益于术前治疗，而老年患者则可能相反。
National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 was initiated in 1988 to determine whether four cycles of doxorubicin/cyclophosphamide given preoperatively improve survival and disease-free survival (DFS) when compared with the same chemotherapy given postoperatively. Secondary aims included the evaluation of preoperative chemotherapy in downstaging the primary breast tumor and involved axillary lymph nodes, the comparison of lumpectomy rates and rates of ipsilateral breast tumor recurrence (IBTR) in the two treatment groups, and the assessment of the correlation between primary tumor response and outcome. Initially published findings were based on a follow-up of 5 years; this report updates results through 9 years of follow-up. There continue to be no statistically significant overall differences in survival or DFS between the two treatment groups. Survival at 9 years is 70% in the postoperative group and 69% in the preoperative group (P =.80). DFS is 53% in postoperative patients and 55% in preoperative patients (P =.50). A statistically significant correlation persists between primary tumor response and outcome, and this correlation has become statistically stronger with longer follow-up. Patients assigned to preoperative chemotherapy received notably more lumpectomies than postoperative patients, especially among patients with tumors greater than 5 cm at study entry. Although the rate of IBTR was slightly higher in the preoperative group (10.7% versus 7.6%), this difference was not statistically significant. Marginally statistically significant treatment-by-age interactions appear to be emerging for survival and DFS, suggesting that younger patients may benefit from preoperative therapy, whereas the reverse may be true for older patients.