Preoperative chemotherapy: Updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27
Preoperative chemotherapy: Updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27
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DOI：
10.1200/jco.2007.15.0235
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发表时间：
2008-02-10
影响因子：
45.3
通讯作者：
Wolmark, Norman
中科院分区：
文献类型：
--
作者：
Rastogi, Priya;Anderson, Stewart J.;Wolmark, Norman
目的：根据美国国家乳腺和肠道外科辅助治疗计划（NSABP）方案B-18，研究术前给予4个周期的阿霉素和环磷酰胺（AC）是否能改善乳腺癌患者的无病生存期（DFS）和总生存期（OS）。方案B-27旨在确定术前AC中添加多西他赛（T）对肿瘤缓解率、DFS和OS的影响。患者和方法分析仅限于符合条件的患者。在B-18中，751例患者被分配接受术前AC，742例患者被分配接受术后AC。在B-27中，784例患者被分配到术前AC然后手术，783例患者被分配到AC然后T和手术，777例患者被分配到AC然后手术，然后T。结果来自B-18的结果显示两组之间的DFS和OS无统计学差异。然而，对于年龄小于50岁的女性，术前化疗有利于DFS和OS（DFS的风险比[HR] = 0.85，P = 0.09; OS的风险比[HR]= 0.81，P = 0.06）。无事件5年条件下的DFS也显示出有利于术前组的强烈趋势（HR = 0.81，P = 0.053）。方案B-27结果表明，AC中加入T对DFS或OS没有显著影响。与术前单独AC相比，术前AC中加入T显著增加了病理完全缓解（pCR）患者的比例（分别为26%和13%; P < .0001）。在这两项研究中，谁实现了pCR的患者继续有显着优越的上级DFS和OS的结果相比，患者谁not.Conclusion B-18和B-27证明，术前治疗是等同于辅助治疗。B-27也显示，术前在AC中加入紫杉烷类可改善反应。
Purpose National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-18 was designed to determine whether four cycles of doxorubicin and cyclophosphamide (AC) administered preoperatively improved breast cancer disease-free survival (DFS) and overall survival (OS) compared with AC administered postoperatively. Protocol B-27 was designed to determine the effect of adding docetaxel (T) to preoperative AC on tumor response rates, DFS, and OS.Patients and Methods Analyses were limited to eligible patients. In B-18, 751 patients were assigned to receive preoperative AC, and 742 patients were assigned to receive postoperative AC. In B-27, 784 patients were assigned to receive preoperative AC followed by surgery, 783 patients were assigned to AC followed by T and surgery, and 777 patients were assigned to AC followed by surgery and then T.Results Results from B-18 show no statistically significant differences in DFS and OS between the two groups. However, there were trends in favor of preoperative chemotherapy for DFS and OS in women less than 50 years old (hazard ratio [HR] = 0.85, P = .09 for DFS; HR = 0.81, P = .06 for OS). DFS conditional on being event free for 5 years also demonstrated a strong trend in favor of the preoperative group (HR = 0.81, P = .053). Protocol B-27 results demonstrated that the addition of T to AC did not significantly impact DFS or OS. Preoperative T added to AC significantly increased the proportion of patients having pathologic complete responses (pCRs) compared with preoperative AC alone (26% v 13%, respectively; P < .0001). In both studies, patients who achieved a pCR continue to have significantly superior DFS and OS outcomes compared with patients who did not.Conclusion B-18 and B-27 demonstrate that preoperative therapy is equivalent to adjuvant therapy. B-27 also showed that the addition of preoperative taxanes to AC improves response.