Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer
Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer
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DOI：
10.1093/jnci/89.22.1673
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发表时间：
1997-11-19
影响因子：
10.3
通讯作者：
Margolese, RG
中科院分区：
文献类型：
--
作者：
Fisher, B;Dignam, J;Margolese, RG
背景资料：国家外科辅助乳腺和肠道项目（NSABP）的B-20研究旨在确定化疗加他莫昔芬治疗腋窝淋巴结阴性、雌激素受体阳性乳腺癌患者是否比单用他莫昔芬获益更大。方法：符合条件的患者（n = 2306）在手术后被随机分配到三个治疗组之一。共有771例有随访数据的患者接受了他莫昔芬单药治疗; 767例接受了甲氨蝶呤、氟尿嘧啶和他莫昔芬（MFT）; 768例接受了环磷酰胺、甲氨蝶呤、氟尿嘧啶和他莫昔芬（CMFT）。Kaplan-Meier法用于估计无病生存期、无远处转移生存期和生存期。报告的P值为双侧。结果如下：通过5年的随访，化疗加他莫昔芬的无病生存率明显优于他莫昔芬单药治疗（MFT为90%，他莫昔芬为85%[P = .01]; CMFT为89%，他莫昔芬为85%[P = .001]）。在无远处疾病生存率（MFT为92%，他莫昔芬为87%[P = 0.008]; CMFT为91%，他莫昔芬为87%[P = 0.006]）和生存率（MFT为97%，他莫昔芬为94%[P = 0.05]; CMFT为96%，他莫昔芬为94%[P = 0.03]）方面观察到类似的获益。与单独使用他莫昔芬相比，MFT和CMFT降低了肿块切除术后同侧乳腺肿瘤复发的风险，以及其他局部、区域和远处部位复发的风险。无论肿瘤大小、肿瘤雌激素或孕激素受体水平或患者年龄如何，两种化疗后治疗失败的风险均降低;然而，49岁或以下患者的降低幅度最大。结论：这项研究和其他NSABP研究的结果表明，符合NSABP方案标准的乳腺癌患者，无论年龄、淋巴结状态、肿瘤大小或雌激素受体状态如何，都是化疗的候选人。
Background: The B-20 study of the National Surgical Adjuvant Breast and Bowel Project (NSABP) was conducted to determine whether chemotherapy plus tamoxifen would be of greater benefit than tamoxifen alone in the treatment of patients with axillary lymph node-negative, estrogen receptor-positive breast cancer. Methods: Eligible patients (n = 2306) were randomly assigned to one of three treatment groups following surgery. A total of 771 patients with followup data received tamoxifen alone; 767 received methotrexate, fluorouracil, and tamoxifen (MFT); and 768 received cyclophosphamide, methotrexate, fluorouracil, and tamoxifen (CMFT). The Kaplan-Meier method was used to estimate disease-free survival, distant disease-free survival, and survival. Reported P values are two-sided. Results: Through 5 years of follow-up, chemotherapy plus tamoxifen resulted in significantly better disease-free survival than tamoxifen alone (90% for MFT versus 85% for tamoxifen [P = .01]; 89% for CMFT versus 85% for tamoxifen [P = .001]). A similar benefit was observed in both distant disease-free survival (92% for MFT versus 87% for tamoxifen [P = .008]; 91% for CMFT versus 87% for tamoxifen [P = .006]) and survival (97% for MFT versus 94% for tamoxifen [P = .05]; 96% for CMFT versus 94% for tamoxifen [P = .03]). Compared with tamoxifen alone, MFT and CMFT reduced the risk of ipsilateral breast tumor recurrence after lumpectomy and the risk of recurrence at other local, regional, and distant sites. Risk of treatment failure was reduced after both types of chemotherapy, regardless of tumor size, tumor estrogen or progesterone receptor level, or patient age; however, the reduction was greatest in patients aged 49 years or less. No subgroup of patients evaluated in this study failed to benefit from chemotherapy. Conclusions: Findings from this and other NSABP studies indicate that patients with breast cancer who meet NSABP protocol criteria, regardless of age, lymph node status, tumor size, or estrogen receptor status, are candidates for chemotherapy.