Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: Findings from National Surgical Adjuvant Breast and Bowel Project B-23
Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: Findings from National Surgical Adjuvant Breast and Bowel Project B-23
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DOI：
10.1200/jco.2001.19.4.931
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发表时间：
2001-02-15
影响因子：
45.3
通讯作者：
Farrar, WB
中科院分区：
文献类型：
--
作者：
Fisher, B;Anderson, S;Farrar, WB
目的：由于对阿霉素/环磷酰胺 (AC) 和环磷酰胺/甲氨蝶呤/氟尿嘧啶 (CMF) 的相对价值的不确定性，以及对雌激素受体阴性肿瘤和腋窝淋巴结阴性患者给予他莫昔芬 (TAM) 联合化疗的适当性的怀疑，促使国家外科辅助乳腺和肠道项目启动了 B-23 研究。 患者和方法： 患者 (n = 2,008 名）被随机分配到 CMF 加安慰剂、CMF 加 TAMI AC 加安慰剂或 AC 加 TAM 组。给予 6 个周期的 CMF，为期 6 个月；进行了四个周期的 AC，为期 63 天。 TAM 每天给予 5 年。通过使用生命表估计来确定无复发生存期（RFS）、无事件生存期（EFS）和生存期（S）。结果的异质性检验使用对数秩统计和 Cox 比例风险模型来检测所有组之间以及根据化疗和激素治疗状态的差异。结果：在 5 年内，四组之间未观察到 RFS、EFS 或 S 存在显着差异（分别为 P = .96、.8 和 .8），对于年龄小于或等于 49 岁的患者（分别为 P = .97、.5 和 .9）或年龄较大的患者大于或等于 50 年（P 分别 = 0.7、0.6 和 0.6）。所有 CMF 和所有 AC 治疗患者之间的比较表明，RFS（两组 5 年均为 87%，P = .9）、EFS（83% 和 82%，P = .6）或 S（89% 和 90%，P = .4）没有显着差异。在年龄小于或等于 49 岁或大于或等于 50 岁的患者中，CMF 和 AC 之间的 RFS、EFS 或 S 没有显着差异。当接受安慰剂的化疗患者与接受 TAM 治疗的患者进行比较时，没有观察到任何结局的显着差异。两组的 RFS 分别为 87% (P = .6)、49 岁患者中的 87% (P = .9)、年龄大于或等于 50 岁的患者中分别为 88% 和 87% (P = .4)。 结论：接受 AC 或 CMF 的患者的结果没有显着差异。任一方案的 TAM 与单独化疗相比均没有显着优势。
Purpose: Uncertainty about the relative worth of doxorubicin/cyclophosphamide (AC) and cyclophosphamide/methotrexate/fluorouracil (CMF), as well as doubt about the propriety of giving tamoxifen (TAM) with chemotherapy to patients with estrogen receptor negative tumors and negative axillary nodes, prompted the National Surgical Adjuvant Breast and Bowel Project to initiate the B-23 study.Patients and Methods: Patients (n = 2,008) were randomly assigned to CMF plus placebo, CMF plus TAMI AC plus placebo, or AC plus TAM. Six cycles of CMF were given for 6 months; four cycles of AC were administered for 63 days. TAM was given daily for 5 years. Relapse-free survival (RFS), event-free survival (EFS), and survival (S) were determined by using life-table estimates. Tests for heterogeneity of outcome used log-rank statistics and Cox proportional hazards models to detect differences across all groups and according to chemotherapy and hormonal therapy status.Results: No significant difference in RFS, EFS, or S was observed among the four groups through 5 years (P =.96,.8, and .8, respectively), for those aged less than or equal to 49 years (P = .97, .5, and .9, respectively), or for those aged greater than or equal to 50 years (P = .7, .6, and .6, respectively). A comparison between all CMF- and all AC-treated patients demonstrated no significant differences in RFS (87% at 5 years in both groups, P =.9), EFS (83% and 82%, P = .6), or S (89% and 90%, P = .4). There were no significant differences in RFS, EFS, or S between CMF and AC in patients aged less than or equal to 49 or greater than or equal to 50 years. No significant difference in any outcome was observed when chemotherapy-treated patients who received placebo were compared with those given TAM. RFS in both groups was 87% (P = .6), 87% in patients aged 49 (P =.9), land 88% and 87%, respectively (P = .4), in those aged greater than or equal to 50 years.Conclusion: There was no significant difference in the outcome of patients who received AC or CMF. TAM with either regimen resulted in no significant advantage over that achieved from chemotherapy alone.