Pico C, Martin M, Jara C, Barnadas A, Pelegri A, Balil A, Camps C, Frau A, Rodriguez-Lescure A, Lopez-Vega J M, De La Haba J, Tres A, Alvarez I, Alba E, Arcusa A, Oltra A, Batista N, Checa T, Perez-Carrion R, Curto J
Servicio de Oncología Médica, Hospital General Universitario de Alicante, Alicante, Spain.
Ann Oncol. 2004 Jan;15(1):79-87. doi: 10.1093/annonc/mdh016.
A prospective randomized clinical trial was implemented to assess whether the concomitant or the sequential addition of tamoxifen to chemotherapy provides improved clinical benefit in the adjuvant treatment of breast cancer in postmenopausal patients.
Four-hundred and eighty-five patients with node-positive operable disease were randomized to receive tamoxifen (20 mg/day) concomitantly (CON) or sequentially (SEQ) to EC chemotherapy (epirubicin 75 mg/m(2) + cyclophosphamide 600 mg/m(2) on day 1, every 21 days for four cycles).
In the 474 fully evaluable patients there were 96 events; eight being second neoplasms and 88 being related to the breast cancer. Of these, 48 of 88 occurred in the CON arm and 40 of 88 in the SEQ arm. The Kaplan-Meier estimation of disease-free survival (DFS) at 5 years was 70% in the CON and 75% in the SEQ group (log-rank test, P = 0.43). Adjusted hazard ratio for treatment was 1.11 (95% confidence interval 0.71-1.73; P = 0.64).
This study fails to show an advantage of one treatment arm over the other, but a trend, albeit non-significant, appears to favor the sequential addition of tamoxifen to epirubicin + cyclophosphamide and, as such, warrants further investigation.
开展了一项前瞻性随机临床试验，以评估在绝经后乳腺癌患者的辅助治疗中，他莫昔芬与化疗同时使用或序贯使用是否能带来更好的临床获益。
485例有可手术的淋巴结阳性疾病的患者被随机分组，分别在接受表柔比星+环磷酰胺（EC）化疗（表柔比星75mg/m²+环磷酰胺600mg/m²，第1天，每21天为一个周期，共四个周期）的同时（CON）或序贯（SEQ）接受他莫昔芬（20mg/天）治疗。
在474例可全面评估的患者中发生了96起事件；其中8起为第二原发性肿瘤，88起与乳腺癌相关。在这些事件中，88起中的48起发生在CON组，88起中的40起发生在SEQ组。CON组和SEQ组5年无病生存率（DFS）的Kaplan-Meier估计值分别为70%和75%（对数秩检验，P = 0.43）。治疗的调整风险比为1.11（95%置信区间0.71 - 1.73；P = 0.64）。
本研究未显示出一个治疗组优于另一个治疗组的优势，但有一种趋势，尽管不显著，似乎支持他莫昔芬序贯添加到表柔比星+环磷酰胺方案中，因此值得进一步研究。
