Boccardo F, Rubagotti A, Amoroso D, Mesiti M, Romeo D, Sismondi P, Giai M, Genta F, Pacini P, Distante V, Bolognesi A, Aldrighetti D, Farris A
Professorial Unit of Medical Oncology and Biostatistics Unit, University and National Cancer Institute, Genoa, Italy.
J Clin Oncol. 2000 Jul;18(14):2718-27. doi: 10.1200/JCO.2000.18.14.2718.
To compare the efficacy of chemotherapy versus that of tamoxifen plus ovarian suppression in pre-/perimenopausal estrogen receptor-positive patients with early breast cancer.
Patients were randomly assigned to receive either six cycles of a standard regimen of cyclophosphamide 100 mg/m(2) orally days 1 to 14, methotrexate 40 mg/m(2) intravenously (IV) days 1 and 8, and fluorouracil 600 mg/m(2) IV days 1 and 8 (CMF), with all drugs restarted on day 29, or 5 years of tamoxifen, 30 mg/d, plus ovarian suppression with surgical oophorectomy, ovarian irradiation, or monthly goserelin 3.6-mg injections. Disease-free survival was the main study end point. Overall survival and toxicity were additional end points.
Between 1989 and 1997, 120 patients were assigned to CMF and 124 to tamoxifen and ovarian suppression (oophorectomy, n = 6; ovarian irradiation, n = 31; and goserelin injections, n = 87). At the time of analysis (median follow-up time, 76 months; range, 9 to 121 months), 82 patients had relapsed and 39 had died. No difference between groups had emerged with respect to either disease-free or overall survival. Treatments were comparable even in respect to age, tumor size, and nodal status, although a nonsignificant trend favored patients with poorly differentiated tumors treated with CMF. Leukopenia, nausea, vomiting, stomatitis, and alopecia were significantly more common in patients treated with CMF. There were few patients who developed benign gynecologic changes in either group, and numbers were comparable.
The combination of tamoxifen with ovarian suppression seems to be safe and to yield comparable results relative to standard CMF.
比较化疗与他莫昔芬加卵巢抑制对绝经前/围绝经期雌激素受体阳性早期乳腺癌患者的疗效。
患者被随机分配接受以下治疗之一：环磷酰胺100mg/m²口服第1至14天、甲氨蝶呤40mg/m²静脉注射（IV）第1天和第8天、氟尿嘧啶600mg/m²IV第1天和第8天（CMF）的标准方案六个周期，所有药物于第29天重新开始使用；或他莫昔芬30mg/d，连用5年，加用手术去势、卵巢放疗或每月注射戈舍瑞林3.6mg进行卵巢抑制。无病生存期是主要研究终点。总生存期和毒性是附加终点。
1989年至1997年期间，120例患者被分配接受CMF治疗，124例患者接受他莫昔芬加卵巢抑制治疗（去势手术，n = 6；卵巢放疗，n = 31；戈舍瑞林注射，n = 87）。在分析时（中位随访时间76个月；范围9至121个月），82例患者复发，39例患者死亡。两组在无病生存期或总生存期方面均未出现差异。即使在年龄、肿瘤大小和淋巴结状态方面，治疗效果也是可比的，尽管有一个无统计学意义的趋势显示CMF治疗的低分化肿瘤患者更占优势。CMF治疗的患者中白细胞减少、恶心、呕吐、口腔炎和脱发明显更常见。两组中发生良性妇科改变的患者很少，且数量相当。
他莫昔芬与卵巢抑制联合使用似乎是安全的，并且与标准CMF相比产生的结果相当。
