Tancini G, Bajetta E, Marchini S, Valagussa P, Bonadonna G, Veronesi U
Cancer Clin Trials. 1979 Winter;2(4):285-92.
In hope of reducing the duration of adjuvant treatment in premenopausal patients with operable breast cancer and histologically positive axillary lymph nodes, a prospective controlled study was started in September 1975. A total of 160 patients were randomized to receive 12 cycles of adjuvant CMF, while 165 were allocated to receive 6 cycles. At 3 years from radical mastectomy, the relapse-free survival was 85.4% in the 12-cycle group compared to 82.6% for the 6-cycle subset (P = 0.29). In both treatment groups, the incidence of treatment failure was directly proportional to the number of involved axillary nodes and to the clinical tumor size. Drug-induced amenorrhea as well as estrogen receptor status failed to significantly affect the results obtained. Treatment failures were more often documented in distant sites, while only 4--5% relapse was observed in local-regional areas. Overall survival was also similar for both treatment arms (86.2% vs. 85.1%, P = 0.49). Toxicity was moderate and reversible and no drug-induced neoplasms were so far observed. Present results achieved with 6 cycles of adjuvant CMF appear encouraging. However, they are still too preliminary to recommend the routine use of 6 cycles instead of the classical 12 cycles.
为了缩短绝经前可手术乳腺癌且腋窝淋巴结组织学检查呈阳性患者的辅助治疗时间，1975年9月开展了一项前瞻性对照研究。总共160例患者被随机分配接受12个周期的辅助性CMF治疗，而165例患者被分配接受6个周期的治疗。在根治性乳房切除术后3年，12周期组的无复发生存率为85.4%，而6周期组为82.6%（P = 0.29）。在两个治疗组中，治疗失败的发生率与腋窝淋巴结受累数目及临床肿瘤大小直接相关。药物性闭经以及雌激素受体状态均未对所获结果产生显著影响。治疗失败更多见于远处部位，而局部区域仅观察到4%-5%的复发。两个治疗组的总生存率也相似（86.2%对85.1%，P = 0.49）。毒性为中度且可逆，目前尚未观察到药物诱发的肿瘤。辅助性CMF 6周期治疗所取得的目前结果似乎令人鼓舞。然而，这些结果仍过于初步，尚不能推荐常规使用6周期而非经典的12周期治疗。
