Rossi A, Bonadonna G, Valagussa P, Veronesi U
Br Med J (Clin Res Ed). 1981 May 2;282(6274):1427-31. doi: 10.1136/bmj.282.6274.1427.
The five-year results of a prospective randomised trial of radical mastectomy (179 patients) versus radical mastectomy followed by adjuvant chemotherapy (207 patients) were analysed. Chemotherapy consisted of 12 monthly cycles of cyclophosphamide, methotrexate, and fluorouracil (CMF). Both relapse-free survival (controls 44.6%, CMF group 59.5%) and total survival (controls 66.2%, CMF group 78.4%) were significantly improved. The findings were related to the number of diseased axillary nodes and amount of drug administered, and were independent of CMF-induced amenorrhoea. Menopausal state alone appeared to affect the five-year results only when the amount of drug administered was not taken into account. Salvage treatment at first relapse failed to improve total survival in the controls compared with the CMF group. Acute toxic manifestations were moderate and reversible. Chronic organ damage and increased incidence of second neoplasms (controls 1.7%, CMF group 1.4%) were not observed. The multimodality approach to treatment of primary breast cancer is a new and important advance. This and other studies are continuing.
对一项前瞻性随机试验的五年结果进行了分析,该试验对比了根治性乳房切除术(179例患者)与根治性乳房切除术后辅助化疗(207例患者)。化疗方案为每28天重复一次,共12个周期的环磷酰胺、甲氨蝶呤和氟尿嘧啶(CMF)联合化疗。无病生存率(对照组44.6%,CMF组59.5%)和总生存率(对照组66.2%,CMF组78.4%)均有显著提高。这些结果与腋窝淋巴结病变数量和给药量有关,且与CMF诱导的闭经无关。仅在未考虑给药量时,绝经状态似乎才会影响五年结果。与CMF组相比,对照组首次复发时的挽救性治疗未能提高总生存率。急性毒性表现为中度且可逆。未观察到慢性器官损伤和第二原发性肿瘤发病率增加(对照组1.7%,CMF组1.4%)。原发性乳腺癌的多模式治疗方法是一项新的重要进展。这项研究和其他研究仍在继续。