Straus K, Lichter A, Lippman M, Danforth D, Swain S, Cowan K, deMoss E, MacDonald H, Steinberg S, d'Angelo T
Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Bethesda, Md. 20892.
J Natl Cancer Inst Monogr. 1992(11):27-32.
In 1979, a prospective, randomized trial was begun at the National Cancer Institute comparing lumpectomy, axillary dissection, and radiation therapy (XRT) to modified radical mastectomy for the treatment of invasive breast cancer, clinical stage T1-2, N0-1, M0. Treatment in the radiation arm consisted of full axillary dissection and gross removal of the tumor, followed by 4500 to 5000 cGy to the whole breast and a boost to the tumor bed of 1500 to 2000 cGy. Patients with positive axillary dissections received radiation to the supraclavicular nodes, in addition to cyclophosphamide and doxorubicin. Two hundred thirty-seven patients entered in the trial between 1979 and 1987 are available for analysis, 116 in the mastectomy arm and 121 in the radiation arm. With a median follow-up of 67.7 months, there are no significant differences in 5-year overall survival (85% vs 89%, mastectomy vs radiation) or 5-year disease-free survival (82% vs 72%, mastectomy vs radiation). Patients in the radiation arm had an actuarial in-breast recurrence rate of 12% at 5 years and 20% at 8 years. There were no major differences between complication rates in the treatment arms. The results of the study indicate that patients with invasive breast cancer, stage I and II, can be treated with lumpectomy, axillary dissection, and radiation therapy with results comparable to those with modified radical mastectomy.
1979年，美国国立癌症研究所开展了一项前瞻性随机试验，比较了乳房肿瘤切除术、腋窝淋巴结清扫术和放射治疗（XRT）与改良根治性乳房切除术治疗临床分期为T1 - 2、N0 - 1、M0的浸润性乳腺癌的效果。放射治疗组的治疗包括完整的腋窝淋巴结清扫和肿瘤大体切除，随后对全乳进行4500至5000厘戈瑞（cGy）的照射，并对肿瘤床追加1500至2000厘戈瑞的照射。腋窝淋巴结清扫结果为阳性的患者，除接受环磷酰胺和阿霉素治疗外，还接受锁骨上淋巴结放射治疗。1979年至1987年期间进入该试验的237例患者可供分析，乳房切除组116例，放射治疗组121例。中位随访67.7个月，5年总生存率（乳房切除术组与放射治疗组分别为85%和89%）或5年无病生存率（乳房切除术组与放射治疗组分别为82%和72%）无显著差异。放射治疗组患者5年时乳房内复发率的精算值为12%，8年时为20%。治疗组之间的并发症发生率无重大差异。该研究结果表明，I期和II期浸润性乳腺癌患者可采用乳房肿瘤切除术、腋窝淋巴结清扫术和放射治疗，其效果与改良根治性乳房切除术相当。
