8-YEAR RESULTS OF A RANDOMIZED CLINICAL-TRIAL COMPARING TOTAL MASTECTOMY AND LUMPECTOMY WITH OR WITHOUT IRRADIATION IN THE TREATMENT OF BREAST-CANCER
8-YEAR RESULTS OF A RANDOMIZED CLINICAL-TRIAL COMPARING TOTAL MASTECTOMY AND LUMPECTOMY WITH OR WITHOUT IRRADIATION IN THE TREATMENT OF BREAST-CANCER
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DOI：
10.1056/nejm198903303201302
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发表时间：
1989-03-30
影响因子：
158.5
通讯作者：
SIDOROVICH, L
中科院分区：
文献类型：
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作者：
FISHER, B;REDMOND, C;SIDOROVICH, L
1985年，我们对1843名妇女进行了为期五年的随机试验，结果表明，在切除标本边缘无肿瘤的情况下，对I期或II期乳腺癌(肿瘤大小为4厘米)患者，乳房节段性切除(肿块切除)后再进行乳房照射是合适的治疗方法。腋窝淋巴结阳性的妇女接受辅助化疗。肿瘤切除后放射治疗的五年存活率为85%，而全乳房切除术为76%，无远处疾病存活率为76%，无远隔疾病存活率为72%，无病存活率为72%，而全乳房切除术为66%。在目前的研究中，我们通过八年的跟踪观察延长了我们的观察范围。肿块切除后接受乳房放射治疗的妇女中，90%的同侧乳房肿瘤没有发生，相比之下，肿块切除后未接受放射治疗的妇女中，这一比例为61%(P<；0.001)。在腋窝淋巴结阳性的患者中，接受放射治疗和辅助化疗的患者中，只有6%的患者同侧乳房肿瘤复发。肿块切除加或不加乳房照射导致无瘤存活率(58。+-)。2.6%)，无远期疾病存活率(65.%+-.2.6%)，以及总存活率(71.+-.2.6%)，与全乳房切除术后观察到的结果(54.+-)无显著差异。2.4%，62.+-2.3%和71%。24%)。接受肿块切除术(加或不加放疗)的妇女的无远处疾病存活率(P=0.2)或存活率(P=0.3)没有显著差异，尽管未接受放疗的同侧乳房肿瘤复发率较高。我们的结论是，我们通过八年的观察与五年的发现是一致的，这些新的发现继续支持在I期或II期乳腺癌患者中使用肿块切除术。我们还得出结论，在接受肿瘤切除术的患者中，放射治疗降低了肿瘤局部复发的可能性。
In 1985 we presented results of a randomized trial involving 1843 women followed for five years that indicated that segmental breast resection (lumpectomy) followed by breast irradiation is appropriate therapy for patients with Stage I or II breast cancer (tumor size, .ltoreq.4 cm), provided that the margins of the resected specimens are free of tumor. Women with positive axillary nodes received adjuvant chemotherapy. Lumpectomy followed by irradiation resulted in a five-year survival rate of 85 percent, as compared with 76 percent for total mastectomy, a rate of survival free of distant disease of 76 percent, as compared with 72 percent, and a disease- free survival rate of 72 percent, as compared with 66 percent. In the current study, we have extended our observations through eight years of follow-up. Ninety percent of the women treated with breast irradiation after lumpectomy remained free of ipsilateral breast tumor, as compared with 61 percent of those not treated with irradiation after lumpectomy (P < 0.001). Among patients with positive axillary nodes, only 6 percent of those treated with radiation and adjuvant chemotherapy had a recurrence of tumor in the ipsilateral breast. Lumpectomy with or without irradiation of the breast resulted in rates of disease-free survival (58 .+-. 2.6 percent), distant-disease-free survival (65 .+-. 2.6 percent), and overall survival (71 .+-. 2.6 percent) that were not significantly different from those observed after total mastectomy (54 .+-. 2.4 percent, 62 .+-. 2.3 percent, and 71 .+-. 2.4 percent, respectively). There was no significant difference in the rates of distant-disease-free survival (P = 0.2) or survival (P = 0.3) among the women who underwent lumpectomy (with or without irradiation), despite the greater incidence of recurrence of tumor in the ipsilateral breast in those who received no radiation. We conclude that our observations through eight years are consistent with the findings at five years and that these new findings continue to support the use of lumpectomy in patients with Stage I or II breast cancer. We also conclude that irradiation reduces the probability of local recurrence of tumor in patients treated with lumpectomy.