Fisher B, Redmond C, Poisson R, Margolese R, Wolmark N, Wickerham L, Fisher E, Deutsch M, Caplan R, Pilch Y
National Surgical Adjuvant Breast and Bowel Project Headquarters, Scaife Hall, Pittsburgh, PA 15261.
N Engl J Med. 1989 Mar 30;320(13):822-8. doi: 10.1056/NEJM198903303201302.
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, less than or equal to 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 less than 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.
1985年，我们公布了一项随机试验的结果，该试验涉及1843名女性，随访了五年，结果表明，对于I期或II期乳腺癌（肿瘤大小小于或等于4厘米）患者，只要切除标本的边缘无肿瘤，乳房部分切除术（肿块切除术）加乳房照射是合适的治疗方法。腋窝淋巴结阳性的女性接受辅助化疗。肿块切除术后加放射治疗的五年生存率为85%，而全乳房切除术为76%；无远处疾病生存率为76%，而全乳房切除术为72%；无病生存率为72%，而全乳房切除术为66%。在当前的研究中，我们将观察期延长至八年随访。肿块切除术后接受乳房照射的女性中，90%同侧乳房无肿瘤，而肿块切除术后未接受照射的女性中这一比例为61%（P<0.001）。在腋窝淋巴结阳性的患者中，接受放疗和辅助化疗的患者只有6%同侧乳房出现肿瘤复发。有或没有乳房照射的肿块切除术导致的无病生存率（58±2.6%）、无远处疾病生存率（65±2.6%）和总生存率（71±2.6%）与全乳房切除术后观察到的结果（分别为54±2.4%、62±2.3%和71±2.4%）没有显著差异。接受肿块切除术（有或没有照射）的女性中，无远处疾病生存率（P = 0.2）或生存率（P = 0.3）没有显著差异，尽管未接受放疗的女性同侧乳房肿瘤复发率更高。我们得出结论，我们八年的观察结果与五年时的发现一致，这些新发现继续支持对I期或II期乳腺癌患者使用肿块切除术。我们还得出结论，照射降低了接受肿块切除术患者肿瘤局部复发的概率。
