Fisher Bernard, Jeong Jong-Hyeon, Anderson Stewart, Bryant John, Fisher Edwin R, Wolmark Norman
National Surgical Adjuvant Breast and Bowel Project, Pittsburgh, PA 15212-5234, USA.
N Engl J Med. 2002 Aug 22;347(8):567-75. doi: 10.1056/NEJMoa020128.
In women with breast cancer, the role of radical mastectomy, as compared with less extensive surgery, has been a matter of debate. We report 25-year findings of a randomized trial initiated in 1971 to determine whether less extensive surgery with or without radiation therapy was as effective as the Halsted radical mastectomy.
A total of 1079 women with clinically negative axillary nodes underwent radical mastectomy, total mastectomy without axillary dissection but with postoperative irradiation, or total mastectomy plus axillary dissection only if their nodes became positive. A total of 586 women with clinically positive axillary nodes either underwent radical mastectomy or underwent total mastectomy without axillary dissection but with postoperative irradiation. Kaplan-Meier and cumulative-incidence estimates of outcome were obtained.
No significant differences were observed among the three groups of women with negative nodes or between the two groups of women with positive nodes with respect to disease-free survival, relapse-free survival, distant-disease-free survival, or overall survival. Among women with negative nodes, the hazard ratio for death among those who were treated with total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.08 (95 percent confidence interval, 0.91 to 1.28; P=0.38), and the hazard ratio for death among those who had total mastectomy without radiation as compared with those who underwent radical mastectomy was 1.03 (95 percent confidence interval, 0.87 to 1.23; P=0.72). Among women with positive nodes, the hazard ratio for death among those who underwent total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.06 (95 percent confidence interval, 0.89 to 1.27; P=0.49).
The findings validate earlier results showing no advantage from radical mastectomy. Although differences of a few percentage points cannot be excluded, the findings fail to show a significant survival advantage from removing occult positive nodes at the time of initial surgery or from radiation therapy.
在乳腺癌女性患者中，与范围较小的手术相比，根治性乳房切除术的作用一直存在争议。我们报告了一项始于1971年的随机试验的25年研究结果，以确定范围较小的手术联合或不联合放射治疗是否与霍尔斯特德根治性乳房切除术同样有效。
共有1079例临床腋窝淋巴结阴性的女性接受了根治性乳房切除术、未进行腋窝清扫但术后接受放疗的全乳房切除术，或仅在淋巴结阳性时进行全乳房切除术加腋窝清扫。共有586例临床腋窝淋巴结阳性的女性接受了根治性乳房切除术或未进行腋窝清扫但术后接受放疗的全乳房切除术。获得了生存结局的Kaplan-Meier估计值和累积发病率估计值。
在三组淋巴结阴性的女性之间，以及两组淋巴结阳性的女性之间，在无病生存率、无复发生存率、无远处疾病生存率或总生存率方面均未观察到显著差异。在淋巴结阴性的女性中，接受全乳房切除术加放疗者与接受根治性乳房切除术者相比，死亡风险比为1.08（95%置信区间为0.91至1.28；P = 0.38），接受未放疗的全乳房切除术者与接受根治性乳房切除术者相比，死亡风险比为1.03（95%置信区间为0.87至1.23；P = 0.72）。在淋巴结阳性的女性中，接受全乳房切除术加放疗者与接受根治性乳房切除术者相比，死亡风险比为1.06（95%置信区间为0.89至1.27；P = 0.49）。
这些结果证实了早期的研究结果，即根治性乳房切除术并无优势。尽管不能排除几个百分点的差异，但这些结果未能显示出在初次手术时切除隐匿性阳性淋巴结或放射治疗能带来显著的生存优势。
