Fisher B, Bauer M, Margolese R, Poisson R, Pilch Y, Redmond C, Fisher E, Wolmark N, Deutsch M, Montague E
N Engl J Med. 1985 Mar 14;312(11):665-73. doi: 10.1056/NEJM198503143121101.
In 1976 we began a randomized trial to evaluate breast conservation by a segmental mastectomy in the treatment of Stage I and II breast tumors less than or equal to 4 cm in size. The operation removes only sufficient tissue to ensure that margins of resected specimens are free of tumor. Women were randomly assigned to total mastectomy, segmental mastectomy alone, or segmental mastectomy followed by breast irradiation. All patients had axillary dissections, and patients with positive nodes received chemotherapy. Life-table estimates based on data from 1843 women indicated that treatment by segmental mastectomy, with or without breast irradiation, resulted in disease-free, distant-disease-free, and overall survival at five years that was no worse than that after total breast removal. In fact, disease-free survival after segmental mastectomy plus radiation was better than disease-free survival after total mastectomy (P = 0.04), and overall survival after segmental mastectomy, with or without radiation, was better than overall survival after total mastectomy (P = 0.07, and 0.06, respectively). A total of 92.3 per cent of women treated with radiation remained free of breast tumor at five years, as compared with 72.1 per cent of those receiving no radiation (P less than 0.001). Among patients with positive nodes 97.9 per cent of women treated with radiation and 63.8 per cent of those receiving no radiation remained tumor-free (P less than 0.001), although both groups received chemotherapy. We conclude that segmental mastectomy, followed by breast irradiation in all patients and adjuvant chemotherapy in women with positive nodes, is appropriate therapy for Stage I and II breast tumors less than or equal to 4 cm, provided that margins of resected specimens are free of tumor.
1976年，我们开展了一项随机试验，以评估通过乳房部分切除术进行保乳治疗I期和II期且肿瘤大小小于或等于4厘米的乳腺肿瘤的效果。该手术仅切除足够的组织，以确保切除标本的边缘无肿瘤。女性被随机分配接受全乳切除术、单纯乳房部分切除术或乳房部分切除术后进行乳房放疗。所有患者均接受腋窝淋巴结清扫，淋巴结阳性的患者接受化疗。基于1843名女性数据的生命表估计表明，采用乳房部分切除术治疗，无论是否进行乳房放疗，其五年无病生存率、无远处疾病生存率和总生存率均不低于全乳切除术后的生存率。事实上，乳房部分切除术后加放疗的无病生存率优于全乳切除术后的无病生存率（P = 0.04），乳房部分切除术无论是否放疗后的总生存率均优于全乳切除术后的总生存率（分别为P = 0.07和0.06）。接受放疗的女性中有92.3%在五年时乳房无肿瘤，而未接受放疗的女性中这一比例为72.1%（P < 0.001）。在淋巴结阳性的患者中，接受放疗的女性中有97.9%无肿瘤，未接受放疗的女性中这一比例为63.8%（P < 0.001），尽管两组均接受了化疗。我们得出结论，对于I期和II期且肿瘤大小小于或等于4厘米的乳腺肿瘤，在所有患者中先进行乳房部分切除术，然后进行乳房放疗，淋巴结阳性的女性进行辅助化疗，是合适的治疗方法，前提是切除标本的边缘无肿瘤。
