Fisher E R, Sass R, Fisher B
Surg Gynecol Obstet. 1985 Sep;161(3):245-9.
Investigation of the biologic significance of delay between biopsy and mastectomy was performed upon women with invasive carcinoma of the breast in protocol four of the NSABP. Since the period of delay was two weeks or less in approximately 75 per cent, no comment concerning the possible effects of longer periods can be made. Life table analyses failed to reveal any difference in ten year survival rates between patients undergoing radical mastectomy management by the one and two step procedures. Similarly, no difference in adjusted ten year survival rate was observed between women managed by the two step procedure who did or did not have residual tumor identified in the mastectomy specimen after the first step or biopsy. Importantly, the clinical or pathologic stages, sizes of tumor or histologic grades were similar in women managed by the one and two step procedures minimizing selection bias. The material used also allowed for study of the possible causative role of biopsy of the breast on the development of sinus histiocytosis in regional axillary lymph nodes. No difference in degree or types of this nodal reaction could be discerned in the lymph nodes of the mastectomy specimens obtained from patients who had undergone the one and two step procedures. This finding indicates that nodal sinus histiocytosis is indeed related to the neoplastic process, albeit in an undefined manner, rather than the trauma of biopsy per se as has been suggested. These results do not invalidate the use of the one step procedure in the management of patients with carcinoma of the breast. Indeed, it is highly likely that it will be commonly used now that breast-conserving operations appear to represent a viable alternative modality for the primary surgical treatment of carcinoma of the breast. Yet, it is apparent that the one step procedure will be performed for technical and practical rather than biologic reasons.
在NSABP方案4中，对患有浸润性乳腺癌的女性进行了活检与乳房切除术之间延迟的生物学意义的研究。由于约75%的延迟时间为两周或更短，因此无法对更长时间延迟的可能影响做出评论。生命表分析未能揭示接受根治性乳房切除术的患者采用一步法和两步法治疗后十年生存率的任何差异。同样，在第一步活检或乳房切除术后乳房切除标本中发现或未发现残留肿瘤的采用两步法治疗的女性之间，调整后的十年生存率也没有差异。重要的是，采用一步法和两步法治疗的女性的临床或病理分期、肿瘤大小或组织学分级相似，从而将选择偏倚降至最低。所使用的材料还允许研究乳房活检对腋窝区域淋巴结窦组织细胞增生症发展的可能致病作用。在接受一步法和两步法治疗的患者的乳房切除标本的淋巴结中，未发现这种淋巴结反应的程度或类型有差异。这一发现表明，淋巴结窦组织细胞增生症确实与肿瘤形成过程有关，尽管方式尚不明确，而不是如所认为的那样与活检本身的创伤有关。这些结果并未否定在乳腺癌患者治疗中使用一步法。事实上，鉴于保乳手术似乎是乳腺癌一期手术治疗的一种可行替代方式，现在很可能会普遍使用一步法。然而，显然一步法将基于技术和实际原因而非生物学原因进行。
