Fisher B, Anderson S, Redmond C K, Wolmark N, Wickerham D L, Cronin W M
N Engl J Med. 1995 Nov 30;333(22):1456-61. doi: 10.1056/NEJM199511303332203.
Previous findings from a clinical trial (Protocol B-06) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP) indicated the worth of lumpectomy and breast irradiation for treating breast cancer. After the discovery by NSABP staff members of falsified information on patients enrolled in the study by St. Luc Hospital in Montreal, separate audits were conducted at St. Luc Hospital and other participating institutions. We report the results of both audits and update the study findings through an average of 12 years of follow-up.
Patients with either negative or positive axillary nodes and tumors 4 cm or less in diameter were randomly assigned to one of three treatments: total mastectomy, lumpectomy followed by breast irradiation, or lumpectomy without irradiation. Three cohorts of patients were analyzed. The first cohort included all 2105 randomized patients, who were analyzed according to the intention-to-treat principle. The second cohort consisted of 1851 eligible patients in the first cohort with known nodal status who agreed to be followed and who accepted their assigned therapy (among those excluded were 6 patients from St. Luc Hospital who were declared ineligible because of falsified biopsy dates). The third cohort consisted of the patients in the second cohort minus the 322 eligible patients from St. Luc Hospital (total, 1529 patients).
Regardless of the cohort, no significant differences were found in overall survival, disease-free survival, or survival free of disease at distant sites between the patients who underwent total mastectomy and those treated by lumpectomy alone or by lumpectomy plus breast irradiation. After 12 years of follow-up, the cumulative incidence of a recurrence of tumor in the ipsilateral breast was 35 percent in the group treated with lumpectomy alone and 10 percent in the group treated with lumpectomy and breast irradiation (P < 0.001).
Our findings continue to indicate that lumpectomy followed by breast irradiation is appropriate therapy for women with either negative or positive axillary nodes and breast tumors 4 cm or less in diameter.
美国国家外科辅助乳腺和肠道项目（NSABP）开展的一项临床试验（方案B - 06）之前的研究结果表明，乳房肿瘤切除术和乳房照射对于治疗乳腺癌具有价值。在NSABP工作人员发现蒙特利尔圣卢克医院纳入该研究的患者存在伪造信息后，分别对圣卢克医院和其他参与机构进行了审核。我们报告这两项审核的结果，并通过平均12年的随访更新研究结果。
腋窝淋巴结阴性或阳性且肿瘤直径4厘米或更小的患者被随机分配至三种治疗方法之一：全乳切除术、乳房肿瘤切除术后进行乳房照射或乳房肿瘤切除术后不进行照射。对三组患者进行了分析。第一组包括所有2105例随机分组的患者，按照意向性分析原则进行分析。第二组由第一组中1851例符合条件且已知淋巴结状态、同意接受随访并接受分配治疗的患者组成（被排除的患者中有6例来自圣卢克医院，因其活检日期造假而被判定不符合条件）。第三组由第二组患者减去来自圣卢克医院的322例符合条件的患者组成（共1529例患者）。
无论在哪一组中，接受全乳切除术的患者与仅接受乳房肿瘤切除术或接受乳房肿瘤切除术加乳房照射的患者相比，在总生存期、无病生存期或远处无病生存期方面均未发现显著差异。经过12年的随访，仅接受乳房肿瘤切除术的组同侧乳房肿瘤复发的累积发生率为35%，接受乳房肿瘤切除术加乳房照射的组为10%（P<0.0
