REANALYSIS AND RESULTS AFTER 12 YEARS OF FOLLOW-UP IN A RANDOMIZED CLINICAL-TRIAL COMPARING TOTAL MASTECTOMY WITH LUMPECTOMY WITH OR WITHOUT IRRADIATION IN THE TREATMENT OF BREAST-CANCER
REANALYSIS AND RESULTS AFTER 12 YEARS OF FOLLOW-UP IN A RANDOMIZED CLINICAL-TRIAL COMPARING TOTAL MASTECTOMY WITH LUMPECTOMY WITH OR WITHOUT IRRADIATION IN THE TREATMENT OF BREAST-CANCER
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DOI：
10.1056/nejm199511303332203
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发表时间：
1995-11-30
影响因子：
158.5
通讯作者：
CRONIN, WM
中科院分区：
文献类型：
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作者：
FISHER, B;ANDERSON, S;CRONIN, WM
背景由国家外科辅助乳腺和鲍尔项目（NSABP）进行的临床试验（方案B-06）的先前结果表明，乳房肿瘤切除术和乳房放射治疗乳腺癌的价值。在NSABP工作人员发现蒙特利尔圣吕克医院参加研究的患者的虚假信息后，在圣吕克医院和其他参与机构进行了单独的稽查。我们报告了两次审计的结果，并通过平均12年的随访更新了研究结果。腋窝淋巴结阴性或阳性且肿瘤直径小于或等于4 cm的患者被随机分配到三种治疗方法中的一种：全乳房切除术，乳房肿瘤切除术后乳房照射，或乳房肿瘤切除术无照射。分析了三个患者队列。第一个队列包括所有2105例随机化患者，根据意向治疗原则进行分析。第二个队列包括第一个队列中的1851例符合条件的患者，这些患者具有已知的淋巴结状态，同意接受随访并接受分配的治疗（排除的患者中有6例来自St. Luc医院，因活检日期伪造而被宣布不合格）。第三队列包括第二队列中的患者减去来自St. Luc医院的322名符合条件的患者（总共1529名患者）。无论是哪一组，接受全乳房切除术的患者与单纯乳房肿瘤切除术或乳房肿瘤切除术加乳房放疗的患者之间的总生存率、无病生存率或远处无病生存率均无显著差异。随访12年后，单纯乳房肿瘤切除术组同侧乳房肿瘤复发的累积发生率为35%，而乳房肿瘤切除术加乳房放疗组为10%（P
Background. Previous findings from a clinical trial (Protocol B-06) conducted by the National Surgical Adjuvant Breast and Bower 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.Methods. 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).Results. 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