Christian M C, McCabe M S, Korn E L, Abrams J S, Kaplan R S, Friedman M A
Cancer Therapy Evaluation Program, National Cancer Institute, Rockville, MD 20892, USA.
N Engl J Med. 1995 Nov 30;333(22):1469-74. doi: 10.1056/NEJM199511303332206.
The National Surgical Adjuvant Breast and Bowel Project (NSABP) Protocol B-06, a clinical trial sponsored by the National Cancer Institute (NCI), has provided evidence of the value of lumpectomy and breast irradiation for treating women with breast cancer in an early stage. Publicity generated by the discovery that the study included fraudulent data on patients enrolled by St. Luc Hospital in Montreal aroused concern about the overall accuracy of the data and conclusions. To address this concern, the NCI conducted an audit of other participating institutions.
In 1994, data on 1554 of the 1809 randomized patients (85.9 percent) enrolled by centers other than St. Luc Hospital were audited at 37 clinical sites in North America. The audit included data on eligibility, survival, disease-free survival, the length of time to a recurrence of cancer in the ipsilateral breast, and documentation of signed informed consent.
End points were assessed for all 1554 patients, and eligibility was assessed for 1507 patients; 47 patients were excluded because their forms were not complete or not returned. A total of 1429 patients had their eligibility status verified. Of a total of 7770 data points examined with respect to the number of positive nodes at base line, treatment characteristics, first events (excluding death), recurrence of cancer in the ipsilateral breast, and survival, 7577 (97.5 percent) were verified, 123 (1.6 percent) could not be verified, and 70 (0.9 percent) were discrepant with the NSABP file. Of the 1554 patients, 1340 (86.2 percent) had all audited items (including eligibility) verified, 69 (4.4 percent) had at least one discrepant item, and 113 (7.3 percent) had at least one unverified item (as a result of missing or incomplete data); 32 (2.1 percent) were not assessed for eligibility but had no other discrepant or unverifiable items. Written informed consent was documented for 1098 patients before surgery and 210 after surgery; no date appeared on the signed form for 137. The informed-consent status was not verified for 71 patients and could not be determined for 38. The rates of verification of end-point data and documentation of written informed consent were similar among the total-mastectomy group, the lumpectomy group, and the group treated by lumpectomy and breast irradiation.
The audit confirms the adequacy of the data on which the reanalysis of Protocol B-06 and the results after 12 years of follow-up are based.
由美国国立癌症研究所（NCI）赞助的一项临床试验——国家外科辅助乳腺和肠道项目（NSABP）B - 06方案，为早期乳腺癌女性患者行乳房肿瘤切除术和乳房放疗的价值提供了证据。该研究发现蒙特利尔圣卢克医院纳入的患者存在欺诈性数据，由此引发的舆论使人们对数据及结论的整体准确性产生担忧。为解决这一担忧，NCI对其他参与机构进行了审计。
1994年，北美37个临床地点对圣卢克医院以外的中心纳入的1809例随机分组患者中的1554例（85.9%）的数据进行了审计。审计内容包括入选资格、生存率、无病生存率、同侧乳房癌症复发时间以及签署知情同意书的记录。
对所有1554例患者的终点指标进行了评估，对1507例患者的入选资格进行了评估；47例患者因表格不完整或未返回而被排除。共有1429例患者的入选资格状态得到核实。在总共7770个关于基线时阳性淋巴结数量、治疗特征、首次事件（不包括死亡）、同侧乳房癌症复发和生存的数据点中，7577个（97.5%）得到核实，123个（1.6%）无法核实，70个（0.9%）与NSABP档案存在差异。在1554例患者中，1340例（86.2%）所有审计项目（包括入选资格）均得到核实，69例（4.4%）至少有一项存在差异，113例（7.3%）至少有一项未得到核实（由于数据缺失或不完整）；32例（2.1%）未评估入选资格，但无其他差异或无法核实的项目。1098例患者在手术前签署了书面知情同意书，210例在手术后签署；137份签署表格上未注明日期。71例患者的知情同意状态未得到核实，38例无法确定。全乳房切除术组、乳房肿瘤切除术组以及乳房肿瘤切除术加乳房放疗组的终点数据核实率和书面知情同意书记录率相似。
此次审计证实了NSABP B - 06方案重新分析及12年随访结果所依据的数据是充分的。
