越来越多的临床研究证据表明，乳腺癌腋窝淋巴结少量转移患者可以避免腋窝淋巴结清扫。不过，临床研究入组患者能否代表原始临床实践人群以及已发表研究的普遍性受到质疑。
2019年6月24日，施普林格·自然《乳腺癌研究与治疗》在线发表瑞典西曼兰省医院、乌普萨拉大学、卡罗林学院、圣戈兰医院的研究报告，利用瑞典全国乳腺癌登记数据，对瑞典乳腺癌前哨淋巴结微转移前瞻研究入组患者是否反映其目标人群以及能否促进研究结局推广实施进行了验证。
该前瞻研究于2014年1月1日～2017年3月31日从23家瑞典医院入组原发性乳腺癌前哨淋巴结微转移患者566例，剔除肿瘤大于5厘米患者12例、术前新辅助治疗患者6例之后，对其余548例避免腋窝淋巴结清扫患者进行分析。为了评定研究结果对于目标人群的普遍性，从瑞典全国乳腺癌登记数据库选择1070例相似患者进行比较。
结果，548例研究入组患者和1070例瑞典全国乳腺癌登记病例的年龄、肿瘤特征、乳房手术方式、术后辅助治疗无显著差异。研究入组患者与全国登记病例相比，仅前哨淋巴结微转移平均数较低（1.06比1.09，P=0.037）。
因此，该研究结果表明，入组患者能够代表瑞典乳腺癌目标人群。虽然研究入组患者与瑞典全国乳腺癌登记人群之间存在某些细微差异，但是将来开展的研究结局应该可以推广到其他乳腺癌前哨淋巴结活检微转移患者。
此外，本文于2019年6月14日收稿，2019年6月17日即被录用，2019年6月24日即被发表，与其他论文从收稿到发表往往需要数月至数年相比堪称神速。
Breast Cancer Res Treat. 2019 Jun 24.
Do clinical trials truly mirror their target population? An external validity analysis of national register versus trial data from the Swedish prospective SENOMIC trial on sentinel node micrometastases in breast cancer.
Y. Andersson, L. Bergkvist, J. Frisell, J. de Boniface.
Vastmanland County Hospital, Vasteras, Sweden; Uppsala University, Vastmanland County Hospital, Vasteras, Sweden; Karolinska University Hospital, Stockholm, Sweden; Karolinska Institutet, Stockholm, Sweden; Capio St Goran's Hospital, Stockholm, Sweden.
PURPOSE: Increasing evidence suggests that completion axillary lymph node dissection (ALND) may be omitted in breast cancer patients with limited axillary nodal metastases. However, the representativeness of trial participants for the original clinical practice population, and thus, the generalizability of published trials have been questioned. We propose the use of background data from national registers as a means to assess whether trial participants mirror their target population and to strengthen the generalizability and implementation of trial outcomes.
METHODS: The Swedish prospective SENOMIC trial, omitting a completion ALND in breast cancer patients with sentinel lymph node micrometastases, reached full target accrual in 2017. To assess the generalizability of trial results for the target population, a comparative analysis of trial participants versus cases reported to the Swedish National Breast Cancer Register (NKBC) was performed.
RESULTS: Comparing 548 trial participants and 1070 NKBC cases, there were no significant differences in age, tumor characteristics, breast surgery, or adjuvant treatment. Only the mean number of sentinel lymph nodes with micrometastasis per individual was lower in trial participants than in register cases (1.06 vs. 1.09, p=0.037).
CONCLUSIONS: Patients included in the SENOMIC trial are acceptably representative of the Swedish breast cancer target population. There were some minor divergences between trial participants and the NKBC population, but taking these into consideration, upcoming trial outcomes should be generalizable to breast cancer patients with micrometastases in their sentinel lymph node biopsy.
KEYWORDS: Breast cancer Sentinel node biopsy Micrometastases Axillary lymph node dissection Cohort study Register
DOI: 10.1007/s10549-019-05328-3
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