Hagen A A, Hrushesky W J
Free University Berlin, Department of Obstetrics and Gynecology, University Medical Center Benjamin Franklin, Germany.
Am J Surg. 1998 Mar;175(3):245-61. doi: 10.1016/s0002-9610(97)00294-8.
This is a critical review of the growing body of data, 32 retrospective studies of the outcomes of 9,665 women published since 1989, relevant to the possibility that the timing of primary breast cancer resection within the menstrual cycle impacts breast cancer recurrence and/or spread and patient survival. This article evaluates and contrasts the adequacy of information and data analysis presented in each publication. The overall purpose of this exercise is to rigorously determine the relative strength of the hypothesis that the menstrual cycle timing of operation impacts outcome and, thereby, to determine whether or not a specific change in the practice of breast surgical oncology can be recommended.
The single most completely reported and thoroughly analyzed series, involving 1,175 young women, indicates that surgical resection timing is likely to be relevant to outcome. Seven additional high-quality studies involving 2,864 women have been most completely reported. While two of these eight find no impact, six (75%) of these studies find that breast cancer outcome is affected by operative timing. Nine of the remaining 24 less-complete studies report a statistically significant effect of operative timing. Among these 15 studies of the fates of more than 5,000 women, the opportune menstrual cycle phase almost invariably includes the putative luteal phase. A large number of retrospective studies of widely varying quality find no outcome difference as a function of resection timing. The adequacy of design of each of four ongoing prospective studies is found lacking.
Although it is likely that the menstrual cycle phase of operation is relevant to outcome, the nature of the available data cannot allow a clear recommendation of precisely when to operate. It is, therefore, concluded that current retrospective data are inadequate to recommend an immediate change in practice. Prospective studies of this potentially important question are essential. The prospective trials initiated to date will not be able to definitively answer this question because of inadequate chronobiological design. The minimal requirements for adequate prospective study are delineated.
这是对自1989年以来发表的32项回顾性研究（涉及9665名女性的结果）相关数据的批判性综述，这些数据与原发性乳腺癌在月经周期内的切除时间是否会影响乳腺癌复发和/或扩散以及患者生存的可能性有关。本文评估并对比了每份出版物中所呈现信息和数据分析的充分性。此项工作的总体目的是严格确定手术时间影响预后这一假设的相对强度，从而确定是否可以推荐乳腺外科肿瘤学实践中的特定改变。
唯一一项报告最完整且分析最透彻的系列研究，涉及1175名年轻女性，表明手术切除时间可能与预后相关。另外七项涉及2864名女性的高质量研究报告最为完整。在这八项研究中，两项未发现影响，而六项（75%）研究发现乳腺癌预后受手术时间影响。其余24项不太完整的研究中有九项报告手术时间有统计学显著影响。在这15项涉及5000多名女性命运的研究中，合适的月经周期阶段几乎总是包括假定的黄体期。大量质量差异很大的回顾性研究未发现切除时间与预后有差异。发现四项正在进行的前瞻性研究中每项的设计都存在不足。
尽管手术的月经周期阶段可能与预后相关，但现有数据的性质无法明确推荐具体的手术时间。因此，得出结论，目前的回顾性数据不足以推荐立即改变实践。对这个潜在重要问题进行前瞻性研究至关重要。由于时间生物学设计不足，迄今为止启动的前瞻性试验无法明确回答这个问题。阐述了充分的前瞻性研究的最低要求。
