Athavale Ram, Naik R, Godfrey K A, Cross P, Hatem M H, de Barros Lopes A
Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Sheriff Hill, Gateshead NE9 6SX, UK.
Eur J Obstet Gynecol Reprod Biol. 2008 Mar;137(1):97-102. doi: 10.1016/j.ejogrb.2007.02.009. Epub 2007 Mar 26.
Surgical excision is currently the standard treatment for vulvar intraepithelial neoplasia (VIN). To date it has proved difficult to evaluate the management of VIN in reported series due to heterogeneity in datasets. The objective of this study was to justify standardised data presentation to permit comparison between series and facilitate determination of an optimal strategy for management of VIN. We propose auditable indicators of performance to benchmark management and outcomes. This may also enable definition of a surgical control arm for future novel therapy studies.
Data from the Northern Gynaecological Oncology Centre (NGOC), UK on women with proven VIN diagnosed between 1989 and 2004 who attended the vulvar review clinic are presented and analysed alongside three large retrospective series by Jones et al. [Jones RW, Rowan DM, Stewart AW. Vulvar intraepithelial neoplasia: aspects of the natural history and outcome in 405 women. Obstet Gynecol 2005;106(6):1319-26], Herod et al. [Herod JJ, Shafi MI, Rollason TP, Jordan JA, Luesley DM. Vulvar intraepithelial neoplasia: long term follow up of treated and untreated women. Br J Obstet Gynaecol 1996;103(5):446-52], McNally et al. [McNally OM, Mulvany NJ, Pagano R, Quinn MA, Rome RM. VIN 3: a clinicopathologic review. Int J Gynecol Cancer 2002;12(5):490-5] against proposed performance indicators to illustrate the deficiencies in current data presentation.
Demographics and indicators such as degree of pathological expertise, definition of early stromal invasion and use of International Society for the study of Vulvovaginal Disease (ISSVD) classification were usually well documented. The description of lesions including size and focality were not always documented, nor the proportion examined by co-specialists. Numbers of primary treatments were well described but the indications for treatment, completeness of excision and VIN subclassification were not. Subsequent surgical treatments were inconsistently reported including the pathological details and intervals between treatments. Symptomatology was not well reported. Information on follow-up intervals and duration of follow-up with an indication of patient compliance was inadequate. Outcome data on recurrence of VIN and progression to carcinoma (early stromal invasion or frankly invasive carcinoma) were included in all series.
Consensus on the ideal management of VIN or evaluation of new strategies will prove impossible without standardised data presentation. We propose a number of performance indicators that will facilitate evaluation of future studies or series against the current benchmark of surgical treatment for VIN.
手术切除目前是外阴上皮内瘤变(VIN)的标准治疗方法。由于数据集的异质性,迄今为止,在已发表的系列研究中评估VIN的管理情况颇具难度。本研究的目的是证明标准化数据呈现的合理性,以便系列研究之间能够进行比较,并有助于确定VIN管理的最佳策略。我们提出了可审计的性能指标,以衡量管理情况和结果。这也可能有助于为未来的新疗法研究定义一个手术对照臂。
展示并分析了英国北部妇科肿瘤中心(NGOC)关于1989年至2004年间确诊为VIN且前往外阴复查门诊就诊的女性的数据,并将其与Jones等人[Jones RW, Rowan DM, Stewart AW. Vulvar intraepithelial neoplasia: aspects of the natural history and outcome in 405 women. Obstet Gynecol 2005;106(6):1319 - 26]、Herod等人[Herod JJ, Shafi MI, Rollason TP, Jordan JA, Luesley DM. Vulvar intraepithelial neoplasia: long term follow up of treated and untreated women. Br J Obstet Gynaecol 1996;103(5):446 - 52]、McNally等人[McNally OM, Mulvany NJ, Pagano R, Quinn MA, Rome RM. VIN 3: a clinicopathologic review. Int J Gynecol Cancer 2002;12(5):490 - 5]的三个大型回顾性系列研究的数据进行对比,以对照拟议的性能指标,说明当前数据呈现方式的不足之处。
人口统计学数据以及诸如病理专业程度、早期间质浸润的定义和国际外阴阴道疾病研究学会(ISSVD)分类的使用等指标通常记录良好。病变的描述,包括大小和病灶范围,并非总是有记录,共同专科医生检查的比例也未记录。主要治疗的次数描述得很清楚,但治疗指征、切除的完整性和VIN的亚分类情况并未记录。后续手术治疗的报告不一致,包括病理细节和治疗间隔。症状学方面的报告也不充分。关于随访间隔和随访持续时间以及患者依从性的信息不足。所有系列研究均纳入了VIN复发和进展为癌(早期间质浸润或明显浸润性癌)的结果数据。
如果没有标准化的数据呈现,就不可能就VIN的理想管理或新策略的评估达成共识。我们提出了一些性能指标,这将有助于对照当前VIN手术治疗的基准来评估未来的研究或系列研究。