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局部晚期外阴癌:外阴切除术的单中心回顾及手术、化疗和放疗替代方案的系统综述。一项国际性协作 RCT 是否注定要被归入“太难做”的那一栏?

Locally advanced vulva cancer: A single centre review of anovulvectomy and a systematic review of surgical, chemotherapy and radiotherapy alternatives. Is an international collaborative RCT destined for the "too difficult to do" box?

机构信息

Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead NE9 6SX, UK; Northern Institute for Cancer Research, Newcastle University, Medical School, Framlington Place NE2 4AH, UK. Electronic address: Rachel.O'

Northern Gynaecological Oncology Centre, Queen Elizabeth Hospital, Gateshead NE9 6SX, UK.

出版信息

Gynecol Oncol. 2017 Feb;144(2):438-447. doi: 10.1016/j.ygyno.2016.12.007. Epub 2016 Dec 27.

DOI:10.1016/j.ygyno.2016.12.007
PMID:28034465
Abstract

INTRODUCTION

Treatment of locally advanced vulva cancer (LAVC) remains challenging. Due to the lack of randomised trials many questions regarding the indications for different treatment options and their efficacy remain unanswered.

METHODS

In this retrospective study we provide the largest published series of LAVC patients treated with anovulvectomy, reporting oncological outcomes and morbidity. Additionally, a systematic literature review was performed for all treatment options 1946-2015.

RESULTS

In our case series, 57/70 (81%) patients were treated in the primary setting with anovulvectomy and 13 patients underwent anovulvectomy for recurrent disease. The median overall survival (OS) was 69months (1-336) with disease specific survival of 159months (1-336). Following anovulvectomy for primary disease, time to progression and OS were significantly higher in node negative disease (10 vs. 96months; 19 vs. 121months, p<0.0001). Post-surgical complications were observed in 36 (51.4%), the majority of which were Grade I/II infections. There was one peri-operative death. Review of the literature showed that chemotherapy, radiotherapy or combination treatments are alternatives to surgery. Evidence relating to all of these consisted mostly of small retrospective series, which varied considerably in terms of patient characteristics and treatment schedules. Significant patient and treatment heterogeneity prevented meta-analysis with significant biases in these studies. It was unclear if survival or morbidity was better in any one group with a lack of data reporting complications, quality of life, and long term follow-up. However, results for chemoradiation are encouraging enough to warrant further investigation.

CONCLUSIONS

There remains inadequate evidence to identify an optimal treatment for LAVC. However, there is sufficient evidence to support a trial of anovulvectomy versus chemoradiation. Discussions and consensus would be needed to determine trial criteria including the primary outcome measure. Neoadjuvant chemotherapy or radiotherapy alone may be best reserved for the palliative setting or metastatic disease.

摘要

简介

局部晚期外阴癌(LAVC)的治疗仍然具有挑战性。由于缺乏随机试验,许多关于不同治疗选择的适应证及其疗效的问题仍未得到解答。

方法

在这项回顾性研究中,我们提供了已发表的最大系列局部晚期外阴癌患者接受外阴切除术治疗的资料,报告了肿瘤学结果和发病率。此外,还对 1946 年至 2015 年的所有治疗选择进行了系统的文献复习。

结果

在我们的病例系列中,57/70(81%)例患者在原发性疾病中接受外阴切除术治疗,13 例患者因复发性疾病接受外阴切除术。中位总生存期(OS)为 69 个月(1-336),疾病特异性生存期为 159 个月(1-336)。对于原发性疾病的外阴切除术,淋巴结阴性疾病的疾病进展时间和 OS 明显更高(10 与 96 个月;19 与 121 个月,p<0.0001)。手术后并发症在 36 例(51.4%)中观察到,其中大多数为 I/II 级感染。有 1 例围手术期死亡。文献复习显示,化疗、放疗或联合治疗是手术的替代方法。与这些方法相关的证据主要来自小的回顾性系列研究,这些研究在患者特征和治疗方案方面差异很大。这些研究存在显著的患者和治疗异质性,无法进行荟萃分析,存在显著的偏倚。不清楚任何一组的生存或发病率是否更好,因为缺乏报告并发症、生活质量和长期随访的数据。然而,放化疗的结果令人鼓舞,足以进一步研究。

结论

目前还没有足够的证据确定局部晚期外阴癌的最佳治疗方法。然而,有足够的证据支持外阴切除术与放化疗的比较试验。需要进行讨论和达成共识,以确定试验标准,包括主要结局指标。新辅助化疗或放疗可能最好保留用于姑息治疗或转移性疾病。

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