Wagner Marise M, van der Zee Ate G J, Oonk Maaike H M
Department of Obstetrics and Gynecology, University Medical Center Groningen, University of Groningen, 9700 RB Groningen, The Netherlands.
Cancers (Basel). 2022 Apr 13;14(8):1956. doi: 10.3390/cancers14081956.
Surgical management of vulvar cancer is associated with high morbidity rates. The main aim of the GROINSS-V studies is reducing treatment-related morbidity by finding safe alternative treatment options in early-stage vulvar cancer patients. This article reviews the history, results, and updates of the GROINSS-V studies. The first GROINSS-V study was a multicenter observational study (from 2000 to 2006), which investigated the safety and clinical applicability of the sentinel lymph node procedure in patients with early-stage vulvar cancer. GROINSS-V-I showed that omitting inguinofemoral lymphadenectomy was safe in early-stage vulvar cancer patients with a negative sentinel lymph node, with an impressive reduction in treatment-related morbidity. GROINSS-V-II, a prospective multicenter phase II single-arm treatment trial (from 2005 to 2016) investigated whether radiotherapy could be a safe alternative for inguinofemoral lymphadenectomy in patients with a metastatic sentinel lymph node. This study showed that radiotherapy in patients with sentinel lymph node micrometastases (≤2 mm) was safe in terms of groin recurrence rate and with less treatment-related morbidity. These results, published in August 2021, should be implemented in (inter)national treatment guidelines for vulvar cancer. GROINSS-V-III recently started including patients. This study investigates the effectiveness and safety of chemoradiation in patients with a macrometastasis (>2 mm) in the sentinel lymph node.
外阴癌的手术治疗伴随着较高的发病率。GROINSS-V研究的主要目的是通过为早期外阴癌患者寻找安全的替代治疗方案来降低治疗相关的发病率。本文回顾了GROINSS-V研究的历史、结果及进展。首个GROINSS-V研究是一项多中心观察性研究(2000年至2006年),该研究调查了前哨淋巴结活检术在早期外阴癌患者中的安全性及临床适用性。GROINSS-V-I研究表明,对于前哨淋巴结阴性的早期外阴癌患者,省略腹股沟股淋巴结清扫术是安全的,且治疗相关的发病率显著降低。GROINSS-V-II是一项前瞻性多中心II期单臂治疗试验(2005年至2016年),研究了对于前哨淋巴结转移的患者,放射治疗是否可作为腹股沟股淋巴结清扫术的安全替代方案。该研究表明,对于前哨淋巴结微转移(≤2 mm)的患者,放射治疗在腹股沟复发率方面是安全的,且治疗相关的发病率较低。这些于2021年8月发表的结果应纳入外阴癌的(国际)治疗指南中。GROINSS-V-III最近开始纳入患者。该研究调查了前哨淋巴结存在大转移灶(>2 mm)的患者接受放化疗的有效性和安全性。