University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
Mount Sinai Medical Center, Miami Beach, FL.
J Clin Oncol. 2021 Nov 10;39(32):3623-3632. doi: 10.1200/JCO.21.00006. Epub 2021 Aug 25.
The Groningen International Study on Sentinel nodes in Vulvar cancer (GROINSS-V)-II investigated whether inguinofemoral radiotherapy is a safe alternative to inguinofemoral lymphadenectomy (IFL) in vulvar cancer patients with a metastatic sentinel node (SN).
GROINSS-V-II was a prospective multicenter phase-II single-arm treatment trial, including patients with early-stage vulvar cancer (diameter < 4 cm) without signs of lymph node involvement at imaging, who had primary surgical treatment (local excision with SN biopsy). Where the SN was involved (metastasis of any size), inguinofemoral radiotherapy was given (50 Gy). The primary end point was isolated groin recurrence rate at 24 months. Stopping rules were defined for the occurrence of groin recurrences.
From December 2005 until October 2016, 1,535 eligible patients were registered. The SN showed metastasis in 322 (21.0%) patients. In June 2010, with 91 SN-positive patients included, the stopping rule was activated because the isolated groin recurrence rate in this group went above our predefined threshold. Among 10 patients with an isolated groin recurrence, nine had SN metastases > 2 mm and/or extracapsular spread. The protocol was amended so that those with SN macrometastases (> 2 mm) underwent standard of care (IFL), whereas patients with SN micrometastases (≤ 2 mm) continued to receive inguinofemoral radiotherapy. Among 160 patients with SN micrometastases, 126 received inguinofemoral radiotherapy, with an ipsilateral isolated groin recurrence rate at 2 years of 1.6%. Among 162 patients with SN macrometastases, the isolated groin recurrence rate at 2 years was 22% in those who underwent radiotherapy, and 6.9% in those who underwent IFL ( = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL.
Inguinofemoral radiotherapy is a safe alternative for IFL in patients with SN micrometastases, with minimal morbidity. For patients with SN macrometastasis, radiotherapy with a total dose of 50 Gy resulted in more isolated groin recurrences compared with IFL.
《格罗宁根国际外阴癌前哨淋巴结研究-Ⅱ》（GROINSS-V-Ⅱ）旨在探讨对于前哨淋巴结（SN）转移的早期外阴癌（直径<4cm 且影像学未见淋巴结转移）患者，腹股沟-股部放疗是否可以替代腹股沟-股部淋巴结清扫术（IFL）。
GROINSS-V-Ⅱ是一项前瞻性多中心Ⅱ期单臂治疗试验，纳入了接受了原发性外科治疗（局部切除术加 SN 活检）的早期外阴癌（直径<4cm 且影像学未见淋巴结转移）患者。SN 阳性的患者（任何大小的转移）接受腹股沟-股部放疗（50Gy）。主要终点为 24 个月时的腹股沟复发率。规定了出现腹股沟复发时的终止规则。
2005 年 12 月至 2016 年 10 月，共有 1535 例符合条件的患者入组。322 例（21.0%）患者的 SN 显示转移。2010 年 6 月，纳入 91 例 SN 阳性患者，由于该组的孤立性腹股沟复发率超过了我们预先设定的阈值，终止规则被激活。在 10 例孤立性腹股沟复发的患者中，9 例的 SN 转移灶>2mm 且/或有外囊扩散。因此修订了方案，对 SN 有宏转移（>2mm）的患者采用标准治疗（IFL），而对 SN 有微转移（≤2mm）的患者继续接受腹股沟-股部放疗。在 160 例 SN 微转移患者中，126 例接受了腹股沟-股部放疗，2 年时同侧孤立性腹股沟复发率为 1.6%。在 162 例 SN 宏转移患者中，接受放疗的患者 2 年时的孤立性腹股沟复发率为 22%，接受 IFL 的患者为 6.9%（=0.011）。与 IFL 相比，放疗后的治疗相关发病率较低。
对于 SN 微转移的患者，腹股沟-股部放疗是 IFL 的一种安全替代方法，发病率较低。对于 SN 有宏转移的患者，50Gy 总剂量的放疗与 IFL 相比导致更多的孤立性腹股沟复发。
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