PURPOSE 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). METHODS 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. RESULTS 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 ( P = .011). Treatment-related morbidity after radiotherapy was less frequent compared with IFL. CONCLUSION 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.
Characterization of adnexal masses to identify patients with malignant ovarian tumors preoperatively for referral to a cancer center for treatment has been extensively studied. A simple algorithm called "risk of malignancy index" (RMI) reported by Jacobs incorporated the serum CA125 level, menopausal status, and ultrasound morphologic features. This algorithm has subsequently been tested on retrospective and prospective data with encouraging results. However, these studies did not include cases that had had both their serum CA125 measurements and ultrasound examinations from a diverse range of laboratories and sonographers. The purpose of this study was to determine the effectiveness of the RMI algorithm for identifying cases of ovarian malignancy presenting at cancer units for subsequent referral to a cancer center. All cases of suspected ovarian malignancy referred to the Northern Gynaecological Oncology Centre (NGOC) during an 18-month period were identified from the NGOC database. A case note review was performed, and the following data were extracted: patient demographics, the referring physician and the operating surgeon, ultrasound morphology, serum CA125 levels, and menopausal status. All patients had their ultrasound performed by sonographers at the peripheral unit according to local protocols. A total of 182 patients with a pelvic mass were referred to the center for surgery. A total of 24% patients had benign tumors, 6% had tumors of borderline malignancy, and 70% had invasive tumors. A total of 145 cases had an RMI >200; 125 of these had ovarian or peritoneal cancers. An RMI >200 had a sensitivity of 88.5% for diagnosing invasive lesions. The overall sensitivity of this algorithm for diagnosing all borderline, invasive ovarian, or primary peritoneal lesions was 87.4%, and the positive predictive value was 86.8%. Our data confirm the effectiveness of the RMI algorithm in clinical practice for the identification and subsequent referral to cancer centers of cases of potential ovarian malignancy. We therefore recommend its continued use.
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