Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I
Introduction
In 2008 the results of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I showed, that in case of a negative sentinel node (SN) it is safe to omit an inguinofemoral lymphadenectomy [1]. In this prospective international observational study early-stage vulvar cancer patients with squamous cell cancer (SCC) of the vulva, < 4 cm in diameter, with a depth of invasion > 1 mm and without suspicious groin nodes at palpation were included. In 2012 Levenback et al. published the results of the GOG-173 study, which with respect to diagnostic accuracy closely replicated those of GROINSS-V-I [2]. Since the publication of these two seminal trials the SN procedure has been integrated in the standard treatment of pre-selected patients with early-stage vulvar carcinoma world-wide [3].
Previous retrospective studies indicate that 20–23% of all patients with vulvar cancer will have a local recurrence [4], [5], [6]. Treatment of a local recurrence in general is with curative intent and most often will consist of wide local excision. In addition, for those patients previously treated with the SN procedure, inguinofemoral lymphadenectomy is indicated for recurrent macro-invasive disease, because little information exists on the diagnostic accuracy of the SN procedure in the treatment of recurrent disease [7], [8]. Those patients with recurrent disease will therefore no longer benefit from the reduction in morbidity associated with the SN procedure.
No long-term follow-up data are available for large populations of patients with vulvar cancer, who underwent the SN procedure as part of their primary treatment. GROINSS-V-I showed that in patients with a negative SN short and long-term treatment-related complications were significantly decreased with a very low risk for groin recurrences. However, the mean follow-up time of 35 months (range 2–87 months) of SN negative patients in this first publication was relatively short [1].
GROINSS-V-I included patients from 2000 until 2006. In 2008 the first results for SN negative and in 2010 the results for SN positive patients were presented [1], [9]. For the current study, we updated the follow-up for all patients with unifocal disease. The primary objective was to evaluate long-term follow-up of these patients regarding recurrent disease and survival.
Section snippets
Patients
From March 2000 until June 2006 GROINSS-V-I included 403 patients from 15 medical centers as previously described [1]. In October 2003, of 139 patients with a negative SN on study, two patients with multifocal disease and a negative SN suffered from a groin recurrence within a short period of time. Despite the fact that the stopping rule had not yet been activated, it was decided to amend the protocol and to further exclude patients with multifocal disease [1]. Therefore we focused on the
Patient characteristics
From March 2000 until June 2006, 377 patients with unifocal SCC of the vulva were included in GROINSS-V-I and underwent the SN procedure. In 253 (67.1%) patients the SN was found to be negative and in 124 (32.9%) patients the SN showed metastatic disease. Patient characteristics are described in Table 1.
Follow-up and recurrences
Median follow-up time was 105 months (range 0–179). Sixty-three patients did not complete the first two years of follow-up: eight patients were lost to follow-up and 55 patients died within the
Discussion
Our update of GROINSS-V-I demonstrates that long-term survival is very good for patients with early-stage vulvar cancer and a negative SN and much worse for patients with a positive SN, stressing the importance of SN status as a prognostic factor. Our prospective study reveals, that on the long-term a significant proportion of patients will develop a local recurrence, regardless of SN status and that these local recurrences may occur even a long time after primary treatment. In contrast to
Acknowledgments
The authors have no potential conflicts of interest to declare.
References (17)
- et al.
Sentinel lymph node biopsy in vulvar cancer: systematic review, meta-analysis and guideline recommendations
Gynecol. Oncol.
(2015) - et al.
Patterns and frequency of recurrences of squamous cell carcinoma of the vulva
Gynecol. Oncol.
(2006) - et al.
Sentinel lymph node detection in locally recurrent carcinoma of the vulva
BJOG
(2001) - et al.
Size of sentinel-node metastasis and chances of non-sentinel-node involvement and survival in early stage vulvar cancer: results from GROINSS-V, a multicentre observational study
Lancet Oncol.
(2010) - et al.
Long-term follow-up of vulvar cancer patients evaluated with sentinel lymph node biopsy alone
Gynecol. Oncol.
(2014) - et al.
Long-term survival and disease recurrence in patients with primary squamous cell carcinoma of the vulva
Gynecol. Oncol.
(2005) Residual anogenital lichen sclerosus after cancer surgery has a high risk for recurrence: a clinicopathological study of 75 women
Gynecol. Oncol.
(Nov 2011)- et al.
Comparison of outcome and recurrence-free survival after sentinel lymph node biopsy and lymphadenectomy in vulvar cancer
Gynecol. Oncol.
(2008)
Cited by (210)
Nuclear Medicine and Molecular Imaging Applications in Gynecologic Malignancies: A Comprehensive Review
2024, Seminars in Nuclear MedicineAccuracy of ICG compared with technetium-99 m for sentinel lymph node biopsy in vulvar cancer
2024, European Journal of Obstetrics and Gynecology and Reproductive BiologyNavigating the Complexities of Lymph Node Management in Vulvar Cancer: Insights and Perspectives
2024, Practical Radiation OncologyBritish Gynaecological Cancer Society (BGCS) vulval cancer guidelines: An update on recommendations for practice 2023
2024, European Journal of Obstetrics and Gynecology and Reproductive BiologyVulvar cancer management and wrangling recurrent disease: A report from the society of gynecologic oncology journal club
2023, Gynecologic Oncology Reports