Elsevier

Gynecologic Oncology

Volume 140, Issue 1, January 2016, Pages 8-14
Gynecologic Oncology

Sentinel nodes in vulvar cancer: Long-term follow-up of the GROningen INternational Study on Sentinel nodes in Vulvar cancer (GROINSS-V) I

https://doi.org/10.1016/j.ygyno.2015.09.077Get rights and content

Highlights

  • Ten year disease-specific survival is 91% for patients with a negative sentinel node.

  • Local recurrence rate at ten year after primary treatment is 39.5% for all patients.

  • Disease-specific survival decreases significantly in case a local recurrence occurs.

Abstract

Objective

In 2008 GROINSS-V-I, the largest validation trial on the sentinel node (SN) procedure in vulvar cancer, showed that application of the SN-procedure in patients with early-stage vulvar cancer is safe. The current study aimed to evaluate long-term follow-up of these patients regarding recurrences and survival.

Methods

From 2000 until 2006 GROINSS-V-I included 377 patients with unifocal squamous cell carcinoma of the vulva (T1,<4 cm), who underwent the SN-procedure. Only in case of SN metastases an inguinofemoral lymphadenectomy was performed. For the present study follow-up was completed until March 2015.

Results

The median follow-up was 105 months (range 0–179). The overall local recurrence rate was 27.2% at 5 years and 39.5% at 10 years after primary treatment, while for SN-negative patients 24.6% and 36.4%, and for SN-positive patients 33.2% and 46.4% respectively (p = 0.03). In 39/253 SN-negative patients (15.4%) an inguinofemoral lymphadenectomy was performed, because of a local recurrence. Isolated groin recurrence rate was 2.5% for SN-negative patients and 8.0% for SN-positive patients at 5 years. Disease-specific 10-year survival was 91% for SN-negative patients compared to 65% for SN-positive patients (p < .0001). For all patients, 10-year disease-specific survival decreased from 90% for patients without to 69% for patients with a local recurrence (p < .0001).

Conclusions

Survival is very good for patients with a negative SN, but still 36% of these patients, as well as 46% of the patients with a positive SN, will have a local recurrence. Although a local recurrence is treated with curative intent, the disease-specific survival of these patients decreases significantly.

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.

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