Faculty Opinions recommendation of Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II.

2021 ◽  
Author(s):  
Eva Chalas
Keyword(s):  
Sentinel Node ◽  
Cancer Patients ◽  
Vulvar Cancer ◽  
Inguinofemoral Lymphadenectomy

scholarly journals Radiotherapy Versus Inguinofemoral Lymphadenectomy as Treatment for Vulvar Cancer Patients With Micrometastases in the Sentinel Node: Results of GROINSS-V II

2021 ◽  
pp. JCO.21.00006
Author(s):  
Maaike H. M. Oonk ◽  
Brian Slomovitz ◽  
Peter J. W. Baldwin ◽  
Helena C. van Doorn ◽  
Jacobus van der Velden ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Cancer Patients ◽  
Recurrence Rate ◽  
Vulvar Cancer ◽  
Early Stage ◽  
International Study ◽  
Lymph Node Involvement ◽  
Stopping Rules ◽  
Safe Alternative ◽  
Inguinofemoral Lymphadenectomy

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.

scholarly journals Sentinel Node Dissection Is Safe in the Treatment of Early-Stage Vulvar Cancer

2008 ◽  
Vol 26 (6) ◽  
pp. 884-889 ◽  
Author(s):  
Ate G.J. Van der Zee ◽  
Maaike H. Oonk ◽  
Joanne A. De Hullu ◽  
Anca C. Ansink ◽  
Ignace Vergote ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Cancer Patients ◽  
Vulvar Cancer ◽  
Early Stage ◽  
Node Dissection ◽  
Sentinel Node Procedure ◽  
Sentinel Node Dissection ◽  
Inguinofemoral Lymphadenectomy ◽  
Negative Sentinel Node

Purpose To investigate the safety and clinical utility of the sentinel node procedure in early-stage vulvar cancer patients. Patients and Methods A multicenter observational study on sentinel node detection using radioactive tracer and blue dye was performed in patients with T1/2 (< 4 cm) squamous cell cancer of the vulva. When the sentinel node was found to be negative at pathologic ultrastaging, inguinofemoral lymphadenectomy was omitted, and the patient was observed with follow-up for 2 years at intervals of every 2 months. Stopping rules were defined for the occurrence of groin recurrences. Results From March 2000 until June 2006, a sentinel node procedure was performed in 623 groins of 403 assessable patients. In 259 patients with unifocal vulvar disease and a negative sentinel node (median follow-up time, 35 months), six groin recurrences were diagnosed (2.3%; 95% CI, 0.6% to 5%), and 3-year survival rate was 97% (95% CI, 91% to 99%). Short-term morbidity was decreased in patients after sentinel node dissection only when compared with patients with a positive sentinel node who underwent inguinofemoral lymphadenectomy (wound breakdown in groin: 11.7% v 34.0%, respectively; P < .0001; and cellulitis: 4.5% v 21.3%, respectively; P < .0001). Long-term morbidity also was less frequently observed after removal of only the sentinel node compared with sentinel node removal and inguinofemoral lymphadenectomy (recurrent erysipelas: 0.4% v 16.2%, respectively; P < .0001; and lymphedema of the legs: 1.9% v 25.2%, respectively; P < .0001). Conclusion In early-stage vulvar cancer patients with a negative sentinel node, the groin recurrence rate is low, survival is excellent, and treatment-related morbidity is minimal. We suggest that sentinel node dissection, performed by a quality-controlled multidisciplinary team, should be part of the standard treatment in selected patients with early-stage vulvar cancer.

scholarly journals Limiting the morbidity of inguinofemoral lymphadenectomy in vulvar cancer patients; a review

2017 ◽  
Vol 17 (7) ◽  
pp. 615-624 ◽  
Author(s):  
Anne-Floor W. Pouwer ◽  
Henriette J. Arts ◽  
Jacobus van der Velden ◽  
Joanne A. de Hullu
Keyword(s):  
Cancer Patients ◽  
Vulvar Cancer ◽  
Inguinofemoral Lymphadenectomy

Volume-controlled versus short drainage after inguinofemoral lymphadenectomy in vulvar cancer patients: A Dutch nationwide prospective study

2017 ◽  
Vol 146 (3) ◽  
pp. 580-587 ◽  
Author(s):  
A.W. Pouwer ◽  
F. Hinten ◽  
J. van der Velden ◽  
R.G.V. Smolders ◽  
B.F.M. Slangen ◽  
...  
Keyword(s):  
Prospective Study ◽  
Cancer Patients ◽  
Vulvar Cancer ◽  
Volume Controlled ◽  
Inguinofemoral Lymphadenectomy

Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden

2019 ◽  
Vol 30 (3) ◽  
pp. 402-405
Author(s):  
Diana Zach ◽  
Paivi Kannisto ◽  
Katja Stenström Bohlin ◽  
Louise Moberg ◽  
Preben Kjölhede
Keyword(s):  
Local Recurrence ◽  
Sentinel Node ◽  
Sentinel Node Biopsy ◽  
Negative Predictive Value ◽  
Primary Tumor ◽  
Predictive Value ◽  
Detection Rate ◽  
Vulvar Cancer ◽  
Node Biopsy ◽  
Inguinofemoral Lymphadenectomy

BackgroundIn squamous cell vulvar cancer, sentinel node biopsy is accepted as standard treatment in well-defined patient groups and has reduced surgical morbidity considerably. Currently, due to the lack of evidence, it cannot be offered to patients with tumors of 4 cm diameter or greater or with multifocal tumors, or in local recurrences.Primary objectiveThis study is primarily a pilot and feasibility trial, aiming to evaluate if the prerequisites concerning detection rate and negative predictive value are satisfactory before the implementation of a multinational trial.Study hypothesisSentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort.Trial designThis study is planned as a prospective, national, multicenter interventional trial. Participating patients will undergo a sentinel node biopsy in addition to an inguinofemoral lymphadenectomy.Inclusion and exclusion criteriaInclusion criteria: for women in group 1, a primary tumor ≥4 cm in diameter; in group 2, a multifocal primary tumor; in group 3, a local recurrence without previous inguinofemoral lymphadenectomy or radiation to the groins; in group 4, a local recurrence, with previous inguinofemoral lymphadenectomy and/or radiation to the groins.Primary endpointThe primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure.Sample sizeIn each of the four study arms, recruitment of 20–30 patients is planned.Estimated dates for completing recruitment and presenting resultsRecruitment will take place between November 2019 and October 2021. Results will be available in December 2021.Trial registrationThe trial is registered at “ClinicalTrials.gov” (ID: NCT04147780).

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