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).

Comparison of recurrence after vulvectomy and lymphadenectomy with and without sentinel node biopsy in early stage vulvar cancer

2006 ◽  
Vol 103 (3) ◽  
pp. 865-870 ◽  
Author(s):  
José M. Martínez-Palones ◽  
María A. Pérez-Benavente ◽  
Antonio Gil-Moreno ◽  
Berta Díaz-Feijoo ◽  
Isabel Roca ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Sentinel Node Biopsy ◽  
Vulvar Cancer ◽  
Early Stage ◽  
Node Biopsy

Comparison of Recurrence after Vulvectomy and Lymphadenectomy With and Without Sentinel Node Biopsy in Early Stage Vulvar Cancer

2007 ◽  
Vol 62 (4) ◽  
pp. 240-242 ◽  
Author(s):  
Jos?? M. Mart??nez-Palones ◽  
Mar??a A. P??rez-Benavente ◽  
Antonio Gil-Moreno ◽  
Berta D??az-Feijoo ◽  
Isabel Roca ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Sentinel Node Biopsy ◽  
Vulvar Cancer ◽  
Early Stage ◽  
Node Biopsy

The Importance of Adequate Primary Tumor Excision Margins and Sentinel Node Biopsy in Achieving Optimal Locoregional Control for Patients With Thick Primary Melanomas

2013 ◽  
Vol 258 (1) ◽  
pp. 152-157 ◽  
Author(s):  
Sandro Pasquali ◽  
Lauren E. Haydu ◽  
Richard A. Scolyer ◽  
Julie B. Winstanley ◽  
Andrew J. Spillane ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Sentinel Node Biopsy ◽  
Primary Tumor ◽  
Locoregional Control ◽  
Tumor Excision ◽  
Node Biopsy ◽  
Excision Margins

scholarly journals Sentinel node biopsy in vulvar cancer: A critical appraisal

2017 ◽  
Vol 03 (01) ◽  
pp. 005-011
Author(s):  
Neville Hacker ◽  
Ellen Barlow
Keyword(s):  
Sentinel Node ◽  
Sentinel Node Biopsy ◽  
Vulvar Cancer ◽  
False Negative ◽  
False Negative Rate ◽  
Groin Dissection ◽  
Loss Of Life ◽  
Risks And Benefits ◽  
Node Biopsy ◽  
Negative Rate

AbstractSince the incorporation of inguinal-femoral lymphadenectomy into the management of patients with vulvar cancer in the mid-20th century, there have been attempts to modify or eliminate the groin dissection to decrease the risk of lower limb lymphedema. Early attempts were significantly flawed and resulted in much unnecessary loss of life because recurrence in an undissected groin is usually fatal. The best compromise yet to decrease the risk of lymphedema is sentinel node biopsy, but accumulated evidence now suggests that the false-negative rate for this procedure, if used for lesions up to 4 cm in diameter, is between 5% and 10%. Most women, properly informed of risks and benefits, are not prepared to take a 1% risk of dying from recurrent vulvar cancer to avoid lymphedema. This is the risk involved, assuming a false-negative rate of 5% and an incidence of positive nodes of 20%. For this reason, sentinel node biopsy should not be considered to be standard practice for patients with early vulvar cancer.

Equivalence randomized trial comparing treatment based on sentinel node biopsy versus neck dissection in operable T1-T2N0 oral and oropharyngeal cancer.

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 6501-6501 ◽  
Author(s):  
Renaud Garrel ◽  
Françoise Perriard ◽  
Valentin Favier ◽  
Fanny Richard ◽  
Jean Pierre Daures ◽  
...  
Keyword(s):  
Sentinel Node ◽  
Hospital Stay ◽  
Neck Dissection ◽  
Sentinel Node Biopsy ◽  
Primary Tumor ◽  
Functional Outcomes ◽  
Relapse Free Survival ◽  
Free Survival ◽  
Node Biopsy ◽  
Survival Difference

6501 Background: Although sentinel node (SN) biopsy is known to be accurate in operable oral and oropharyngeal cT1-T2N0 squamous cell carcinomas (OC), the oncological equivalence of a treatment based on SN compared to that based on neck dissection (ND) has to be evaluated. Methods: A prospective multicenter randomized medico economic study included patients with OC operated of primary tumor and systematic neck dissection in ND-arm (standard treatment) versus patients operated of primary tumor and SN biopsy only if negative or ND if SN biopsy positive (SN-arm, experimental treatment). Primary endpoint was neck-relapse-free survival at 2 years and 5 years. Hypothesis of equivalence was tested with a delta of 10%. Functional outcomes were assessed by comparing the length of the hospital stay, the number of physiotherapy prescriptions and dysfunctions in neck and shoulder scales during the 2 post-operative years. Results: Out of 307 included patients in 10 hospital centers, 279 evaluable cases showed a neck-relapse-free survival at 2 years and 5 years respectively of 89,6% (95%CI: 0.827; 0.938) and 89,6 %, (95%CI: 0.827; 0.938) in the ND-arm (14 neck relapses out of 139 patients) and of 90,7% (95%CI: 0.842; 0.946) and 89,4% (95%CI: 0.823; 0.938) in the SN-arm (13 neck relapses out of 140 patients). The survival difference between the two arms was less than the 10% expected interval, confirming the equivalence with p = 0.008. The median length of hospital stay was 7 days (ext. 3-30) in SN-arm and 8 days (ext. 2-94) in ND-arm (Wilcoxon’s test, p = 0.001). The other functional outcomes were statistically worse in the ND-arm at the 2nd, 4th and 6th postoperative months. There was no more difference at 12 months and later. Conclusions: This study demonstrated the oncological equivalence of the SN approach compared to the ND approach in a multicenter study with a lower morbidity and care consumption in the SN approach during the 6 first post-operative months. Treatment based on sentinel node biopsy is established as a standard of care in OC. Clinical trial information: NCT02855723 .

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