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

Zach, Diana ; Kannisto, Paivi LU ; Stenström Bohlin, Katja ; Moberg, Louise LU and Kjölhede, Preben (2019) In International Journal of Gynecological Cancer
Abstract

Background: In 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 objective: This 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 hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This study is planned as a... (More)

Background: In 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 objective: This 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 hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This 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 criteria: Inclusion 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 endpoint: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. Sample size: In each of the four study arms, recruitment of 20-30 patients is planned. Estimated dates for completing recruitment and presenting results: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021.

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author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
sentinel lymph node, vulvar and vaginal cancer
in
International Journal of Gynecological Cancer
publisher
Elsevier
external identifiers
  • pmid:31796533
  • scopus:85076047454
ISSN
1048-891X
DOI
10.1136/ijgc-2019-000938
language
English
LU publication?
yes
id
32eb3054-936c-4caf-a07f-25bce3f5b3c1
date added to LUP
2020-01-02 12:30:52
date last changed
2025-04-04 15:03:41
@article{32eb3054-936c-4caf-a07f-25bce3f5b3c1,
  abstract     = {{<p>Background: In 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 objective: This 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 hypothesis: Sentinel node biopsy has an acceptable negative predictive value and detection rate in the study cohort. Trial design: This 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 criteria: Inclusion 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 endpoint: The primary endpoints are the detection rate and the negative predictive value of the sentinel node procedure. Sample size: In each of the four study arms, recruitment of 20-30 patients is planned. Estimated dates for completing recruitment and presenting results: Recruitment will take place between November 2019 and October 2021. Results will be available in December 2021.</p>}},
  author       = {{Zach, Diana and Kannisto, Paivi and Stenström Bohlin, Katja and Moberg, Louise and Kjölhede, Preben}},
  issn         = {{1048-891X}},
  keywords     = {{sentinel lymph node; vulvar and vaginal cancer}},
  language     = {{eng}},
  month        = {{12}},
  publisher    = {{Elsevier}},
  series       = {{International Journal of Gynecological Cancer}},
  title        = {{Can we extend the indication for sentinel node biopsy in vulvar cancer? A nationwide feasibility study from Sweden}},
  url          = {{http://dx.doi.org/10.1136/ijgc-2019-000938}},
  doi          = {{10.1136/ijgc-2019-000938}},
  year         = {{2019}},
}