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GYNAECOLOGY| Volume 34, ISSUE 11, P1053-1065, November 2012

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Sentinel Lymph Node Biopsy in Vulvar Cancer: A Health Technology Assessment for the Canadian Health Care Context

DOI:https://doi.org/10.1016/S1701-2163(16)35435-4
Sentinel Lymph Node Biopsy in Vulvar Cancer: A Health Technology Assessment for the Canadian Health Care Context
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      Abstract

      Objective

      Inguinofemoral lymphadenectomy for vulvar cancer is associated with a high incidence of groin wound complications and lymphedema. Sentinel lymph node biopsy (SLNB) is a morbidity-reducing alternative to lymphadenectomy. The objective of this health technology assessment was to determine the clinical effectiveness, costeffectiveness, and organizational feasibility of SLNB in the Canadian health care system.

      Methods

      A review of the English-language literature published from January 1992 to October 2011 was performed across five databases and six grey-literature sources. Predetermined eligibility criteria were used to select studies, and results in the clinical, economic, and organizational domains were summarized. Included studies were evaluated for methodologic quality using the Newcastle-Ottawa Scale.

      Results

      Of 825 reports identified, 88 observational studies met the eligibility criteria. Overall study quality was poor, with a median Newcastle-Ottawa Scale score of 2 out of 9 stars. Across all studies, the detection rate of the sentinel lymph node was 82.2% per groin and the false-negative rate was 6.3%. The groin recurrence rate after negative SLNB was 3.6% compared with 4.3% after negative lymphadenectomy, and complications were reduced after SLNB. No economic evaluations were identified comparing SLNB to lymphadenectomy. Safe implementation of SLNB requires appropriate patient selection, detection technique, and attention to the learning curve.

      Conclusion

      Although study quality is poor, the available data suggest implementation of SLNB may be safe and feasible in Canadian centres with adequate procedural volumes, assuming that implementation includes careful patient selection, careful technique, and ongoing quality assessment. Cost-effectiveness has yet to be determined.

      Résumé

      Objectif

      La lymphadénectomie inguino-fémorale visant le cancer de la vulve est associée à une forte incidence de complications de plaie inguinale et de lymphoedème. La biopsie du ganglion sentinelle (BGS) est une solution de rechange à la lymphadénectomie qui permet d’atténuer la morbidité. Cette évaluation de la technologie du domaine de la santé avait pour objectif de déterminer l’efficacité clinique, la rentabilité et la faisabilité organisationnelle de la BGS au sein du système de santé canadien.

      Méthodes

      Une analyse de la littérature publiée en anglais entre janvier 1992 et octobre 2011 a été menée dans cinq bases de données et au sein de six sources de « littérature grise ». Des critères d’admissibilité prédéterminés ont été utilisés pour sélectionner les études et les résultats relevant des domaines clinique, économique et organisationnel ont été résumés. Les études admises ont fait l’objet d’une évaluation visant la qualité méthodologique au moyen de l’échelle Newcastle-Ottawa.

      Résultats

      Parmi les 825 rapports identifiés, 88 études observationnelles ont répondu aux critères d’admissibilité. La qualité globale des études était faible, le score médian sur l’échelle Newcastle-Ottawa étant de deux étoiles sur neuf. Dans ces études, le taux de détection du ganglion sentinelle était de 82,2 % par aine et le taux de faux négatif était de 6,3 %. Le taux de récurrence inguinale à la suite d’une BGS négative était de 3,6 %, par comparaison avec 4,3 % à la suite d’une lymphadénectomie négative; de plus, les complications étaient atténuées à la suite de la BGS. Aucune évaluation économique comparant la BGS à la lymphadénectomie n’a été identifiée. La mise en oeuvre en toute sûreté de la BGS nécessite qu’une attention particulière soit portée à la sélection des patientes, à la technique de détection et à la courbe d’apprentissage.

      Conclusions

      Bien que la qualité des études ait été faible, les données disponibles semblent indiquer que la mise en oeuvre de la BGS peut s’effectuer en toute sûreté et s’avérer faisable au sein des centres canadiens qui comptent des volumes d’intervention adéquats; bien sûr, cela présume que cette mise en oeuvre inclut une sélection soignée des patientes, une technique rigoureuse et un contrôle continu de la qualité. La rentabilité demeure à déterminer.

      Key Words

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      Article info

      Publication history

      Accepted: June 11, 2012
      Received: March 16, 2012

      Footnotes

      Competing Interests: None declared.

      Identification

      DOI: https://doi.org/10.1016/S1701-2163(16)35435-4

      Copyright

      © 2012 Society of Obstetricians and Gynaecologists of Canada. Published by Elsevier Inc. All rights reserved.

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