Sentinel lymph node biopsy and morbidity outcomes in early cervical cancer: Results of a multicentre randomised trial (SENTICOL-2).


Journal

European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373

Informations de publication

Date de publication:
05 2021
Historique:
received: 13 12 2020
revised: 24 01 2021
accepted: 02 02 2021
pubmed: 28 3 2021
medline: 26 10 2021
entrez: 27 3 2021
Statut: ppublish

Résumé

Pelvic lymph node dissection has been the standard of care for patients with early cervical cancer. Sentinel node (SN) mapping is safe and feasible and may increase the detection of metastatic disease, but benefits of omitting pelvic lymph node dissection in terms of decreased morbidity have not been demonstrated. In an open-label study, patients with early cervical carcinoma (FIGO 2009 stage IA2 to IIA1) were randomly assigned to SN resection alone (SN arm) or SN and pelvic lymph node dissection (SN + PLND arm). SN resection was followed by radical surgery of the tumour (radical hysterectomy or radical trachelectomy). The primary end-point was morbidity related to the lymph node dissection; 3-year recurrence-free survival was a secondary end-point. A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) or SN + PLND arm (101 patients). Most patients had stage IB1 lesion (87.4%). No false-negative case was observed in SN + PLND arm. Lymphatic morbidity was significantly lower in the SN arm (31.4%) than in the SN + PLND arm (51.5%; p = 0.0046), as was the rate of postoperative neurological symptoms (7.8% vs. 20.6%, p = 0.01, respectively). However, there was no significant difference in the proportion of patients with significant lymphoedema between the two groups. During the 6-month postoperative period, the difference in morbidity decreased over time. The 3-year recurrence-free survival was not significantly different (92.0% in SN arm and 94.4% in SN + PLND arm). SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.

Identifiants

pubmed: 33773275
pii: S0959-8049(21)00091-5
doi: 10.1016/j.ejca.2021.02.009
pii:
doi:

Types de publication

Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

307-315

Investigateurs

P Morice (P)
P Mathevet (P)
E Stoeckle (E)
D Querleu (D)
V Fourchotte (V)
F Lécuru (F)
A S Bats (AS)
M Baron (M)
O Graesslin (O)
J Lévèque (J)
B Ott (B)
E Daraï (E)
D Lanvin (D)
C Pomel (C)
H Marret (H)
G Mage (G)
G Houvenaeghel (G)
J J Baldauf (JJ)
V Conri (V)
S Douvier (S)
Y Delpech (Y)
E Leblanc (E)
Y Fouché (Y)
L Boulanger (L)
P Descamps (P)
J M Classe (JM)
D Raudrant (D)
P Rouanet (P)

Informations de copyright

Copyright © 2021 The Authors. Published by Elsevier Ltd.. All rights reserved.

Déclaration de conflit d'intérêts

Conflict of interest statement The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Auteurs

Patrice Mathevet (P)

Patrice Mathevet, CHU Vaudois, Service de Gynécologie, Avenue P. Decker 2, 1011, Lausanne, Switzerland; Hospices Civils de Lyon, Public Health Department, Lyon, 69003, France. Electronic address: Patrice.Mathevet@chuv.ch.

Fabrice Lécuru (F)

Fabrice Lécuru and Virginie Fourchotte, Breast Gynecology and Reconstructive Surgery Department, Curie Institute, 26 Rue D'Ulm, 75005 Paris, France.

Catherine Uzan (C)

Catherine Uzan, Institut Gustave Roussy, 114 Rue Edouard Vaillant, 94805, Villejuif Cedex, France; Hôpital Pitié Salpétrière, Service de Gynécologie, 83 Boulevard de L'hôpital 75013 Paris, France; Institut Universitaire de Cancérologie, Université Sorbonne, INSERM U938, Paris, France.

Florent Boutitie (F)

Florent Boutitie, Hospices Civils de Lyon, Service de Biostatistique, 69003 Lyon, France; Université Lyon 1, Laboratoire de Biométrie et Biologie Evolutive, Equipe Biostatistique-Santé, 69100 Villeurbanne, France.

Laurent Magaud (L)

Laurent Magaud, Hospices Civils de Lyon, Département de Santé Publique, 69003 Lyon, France; Université Lyon 1, EA 7425 HESPER, 69008 Lyon, France.

Frederic Guyon (F)

Frédéric Guyon, Institut Bergonié, 229 Cours de L'Argonne, 33000 Bordeaux, France.

Denis Querleu (D)

Denis Querleu, Institut Claudius Regaud, 1 Av. Irène Joliot-Curie, 31059 Toulouse Cedex 9, France; ESGO, Brussels, Belgium.

Virginie Fourchotte (V)

Fabrice Lécuru and Virginie Fourchotte, Breast Gynecology and Reconstructive Surgery Department, Curie Institute, 26 Rue D'Ulm, 75005 Paris, France.

Marc Baron (M)

Centre Henri Becquerel, 1 Rue D'Amiens, 76038 Rouen, France.

Anne-Sophie Bats (AS)

Anne-Sophie Bats, Hôpital Européen Georges Pompidou, Service de Gynécologie, 20-40 Rue Leblanc, 75908 Paris Cedex 15, France.

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