Patrice Mathevet1, Fabrice Lécuru2, Catherine Uzan3, Florent Boutitie4, Laurent Magaud5, Frederic Guyon6, Denis Querleu7, Virginie Fourchotte2, Marc Baron8, Anne-Sophie Bats9. 1. 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. 2. Fabrice Lécuru and Virginie Fourchotte, Breast Gynecology and Reconstructive Surgery Department, Curie Institute, 26 Rue D'Ulm, 75005 Paris, France. 3. 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. 4. 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. 5. Laurent Magaud, Hospices Civils de Lyon, Département de Santé Publique, 69003 Lyon, France; Université Lyon 1, EA 7425 HESPER, 69008 Lyon, France. 6. Frédéric Guyon, Institut Bergonié, 229 Cours de L'Argonne, 33000 Bordeaux, France. 7. Denis Querleu, Institut Claudius Regaud, 1 Av. Irène Joliot-Curie, 31059 Toulouse Cedex 9, France; ESGO, Brussels, Belgium. 8. Centre Henri Becquerel, 1 Rue D'Amiens, 76038 Rouen, France. 9. Anne-Sophie Bats, Hôpital Européen Georges Pompidou, Service de Gynécologie, 20-40 Rue Leblanc, 75908 Paris Cedex 15, France.
Abstract
INTRODUCTION: 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. MATERIALS AND METHODS: 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. RESULTS: A total of 206 patients were eligible and randomly assigned to the SN arm (105 patients) orSN + 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). CONCLUSION:SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.
RCT Entities:
INTRODUCTION: 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. MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSION: SN resection alone is associated with early decreased lymphatic morbidity when compared with SN + PLND in early cervical cancer.
Authors: Soo Jin Park; Tae Wook Kong; Taehun Kim; Maria Lee; Chel Hun Choi; Seung-Hyuk Shim; Ga Won Yim; Seungmee Lee; Eun Ji Lee; Myong Cheol Lim; Suk-Joon Chang; Sung Jong Lee; San Hui Lee; Taejong Song; Yoo-Young Lee; Hee Seung Kim; Eun Ji Nam Journal: BMC Cancer Date: 2022-03-26 Impact factor: 4.430