Stefano Uccella1, Camilla Nero2, Enrico Vizza3, Virginia Vargiu2, Giacomo Corrado2, Nicolò Bizzarri2, Fabio Ghezzi4, Francesco Cosentino5, Luigi Carlo Turco5, Anna Fagotti2, Giovanni Scambia6. 1. Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Dipartimento per le Scienze della Salute della Donna e del Bambino, Roma, Italia; Division of Obstetrics and Gynecology, Department of Maternal, Neonatal, and Infant Health, Ospedale degli Infermi, ASL Biella, Ponderano (Biella), Italia. 2. Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Dipartimento per le Scienze della Salute della Donna e del Bambino, Roma, Italia. 3. Gynecologic Oncology Division, National Cancer Institute, Regina Elena, Roma, Italia. 4. Department of Obstetrics and Gynecology, University of Insubria, Varese, Italia. 5. Gynecologic Oncology Division, Fondazione Giovanni Paolo II, Campobasso, Italia. 6. Fondazione Policlinico Universitario A. Gemelli IRCCS, Gynecologic Oncology, Dipartimento per le Scienze della Salute della Donna e del Bambino, Roma, Italia. Electronic address: giovanni.scambia@policlinicogemelli.it.
Abstract
BACKGROUND: Systematic paraaortic and bilateral pelvic lymphadenectomy is the standard of a comprehensive surgical staging in presumed early epithelial ovarian cancer, but no prospective randomized evidence suggests a possible therapeutic value. Moreover, this procedure is associated with potential severe morbidity. The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective study designed to test whether sentinel node detection can accurately predict nodal status in a cohort of women with early epithelial ovarian cancer. OBJECTIVES: We here present the results of the first part of the Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial, regarding the feasibility of the sentinel lymph node technique and the preliminary findings regarding its safety and accuracy. STUDY DESIGN: The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective, phase II, single-arm study included patients with presumed stages I-II epithelial ovarian cancer planned for immediate or delayed minimally invasive comprehensive staging. The ovarian pedicle is injected with 2 mL of a 1.25 mg/mL indocyanine green solution. The pelvic and lumboaortic retroperitoneum is then accessed and inspected to identify and remove sentinel nodes. After sentinel node procedure, staging is completed including systematic pelvic and paraaortic lymphadenectomy. Assuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d = 5%, a type I error α = 0.05, a sample size of 160 patients is needed to test the general hypothesis. Here we present the preliminary results on the first 31 patients enrolled. RESULTS: Thirty-one patients were included. Sentinel node was identified in 21 patients (detection rate, 67.7%). The detection rate was significantly higher in women undergoing immediate vs delayed staging (88.9% vs 41.7%, P = .003). Four patients had positive nodes. In all the patients with lymphatic dissemination, a positive sentinel node was identified (sensitivity, 100%; false-negative rate, 0%; negative predictive value, 100%). One (3.2%) intra- and 2 (6.5%) postoperative grade I complications occurred. CONCLUSION: Our data show that the detection of sentinel node in early epithelial ovarian cancer is low when patients are submitted to delayed-staging surgery. However, sentinel node procedure is feasible and has the potential to provide reliable and useful information on nodal status and may allow the avoidance of systematic lymphadenectomy in the majority of patients.
BACKGROUND: Systematic paraaortic and bilateral pelvic lymphadenectomy is the standard of a comprehensive surgical staging in presumed early epithelial ovarian cancer, but no prospective randomized evidence suggests a possible therapeutic value. Moreover, this procedure is associated with potential severe morbidity. The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective study designed to test whether sentinel node detection can accurately predict nodal status in a cohort of women with early epithelial ovarian cancer. OBJECTIVES: We here present the results of the first part of the Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial, regarding the feasibility of the sentinel lymph node technique and the preliminary findings regarding its safety and accuracy. STUDY DESIGN: The Sentinel Lymph Nodes in Early-Stage Ovarian Cancer trial is a prospective, phase II, single-arm study included patients with presumed stages I-II epithelial ovarian cancer planned for immediate or delayed minimally invasive comprehensive staging. The ovarian pedicle is injected with 2 mL of a 1.25 mg/mL indocyanine green solution. The pelvic and lumboaortic retroperitoneum is then accessed and inspected to identify and remove sentinel nodes. After sentinel node procedure, staging is completed including systematic pelvic and paraaortic lymphadenectomy. Assuming a sensitivity of 98.5% in predicting positive sentinel lymph nodes at histology, a pathological lymph node prevalence of 14.2%, a precision of estimate (ie, the maximum marginal error) d = 5%, a type I error α = 0.05, a sample size of 160 patients is needed to test the general hypothesis. Here we present the preliminary results on the first 31 patients enrolled. RESULTS: Thirty-one patients were included. Sentinel node was identified in 21 patients (detection rate, 67.7%). The detection rate was significantly higher in women undergoing immediate vs delayed staging (88.9% vs 41.7%, P = .003). Four patients had positive nodes. In all the patients with lymphatic dissemination, a positive sentinel node was identified (sensitivity, 100%; false-negative rate, 0%; negative predictive value, 100%). One (3.2%) intra- and 2 (6.5%) postoperative grade I complications occurred. CONCLUSION: Our data show that the detection of sentinel node in early epithelial ovarian cancer is low when patients are submitted to delayed-staging surgery. However, sentinel node procedure is feasible and has the potential to provide reliable and useful information on nodal status and may allow the avoidance of systematic lymphadenectomy in the majority of patients.
Authors: Victor Lago; Pilar Bello; Beatriz Montero; Luis Matute; Pablo Padilla-Iserte; Susana Lopez; Tiermes Marina; Marc Agudelo; Santiago Domingo Journal: Int J Gynecol Cancer Date: 2020-05-23 Impact factor: 3.437
Authors: Pim Laven; Roy Kruitwagen; Petra Zusterzeel; Brigitte Slangen; Toon van Gorp; Jochem van der Pol; Sandrina Lambrechts Journal: J Ovarian Res Date: 2021-10-13 Impact factor: 4.234
Authors: Stanley P Leong; Alexander Pissas; Muriel Scarato; Francoise Gallon; Marie Helene Pissas; Miguel Amore; Max Wu; Mark B Faries; Amanda W Lund Journal: Clin Exp Metastasis Date: 2021-10-15 Impact factor: 5.150