Aortic utero-ovarian sentinel nodes and left infrarenal aortic lymph node dissection by ICG supported navigation.
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ABSTRACT:
SUBMITTER: Kimmig R
PROVIDER: S-EPMC5310174 | biostudies-literature | 2017 May
REPOSITORIES: biostudies-literature
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Aortic utero-ovarian sentinel nodes and left infrarenal aortic lymph node dissection by ICG supported navigation.
Kimmig Rainer R Rusch Peter P Buderath Paul P Aktas Bahriye B
Gynecologic oncology reports 20170209
•Visualization of paraaortic sentinel compartments in endometrial cancer•Nerve sparing dissection of left paraaortic infrarenal lymph compartment•Educational video may be basis for standardization of paraaortic sentinel node dissection. ...[more]
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Project description:IntroductionBreast cancer surgery currently focuses on de-escalating treatment without compromising patient survival. Axillary radiotherapy (ART) now replaces axillary lymph node dissection (ALND) in patients with limited sentinel lymph node (SLN) involvement during the primary surgery, and this has significantly reduced the incidence of lymphedema without worsening the prognosis. However, patients treated with neoadjuvant systemic treatment (NST) cannot benefit from this option despite the low incidence of residual disease in the armpit in most cases. Data regarding the use of radiotherapy instead of ALND in this population are lacking. This study will assess whether ART is non-inferior to ALND in terms of recurrence and overall survival in patients with positive SLN after NST, including whether it reduces surgery-related adverse effects.Methods and analysesThis multicenter, randomized, open-label, phase 3 trial will enroll 1660 patients with breast cancer and positive SLNs following NST in approximately 50 Spanish centers over 3 years. Patients will be stratified by NST regimen and nodal involvement (isolated tumoral cells or micrometastasis versus macrometastasis) and randomly assigned 1:1 to ART without ALND (study arm) or ALND alone (control arm). Level 3 and supraclavicular radiotherapy will be added in both arms. The primary outcome is the 5-year axillary recurrence determined by clinical and radiological examination. The secondary outcomes include lymphedema or arm dysfunction, quality of life based (EORTC QLQ-C30 and QLQ-BR23 questionnaires), disease-free survival, and overall survival.DiscussionThis study aims to provide data to confirm the efficacy and safety of ART over ALND in patients with a positive SLN after NST, together with the impact on morbidity.Ethics and disseminationThe Research Ethics Committee of Bellvitge University Hospital approved this trial (Protocol Record PR148/21, version 3, 1/2/2022) and all patients must provide written informed consent. The involvement of around 50 centers across Spain will facilitate the dissemination of our results.Trial registrationClinicalTrials.gov, identifier number NCT04889924.
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Project description:BackgroundThe SUCCOR cohort was developed to analyse the overall and disease-free survival at 5 years in women with FIGO 2009 stage IB1 cervical cancer. The aim of this study was to compare the use of adjuvant therapy in these women, depending on the method used to diagnose lymphatic node metastasis.Patients and methodsWe used data from the SUCCOR cohort, which collected information from 1049 women with FIGO 2009 stage IB1 cervical cancer who were operated on between January 2013 and December 2014 in Europe. We calculated the adjusted proportion of women who received adjuvant therapy depending on the lymph node diagnosis method and compared disease free and overall survival using Cox proportional-hazards regression models. Inverse probability weighting was used to adjust for baseline potential confounders.ResultsThe adjusted proportion of women who received adjuvant therapy was 33.8% in the sentinel node biopsy + lymphadenectomy (SNB+LA) group and 44.7% in the LA group (p = 0.02), although the proportion of positive nodal status was similar (p = 0.30). That difference was greater in women with negative nodal status and positive Sedlis criteria (difference 31.2%, p = 0.01). Here, those who underwent a SNB+LA had an increased risk of relapse [hazard ratio (HR) 2.49, 95% confidence interval (CI) 0.98-6.33, p = 0.056] and risk of death (HR 3.49, 95% CI 1.04-11.7, p = 0.042) compared with those who underwent LA.ConclusionsWomen in this study were less likely to receive adjuvant therapy if their nodal invasion was determined using SNB+LA compared with LA. These results suggest a lack of therapeutic measures available when a negative result is obtained by SNB+LA, which may have an impact on the risk of recurrence and survival.
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