May 15 - 17, 2025 Brasilia - Brazil

Carlos Inácio de Paula Award

Awarded 2023

SENTINEL LYMPH NODE BIOPSY VERSUS NO AXILLARY SURGERY IN EARLY BREAST CANCER CLINICALLY AND ULTRASONOGRAPHICALLY NODE NEGATIVE: A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL – VENUS TRIAL EARLY RESULTS AFTER 3.5 YEARS OF STUDY INCEPTION 

Danielle Cristina Miyamoto Araújo¹, Giuliano Mendes Duarte¹, Maria Beatriz de Paula Leite Kraft Enz Hubert¹, Rodrigo Menezes Jales¹, Luis Otávio Sarian¹, Eduardo Carvalho Pessoa², Idam de Oliveira Júnior³, VENUS TRIAL Group4

¹ Departamento de Ginecologia e Obstetrícia da Faculdade de Ciências Médicas da Universidade Estadual de Campinas (UNICAMP)|Campinas|São Paulo|Brasil
² Departamento de Ginecologia e Obstetrícia da Universidade Estadual Paulista Júlio de Mesquita Filho (UNESP)|Botucatu|São Paulo|Brasil
³ Departamento de Mastologia e Reconstrução Mamária do Hospital de Câncer de Barretos|Barretos|São Paulo|Brasil
4 VENUS TRIAL Group|Brasil|Brasil|Brasil

Objective: The VENUS trial is an ongoing prospective, multi-center, non–inferiority randomized controlled clinical trial aimed at comparing the disease-free and overall survival of T1-2 N0 M0 breast cancer patients subjected to either a) sentinel lymph node (group sentinel) or b) no axillary surgery (group no-sentinel). This is a partial report on the initial data so far collected 3.5 years after the trial started. VENUS differs from previous similar trials in that women undergoing mastectomy and neoadjuvant chemotherapy are accepted. Methodology: The protocol was approved by the local research ethics committee (CAAE: 068051 18.2.0000.5404). Initial axillary status was ascertained through physical examination and axillary ultrasound. Randomization is being stratified by age and clinical tumor size. Secondary endpoints include regional recurrence free survival, axillary recurrence rate, axillary morbidity rate, ultrasound accuracy and cost-effectiveness. The sample size was estimated at 800 participants. Primary and secondary endpoints will be reported after 5 years of follow-up of the completed cohorts. VENUS trial is registered in Clinical Trials (Identifier: NCT05315154) and ReBEC (Identifier: RBR-8g6jbf). Results: As of February 2023, 176 patients were enrolled and 156 were randomized to the sentinel (84 patients) and no-sentinel (72 patients) groups. Current mean follow-up time is 18.57 (+ 8.52) months. Patients are statistically evenly distributed across study groups regarding age and molecular subtype. Sentinel lymph node positivity in the sentinel group was 17.8% (1.19% isolated tumor cells, 3.57% micrometastasis, 11.90% 1-3 macrometastasis, and 1.19% > 4 macrometastasis). There were no axillary recurrences in both groups. Conclusion: Up until now, with nearly 20% of the trial completed, VENUS showed no significant difference regarding its posted objectives in women undergoing or not sentinel lymph node dissection.

Keywords: Breast neoplasms, Breast cancer, Sentinel lymph node biopsy, Breast cancer treatment, Axillary surgery, Ultrasound

Awarded 2022

COMPARATIVE ANALYSIS OF THE DEGREE OF PATIENT SATISFACTION AFTER BREAST-CONSERVING SURGERY WITH OR WITHOUT ONCOPLASTIC SURGERY: A SYSTEMATIC REVIEW AND META-ANALYSIS

Fabiana Christina Araújo Pereira Lisboa1, Lucimara Priscila Campos Veras2, Régis Resende Paulinelli3, João Batista de Sousa1

1University of Brasilia, Brasília (DF) – Brazil
2Foundation for Teaching and Research in Health Sciences, Brasília (DF) – Brazil
3Federal University of Goias, Goiânia (GO) – Brazil

Objective: A systematic review was carried out on the comparative analysis of the degree of satisfaction of patients undergoing breast-conserving surgery for the treatment of breast cancer, with and without oncoplastic surgery, in addition to performing a meta-analysis to integrate the results of studies carried out with different questionnaires for arrive at a summary measure that could homogenize and categorize this complex comparative analysis arising from such diverse quantitative collection methods.
Methodology: Systematic review with literature searches in MEDLINE (by PubMed), EMBASE, Clinical Trials, Scopus, Web of Science, BVS e Oppen gray. The Joanna Briggs Institute tools were used to evaluate the methodological quality of the studies. Data were summarized through meta-analyses using a random effects model and considered relative risk (RR) measures and their confidence intervals (95% CI).
Results: After eligibility assessment, we included 6 studies in the systematic review and in the quantitative analysis, encompassing a total of 1,110 patients. The studies included seemed to have overall good methodological quality. There was no statistically significant difference for the aesthetic outcome between women who underwent oncoplastic and conservative surgery (RR = 0.98; 95% CI = 0.91-1.04). Patients undergoing conservative surgery with oncoplastic surgery have more advanced staging, greater tumor size and resected specimen weight compared to classical surgery. In addition to a higher frequency of breast tumor location unfavorable to the best aesthetic result (central, medial or inferior).
Conclusion: The degree of patient satisfaction with conservative surgery, with or without oncoplastic surgery, is similar between the groups. The time elapsed from the surgery to the measurement of the outcome and the tumor conditions seem to have an impact on this result. There is no specific and standardized questionnaire to assess patient satisfaction with conservative surgery, bringing limited and controversial results. A standardization in the quantification of this data in further studies is suggested.
Keywords: Breast Neoplasms; Mammaplasty; Mastectomy, Segmental; Patient Satisfaction