ANGELITA HABR GAMA
Projetos de Pesquisa
Unidades Organizacionais
Departamento de Gastroenterologia, Faculdade de Medicina - Docente
4 resultados
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Agora exibindo 1 - 4 de 4
- Rectal Cancer and Organ-Preservation: Safety First, Then the King(2023) FERNANDEZ, Laura M.; JULIAO, Guilherme P. Sao; RENEHAN, Andrew G.; BEETS, Geerard L.; PAPOILA, Ana L.; VAILATI, Bruna B.; KRANENBARG, Elma Meershoek-Klein; ROODVOETS, Annet G. H.; FIGUEIREDO, Nuno L.; VELDE, Cornelis J. H. van de; HABR-GAMA, Angelita; PEREZ, Rodrigo O.
- A multi-centre randomized controlled trial investigating Consolidation Chemotherapy with and without oxaliplatin in distal rectal cancer and Watch & Wait(2023) HABR-GAMA, Angelita; JULIAO, Guilherme Pagin Sao D.; ORTEGA, Cinthia D.; VAILATI, Bruna Borba; ARAUJO, Sergio; JORGE, Thiago; SABBAGA, Jorge L.; ROSSI, Gustavo L.; D'ALPINO, Renata; KATER, Fabio Roberto; AGUILAR, Patricia Bailao; MATTACHEO, Adrian; PEREZ, Rodrigo OlivaBackground Neoadjuvant chemoradiation(nCRT) has been considered the preferred initial treatment strategy for distal rectal cancer. Advantages of this approach include improved local control after radical surgery but also the opportunity for organ preserving strategies (Watch and Wait-WW). Consolidation chemotherapy(cCT) regimens using fluoropyrimidine-based with or without oxalipatin following nCRT have demonstrated to increase complete response and organ preservation rates among these patients. However, the benefit of adding oxaliplatin to cCT compared to fluoropirimidine alone regimens in terms of primary tumor response remains unclear. Since oxalipatin-treatment may be associated with considerable toxicity, it becomes imperative to understand the benefit of its incorporation into standard cCT regimens in terms of primary tumor response. The aim of the present trial is to compare the outcomes of 2 different cCT regimens following nCRT (fluoropyrimidine-alone versus fluoropyrimidine + oxaliplatin) for patients with distal rectal cancer.Methods In this multi-centre study, patients with magnetic resonance-defined distal rectal tumors will be randomized on a 1:1 ratio to receive long-course chemoradiation (54 Gy) followed by cCT with fluoropyrimidine alone versus fluoropyrimidine + oxaliplatin. Magnetic resonance(MR) will be analyzed centrally prior to patient inclusion and randomization. mrT2-3N0-1 tumor located no more than 1 cm above the anorectal ring determined by sagittal views on MR will be eligible for the study. Tumor response will be assessed after 12 weeks from radiotherapy(RT) completion. Patients with clinical complete response (clinical, endoscopic and radiological) may be enrolled in an organ-preservation program(WW). The primary endpoint of this trial is decision to organ-preservation surveillance (WW) at 18 weeks from RT completion. Secondary endpoints are 3-year surgery-free survival, TME-free survival, distant metastases-free survival, local regrowth-free survival and colostomy-free survival.Discussion Long-course nCRT with cCT is associated with improved complete response rates and may be a very attractive alternative to increase the chances for organ-preservation strategies. Fluoropyrimidine-based cCT with or without oxaliplatin has never been investigated in the setting of a randomized trial to compare clinical response rates and the possibility of organ-preservation. The outcomes of this study may significantly impact clinical practice of patients with distal rectal cancer interested in organ-preservation.
- Local Regrowth and the Risk of Distant Metastases Among Patients Undergoing Watch-and-Wait for Rectal Cancer: What Is the Best Control Group? Multicenter Retrospective Study(2024) JULIAO, Guilherme Pagin Sao; FERNANDEZ, Laura M.; VAILATI, Bruna Borba; HABR-GAMA, Angelita; AZEVEDO, Jose M.; SANTIAGO, Ines A.; PARES, Oriol; PARVAIZ, Amjad; VENDRELY, Veronique; RULLIER, Anne; RULLIER, Eric; DENOST, Quentin; PEREZ, Rodrigo OlivaBACKGROUND:A proportion of rectal cancer patients who achieve a clinical complete response may develop local regrowth. Although salvage appears to provide appropriate local control, the risk of distant metastases is less known.OBJECTIVE:To compare the risk of distant metastases between patients who achieve a clinical complete response (watch-and-wait strategy) and subsequent local regrowth and patients managed by surgery after chemoradiation.DESIGN:Retrospective multicenter cohort study.SETTINGS:This study used data of patients from 3 institutions who were treated between 1993 and 2019.PATIENTS:Patients with initial clinical complete response (after neoadjuvant therapy) followed by local regrowth and patients with near-complete pathological response (<= 10%) after straightforward surgery after chemoradiation were included.MAIN OUTCOME MEASURES:Univariate and multivariate analyses were performed to identify risk factors for distant metastases. Kaplan-Meier curves were created (log-rank test) to compare survival outcomes. Analyses were performed using time zero as last day of radiation therapy or as date of salvage resection in the local regrowth group.RESULTS:Twenty-one of 79 patients with local regrowth developed distant metastases, whereas only 10 of 74 after upfront total mesorectal excision following neoadjuvant chemoradiation therapy (p = 0.04). Local regrowth and final pathology (ypT3-4) were the only independent risk factors associated with distant metastases. When using date of salvage resection as time zero, distant metastases-free survival rates were significantly inferior for patients with local regrowth (70% vs 86%; p = 0.01).LIMITATIONS:Small number of patients, many neoadjuvant therapies, and selection bias.CONCLUSIONS:Patients undergoing watch-and-wait strategy who develop local regrowth are at higher risk for development of distant metastases compared to patients with near-complete pathological response managed by upfront surgery after chemoradiation. See Video Abstract
- The Risk of Distant Metastases in Patients With Clinical Complete Response Managed by Watch and Wait After Neoadjuvant Therapy for Rectal Cancer: The Influence of Local Regrowth in the International Watch and Wait Database(2023) FERNANDEZ, Laura M.; JULIO, Guilherme P. Sao; RENEHAN, Andrew G.; BEETS, Geerard L.; PAPOILA, Ana L.; VAILATI, Bruna B.; BAHADOER, Renu R.; KRANENBARG, Elma Meershoek-Klein; ROODVOETS, Annet G. H.; FIGUEIREDO, Nuno L.; VELDE, Cornelis J. H. Van de; HABR-GAMA, Angelita; PEREZ, Rodrigo O.BACKGROUND: Nearly 30% of patients with rectal cancer develop local regrowth after initial clinical complete response managed by watch and wait. These patients might be at higher risk for distant metastases. OBJECTIVE: This study aimed to investigate risk factors for distant metastases using time-dependent analyses. DESIGN: Data from an international watch and wait database were retrospectively reviewed. Cox regression analysis was used to determine risk factors for worse distant metastases-free survival. Conditional survival modeling was used to investigate the impact of risk factors on the development of distant metastases. SETTING: Retrospective, multicenter database. PATIENTS: A total of 793 patients (47 institutions) with rectal cancer and clinical complete response to neoadjuvant treatment from the International Watch & Wait Database were included. MAIN OUTCOME MEASURES: Distant metastases-free survival. RESULTS: Of the 793 patients managed with watch and wait (median follow-up 55.2 mo), 85 patients (10.7%) had distant metastases. Fifty-one of 85 patients (60%) had local regrowth at any time. Local regrowth was an independent factor associated with worse distant metastases-free survival in the multivariable model. Using conditional estimates, patients with local regrowth without distant metastases for 5 years (from decision to watch and wait) remained at higher risk for development of distant metastases for 1 subsequent year compared to patients without local regrowth (5-year conditional distant metastases-free survival 94.9% vs 98.4%). LIMITATIONS: Lack of information on adjuvant chemotherapy, salvage surgery for local regrowth, and heterogeneity of individual surveillance/follow-up strategies used may have affected results. CONCLUSIONS: In patients with clinical complete response managed by watch and wait, development of local regrowth at any time is a risk factor for distant metastases. The risk of distant metastases remains higher for 5 years after development of local regrowth. See Video Abstract at http://links.lww.com/DCR/C53.