CINTHIA DENISE ORTEGA
Projetos de Pesquisa
Unidades Organizacionais
Instituto de Radiologia, Hospital das Clínicas, Faculdade de Medicina
5 resultados
Resultados de Busca
Agora exibindo 1 - 5 de 5
- 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.
conferenceObject Prospective study of biomarkers in squamous cell carcinoma of the anal canal (SCCAC) and their influence on treatment outcomes: Five-year long-term results.(2020) MONIZ, Camila Motta Venchiarutti; RIECHELMANN, Rachel Pimenta; BRAGHIROLI, Maria Ignez; RIBEIRO, Suilane Coelho; RIVELLI, Thomas Giollo; BARIANI, Giovanni M.; CHEN, Andre Tsin Chih; NAHAS, Caio; BONADIO, Renata Colombo; ORTEGA, Cinthia; FRANCO, Rejane; MEIRELES, Sibele; PEREIRA, Allan Andresson Lima; SABBAGA, Jorge; COUDRY, Renata A.; HOFF, Paulo Marcelo- Definitive chemoradiotherapy for squamous cell carcinoma of the anal canal (SCCAC) with cisplatin and capecitabine: A prospective cohort-preliminary results.(2021) DORNELLAS, Abraao; MORAES, Priscila Muniz; VICTOR, Carolina Ribeiro; BONADIO, Renata Colombo; BRAGHIROLI, Maria Ignez; CHEN, Andre Tsin Chih; ORTEGA, Cinthia; NAHAS, Caio; HOFF, Paulo Marcelo; MOTTA, Camila; MONIZ, Venchiarutti
- A Prospective Cohort Study of Biomarkers in Squamous Cell Carcinoma of the Anal Canal (SCCAC) and their Influence on Treatment Outcomes(2021) MONIZ, Camila Motta Venchiarutti; RIECHELMANN, Rachel Pimenta; OLIVEIRA, Suilane Coelho Ribeiro; BARIANI, Giovanni Mendonca; RIVELLI, Thomas Giollo; ORTEGA, Cintia; PEREIRA, Allan Andresson Lima; MEIRELES, Sibele Inacio; FRANCO, Rejane; CHEN, Andre; BONADIO, Renata Colombo; NAHAS, Caio; SABBAGA, Jorge; COUDRY, Renata Almeida; BRAGHIROLI, Maria Ignez; HOFF, Paulo MarceloBackground: Although Chemoradiation (CRT) is the curative treatment for SCCAC, many patients present primary resistance. Since it is a rare tumor, response predictors remain unknown. Methods: We performed a prospective cohort study to evaluate biomarkers associated with CRT response, progression-free survival (PFS), and overall survival (OS). The primary endpoint was response at 6 months (m). Tumor DNA and HPV were analyzed by next-generation sequencing, while KI-67 and PD-L1 by immunohistochemistry in tumor tissue. Results: Seventy-eight patients were recruited between October/2011 and December/2015, and 75 were response evaluable. The median age was 57 years, 65% (n=49) were stage III and 12% (n=9) were HIV positive (HIV+). At 6m, 62.7% (n=47) presented CR. On multivariate analyses, stage II patients were 4.7 more likely to achieve response than stage III (OR, 4.70; 95%CI, 1.36-16.30; p=0.015). HIV+ was associated with a worse response (OR, 5.72; 95%CI, 2.5-13.0; p<0.001). 5-year PFS and OS rates were 63.3% and 76.4%, respectively, with a median follow up of 66m. On multivariate analyses, older age (HR 1.06, p=0.022, 95%IC 1.01-1.11) and absence of CR at 6m (HR 3.36, p=0.007, 95%IC 1.39-8.09) were associated with inferior OS. The 5-year OS rate was 62.5% in HIV+ group compared to 78% among HIVpts, although this difference was not statistically significant (p=0.4). PIK3CA, MET and TP53 mutations, HPV, Ki-67 expression, and PD-L1 expression, were not associated with PFS and OS. Conclusions: Clinical stage III and HIV+ were associated with worse response to CRT at 6m. The absence of CR was the main factor associated with poor 5-year OS.
- A randomized, open-label, parallel-design phase III study to compare adjuvant 5-FU plus oxaliplatin (mFLOX) versus observation in locally advanced rectal cancer after neoadjuvant chemoradiation(2020) BRAGHIROLI, M. I.; MONIZ, C. M. V.; RIECHELMANN, R. S. P.; DORNELLAS, A. F. L.; CAPARELLI, F.; ALBAN, L.; ALEX, A.; BARIANI, G. M.; LEITE, L. A. Senna; RIVELLI, T. Giollo; NEBULONI, D.; ORTEGA, C.; BRAGHIROLI, O. F. M.; MOUTINHO, K.; NAHAS, S.; NAHAS, C.; COTTI, G.; SABBAGA, J.; CECONELLO, I.; HOFF, P. M.