MARIA IGNEZ FREITAS MELRO BRAGHIROLI
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina
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conferenceObject A phase II trial of metformin and fluorouracil (MetFU) for patients (pts) with metastatic colorectal cancer (mCRC) refractory to standard treatment(2014) MIRANDA, Vanessa Costa; FARIA, Luiza Dib; BRAGHIROLI, Maria Ignez Freitas Melro; JACOBS, Monica; SABBAGA, Jorge; HOFF, Paulo Marcelo; RIECHELMANN, Rachel PimentaconferenceObject 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- A Prospective Cohort Study of Biomarkers in Squamous Cell Carcinoma of the Anal Canal (SCCAC) and their Influence on Treatment Outcomes(2021) MONIZ, C. M. V.; RIECHELMANN, R. P.; OLIVEIRA, S. C. R.; BARIANI, G. M.; RIVELLI, T. G.; ORTEGA, C.; PEREIRA, A. A. L.; MEIRELES, S. I.; FRANCO, R.; CHEN, A.; BONADIO, R. C.; NAHAS, C.; SABBAGA, J.; COUDRY, R. A.; BRAGHIROLI, M. I.; HOFF, P. M.Background: 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. © The author(s).
- Phase 2 Trial of Metformin Combined With 5-Fluorouracil in Patients With Refractory Metastatic Colorectal Cancer(2016) MIRANDA, Vanessa C.; BRAGHIROLI, Maria Ignez; FARIA, Luiza Dib; BARIANI, Giovanni; ALEX, Alexandra; BEZERRA NETO, Joao Evangelista; CAPARELI, Fernanda C.; SABBAGA, Jorge; SANTOS, Juliana Ferreira Lobo dos; HOFF, Paulo M.; RIECHELMANN, Rachel P.Effects of metformin in colorectal cancer have not been tested in clinical trials. In this phase 2 trial with 50 patients, metformin and 5-fluorouracil (5-FU) showed median progression-free survival of 2 months and overall survival of 7.9 months. However, among patients who experienced stable disease at 8 weeks, disease stabilization lasted for 5.6 months and patients survived for 16 months. Obese patients and those with longer periods off 5-FU seemed to derive more benefit. Background: Observational and preclinical studies have suggested that metformin has antitumor effects in solid tumors, including colorectal cancer (CRC). However, the effects of metformin in CRC have not been tested in clinical trials. Patients and Methods: This was a single-center, single-arm phase 2 clinical trial where histologically confirmed CRC patients with measurable and progressing metastatic disease previously treated with 5-fluorouracil (5-FU), irinotecan, oxaliplatin, and an antieepidermal growth factor receptor (if the tumor was RAS wild type) were enrolled to receive metformin 850 mg orally continuously 2 times a day plus 5-FU 425 mg/m(2) and leucovorin 50 mg intravenously weekly until disease progression, unacceptable toxicity, or withdrawal of consent. The primary end point was disease control rate at 8 weeks. Results: Among 50 patients included, 11 (22%) met the primary end point. The median progression-free survival was 1.8 months and the median overall survival 7.9 months. Analyzing only the 11 patients who experienced disease control at 8 weeks, their median progression-free survival was 5.6 months and their median overall survival was 16.2 months. There was a trend for prolonged median survival for obese patients (12.4 vs. 5.8 months) and those longer off 5-FU. The treatment was well tolerated; the main adverse effects were diarrhea, nausea, vomiting, and myelotoxicity. Conclusion: Metformin and 5-FU showed an overall modest but intriguing activity in patients with refractory CRC in this phase 2 study. Some patients experienced long-term disease control. Further trials are needed to confirm these results, particularly in obese patients with CRC.
conferenceObject Does cytotoxic chemotherapy (CT) have a role in palliative treatment of hepatocellular carcinoma (HCC)?(2018) MARTA, Guilherme Nader; FONSECA, Leonardo Gomes da; BRAGHIROLI, Maria Ignez Freitas Melro; HOFF, Paulo Marcelo; SABBAGA, Jorge- 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.
conferenceObject Young-age onset colorectal cancer: Analysis of incidence, clinical features and outcomes(2017) FUJIKI, F. K.; VICENTINI, M. F. B.; SILVA, A. C. B.; ZAMBRANO, E. M.; FONSECA, L. G.; BRAGHIROLI, M. I.; SABBAGA, J.; HOFF, P. M.article 6 Citação(ões) na Scopus Is Surgery Always Necessary in Rectal Cancer?(2014) SABBAGA, Jorge; BRAGHIROLI, Maria Ignez; HOFF, Paulo M.Rectal cancer is a major health problem around the world, representing about one-third of the total colorectal cancer cases. Because of its anatomical location, there is a higher risk of local recurrence, and treatment often requires a complex multidisciplinary approach which includes neoadjuvant radiotherapy, chemotherapy, and a radical surgical procedure that commonly leads to a permanent colostomy. The cure rate with this strategy is good, with some patients having no residual disease in the surgical specimen. While the prognosis for those Patients is excellent, their quality of life is permanently compromised. In this article, we review risks and benefits of the standard treatment approach and compare standard treatment with alternative methods aimed at rectal preservation.conferenceObject Irinotecan combined with Panitumumab or cetuximab as third-line treatment for metastatic colorectal cancer.(2022) BRAGHIROLI, Maria Ignez; VICENTINI, Maria Fernanda Batistuzzo; FONSECA, Leonardo Gomes da; SOUZA, Karla Teixeira; BONADIO, Renata Colombo; BRAGHIROLI, Oddone Freitas Melro; MATHIAS, Maria Cecilia Machado; TALANS, Aley; MENDOZA, Maria Elizabeth Zambrano; MARTINS, Juliana Goes; SABAGGA, Jorge; MONIZ, Camila Venchiarutti Motta Venchiarutti; HOFF, Paulo Marcelo- Real-world Data for High-risk Stage II Colorectal Cancer - The Role of Tumor Side in the Adjuvant Setting(2021) ARAUJO, Camila S.; MONIZ, Camila M. Venchiarutti; BONADIO, Renata C.; WATARAI, Gabriel Y.; ROJAS, Jessica; NOGUEIRA, Pedro V. S.; MARTINEZ, Jessica K.; MORAES, Priscila M. G.; I, Maria Braghiroli; SABBAGA, Jorge; HOFF, Paulo M.The impact of sidedness in the high-risk stage II colorectal cancer setting is uncertain. Although controversial, data suggest a modest benefit of adjuvant chemotherapy in this scenario. This study analyzes the overall survival and recurrence-free survival according to the tumor side and considers adjuvant chemotherapy exposure and clinical and molecular features. In this retrospective cohort, the tumor side did not influence overall survival. Background: The impact of sidedness in the high-risk stage II colorectal cancer (CRC) setting is uncertain. Although controversial, available data suggest a possible modest benefit of adjuvant chemotherapy (CT) in the adjuvant scenario. The aim of this study is to analyze the overall survival (OS) and recurrence-free survival (RFS) according to the tumor side. Patients and Methods: In this single-center retrospective cohort, we analyzed patients treated between January 2011 and December 2018. We evaluated OS and RFS of high-risk patients according to the tumor side and considering adjuvant CT exposure and clinical and molecular features. Results: A total of 1047 patients with stage II CRC were evaluated. Of these, 540 had high-risk criteria and microsatellite stability (MSS) or unknown status. One hundred fifty-seven (29%) patients had right-sided tumors, and 352 (65.2%) had left-sided tumors. Most patients received adjuvant CT, and the majority of them had T3 stage tumors, >= 12 lymph node resection, left tumor, MSS, and moderate differentiation. OS did not differ according to tumor side (5-year OS rates: 81.9% for right-sided tumors vs. 83% for left-sided tumors; hazard ratio, 0.91; 95% confidence interval, 0.55-1.53; P = .744). Adjuvant CT was associated with a superior RFS and OS, with 5-year OS rates of 87.7% versus 76.1% in the no-adjuvant group (hazard ratio, 0.46; 95% CI, 0.28-0.73; P = .001). Conclusion: The tumor side did not influence the outcomes in this study. Adjuvant CT was associated with improved RFS and OS in patients with high-risk stage II CRC, with a total gain of 11.6% in 5-year OS.