FERNANDA CUNHA CAPARELI
Índice h a partir de 2011
4
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico
6 resultados
Resultados de Busca
Agora exibindo 1 - 6 de 6
- 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.
- A retrospective study of chemoradiotherapy (CRT) versus chemotherapy (CT) as adjuvant treatment for localized gastric cancer (LGC)(2016) GIRARDI, D. D. M.; PEREIRA, G. C.; NEGRAO, M.; LIMA, M. A.; FELIZOLA, M. M.; FOGACE, R. N.; CAPARELI, F. C.; SABBAGA, J.; HOFF, P. M.
- 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.
- Chemoradiotherapy versus chemotherapy as adjuvant treatment for localized gastric cancer: a propensity score-matched analysis(2018) GIRARDI, Daniel M.; LIMA, Mariana A. de; PEREIRA, Gabriel C. B.; NEGRAO, Marcelo V.; LOPEZ, Rossana V. M.; CAPARELI, Fernanda C.; SABBAGA, Jorge; HOFF, Paulo Marcelo G.Background: Treatment of localized gastric cancer (LGC) consists of surgical resection followed by adjuvant treatment. Both chemoradiation (CRT) and chemotherapy (CT) regimens have shown benefit in survival outcomes versus observation. However, there are few data comparing these approaches. Methods: This study included consecutive patients with LGC treated at Instituto do Cancer do Estado de Sao Paulo (ICESP) from 2012 to 2015. CRT was based on the INT-0116 regimen and CT consisted of a platinum and fluoropyrimidine doublet. Treatment choice was based on physician preference. Toxicity was evaluated for every cycle. Overall survival (OS) analysis was performed by Kaplan-Meier. A propensity score-matched analysis was performed to minimize selection bias. Results: A total of 309 patients were evaluated, 227 in CRT group and 82 in CT group. The most prevalent grade 3/4 toxicities in CRT and CT groups were: nausea/vomiting (9.25 vs 4.9%), fatigue (9.3% vs 2.4%), mucositis (4.4% vs 1.2%), neutropenia (37.8% vs 20.9%), febrile neutropenia (3.9% vs 0%), anemia (4.3% vs 6.1%), thrombocytopenia (2.6% vs 4.9%), neuropathy (0 vs 2.4%) and hand-foot syndrome (0.4% vs 2.4%). Two grade 5 toxicities (febrile neutropenia and anemia) occurred in CRT group. There was no difference in the pattern of recurrence. After a median follow-up of 23.5 months (CRT) and 20.6 months (CT), there was no difference in OS between groups. Conclusions: CT and CRT present similar efficacy and tolerability as adjuvant treatment for LGC.
conferenceObject Clinical characteristics at diagnosis of patients who survive more than 5 years after diagnosis of metastatic colorectal cancer (mCRC).(2013) ABRAHAO, Manuel Cruz; SANTOS, Joao Paulo Velloso Medrado; PAVAN, Thayse; HOFF, Paulo M.; KATZ, Artur; SABBAGA, Jorge; AZEVEDO, Fernanda; FREITAS, Daniel; SARAGIOTTO, Daniel F.; COSTA, Frederico- Safety and Efficacy of a Modified FLOX Adjuvant Regimen for Patients With Stage III Colorectal Cancer Treated in the Community(2017) PROTASIO, Bruno Mendonca; MATUTINO, Adriana; LAGE, Liana Valente; SANTANA, Iuri; RAMOS, Ricardo; SABBAGA, Jorge; CAPARELI, Fernanda; SARAGIOTTO, Daniel; RIECHELMANN, Rachel; HOFF, Paulo M.The efficacy and safety of adjuvant modified FLOX (combination of oxaliplatin with a bolus regimen of fluorouracil) for patients with stage III colorectal cancer were analyzed retrospectively. A total of 267 patients were included, with a 74.9% rate of a 2-year disease-free survival and a Grade >= 3 toxicity rate of 36.7%. Age 70 years or older was associated with a higher risk of Grade >= 3 adverse events, suggesting that adjuvant oxaliplatin should be restricted to patients younger than 70 years. Background: The efficacy and safety of the combination of a fluoropyrimidine with oxaliplatin for patients with stage III colorectal cancer (CRC) have been evaluated in selected patients who took part in clinical trials. We evaluated the outcomes of FLOX (bolus fluorouracil [5-FU] combined with oxaliplatin) in patients with resected stage III CRC treated in the community in a large cancer center. Patients and Methods: We performed a retrospective unicenter cohort study of all consecutive stage III CRC patients who received adjuvant chemotherapy with an mFLOX (modified FLOX) regimen. The schedule consisted of 5-FU bolus 500 mg/m(2) and bolus of leucovorin 20 mg/m(2) per week for 6 consecutive weeks and oxaliplatin 85 mg/m(2) in a 2-hour infusion at weeks 1, 3, and 5, every 8 weeks. Logistic regression multivariate analyses were used to evaluate prognostic factors for relapse at 2 years, and to investigate potential predictors of Grade >= 3 toxicity. Results: A total of 267 consecutive patients were eligible and included. The median age was 59 years and pathological stage was mostly IIIB (68.2%). With a median follow-up of 24 months, n = 67 patients (25.1%) relapsed, representing a 74.9% rate of disease-free survival at 2 years. In multivariable analyses, urgent surgery (odds ratio [OR], 1.89; 95% confidence interval [CI], 1.02-3.48; P =.042), angiolymphatic invasion (OR, 1.92; 95% CI, 1.05-3.52; P =.034), and any interruption or dose reduction of chemotherapy (OR, 2.37; 95% CI, 1.31-4.27; P =.004) were predictors of recurrence or death at 2 years. Nine patients (3.4%) died from any cause within 60 days of starting mFLOX. Grade >= 3 toxicity occurred in 98 (36.7%) patients, with diarrhea (n = 43; 16.1%) and neutropenia (n = 38; 15.3%) being the most frequent ones. Peripheral neurotoxicity Grade >= 3 occurred in 5 patients (1.8%). Age 70 years or older (OR, 5.85; 95% CI, 2.5-13.66; P <=.001) was independently associated with a higher risk of a Grade >= 3 adverse events. Conclusion: Results suggest that the effectiveness of combining oxaliplatin with bolus 5-FU in patients in the community is reasonably similar to that obtained in clinical trials. However, community patients presented a higher risk of death, especially for those who were older than 70 years. Adjuvant oxaliplatin should be used carefully and probably restricted to fit patients younger than 70 years in this setting.