TULIO EDUARDO FLESCH PFIFFER

Índice h a partir de 2011
9
Projetos de Pesquisa
Unidades Organizacionais
Instituto do Câncer do Estado de São Paulo, Hospital das Clínicas, Faculdade de Medicina - Médico

Filtros

Mostrar mais
Limpar filtros

Configurações

Autor: PFIFFER, Tulio Eduardo Flesch ×

Resultados de Busca

Agora exibindo 1 - 10 de 10
  • article 668 Citação(ões) na Scopus
    Ramucirumab versus placebo as second-line treatment in patients with advanced hepatocellular carcinoma following first-line therapy with sorafenib (REACH): a randomised, double-blind, multicentre, phase 3 trial
    (2015) ZHU, Andrew X.; PARK, Joon Oh; RYOO, Baek-Yeol; YEN, Chia-Jui; POON, Ronnie; PASTORELLI, Davide; BLANC, Jean-Frederic; CHUNG, Hyun Cheol; BARON, Ari D.; PFIFFER, Tulio Eduardo Flesch; OKUSAKA, Takuji; KUBACKOVA, Katerina; TROJAN, Jorg; SASTRE, Javier; CHAU, Ian; CHANG, Shao-Chun; ABADA, Paolo B.; YANG, Ling; SCHWARTZ, Jonathan D.; KUDO, Masatoshi
    Background VEGF and VEGF receptor-2-mediated angiogenesis contribute to hepatocellular carcinoma pathogenesis. Ramucirumab is a recombinant IgG1 monoclonal antibody and VEGF receptor-2 antagonist. We aimed to assess the safety and efficacy of ramucirumab in advanced hepatocellular carcinoma following first-line therapy with sorafenib. Methods In this randomised, placebo-controlled, double-blind, multicentre, phase 3 trial (REACH), patients were enrolled from 154 centres in 27 countries. Eligible patients were aged 18 years or older, had hepatocellular carcinoma with Barcelona Clinic Liver Cancer stage C disease or stage B disease that was refractory or not amenable to locoregional therapy, had Child-Pugh A liver disease, an Eastern Cooperative Oncology Group performance status of 0 or 1, had previously received sorafenib (stopped because of progression or intolerance), and had adequate haematological and biochemical parameters. Patients were randomly assigned (1:1) to receive intravenous ramucirumab (8 mg/kg) or placebo every 2 weeks, plus best supportive care, until disease progression, unacceptable toxicity, or death. Randomisation was stratified by geographic region and cause of liver disease with a stratified permuted block method. Patients, medical staff, investigators, and the funder were masked to treatment assignment. The primary endpoint was overall survival in the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01140347. Findings Between Nov 4, 2010, and April 18, 2013, 565 patients were enrolled, of whom 283 were assigned to ramucirumab and 282 were assigned to placebo. Median overall survival for the ramucirumab group was 9.2 months (95% CI 8.0-10.6) versus 7.6 months (6.0-9.3) for the placebo group (HR 0.87 [95% CI 0.72-1.05]; p=0.14). Grade 3 or greater adverse events occurring in 5% or more of patients in either treatment group were ascites (13 [5%] of 277 patients treated with ramucirumab vs 11 [4%] of 276 patients treated with placebo), hypertension (34 [12%] vs ten [4%]), asthenia (14 [5%] vs five [2%]), malignant neoplasm progression (18 [6%] vs 11 [4%]), increased aspartate aminotransferase concentration (15 [5%] vs 23 [8%]), thrombocytopenia (13 [5%] vs one [<1%]), hyperbilirubinaemia (three [1%] vs 13 [5%]), and increased blood bilirubin (five [2%] vs 14 [5%]). The most frequently reported (>= 1%) treatment-emergent serious adverse event of any grade or grade 3 or more was malignant neoplasm progression. Interpretation Second-line treatment with ramucirumab did not significantly improve survival over placebo in patients with advanced hepatocellular carcinoma. No new safety signals were noted in eligible patients and the safety profile is manageable.
  • bookPart
    Tumores neuroendócrinos do pâncreas
    (2013) HOFF, Ana Oliveira; RIECHELMANN, Rachel Simões Pimenta; PFIFFER, Tulio Eduardo Flesch
  • article
    Safety and efficacy of sorafenib in patients with Child-Pugh B advanced hepatocellular carcinoma
    (2015) FONSECA, Leonardo Gomes Da; BARROSO-SOUSA, Romualdo; BENTO, Afonso Da Silva Alves; BLANCO, Bruna Paccola; VALENTE, Gabriel Luis; PFIFFER, Tulio Eduardo Flesch; HOFF, Paulo Marcelo; SABBAGA, Jorge
    Sorafenib demonstrated a survival benefit in the treatment of advanced hepatocellular carcinoma (HCC) in phase III trials. However, almost all the patients included in those trials exhibited well-preserved liver function (Child-Pugh A). The aim of this study was to describe our experience with sorafenib in Child-Pugh B HCC patients. A database of patients with advanced HCC treated with sorafenib was retrospectively evaluated. The median overall survival of Child-Pugh B patients (n=20) was 2.53 months [95% confidence interval (CI): 0.33-5.92 months] and of Child-Pugh A patients (n=100) 9.71 months (95% CI: 6.22-13.04). Child-Pugh B patients had a significantly poorer survival compared to Child-Pugh A patients (P=0.002). The toxicities were similar between the two groups. Metastasis, vascular invasion and alpha-fetoprotein level >1,030 ng/ml were not associated with survival among Child-Pugh B patients (P=0.281, 0.189 and 0.996, respectively). Although the survival outcomes were worse in Child-Pugh B patients treated with sorafenib, the toxicity profile was manageable. Therefore, there remains the question of whether to treat this subgroup of patients and more data are required to define the role of sorafenib in the context of liver dysfunction.
  • conferenceObject
    Phase II trial of inetforrnin and paclitaxel for patients with gemcitabine-refractory advanced adenocarcinoma of the pancreas
    (2014) FERRARI, Anezlca Carvalho Rubin De Celia; PFIFFER, Tulio Eduardo Flesch; ALEX, Alexandra Khichfy; NEBULONL, Danielle R.; CARNELRO, Allyne Q.; CAPARELL, Fernanda Cunha; LEITE, Luiz Antonio Senna; BRAGHIROLI, Maria Ignez Freitas Meiro; LOBO, Juliana; HOFF, Paulo Marcelo; RIECHELMANN, Rachel Pimenta
  • article 10 Citação(ões) na Scopus
    Validation of questionnaire on the Spiritual Needs Assessment for Patients (SNAP) questionnaire in Brazilian Portuguese
    (2016) TOLOI, Diego de Araujo; UEMA, Deise; MATSUSHITA, Felipe; ANDRADE, Paulo Antonio da Silva; BRANCO, Tiago Pugliese; CHINO, Fabiana Tomie Becker de Carvalho; GUERRA, Raquel Bezerra; PFIFFER, Tulio Eduardo Flesch; CHIBA, Toshio; GUINDALINI, Rodrigo Santa Cruz; SULMASY, Daniel P.; RIECHELMANN, Rachel P.
    Objectives: Spirituality is related to the care and the quality of life of cancer patients. Thus, it is very important to assess their needs. The objective of this study was the translation and cultural adjustment of the Spiritual Needs Assessment for Patients ( SNAP) questionnaire to the Brazilian Portuguese language. Methodology: The translation and cultural adjustment of the SNAP questionnaire involved six stages: backtranslation, revision of backtranslation, translation to the original language and adjustments, pre-test on ten patients, and test and retest with 30 patients after three weeks. Adult patients, with a solid tumour and literate with a minimum of four years schooling were included. For analysis and consistency we used the calculation of the Cronbach alpha coefficient and the Pearson linear correlation. Results: The final questionnaire had some language and content adjustments compared to the original version in English. The correlation analysis of each item with the total score of the questionnaire showed coefficients above 0.99. The calculation of the Cronbach alpha coefficient was 0.9. The calculation of the Pearson linear correlation with the test and retest of the questionnaire was equal to 0.95. Conclusion: The SNAP questionnaire translated into Brazilian Portuguese is adequately reliable and consistent. This instrument allows adequate access to spiritual needs and can help patient care.
  • conferenceObject
    High-grade extrapulmonary neuroendocrine carcinomas and small cell lung cancer: Different entities, same treatment.
    (2015) REGO, Juliana Florinda De Mendonga; MEDEIROS, Raphael Salles S.; BRAGHIROLI, Maria Ignez Freitas Melro; GALVAO, Breno; BEZERRA NETO, Joao Evangelista; MUNHOZ, Rodrigo Ramella; GUERRA, Juliana Mariotti; KIMURA, Lidia; NONOGAKI, Suely; PFIFFER, Tulio Eduardo Flesch; CASTRO, Gilberto; HOFF, Paulo Marcelo; ROCHA FILHO, Duilio; COSTA, Frederico; RIECHELMANN, Rachel Pimenta
  • conferenceObject
    Low energy amplitude modulated radiofrequency electromagnetic fields in combination with standard treatment or as monotherapy to show improvement in quality of life in patients with advanced hepatocellular carcinoma.
    (2021) SOUSA, Micelange Carvalho; COSTA, Frederico; LIMA, Pablo Diego; SETOGUTE, Yone De Camargo; GUMZ, Brenda Pires; AZEVEDO, Fernanda; SABBAGA, Jorge; JARDIM, Denis Leonardo Fontes; FREITAS, Daniela; PFIFFER, Tulio Eduardo Flesch; SANTOS, Elizabeth; CASTRIA, Tiago Biachi De; HORVAT, Natally; FRANCA, Regis; TESTAGROSSA, Leonardo; IEMMA, Antonio Francisco; TUSZYNSKI, Jack
  • conferenceObject
    Evaluation of predictive biomarkers of response and prognosis in patients with high-grade extrapulmonary neuroendocrine carcinomas treated with platin-based chemotherapy.
    (2015) REGO, Juliana Florinda De Mendonga; MEDEIROS, Raphael Salles S.; BRAGHIROLI, Maria Ignez Freitas Melro; BEZERRA NETO, Joao Evangelista; MUNHOZ, Rodrigo Ramella; GUERRA, Juliana Mariotti; KIMURA, Lidia; NONOGAKI, Suely; PFIFFER, Tulio Eduardo Flesch; GALVAO, Breno; HOFF, Paulo Marcelo; ROCHA FILHO, Duilio; COSTA, Frederico; RIECHELMANN, Rachel Pimenta
  • article 41 Citação(ões) na Scopus
    Pre-treatment neutrophil-to-lymphocyte ratio affects survival in patients with advanced hepatocellular carcinoma treated with sorafenib
    (2014) FONSECA, Leonardo Gomes da; BARROSO-SOUSA, Romulado; BENTO, Afonso da Silva Alves; BLANCO, Bruna Paccola; VALENTE, Gabriel Luis; PFIFFER, Tulio Eduardo Flesch; HOFF, Paulo Marcelo; SABBAGA, Jorge
    Sorafenib is the first systemic therapy to demonstrate survival benefit in advanced hepatocellular carcinoma (HCC) in randomized controlled trials with rigorous patient selection. Neutrophil-to-lymphocyte ratio (NLR) has been shown to be associated with poor survival in various solid tumors. Our aim is to evaluate the prognostic role of NLR in HCC patients treated with sorafenib. A total of 105 advanced HCC patients treated with sorafenib were retrospectively reviewed, and relevant data from the clinical records were collected. Univariate and multivariate analysis were carried out to identify factors associated with survival. The median age of the cohort was 59.7 years, and 84.8 % were Child-Pugh class A, and 86.7 % had ECOG performance status 0 or 1. Median duration of sorafenib treatment was 100 days. Median overall survival (OS) of the entire cohort was 8.03 months. Median OSwas 5.23 months (95 % CI 2.96-7.50 months) and 10.05 months (95 % IC 2.52-18.47 months) for patients with NLR>3.5 and NLR <= 3.5, respectively (p = 0.002). Alpha-fetoprotein [1,030 ng/mL and serum albumin B3.8 g/dL were also associated with worse prognosis (p = 0.006 and p = 0.042, respectively). The subgroup of patients with high alpha-fetoprotein, low albumin and NLR>3.5 had median OS of 1.7 months, whereas the subgroup with none of these parameters had median OS of 16.5 months (p< 0.001). NLR affects survival in advanced HCC patients treated with sorafenib. Selecting HCC patients based on the laboratorial features may improve the therapeutic effectiveness of sorafenib.
  • conferenceObject
    Ramucirumab (RAM) as second-line treatment in patients (pts) with advanced hepatocellular carcinoma (HCC): Analysis of patients with elevated alpha-fetoprotein (AFP) from the randomized phase III REACH study
    (2015) ZHU, Andrew X.; RYOO, Baek-Yeol; YEN, Chia-Jui; KUDO, Masatoshi; POON, Ronnie Tung-Ping; PASTORELLI, Davide; BLANC, Jean-Frederic; CHUNG, Hyun Cheol; BARON, Ari David; PFIFFER, Tulio Eduardo Flesch; OKUSAKA, Takuji; KUBACKOVA, Katerina; TROJAN, Jorg; SASTRE, Javier; CHAU, Ian; CHANG, Shao-Chun; ABADA, Paolo; YANG, Ling; HSU, Yanzhi; PARK, Joon Oh