GILBERTO DE CASTRO JUNIOR
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 - Líder
LIM/24 - Laboratório de Oncologia Experimental, Hospital das Clínicas, Faculdade de Medicina - Líder
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- Afatinib versus methotrexate in older patients with second-line recurrent and/or metastatic head and neck squamous cell carcinoma: subgroup analysis of the LUX-Head & Neck 1 trial(aEuro)(2016) CLEMENT, P. M.; GAULER, T.; MACHIELS, J. P.; HADDAD, R. I.; FAYETTE, J.; LICITRA, L. F.; TAHARA, M.; COHEN, E. E. W.; CUPISSOL, D.; GRAU, J. J.; GUIGAY, J.; CAPONIGRO, F.; CASTRO JR., G. de; VIANA, L. de Souza; KEILHOLZ, U.; CAMPO, J. M. del; CONG, X. J.; EHRNROOTH, E.; VERMORKEN, J. B.In the LUX-Head & Neck 1 study, older age (a parts per thousand yen65 years) did not adversely affect the benefit in patient-reported outcomes and antitumor activity observed with afatinib over methotrexate, which was consistent with findings from the overall population. Safety in older patients was also consistent with the overall population, favoring afatinib in terms of fewer dose reductions and discontinuations.In the phase III LUX-Head & Neck 1 (LHN1) trial, afatinib significantly improved progression-free survival (PFS) versus methotrexate in recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients progressing on/after platinum-based therapy. This report evaluates afatinib efficacy and safety in prespecified subgroups of patients aged a parts per thousand yen65 and < 65 years. Patients were randomized (2:1) to 40 mg/day oral afatinib or 40 mg/m(2)/week intravenous methotrexate. PFS was the primary end point; overall survival (OS) was the key secondary end point. Other end points included: objective response rate (ORR), patient-reported outcomes, tumor shrinkage, and safety. Disease control rate (DCR) was also assessed. Of 483 randomized patients, 27% (83 afatinib; 45 methotrexate) were aged a parts per thousand yen65 years (older) and 73% (239 afatinib; 116 methotrexate) < 65 years (younger) at study entry. Similar PFS benefit with afatinib versus methotrexate was observed in older {median 2.8 versus 2.3 months, hazard ratio (HR) = 0.68 [95% confidence interval (CI) 0.45-1.03], P = 0.061} and younger patients [2.6 versus 1.6 months, HR = 0.79 (0.62-1.01), P = 0.052]. In older and younger patients, the median OS with afatinib versus methotrexate was 7.3 versus 6.4 months [HR = 0.84 (0.54-1.31)] and 6.7 versus 6.2 months [HR = 0.98 (0.76-1.28)]. ORRs with afatinib versus methotrexate were 10.8% versus 6.7% and 10.0% versus 5.2%; DCRs were 53.0% versus 37.8% and 47.7% versus 38.8% in older and younger patients, respectively. In both subgroups, the most frequent treatment-related adverse events were rash/acne (73%-77%) and diarrhea (70%-80%) with afatinib, and stomatitis (43%) and fatigue (31%-34%) with methotrexate. Fewer treatment-related discontinuations were observed with afatinib (each subgroup 7% versus 16%). A trend toward improved time to deterioration of global health status, pain, and swallowing with afatinib was observed in both subgroups. Advancing age (a parts per thousand yen65 years) did not adversely affect clinical outcomes or safety with afatinib versus methotrexate in second-line R/M HNSCC patients. NCT01345682 (ClinicalTrials.gov).
- Pembrolizumab (pembro) vs docetaxel (doce) for previously treated, PD-L1-expressing NSCLC: Updated outcomes of KEYNOTE-010(2016) HERBST, R. S.; BAAS, P.; KIM, D-W.; FELIP, E.; PEREZ-GRACIA, J. L.; HAN, J-Y.; MOLINA, J.; KIM, J-H.; ARVIS, C. Dubos; AHN, M-J. A.; MAJEM, M.; FIDLER, M. J.; CASTRO JR., G. De; GARRIDO, M.; SHENTU, Y.; LUBINIECKI, G. M.; GARON, E. B.
- The wolf in sheep's clothing: Microtomographic aspects of clinically incipient radiation-related caries(2016) MORAIS-FARIA, Karina; NEVES-SILVA, Rodrigo; LOPES, Marcio-Ajudarte; RIBEIRO, Ana-Carolina-Prado; CASTRO JR., Gilberto de; CONCEICAO-VASCONCELOS, Karina-Gondim-Moutinho da; BRANDAO, Thais-Bianca; SANTOS-SILVA, Alan-RogerBackground: Radiation-related caries (RRC) can cause rapid progression, with a high potential for dental destruction affecting mainly cervical and incisal areas. Unlike the injuries that occur in the conventional caries, incipient RRC present in unusual surfaces have difficult diagnosis and classification stages of cavitation. Material and Methods: Evaluate the radiographic patterns of demineralization of RRC by using micro-CT. Ten teeth with incipient RRC and 10 teeth with incipient conventional caries (control group) matched by anatomic teeth group and caries affected surfaces were evaluated by X-ray microtomography (micro-CT) Skyscan 1174V2 (50Kv, 1.3 megapixel, Kontich, Belgium). Teeth were placed in a standard position for micro-CT (coronal, transaxial and sagittal sections) during images acquisition. Lesions were classified according to the depth of invasion and relationship with enamel, dentin and pulp. Results: RRC samples presented deeper lesions with higher involvement of enamel and dentin. Control group presented focal and superficial lesions with lower involvement of enamel and dentin. Conclusions: Incipient RRC present aggressive microtomographic patterns of demineralization when compared to conventional caries, as indicated by deep lesions, regardless of its clinically incipient aspects.
bookPart Câncer de pulmão(2016) ROITBERG, Felipe Santa Rosa; BITTON, Rafael Caparica; CASTRO JUNIOR, Gilberto deconferenceObject Assessment of health-related quality of life (HRQoL) in KEYNOTE-010: A phase 2/3 study of pembrolizumab vs docetaxel in patients with previously treated advanced NSCLC(2016) BARLESI, F.; GARON, E.; KIM, D-W.; FELIP, E.; HAN, J-Y.; KIM, J-H.; AHN, M-J. A.; FIDLER, M. J.; GUBENS, M. A.; CASTRO, G.; SURMONT, V.; LI, Q.; DEITZ, A. C.; LUBINIECKI, G.; HERBST, R. S.- Sorafenib for the Treatment of Progressive Metastatic Medullary Thyroid Cancer: Efficacy and Safety Analysis(2016) CASTRONEVES, Luciana Audi de; NEGRAO, Marcelo Vailati; FREITAS, Ricardo Miguel Costa de; PAPADIA, Carla; LIMA JR., Jose Viana; FUKUSHIMA, Julia T.; SIMAO, Eduardo Furquim; KULCSAR, Marco Aurelio Vamondes; TAVARES, Marcos Roberto; JORGE, Alexander Augusto de Lima; CASTRO, Gilberto de; HOFF, Paulo Marcelo; HOFF, Ana OliveiraBackground: Treatment of advanced medullary thyroid carcinoma (MTC) was recently improved with the approval of vandetanib and cabozantinib. However, there is still a need to explore sequential therapy with more than one tyrosine kinase inhibitor (TKI) and to explore alternative therapies when vandetanib and cabozantinib are not available. This study reports the authors' experience with sorafenib as a treatment for advanced MTC. Methods: This is a retrospective longitudinal study of 13 patients with progressive metastatic MTC treated with sorafenib 400mg twice daily between December 2011 and January 2015. The primary endpoints were to evaluate response and progression-free survival (PFS) in patients treated with sorafenib outside a clinical trial. The secondary endpoint was an assessment of the toxicity profile. One patient was excluded because of a serious allergic skin rash one week after starting sorafenib. Results: The analysis included 12 patients with metastatic MTC (median age 48 years), 10 with sporadic and 2 with hereditary disease. The median duration of treatment was 11 months, and the median follow-up was 15.5 months. At data cutoff, 2/12 (16%) patients were still on treatment for 16 and 34 months. According to Response Evaluation Criteria in Solid Tumors analysis, 10 (83.3%) patients showed stable disease, and two (16.6%) had progression of disease; no partial response was observed. The median PFS was nine months. However, three patients with extensive and rapidly progressive disease died within three months of sorafenib treatment. The median PFS excluding these three patients was 12 months. Adverse events (AE) occurred in nine (75%) patients. The main AEs were skin toxicity, weight loss, and fatigue. Five (41.6%) patients needed dose reduction, and one patient discontinued treatment because of toxicity. Conclusions: Treatment with sorafenib in progressive metastatic MTC is well tolerated and resulted in disease control and durable clinical benefit in 75% of patients. Sorafenib treatment could be considered when vandetanib and cabozantinib are not available or after failing these drugs.
- Pembrolizumab vs docetaxel for previously treated advanced NSCLC with a PD-L1 tumor proportion score (TPS) 1%-49%; Results from KEYNOTE-010.(2016) GARON, Edward B.; HERBST, Roy S.; KIM, Dong-Wan; FELIP, Enriqueta; PEREZ-GRACIA, Jose Luis; HAN, Ji-Youn; KIM, Joo-Hang; ARVIS, Catherine Dubos; AHN, Myung-Ju; MAJEM, Margarita; FIDLER, Mary J.; GUBENS, Matthew A.; CASTRO, Gilberto; GARRIDO, Marcelo; SHENTU, Yue; IM, Ellie; LUBINIECKI, Gregory M.; BAAS, Paul
conferenceObject Pembrolizumab vs Docetaxel for Previously Treated NSCLC (KEYNOTE-010): Archival vs New Tumor Samples for PD-L1 Assessment(2016) HERBST, Roy S.; BAAS, Paul; PEREZ-GRACIA, Jose L.; FELIP, Enriqueta; KIM, Dong-Wan; HAN, Ji-Youn; MOLINA, Julian; KIM, Joo-Hang; ARVIS, Catherine Dubos; AHN, Myung-Ju; MAJEM, Margarita; FIDLER, Mary Jo; SURMONT, Veerle; CASTRO JR., Gilberto De; GARRIDO, Marcelo; SHENTU, Yue; DOLLED-FILHART, Marisa; IM, Ellie; GARON, Edward B.- p16 expression and its prognostic impact in HNSCC pts in Bel'm-Brazil.(2016) GOMES, Amanda Raquel da Silva; BARRA, Williams Fernandes; BECHARA, Millene A.; COSTA, Juliana P. N. da; CARVALHO, Maria Fernanda V. L. de; SILVA, Carlos Augusto; MAGALHAES, Jose L. L.; NASCIMENTO, Eliude R.; PACHECO, Fernando Chalu; CASTRO, Gilberto
bookPart Quimioterapia(2016) CASTRO JUNIOR, Gilberto de