Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 29
Filter
1.
Brasília; CONITEC; set. 2021. 678 p. (Relatório para sociedade: informações sobre recomendações de incorporação de medicamentos e outras tecnologias no SUS, 282).
Monography in Portuguese | ColecionaSUS, LILACS, ColecionaSUS | ID: biblio-1362845

ABSTRACT

Este documento é uma versão resumida do relatório técnico da Comissão Nacional de Incorporação de Tecnologias no Sistema Único de Saúde ­ Conitec e foi elaborado numa linguagem simples, de fácil compreensão, para estimular a participação da sociedade no processo de Avaliação de Tecnologias em Saúde (ATS) que antecede a incorporação, exclusão ou alteração de medicamentos, produtos e procedimentos utilizados no SUS. As recomendações da Comissão são submetidas à consulta pública pelo prazo de 20 dias. Após analisar as contribuições recebidas na consulta pública, a Conitec emite a recomendação final, que pode ser a favor ou contra a incorporação, exclusão ou alteração da tecnologia analisada. A recomendação final é, então, encaminhada ao Secretário de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde do Ministério da Saúde -SCTIE/MS, que decide sobre quais tecnologias em saúde serão disponibilizadas no SUS


Subject(s)
Humans , Pyridines/therapeutic use , Carcinoma, Renal Cell/drug therapy , Antineoplastic Agents, Immunological/therapeutic use , Nivolumab/therapeutic use , Kidney Neoplasms/drug therapy , Anilides/therapeutic use , Technology Assessment, Biomedical , Cost-Benefit Analysis , Neoplasm Metastasis
2.
Brasília; MS; jun. 2021. 681 p. ilus, tab.(Relatório de recomendação: medicamento, 661).
Monography in Portuguese | ColecionaSUS, LILACS, ColecionaSUS, BRISA | ID: biblio-1362749

ABSTRACT

Relatório técnico com Leis que estabelece que a incorporação, a exclusão ou a alteração de novos medicamentos, produtos e procedimentos, bem como a constituição ou alteração de protocolo clínico ou de diretriz terapêutica são atribuições do Ministério da Saúde (MS). A estrutura de funcionamento da Conitec é composta por Plenário e Secretaria-Executiva. A gestão e a coordenação das atividades da Conitec, bem como a emissão do relatório de recomendação sobre as tecnologias analisadas são de responsabilidade da Secretaria-Executiva ­ exercida pelo Departamento de Gestão e Incorporação de Tecnologias e Inovação em Saúde (DGITIS/SCTIE/MS).


Subject(s)
Humans , Pyridines/therapeutic use , Carcinoma, Renal Cell/drug therapy , Antineoplastic Agents, Immunological/therapeutic use , Nivolumab/therapeutic use , Kidney Neoplasms/drug therapy , Anilides/therapeutic use , Technology Assessment, Biomedical , Cost-Benefit Analysis , Neoplasm Metastasis
3.
Medicina (B.Aires) ; 81(3): 427-431, jun. 2021. graf
Article in Spanish | LILACS | ID: biblio-1346480

ABSTRACT

Resumen La migraña es un trastorno muy prevalente que afecta a alrededor del 15% de los sujetos adultos. Es clasificada por la Organización Mundial de la Saludentre los primeros puestos como causa de discapacidad. Los tratamientos preventivos habituales hasta ahora derivan de otras indicaciones y por serendipia se utilizan en prevención de migraña: betabloqueantes, drogas antiepilépticas, antidepresivos tricíclicos, bloquean tes de canales de calcio, toxina botulínica. Todas ellas han mostrado eficacia similar al 50% en reducir el número de episodios migrañosos pese a efectos secundarios indeseados. Durante los últimos años, se ha evaluado la eficacia y seguridad de los anticuerpos monoclonales (AM) que actúan sobre la vía del péptido relacionado con el gen de la calcitonina (CGRP) en migraña. Dicho péptido es relevante en la activación del dolor en territorio meníngeoy es mediado por terminales nerviosas trigeminales una vez activado el proceso migrañoso. Su dosaje en crisis migrañosas ha sido elevado en diversos estudios y su neutralización/bloqueo, redunda en alivio del dolor. Los anticuerpos monoclonales erenumab, galcanezumab, fremanezumab, eptinezumab aprobados en el mercado EE.UU./Europa desde 2018 y tras varios trabajos de Fase III y abiertos de extensión, mostraron clara seguridad yeficacia y están presentes en nuestro medio desde mediados de 2019. Desarrollamos la racionalidad e indicaciones de uso de los mismos.


Abstract Migraine is a very prevalent disorder that is estimated to affect about 10-15% of adult subjects. Ac cording to the World Health Organization migraine is one of the first causes of disability. Traditional preventive treatments discovered by serendipity include Beta blockers, antinconvulsants drugs, calcium channel blockers, tricyclic antidepressants and onabotulinum A and offer about 50% efficacy after controlled placebo trials and real life use. Because of lack of adherence and adverse events, there is a loss of beneficial sustain on these treat ments. Recently, the efficacy and safety of monoclonal antibodies (MA) that act on the peptide pathway related to the calcitonin gene (CGRP) has been evaluated in migraine, being the first specific tailored treatment on one of the multiple targets on migraine. This family of drugs: erenumab, galcanezumab, fremanezumab, eptinezumab, finished Fase III, extensions trials and many of them are in the market approved since 2018.Since 2019 are available in Argentina. We will describe the rationale for the prescription of this family of new drugs for migraine.


Subject(s)
Humans , Adult , Antineoplastic Agents, Immunological/therapeutic use , Migraine Disorders/prevention & control , Migraine Disorders/drug therapy , Argentina , Calcitonin Gene-Related Peptide Receptor Antagonists/therapeutic use , Antibodies, Monoclonal/therapeutic use
4.
Chinese Journal of Lung Cancer ; (12): 632-645, 2021.
Article in Chinese | WPRIM | ID: wpr-922238

ABSTRACT

BACKGROUND@#Lung cancer is the leading cause of cancer-related death, of which non-small cell lung cancer (NSCLC) is the most common type. Immune checkpoint inhibitors (ICIs) have now become one of the main treatments for advanced NSCLC. This paper retrospectively investigated the effect of peripheral blood inflammatory indexes on the efficacy of immunotherapy and survival of patients with advanced non-small cell lung cancer, in order to find strategies to guide immunotherapy in NSCLC.@*METHODS@#Patients with advanced non-small cell lung cancer who were hospitalized in The Affiliated Cancer Hospital of Nanjing Medical University from October 2018 to August 2019 were selected to receive anti-PD-1 (pembrolizumab, sintilimab or toripalimab) monotherapy or combination regimens. And were followed up until 10 December 2020, and the efficacy was evaluated according to RECIST1.1 criteria. Progression-free survival (PFS) and overall survival (OS) were followed up for survival analysis. A clinical prediction model was constructed to analyze the predictive value of neutrophil-to-lymphocyte ratio (NLR) based on NLR data at three different time points: before treatment, 6 weeks after treatment and 12 weeks after treatment (0w, 6w and 12w), and the accuracy of the model was verified.@*RESULTS@#173 patients were finally included, all of whom received the above treatment regimen, were followed up for a median of 19.7 months. The objective response rate (ORR) was 27.7% (48/173), the disease control rate (DCR) was 89.6% (155/173), the median PFS was 8.3 months (7.491-9.109) and the median OS was 15.5 months (14.087-16.913). The chi-square test and logistic multi-factor analysis showed that NLR6w was associated with ORR and NLR12w was associated with ORR and DCR. Further Cox regression analysis showed that NLR6w and NLR12w affected PFS and NLR0w, NLR6w and NLR12w were associated with OS.@*CONCLUSIONS@#In patients with advanced non-small cell lung cancer, NLR values at different time points are valid predictors of response to immunotherapy, and NLR <3 is often associated with a good prognosis.


Subject(s)
Aged , Antibodies, Monoclonal, Humanized/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Biomarkers/blood , Carcinoma, Non-Small-Cell Lung/pathology , Female , Humans , Immunotherapy/methods , Inflammation/blood , Leukocyte Count , Lung Neoplasms/pathology , Lymphocytes , Male , Middle Aged , Neutrophils , Predictive Value of Tests , Prognosis , Retrospective Studies , Survival Analysis , Treatment Outcome
5.
Chinese Medical Journal ; (24): 261-267, 2021.
Article in English | WPRIM | ID: wpr-921259

ABSTRACT

Antibody-drug conjugates (ADCs) combine the high specificity of monoclonal antibodies with the high anti-tumor activity of small molecular cytotoxic payloads. The anti-tumor activity of ADCs is mainly achieved by the direct blocking of the receptor by monoclonal antibodies, direct action and bystander effect of cytotoxic drugs, and antibody-dependent cell-mediated cytotoxicity and complement-dependent cytotoxicity. ADCs have been used in adjuvant therapy and rescue treatment of human epidermal receptor 2 (HER2)-positive breast cancer, greatly improving the prognosis of breast cancer patients. Several ongoing clinical trials of ADC for breast cancer and other solid tumors proved the potential of ADCs will provide more promising treatment options for patients with malignant tumors. This review introduces the mechanism and latest clinical progress of ADC drugs approved for HER2-positive breast cancer to guide clinical practice and conduct research.


Subject(s)
Antineoplastic Agents/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Breast Neoplasms/drug therapy , Female , Humans , Immunoconjugates/therapeutic use , Receptor, ErbB-2
6.
Autops. Case Rep ; 11: e2021261, 2021. tab, graf
Article in English | LILACS | ID: biblio-1285410

ABSTRACT

Immune-mediated encephalitis as an adverse event due to checkpoint inhibitors is very rare. We describe herein the case of a 38-year-old woman with metastatic triple-negative breast cancer who developed seizures and somnolence twelve days after receiving the first dose of Atezolizumab. Work up ruled out all infectious etiologies, and the patient was eventually diagnosed with immune-mediated meningoencephalitis. Symptoms recovered with a high-dose of steroids, and she was found to have an excellent response on follow-up imaging, which raised the question of whether a relationship exists between the occurrence, and severity of the adverse event and the response to treatment. Only a few other cases of atezolizumab-related encephalitis have been published. Early recognition and treatment are crucial; the reason why we are describing this case along with a review of the literature and a review on all the neurological immune-related adverse events due to the different checkpoint inhibitors.


Subject(s)
Humans , Female , Adult , Adenocarcinoma , Triple Negative Breast Neoplasms/pathology , Antineoplastic Agents, Immunological/adverse effects , Meningoencephalitis/pathology , Drug-Related Side Effects and Adverse Reactions , Immunotherapy/adverse effects , Neurologic Manifestations
7.
Rev. cuba. hematol. inmunol. hemoter ; 35(3): e1014, jul.-set. 2019. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1093280

ABSTRACT

Introducción: El rituximab, anticuerpo quimérico que reconoce la molécula CD20 humana, se ha utilizado en el tratamiento de diversos trastornos linfoproliferativos de células B. Para la selección de los potenciales beneficiarios del tratamiento con rituximab se han desarrollado técnicas que, mediante el uso de anticuerpos monoclonales, detectan la presencia del CD20 en los linfocitos de estos pacientes. Objetivo: Obtener y caracterizar un anticuerpo recombinante IgG1 de ratón específico para la molécula CD20 humana, que contenga las regiones variables del anticuerpo rituximab. Métodos: Para la expresión estable del anticuerpo recombinante se empleó la transducción lentiviral de células de embrión de riñón humano (HEK293). La caracterización inmunoquímica del anticuerpo se realizó por la técnica de Western Blot y su capacidad de reconocimiento de la molécula CD20 humana se evaluó por citometría de flujo e inmunohistoquímica. Resultados: Se obtuvo el anticuerpo 1F5 que reconoce, por citometría de flujo, la molécula CD20 en líneas celulares humanas de origen linfoide, así como en células de sangre periférica de humanos sanos y pacientes con trstornos linfoproliferativos de células B. Sin embargo, la técnica de inmunohistoquímica solo permitió detectar con este anticuerpo la molécula CD20 en tejidos frescos, no así en los embebidos en parafina. Conclusiones: Este trabajo sugiere las potencialidades del uso del anticuerpo 1F5 para las mediciones de la expresión de CD20 por citometría de flujo en pacientes con leucemias B o linfomas B avanzados en fase de leucemización. Esto complementaría los estudios para la selección apropiada de pacientes para el tratamiento con el rituximab(AU)


Introduction: Rituximab, chimeric antibody specific for human CD20 molecule, has been widely used in the treatment of several B-cell linfoproliferative disorders. For the selection of patients with the greatest potential to benefit from the therapy with rituximab, a number of techniques using monoclonal antibodies have been developed to detect the CD20 molecule. Objective: To obtain and to characterize a mouse IgG1 recombinant antibody, specific for human CD20, that contains the variable regions of rituximab. Methods: The lentiviral transduction of human embryonic kidney cells (HEK293) was used for the stable expression of the recombinant antibody. The immunochemical characterization of the antibody was performed by Western Blot and the recognition of CD20 was evaluated by immunohistochemistry and flow cytometry. Results: We generated the antibody 1F5, able to recognize by flow cytometry the CD20 molecule expressed on lymphoid human cell lines, as well as peripheral blood mononuclear cells from healthy donors and patients with B-cell lymphoproliferative disorders. However, 1F5 antibody detected the CD20 molecule on fresh tissues, but not on formalin-fixed paraffin embedded tissues,by immunohistochemistry. Conclusions: This work suggests the potential use of 1F5 antibody for the measurement of CD20 expression by flow cytometry in patients with B-cell leukemias or B-cell lymphomas in phase of leukemization. This could complement the studies to ensure the appropriate selection of patients for the treatment with rituximab(AU)


Subject(s)
Humans , Male , Female , Immunoglobulin G/analysis , Patient Selection/ethics , Rituximab/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Antibodies/therapeutic use , Antibody Formation , Blotting, Western/methods , Antigens, CD20/analysis
9.
Rev. bras. ter. intensiva ; 31(2): 258-261, abr.-jun. 2019. tab
Article in Portuguese | LILACS | ID: biblio-1013769

ABSTRACT

RESUMO A segurança e a eficácia do rituximabe em pacientes com comprometimento renal não foram estabelecidas, e o mesmo ocorre com os efeitos da hemodiálise nos níveis séricos de rituximabe. Atualmente, apenas alguns relatos de caso avaliaram o nível sérico de rituximabe antes e após a diálise. Não foram até aqui publicados dados relativos ao uso de rituximabe em pacientes sob terapia de substituição renal contínua. Os autores apresentam um caso referente a uma mulher com 59 anos de idade atendida com quadro de tetraparesia paraneoplásica. Ela foi admitida no serviço de medicina intensiva devido a hemorragia alveolar com insuficiência respiratória e lesão renal aguda, que necessitou da utilização de terapia de substituição renal contínua. Após os procedimentos diagnósticos, estabeleceu-se o diagnóstico de linfoma linfoplasmocítico. Deu-se início ao tratamento com rituximabe e ciclofosfamida. Os níveis de rituximabe foram determinados no soro e no dialisato. Não se encontrou qualquer nível de rituximabe no dialisato. A paciente faleceu após 2 meses no serviço de medicina intensiva por pneumonia nosocomial causada por Pseudomonas aeruginosa resistente a múltiplos fármacos.


ABSTRACT Rituximab safety and efficacy in patients with renal impairment have not been established, nor have the effects of hemodialysis on serum rituximab level. There are only a few published case reports assessing serum rituximab level pre- and postdialysis. No data have been published regarding the usage of rituximab in patients with continuous renal replacement therapy. The authors present a case of a 59-year-old female patient who presented with paraneoplastic tetraparesis. She was admitted to the intensive care unit due to alveolar hemorrhage with respiratory failure and acute kidney injury requiring continuous renal replacement therapy. After a diagnostic workup, the diagnosis of lymphoplasmacytic lymphoma was established. Therapy with rituximab and cyclophosphamide was started. Rituximab levels were determined in serum and dialysate. No rituximab was found in the dialysate. The patient died after 2 months in the intensive care unit from nosocomial pneumonia due to multidrug-resistant Pseudomonas aeruginosa.


Subject(s)
Humans , Female , Lymphoma, Non-Hodgkin/drug therapy , Acute Kidney Injury/therapy , Rituximab/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Continuous Renal Replacement Therapy , Lymphoma, Non-Hodgkin/complications , Fatal Outcome , Acute Kidney Injury/complications , Middle Aged
10.
Rev. méd. Chile ; 147(3): 275-280, mar. 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-1004347

ABSTRACT

Background: Waldenström macroglobulinemia (WM) is an uncommon indolent B-cell lymphoma, due to the proliferation of lymphoplasmacytic cells, and secretion of a monoclonal IgM protein. Aim: To evaluate the clinical characteristics, management and results of treatment of patients with WM at a public hospital in Chile. Patients and Methods: Review of medical records of 31 patients aged 43 to 85 years (16 males) with WM diagnosed between 2002 and 2017. Clinical features and survival were recorded. Results: All patients had bone marrow compromise, and 31%, extranodal involvement. According to the International Prognostic Score System for WM (IPSSWM) 16, 58 and 26% were at low, intermediate and high risk, respectively. Twenty-five patients (81%) were treated, 32% with plasmapheresis and 36% with rituximab. Four cases (16%) achieved complete remission. Median follow up was 35 months (range 6-159). Estimated overall survival (OS) at 5 and 10 years was 74% and 53%, respectively. According to IPSSWM, the estimated five-year OS was 80, 92 and 39%, for low, intermediate and high-risk patients, respectively. Conclusions: OS was similar to that reported abroad, except for low risk patients, probably due to the low number of cases and short follow up. An improved survival should be expected with the routine use of immunochemotherapy.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Waldenstrom Macroglobulinemia/diagnosis , Vincristine , Biopsy , Bone Marrow/pathology , Prednisone/therapeutic use , Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Chile/epidemiology , Survival Rate , Retrospective Studies , Treatment Outcome , Waldenstrom Macroglobulinemia/mortality , Waldenstrom Macroglobulinemia/drug therapy , Cyclophosphamide/therapeutic use , Rituximab/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use
11.
Chinese Journal of Lung Cancer ; (12): 118-124, 2019.
Article in Chinese | WPRIM | ID: wpr-775655

ABSTRACT

Lung cancer is the most commonly diagnosed cancer worldwide. Malignant pleural effusion (MPE) caused by advanced lung cancer seriously affect the patients' quality of life and prognosis. The management of MPE includes thoracentesis, pleurodesis, indwelling pleural catheters and drug perfusion in pleural cavity. Vascular endothelial growth factor (VEGF) and its receptor are a group of important ligands and receptors that affect angiogenesis. They are the main factors controlling angiogenesis, and they play an important role in the formation of MPE. Bevacizumab is a recombinant humanized VEGF monoclonal antibody, competitively binding to endogenous VEGF receptor. Bevacizumab can inhibit new blood vessel formation, reduce vascular permeability, prevent pleural effusion accumulation and slow the growth of cancers. This review aims to discuss the progress of bevacizumab in the treatment of MPE caused by non-small cell lung cancer (NSCLC), and explore the clinical application, efficacy, safety and future direction of bevacizumab.
.


Subject(s)
Antineoplastic Agents , Therapeutic Uses , Antineoplastic Agents, Immunological , Therapeutic Uses , Carcinoma, Non-Small-Cell Lung , Pathology , Humans , Pleural Effusion, Malignant , Drug Therapy , Pleural Neoplasms , Drug Therapy
12.
Chinese Journal of Lung Cancer ; (12): 369-379, 2019.
Article in Chinese | WPRIM | ID: wpr-775618

ABSTRACT

In recent years, research on immunotherapy has made great progress. Currently, immunotherapy has made significant breakthrough, especially programmed death 1/programmed death-ligand 1 (PD-1/PD-L1) checkpoint inhibitors (e.g, Nivolumab, Pembrolizumab, Atezolizumab, Durvalumab and Avelumab, etc.) have brought clinical benefits to patients with various pathological types of lung cancer, including squamous cell carcinoma, adenocarcinoma and small cell lung cancer. In this paper, the application value and current status of PD-1/PD-L1 checkpoint inhibitors in lung cancer were comprehensively analyzed by reviewing and interpreting representative clinical studies. Based on the results of various large-scale clinical trials results, the indications of immunotherapy in lung cancer have been continuously broadened, and the details of immunotherapy have also been constantly optimized. However, immunotherapy still faces many challenges, such as the selection of immune combination strategies, the exploration of biomarkers, the management of adverse events, the feasibility of application of driver gene mutation population and so on. In this article, we made a systematic review about the latest progress of PD-1/PD-L1 checkpoint inhibitors in lung cancer, in order to provide cutting-edge reference for the clinical workers.
.


Subject(s)
Animals , Antineoplastic Agents, Immunological , Therapeutic Uses , B7-H1 Antigen , Genetics , Allergy and Immunology , Humans , Immunotherapy , Lung Neoplasms , Drug Therapy , Genetics , Allergy and Immunology , Programmed Cell Death 1 Receptor , Genetics , Metabolism
13.
Chinese Journal of Lung Cancer ; (12): 389-394, 2019.
Article in Chinese | WPRIM | ID: wpr-775615

ABSTRACT

Lung cancer is the most common cause of cancer-related death worldwide. There are two classes of lung cancer: non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). NSCLC represents approximately 85% of all lung cancer cases. Immune checkpoint inhibitors (ICIPs) are a class of inhibitors of programmed death-1 and programmed death-ligand 1. Preclinical studies have shown that ICIPs have shown good clinical efficacy and durable response in diverse cancers. Among them, atezolizumab (MPDL3280), an anti-PD-L1 monoclonal antibody, is being investigated as a potential therapy against solid tumors and hematologic malignancies in humans. Pseudoprogression is reported as one of the unique phenomena with immune therapeutic agents. Here we report case of a person with advanced NSCLC who developed pseudoprogression after receiving immunotherapy. We hope this case could help clinicians to make appropriate decision when assessing therapeutic effects of immunotherapy.
.


Subject(s)
Antibodies, Monoclonal , Antineoplastic Agents, Immunological , Carcinoma, Non-Small-Cell Lung , Diagnostic Imaging , Drug Therapy , Humans , Immunotherapy , Lung Neoplasms , Diagnostic Imaging , Drug Therapy , Male , Middle Aged
14.
Frontiers of Medicine ; (4): 83-93, 2019.
Article in English | WPRIM | ID: wpr-771264

ABSTRACT

Colorectal cancer (CRC) is a common malignant tumor in the digestive tract, and 30%-85% of CRCs express epidermal growth factor receptors (EGFRs). Recently, treatments using cetuximab, also named C225, an anti-EGFR monoclonal antibody, for CRC have been demonstrated to cause an S492R mutation in EGFR. However, little is known about the biological function of S492R EGFR. Therefore, we attempted to elucidate its biological function in CRC cells and explore new treatment strategies for this mutant form. Our study indicated that EGFR and S492R EGFR accelerate the growth of CRC cells in vitro and in vivo and monoclonal antibody CH12, which specifically recognizes an EGFR tumor-specific epitope, can bind efficiently to S492R EGFR. Furthermore, mAb CH12 showed significantly stronger growth suppression activities and induced a more potent antibody-dependent cellular cytotoxicity effect on CRC cells bearing S492R EGFR than mAb C225. mAb CH12 obviously suppressed the growth of CRC xenografts with S492R EGFR mutations in vivo. Thus, mAb CH12 may be a promising therapeutic agent in treating patients with CRC bearing an S492R EGFR mutation.


Subject(s)
Animals , Antibodies, Monoclonal , Pharmacology , Antineoplastic Agents, Immunological , Pharmacology , Caco-2 Cells , Cell Proliferation , Colorectal Neoplasms , Therapeutics , ErbB Receptors , Genetics , Allergy and Immunology , Female , HT29 Cells , Humans , Mice , Mice, Inbred BALB C , Mutation , Xenograft Model Antitumor Assays
15.
Rev. méd. Chile ; 147(1): 9-17, 2019. tab, graf
Article in Spanish | LILACS | ID: biblio-991367

ABSTRACT

Background: Mantle cell lymphoma (MCL) has high relapse and mortality rates. There is a survival benefit when treatment is intensified with cytarabine (AraC), hematopoietic cell transplantation (HCT) and maintenance with rituximab. Aim: To assess the outcomes of patients with MCL treated in a university hospital. Material and Methods: Review of an oncology center database and medical records identifying patients with MCL treated between 2006 and 2017. Death dates were obtained from the death certificate database of the National Identification Service. We analyzed the response rate, overall survival (OS) and progression-free survival (PFS). As a secondary objective, the survival impact of AraC, HCT and maintenance with rituximab, was also analyzed. Results: Information on 20 patients aged 62 ± 11 years, followed for a median of 45 months was retrieved. Eighty-five percent were diagnosed at an advanced stage. The most used first-line regime was R-CHOP in 11 patients, followed by R-HyperCVAD in five. Only 47% achieved complete response. 4-year PFS and OS were of 30 and 77% respectively. Mantle Cell Lymphoma International Prognostic Index (MIPI) significantly predicted PFS and OS. Maintenance with rituximab or HCT was associated with better PFS (48 vs 21 months, p < 0.01). The exposure to AraC or HCT, in refractory or relapsed disease, was associated with an increase in PFS from 9 to 28 months (p = 0,02) and 4-year OS from 40 to 100% (p = 0.05). OS increased even more, from 25 to 100% in those with high-risk MIPI (p = 0.04). Conclusions: The incorporation of AraC, HCT and maintenance with rituximab in the therapeutic backbone of MCL, especially for high-risk cases, was associated with improved survival.


Subject(s)
Humans , Male , Female , Adult , Middle Aged , Aged , Aged, 80 and over , Hematopoietic Stem Cell Transplantation/methods , Lymphoma, Mantle-Cell/surgery , Lymphoma, Mantle-Cell/drug therapy , Cytarabine/therapeutic use , Rituximab/therapeutic use , Antineoplastic Agents, Immunological/therapeutic use , Antimetabolites, Antineoplastic/therapeutic use , Time Factors , Retrospective Studies , Risk Factors , Treatment Outcome , Sex Distribution , Combined Modality Therapy , Age Distribution , Statistics, Nonparametric , Lymphoma, Mantle-Cell/mortality , Kaplan-Meier Estimate , Progression-Free Survival , Neoplasm Recurrence, Local
16.
Rev. cuba. pediatr ; 90(4): e647, set.-dic. 2018. graf
Article in Spanish | LILACS, CUMED | ID: biblio-1042938

ABSTRACT

Introducción: Los tumores localizados en el tallo cerebral en los niños y adolescentes conllevan un mal pronóstico, especialmente aquellos infiltrantes y difusos. Con el tratamiento de radioterapia apenas llegan a más de 15 por ciento de supervivencia y no mejora la cifra con quimioterapia agregada. Objetivos: Estimar el efecto de la asociación del tratamiento radiante con el anticuerpo monoclonal Nimotuzumab en la supervivencia de niños y adolescentes con tumores del tallo cerebral. Método: Estudio clínico no aleatorizado, analítico, longitudinal y prospectivo. Se estudió una serie de 46 pacientes entre 2 y 18 años de edad que padecían de tumores del tallo cerebral, infiltrantes y difusos, desde enero de 2008 y en seguimiento hasta marzo de 2018. Todos se trataron con radioterapia, con dosis entre 54 y 59,8 cGrey, dosis diaria de 1,8 cGrey, y se irradiaban de lunes a viernes. Mientras duró el tratamiento radiante recibieron Nimotuzumab, en la dosis de 150 mg/m2 de superficie corporal, luego semanal con 8 dosis, y finalmente mensual durante uno o dos años. Resultados: Se alcanzó en la serie una supervivencia media de 18,4 meses, y una esperada de 42,9 por ciento a 2 años y 35,5 por ciento a 5 años, estabilizada hasta los 10 años. Conclusiones: La combinación de radioterapia y el anticuerpo monoclonal Nimotuzumab incrementa la supervivencia en niños y adolescentes con tumores del tallo cerebral y es bien tolerada, aun en periodos prolongados, e incluso en casos de recidiva(AU)


Introduction: Tumors localized in the brainstem of children and adolescents entail a bad prognosis, especially those that are intrinsic and diffuse. With radiotherapy treatment, patients barely get a 15 percent of survival, and the numbers don't improve with added chemotherapy. Objectives: To estimate the effect of the association of radiotherapy treatment with Nimotuzumab monoclonal antibody in the survival of children and adolescents with brainstem tumors. . Method: Non randomized, analytical, longitudinal and prospective clinical study that was authorized by the National Regulatory Authority. There was studied a group of 46 patients aged from 2 to 18 years that suffered from intrinsic and diffuse brainstem tumors, from January 2008 (and in follow up) to March 2018. All the patients were treated with radiotherapy, with doses among 54 and 59,8 Grey, daily doses of 1,8 Grey, and from Monday to Friday. While they were under radiotherapy treatment, they get Nimotuzumab, in doses of 150 mg/m2 of corporal surface; then weekly doses of 8 shots; and finally, monthly doses during one or two years. Results: In this group there was a survival mean of 18, 4 months, and an expected survival of 42, 9 percent for 2 years and 35, 5 percent for 5 years that can be stabilized to 10 years. Conclusions: Combination of radiotherapy and Nimotuzumab monoclal antibody can increase the survival from brainstem tumors in children and adolescents(AU)


Subject(s)
Humans , Male , Female , Brain Neoplasms/therapy , Central Nervous System Neoplasms/epidemiology , Antineoplastic Agents, Immunological/therapeutic use , Radiotherapy/methods , Longitudinal Studies , Cuba , Nervous System Neoplasms/radiotherapy
18.
Acta cir. bras ; 33(8): 690-702, Aug. 2018. tab, graf
Article in English | LILACS | ID: biblio-949376

ABSTRACT

Abstract Purpose: To evaluate the toxicity of Erbitux as well as its biosimilar APZ001 antibody (APZ001) in pre-clinical animal models including mice, rabbits and cynomolgus monkeys. Methods: We performed analysis of normal behavior activity, autonomic and non-autonomic nervous functions, nervous-muscle functions, nervous excitability and sensorimotor functions on CD-1 mice. Subsequently, we studied that effects of APZ001 and Erbitux on respiratory system, cardiovascular system and kidney in Cynomolgus monkey models and performed local tolerance experiments on New Zealand rabbits. Results: The comparisons between APZ001 and Erbitux showed no significant differences in mice autonomic nervous system, nervous muscle functions, non-autonomic nervous functions, nervous excitability and sensorimotor functions between treated and untreated group (p>0.05). APZ001 and Erbitux showed negative effect on CD-1 mice in the present of pentobarbital sodium anesthesia (p>0.05). Single administrations of high, medium or low doses of APZ001 did not lead to monkey urine volume alterations (p>0.05). In human tissues, APZ001 and Erbitux showed positive signals in endocardium, lung type II alveolar epithelial cell and surrounding vessels, but showed negative results in kidney and liver tissues. No hemolysis phenomenon and serious side-effects in vessels and muscles were observed in rabbits when administrated with APZ001 and Erbitux respectively. Conclusion: The safety comparisons between APZ001 antibody and Erbitux showed that these two antibodies showed highly similarities in mice, rabbits and cynomolgus monkey animal models in consideration of pharmaceutical effects, indicating APZ001 might be a suitable substitute for Erbitux.


Subject(s)
Humans , Animals , Male , Female , Rabbits , Rats , Biosimilar Pharmaceuticals/toxicity , Cetuximab/toxicity , Antineoplastic Agents, Immunological/toxicity , Reference Values , Time Factors , Immunohistochemistry , Cardiovascular System/drug effects , Models, Animal , Drug Evaluation, Preclinical/methods , Biosimilar Pharmaceuticals/administration & dosage , Cetuximab/administration & dosage , Antineoplastic Agents, Immunological/administration & dosage , Kidney/drug effects , Kidney Function Tests , Macaca fascicularis , Nervous System/drug effects
19.
Medicina (B.Aires) ; 78(1): 29-32, feb. 2018. tab
Article in English | LILACS | ID: biblio-894543

ABSTRACT

Hepatocellular carcinoma (HCC) is the second cause of cancer-related death in the world and is the main cause of death in cirrhotic patients. Unfortunately, the incidence of HCC has grown significantly in the last decade. Curative treatments such as surgery, liver transplantation or percutaneous ablation can only be applied in less than 30% of cases. The multikinase inhibitor sorafenib is the first line therapy for advanced HCC. Regorafenib is the standard of care for second-line patients. However, novel and more specific potent therapeutic approaches for advanced HCC are still needed. The liver constitutes a unique immunological microenvironment, although anti-tumor immunity seems to be feasible with the use of checkpoint inhibitors such as nivolumab. Efficacy may be further increased by combining checkpoint inhibitors or by applying loco-regional treatments. The success of immune checkpoint blockade has renewed interest in immunotherapy in HCC.


El hepatocarcinoma (HCC) es la segunda causa de muerte relacionada con el cáncer en el mundo y es la principal causa de muerte en pacientes cirróticos. Desafortunadamente, la incidencia de HCC ha crecido significativamente en la última década. Los tratamientos curativos como la cirugía, el trasplante de hígado o la ablación solo pueden aplicarse en menos del 30% de los casos. El sorafenib es el tratamiento de primera línea para el HCC avanzado, mientras que el regorafenib se reserva como segunda línea. Sin embargo, todavía son necesarios nuevos enfoques terapéuticos potentes y más específicos para el HCC avanzado. El hígado constituye un microambiente inmunológico único, aunque la inmunidad antitumoral parece ser factible mediante el uso de inhibidores de punto de control como nivolumab. La eficacia puede aumentarse adicionalmente combinando inhibidores de puntos de control inmunitario o aplicando tratamientos loco-regionales. En este sentido, el éxito del uso de anticuerpos monoclonales, que bloquean el control inmunitario, ha renovado el interés en la inmunoterapia para el HCC.


Subject(s)
Humans , Carcinoma, Hepatocellular/drug therapy , Antineoplastic Agents, Immunological/therapeutic use , Immunotherapy/methods , Liver Neoplasms/drug therapy , Antibodies, Monoclonal/therapeutic use , Phenylurea Compounds/therapeutic use , Pyridines/therapeutic use , Clinical Trials as Topic , Sorafenib/therapeutic use , Nivolumab/therapeutic use
20.
Frontiers of Medicine ; (4): 229-235, 2018.
Article in English | WPRIM | ID: wpr-772739

ABSTRACT

On May 23, 2017, the US Food and Drug Administration (FDA) approved a treatment for cancer patients with positive microsatellite instability-high (MSI-H) markers or mismatch repair deficient (dMMR) markers. This approach is the first approved tumor treatment using a common biomarker rather than specified tumor locations in the body. FDA previously approved Keytruda for treatment of several types of malignancies, such as metastatic melanoma, metastatic non-small-cell lung cancer, recurrent or metastatic head and neck cancer, refractory Hodgkin lymphoma, and urothelial carcinoma, all of which carry positive programmed death-1/programmed death-ligand 1 biomarkers. Therefore, indications of Keytruda significantly expanded. Several types of malignancies are disclosed by MSI-H status due to dMMR and characterized by increased neoantigen load, which elicits intense host immune response in tumor microenvironment, including portions of colorectal and gastric carcinomas. Currently, biomarker-based patient selection remains a challenge. Pathologists play important roles in evaluating histology and biomarker results and establishing detection methods. Taking gastric cancer as an example, its molecular classification is built on genome abnormalities, but it lacks acceptable clinical characteristics. Pathologists are expected to act as "genetic interpreters" or "genetic translators" and build a link between molecular subtypes with tumor histological features. Subsequently, by using their findings, oncologists will carry out targeted therapy based on molecular classification.


Subject(s)
Antibodies, Monoclonal, Humanized , Therapeutic Uses , Antineoplastic Agents, Immunological , Therapeutic Uses , Biomarkers, Tumor , Humans , Neoplasms , Drug Therapy , Precision Medicine , Programmed Cell Death 1 Receptor , Treatment Outcome , United States
SELECTION OF CITATIONS
SEARCH DETAIL