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Search Results: 1 - 10 of 874 matches for " Elia Neninger Vinagera "
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CIMAvax®EGF vaccine therapy for non-small cell lung cancer: A weighted log-rank tests-based evaluation  [PDF]
Carmen Viada Gonzalez, Jean-Fran?ois Dupuy, Martha Fors López, Patricia Lorenzo Luaces, Tania Crombet-Ramos, Gisela González Marinello, Elia Neninger Vinagera, Beatriz García Verdecia
Modern Chemotherapy (MC) , 2013, DOI: 10.4236/mc.2013.23006
Abstract:

Time-to-event has become one of the primary endpoints of many clinical trials. Comparing treatments and therapies using time-to-event (or “survival”) data requires some care, since survival differences may occur either early or late in the follow-up period, depending on various factors such as the initial potency or the duration of efficacy of the drugs. In this work, we investigate the effect of the CIMAvax?EGF vaccine therapy on the survival of patients with non-small cell lung cancer, using stratified and unstratified weighted log-rank tests. Weighted log-rank tests are designed to identify early and late survival differences between treatments. Using these tests, we conclude that the vaccine is more efficient than the standard therapy among patients less than 60 years of age.

Stratified Cox Regression Analysis of Survival under CIMAvax®EGF Vaccine  [PDF]
Carmen Viada Gonzalez, Jean-Fran?ois Dupuy, Martha Fors López, Patricia Lorenzo Luaces, Camilo Rodríguez Rodríguez, Gisela González Marinello, Elia Neninger Vinagera, Beatriz García Verdecia, Bárbara Wilkinson Brito, Liana Martínez Pérez, Mayelin Troche de la Concepción, Tania Crombet-Ramos
Journal of Cancer Therapy (JCT) , 2013, DOI: 10.4236/jct.2013.48A002
Abstract:

Background: The Center of Molecular Immunology (CIM) is a center in Cuba devoted to the research, development and manufacturing of biotechnological products. CIMAvax?EGF is a vaccine for the treatment of non-small cell lung cancer patients (NSCL). Purpose: The aim of this work is to evaluate the effects of some potential prognostic factors on the overall survival of patients treated with CIMAvax?EGF vaccine, based on data collected in a phase II and a phase III clinical trials. Methods: The stratified Cox regression model is used to evaluate the effects of these prognostic factors, based on separate analysis for each trial, and on the combined data from both trials. Results: Patients with Performance status 0 or 1, with IV stage of tumor and male under 60 years obtain more benefit in terms of overall survival if they receive CIMAvax?EGF. Conclusions: Vaccinated group has a better performance if patients have a performance status 0 or 1, stage IV and age under 60 years. These prognostic factors influence overall survival in a positive way for those patients that received CIMAvax?EGF.

Safety, immunogenicity and preliminary efficacy of multiple-site vaccination with an Epidermal Growth Factor (EGF) based cancer vaccine in advanced non small cell lung cancer (NSCLC) patients
Rodriguez Pedro C,Neninger Elia,García Beatriz,Popa Xitlally
Journal of Immune Based Therapies and Vaccines , 2011, DOI: 10.1186/1476-8518-9-7
Abstract: The prognosis of patients with advanced non small cell lung (NSCLC) cancer remains dismal. Epidermal Growth Factor Receptor is over-expressed in many epithelial derived tumors and its role in the development and progression of NSCLC is widely documented. CimaVax-EGF is a therapeutic cancer vaccine composed by human recombinant Epidermal Growth Factor (EGF) conjugated to a carrier protein, P64K from Neisseria Meningitides. The vaccine is intended to induce antibodies against self EGF that would block EGF-EGFR interaction. CimaVax-EGF has been evaluated so far in more than 1000 advanced NSCLC patients, as second line therapy. Two separate studies were compared to assess the impact of high dose vaccination at multiple anatomic sites in terms of immunogenicity, safety and preliminary efficacy in stage IIIb/IV NSCLC patients. In both clinical trials, patients started vaccination 1 month after finishing first line chemotherapy. Vaccination at 4 sites with 2.4 mg of EGF (high dose) was very safe. The most frequent adverse events were grade 1 or 2 injection site reactions, fever, headache and vomiting. Patients had a trend toward higher antibody response. The percent of very good responders significantly augmented and there was a faster decrease of circulating EGF. All vaccinated patients and those classified as good responders immunized with high dose at 4 sites, had a large tendency to improved survival.
Safety and Efficacy of Racotumomab-Alum Vaccine as Second-Line Therapy for Advanced Non-Small Cell Lung Cancer  [PDF]
Eduardo Santiesteban, Leslie Perez, Sailyn Alfonso, Elia Neninger, Soraida Acosta, Yoana Flores, Maurenis Hernandez, Carmen Viada, Robin García, Meylán Cepeda, Daymys Estevez, Yoisbel Moreno, Amparo Macías
International Journal of Clinical Medicine (IJCM) , 2014, DOI: 10.4236/ijcm.2014.514113
Abstract:

Despite extensive clinical research in non-small cell lung cancer (NSCLC), overall survival is still poor. Racotumomab-alum is an anti-idiotypic cancer vaccine that targets NeuGcGM3 tumor associated ganglioside. The aim of this study was to evaluate safety and efficacy of racotumomab-alum in advanced NSCLC patients with progressive disease. This expanded access program included 86 histologically confirmed NSCLC patients, 18 years or older age, with advanced disease and without therapeutic option, with ECOG performance status ≤3, adequate organ functions and signed informed consent. The primary endpoint was overall survival and toxicity was measure assessed treatment-related toxicity according CTCAEv3. The study was approved by ethical review boards of participant institutions. Racotumomab-alum treatment consisted in 5 biweekly intradermal doses (1 mg/mL) during the induction phase of treatment (2 months). The maintenance phase consisted in monthly re-immunizations until unacceptable toxicity or PS worsening. The median overall survival time of all patients treated with racotumomab-alum was 8.96 months. The survival rates at 12 and 24 months were 42.8% and 28.0%, respectively. Patients that completed the induction phase of treatment (five doses or more) reached a median OS of 12.1 months. The most common adverse events were injection site reaction, bone pain, cough and asthenia. Racotumomab-alum cancer vaccine could be considered an effective and safe treatment option as second-line therapy for advanced NSCLC. Further clinical studies should be conducted to confirm this result.

¿Es racional y vale la pena operar hígados metastásicos: Experiencia en 20 operaciones
González Villalonga,Jesús Antonio; Neninger Vinageras,Elia; Parrilla Delgado,María; Vallejo Witoska,René;
Revista Cubana de Cirug?-a , 1996,
Abstract: an analysis was carried out on 20 operations in 17 patients that showed metastatic liver: 13 females and 7 males. sixty percent of the metastasis corresponded to colorectal cancer. the 35 % of the major resections is pointed out. there were two surgical accidents. postoperative complications occured in four operations. there was no mortality. a follow up of the 45 % of the operated patients was achieved, and also a survival of 3 to 36 months
Incidencia de infección por el virus de la hepatitis B y C
Neninger Vinageras,Elia; Velbes Marquetti,Pedro; del Castillo Carrillo,Concepción;
Revista Cubana de Medicina , 2001,
Abstract: it is known that patients with malignant tumors, treated with cytostatics, are more exposed to viral infections because of the frequent use of the parenteral route of administration. this study analyzes the frequency of hepatitis b and c in patients under treatment. three hundred and thirty six patients with different tumor locations were studied to analyze the serologic and clinical characteristics of the infested. the viral infection was screened through serologic markers umelissa hbsag and hvc. blood values of alaninoaminotransferase, aspartate aminotransferase and bilirubine. a transcutaneous hepatic biopsy was taken. it was found that 3.27 % of patients caught infection, with predominance of hepatitis b virus infection. it was known that all the patients had been surgically treated and that drug therapy lasted from 4 to 15 months. the main risk factors found were surgeries, frequent parenteral access and blood transfusions. the most evident clinical sign was hepatomegalia. the results reveal a low incidence of b and c viral infection. the importance of carrying out the screening of b and c virus in patients under drug therapy, who present with high levels of hepatic enzymes
Es racional y vale la pena operar hígados metastásicos: Experiencia en 20 operaciones
Jesús Antonio González Villalonga,Elia Neninger Vinageras,María Parrilla Delgado,René Vallejo Witoska
Revista Cubana de Cirugía , 1996,
Abstract: Se analizan los resultados de 20 operaciones en 17 pacientes que mostraron hígado metastásico, 13 del sexo femenino y 7 del masculino. El 60 % de las metástasis correspondió al cáncer colorrectal. Se se ala el 35 % de resecciones mayores. Hubo 2 accidentes quirúrgicos. En 4 operaciones se presentaron complicaciones posoperatorias. No existió mortalidad. Se pudo conseguir un seguimiento del 45 % de los operados, y se logró una sobrevida entre 3 y 36 meses An analysis was carried out on 20 operations in 17 patients that showed metastatic liver: 13 females and 7 males. Sixty percent of the metastasis corresponded to colorectal cancer. The 35 % of the major resections is pointed out. There were two surgical accidents. Postoperative complications occured in four operations. There was no mortality. A follow up of the 45 % of the operated patients was achieved, and also a survival of 3 to 36 months
Tratamiento del carcinoma de células peque as del pulmón y supervivencia a 5 a os: Survival at 5 years Treatment of small cell lung carcinoma
Elia Neninger Vinageras,Concepción del Castillo Carrillo,Carmen Viada,Rebeca Barbán Suárez
Revista Cubana de Medicina , 2008,
Abstract: Se reportaron los resultados de un estudio retrospectivo de pacientes con carcinoma de células peque as de pulmón en todos los estadios de la enfermedad, diagnosticado por citología y/o biopsia de la lesión. Métodos: Se estudiaron 68 enfermos que padecían un carcinoma de células peque as de pulmón en todos los estadios y recibieron tratamiento de primera línea con cisplatino-etopósido y de segunda línea, con ciclofosfamida, doxorubicina y vincristina. Los pacientes de enfermedad limitada fueron evaluados al final del primer ciclo para planificar el tratamiento con radiaciones; los de enfermedad extendida recibieron radiaciones sobre sitios metastáticos o para mejorar algún síntoma. Resultados: La respuesta al tratamiento fue: 25 % de respuesta objetiva (RC y RP) y 56 % de control de la enfermedad. La mediana de supervivencia global fue 10,10 meses. En el sexo femenino se observó tendencia a un incremento de la supervivencia en relación con el masculino (10,23 vs. 9,33 meses). La supervivencia en la enfermedad limitada fue de 12,5 meses y en la enfermedad extendida, de 6,57 meses lo cual fue estadísticamente significativo (p = 0,004). The results of a retrospective study of patients with small cell lung carcinoma in all the stages of the disease diagnosed by cytology and/or biopsy of the lesion were reported. Methods: 68 patients that suffered from a small cell lung carcinoma in all the stages that received first-line treatment with cisplatin-etoposide, and second line treatment with cyclophosphamide, doxorubicin and vincristine were studied. The patients with limited disease were evaluated at the end of the first cycle to plan the treatment with radiations; those with extended disease received radiations on metastic sites or to improve some symptom. Results: The response to the treatment was as follows: 25 % of objective response (CR and PR) and 56 % of control of the disease. The global mean survival was 10.10 months. Among females, it was observed a trend towards an increase of survival compared with males (10.23 vs. 9.33 months). The survival of the limited disease was 12.5 months, whereas in the extended disease it was 6.57 months, which was statistically significant (p = 0,004).
Incidencia de infección por el virus de la hepatitis B y C
Elia Neninger Vinageras,Pedro Velbes Marquetti,Concepción del Castillo Carrillo
Revista Cubana de Medicina , 2001,
Abstract: Se sabe que los pacientes con tumores malignos y tratamiento con citostáticos se encuentran expuestos a sufrir infecciones virales por el uso frecuente de la vía parenteral. En este estudio se analizó la frecuencia de la hepatitis B y C en pacientes sometidos a tratamiento. Se estudiaron 336 pacientes con diferentes localizaciones tumorales, en los que se analizaron las características serológicas y clínicas de los infestados. Se pesquisó la infección viral mediante marcadores serológicos Umelisa HbsAg y HVC. Se determinaron los valores sanguíneos de alaninoaminotransferasa, aspartatoaminotransfera y bilirrubina. Se realizó biopsia hepática percutánea. Se encontró que el 3,27 % de los pacientes contrajo la infección con predominio de infección por el virus B. Se conoció que todos los pacientes habían sido sometidos a tratamiento quirúrgico y que el tiempo de tratamiento con quimioterapia fue entre 4 y 15 meses. Se hallaron como principales factores de riesgo: las intervenciones quirúrgicas, el acceso parenteral frecuente y las transfusiones sanguíneas. El signo clínico más evidenciado fue la hepatomegalia. Los resultados muestran una baja incidencia de infección viral B y C. Se se aló la importancia de realizar el pesquisaje de virus B y C en pacientes sometidos a quimioterapia que presenten elevación de las enzimas hepáticas It is known that patients with malignant tumors, treated with cytostatics, are more exposed to viral infections because of the frequent use of the parenteral route of administration. This study analyzes the frequency of hepatitis B and C in patients under treatment. Three hundred and thirty six patients with different tumor locations were studied to analyze the serologic and clinical characteristics of the infested. The viral infection was screened through serologic markers Umelissa HbsAg and HVC. Blood values of alaninoaminotransferase, aspartate aminotransferase and bilirubine. A transcutaneous hepatic biopsy was taken. It was found that 3.27 % of patients caught infection, with predominance of hepatitis B virus infection. It was known that all the patients had been surgically treated and that drug therapy lasted from 4 to 15 months. The main risk factors found were surgeries, frequent parenteral access and blood transfusions. The most evident clinical sign was hepatomegalia. The results reveal a low incidence of B and C viral infection. The importance of carrying out the screening of B and C virus in patients under drug therapy, who present with high levels of hepatic enzymes
Modelo para la prevención y manejo del cáncer de pulmón en Cuba, 2010
Varona Pérez,Patricia; Torres Barbie,Priscila; Elejalde Larinaga,Angel René; Hernández Caballero,Eduardo Antonio; Neninger Vinageras,Elia; ,;
Revista Cubana de Higiene y Epidemiolog?-a , 2012,
Abstract: introduction: the lung cancer is a serious health problem in cuba affecting both sexes. its high incidence and mortality have a trend to increase more evident in women. its diagnosis frequently is made in the advanced stages. objectives: to standardize procedures allowing from the primary level of care a procedure organized for prevention and management of lung cancer emphasizing the persons in risk, as well as to contribute to reduce the late diagnosis of disease. methods: to construction of algorithm authors took into account the main risk factors of lung cancer and among them that of great contribution: smoking. a structured sequence of steps was organized including the implementation of "strategy" of three a (to find out, to encourage, to advice) proposed by who, suitable for our context and modified when it was applied for the first time in passive smokers. the form was submitted to validation according to the expert criteria. results: an algorithm was designed from the exploration of main risk factors of lung cancer, directed to systematize a preventive behavior of smoking, as well as the management systematics of individual in risk with the active participation of family physician and nurse over all the care process. the result of validation was satisfactory and the expert recommendations were incorporated. final considerations: to achieve the diagnosis in earlier stages of disease and of the contribution to reduction of morbility and mortality which are challenges of current cuban public health, we must to take into account the proposal of this form of prevention and appropriate management of lung cancer from the primary care level.
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