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2. Mixture survival models methodology: an application to cancer immunotherapy assessment in clinical trials

Author

Sanchez, Lizet, Lorenzo-Luaces, Patricia, Fonte, Claudia, and Lage, Agustin

Subjects
Statistics - Applications
Abstract

Progress in immunotherapy revolutionized the treatment landscape for advanced lung cancer, raising survival expectations beyond those that were historically anticipated with this disease. In the present study, we describe the methods for the adjustment of mixture parametric models of two populations for survival analysis in the presence of long survivors. A methodology is proposed in several five steps: first, it is proposed to use the multimodality test to decide the number of subpopulations to be considered in the model, second to adjust simple parametric survival models and mixture distribution models, to estimate the parameters and to select the best model fitted the data, finally, to test the hypotheses to compare the effectiveness of immunotherapies in the context of randomized clinical trials. The methodology is illustrated with data from a clinical trial that evaluates the effectiveness of the therapeutic vaccine CIMAvaxEGF vs the best supportive care for the treatment of advanced lung cancer. The mixture survival model allows estimating the presence of a subpopulation of long survivors that is 44% for vaccinated patients. The differences between the treated and control group were significant in both subpopulations (population of short-term survival: p = 0.001, the population of long-term survival: p = 0.0002). For cancer therapies, where a proportion of patients achieves long-term control of the disease, the heterogeneity of the population must be taken into account. Mixture parametric models may be more suitable to detect the effectiveness of immunotherapies compared to standard models., Comment: 24 pages, 2 figures

Published
2019

3. Identifying predictive biomarkers of CIMAvaxEGF success in advanced Lung Cancer Patients

Author

Luaces, Patricia, Sanchez, Lizet, Saavedra, Danay, Crombet, Tania, Van der Elst, Wim, Alonso, Ariel, Molenberghs, Geert, and Lage, Agustin

Subjects
Statistics - Applications
Abstract

Objectives: To identify predictive biomarkers of CIMAvaxEGF success in the treatment of Non-Small Cell Lung Cancer Patients. Methods: Data from a clinical trial evaluating the effect on survival time of CIMAvax-EGF versus best supportive care were analyzed retrospectively following the causal inference approach. Pre-treatment potential predictive biomarkers included basal serum EGF concentration, peripheral blood parameters and immunosenescence biomarkers (The proportion of CD8 + CD28- T cells, CD4+ and CD8+ T cells, CD4 CD8 ratio and CD19+ B cells. The 33 patients with complete information were included. The predictive causal information (PCI) was calculated for all possible models. The model with a minimum number of predictors, but with high prediction accuracy (PCI>0.7) was selected. Good, rare and poor responder patients were identified using the predictive probability of treatment success. Results: The mean of PCI increased from 0.486, when only one predictor is considered, to 0.98 using the multivariate approach with all predictors. The model considering the proportion of CD4+ T cell, basal EGF concentration, NLR, Monocytes, and Neutrophils as predictors were selected (PCI>0.74). Patients predicted as good responders according to the pre-treatment biomarkers values treated with CIMAvax-EGF had a significant higher observed survival compared with the control group (p=0.03). No difference was observed for bad responders. Conclusions: Peripheral blood parameters and immunosenescence biomarkers together with basal EGF concentration in serum resulted in good predictors of the CIMAvax-EGF success in advanced NSCLC. The study illustrates the application of a new methodology, based on causal inference, to evaluate multivariate pre-treatment predictors, Comment: 5 pages, 1 table, 3 figures

Published
2019

6. Supplementary Figure S1 from A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non–Small Cell Lung Cancer Patients

Author

Rodriguez, Pedro C., primary, Popa, Xitllaly, primary, Martínez, Odeth, primary, Mendoza, Silvia, primary, Santiesteban, Eduardo, primary, Crespo, Tatiana, primary, Amador, Rosa M., primary, Fleytas, Ricardo, primary, Acosta, Soraida C., primary, Otero, Yanine, primary, Romero, Gala N., primary, de la Torre, Ana, primary, Cala, Mireysi, primary, Arzuaga, Lina, primary, Vello, Loisel, primary, Reyes, Delmairis, primary, Futiel, Niurka, primary, Sabates, Teresa, primary, Catala, Mauricio, primary, Flores, Yoanna I., primary, Garcia, Beatriz, primary, Viada, Carmen, primary, Lorenzo-Luaces, Patricia, primary, Marrero, Maria A., primary, Alonso, Liuba, primary, Parra, Jenelin, primary, Aguilera, Nadia, primary, Pomares, Yaisel, primary, Sierra, Patricia, primary, Rodríguez, Gryssell, primary, Mazorra, Zaima, primary, Lage, Agustin, primary, Crombet, Tania, primary, and Neninger, Elia, primary

Published
2023
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7. Supplementary Table S2 from A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non–Small Cell Lung Cancer Patients

Author

Rodriguez, Pedro C., primary, Popa, Xitllaly, primary, Martínez, Odeth, primary, Mendoza, Silvia, primary, Santiesteban, Eduardo, primary, Crespo, Tatiana, primary, Amador, Rosa M., primary, Fleytas, Ricardo, primary, Acosta, Soraida C., primary, Otero, Yanine, primary, Romero, Gala N., primary, de la Torre, Ana, primary, Cala, Mireysi, primary, Arzuaga, Lina, primary, Vello, Loisel, primary, Reyes, Delmairis, primary, Futiel, Niurka, primary, Sabates, Teresa, primary, Catala, Mauricio, primary, Flores, Yoanna I., primary, Garcia, Beatriz, primary, Viada, Carmen, primary, Lorenzo-Luaces, Patricia, primary, Marrero, Maria A., primary, Alonso, Liuba, primary, Parra, Jenelin, primary, Aguilera, Nadia, primary, Pomares, Yaisel, primary, Sierra, Patricia, primary, Rodríguez, Gryssell, primary, Mazorra, Zaima, primary, Lage, Agustin, primary, Crombet, Tania, primary, and Neninger, Elia, primary

Published
2023
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8. Supplementary Table 3 from A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non–Small Cell Lung Cancer Patients

Author

Rodriguez, Pedro C., primary, Popa, Xitllaly, primary, Martínez, Odeth, primary, Mendoza, Silvia, primary, Santiesteban, Eduardo, primary, Crespo, Tatiana, primary, Amador, Rosa M., primary, Fleytas, Ricardo, primary, Acosta, Soraida C., primary, Otero, Yanine, primary, Romero, Gala N., primary, de la Torre, Ana, primary, Cala, Mireysi, primary, Arzuaga, Lina, primary, Vello, Loisel, primary, Reyes, Delmairis, primary, Futiel, Niurka, primary, Sabates, Teresa, primary, Catala, Mauricio, primary, Flores, Yoanna I., primary, Garcia, Beatriz, primary, Viada, Carmen, primary, Lorenzo-Luaces, Patricia, primary, Marrero, Maria A., primary, Alonso, Liuba, primary, Parra, Jenelin, primary, Aguilera, Nadia, primary, Pomares, Yaisel, primary, Sierra, Patricia, primary, Rodríguez, Gryssell, primary, Mazorra, Zaima, primary, Lage, Agustin, primary, Crombet, Tania, primary, and Neninger, Elia, primary

Published
2023
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11. Augmenting antibody response to EGF-depleting immunotherapy: Findings from a phase I trial of CIMAvax-EGF in combination with nivolumab in advanced stage NSCLC

Author

Evans, Rachel, primary, Lee, Kelvin, additional, Wallace, Paul K., additional, Reid, Mary, additional, Muhitch, Jason, additional, Dozier, Askia, additional, Mesa, Circe, additional, Luaces, Patricia L., additional, Santos-Morales, Orestes, additional, Groman, Adrienne, additional, Cedeno, Carlos, additional, Cinquino, Aileen, additional, Fisher, Daniel T., additional, Puzanov, Igor, additional, Opyrchal, Mateusz, additional, Fountzilas, Christos, additional, Dai, Tong, additional, Ernstoff, Marc, additional, Attwood, Kristopher, additional, Hutson, Alan, additional, Johnson, Candace, additional, Mazorra, Zaima, additional, Saavedra, Danay, additional, Leon, Kalet, additional, Lage, Agustin, additional, Crombet, Tania, additional, and Dy, Grace K., additional

Published
2022
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12. Association among Terminally Differentiated T Cells, Frailty, and Dependency in a Group of Cuban Centenarians

Author

Añé-Kourí, Ana Laura, primary, Ledón, Nuris, additional, Ramos, Mercedes Bárbara, additional, González, Amnely, additional, Pereira, Karla, additional, Rodríguez, Marbelys, additional, Vidal, Alejandro, additional, Rodríguez, Yamile, additional, Bicet, Yamile de la Caridad, additional, Llanez-Gregorich, Egda, additional, Lorenzo-Luaces, Patricia, additional, Suárez, Gisela María, additional, Silva, Alexa, additional, Crombet, Tania, additional, Saavedra, Danay, additional, and Lage, Agustin, additional

Published
2022
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13. Association among Terminally Differentiated T Cells, Frailty, and Dependency in a Group of Cuban Centenarians.

Author

Añé-Kourí, Ana Laura, Ledón, Nuris, Ramos, Mercedes Bárbara, González, Amnely, Pereira, Karla, Rodríguez, Marbelys, Vidal, Alejandro, Rodríguez, Yamile, Bicet, Yamile de la Caridad, Llanez-Gregorich, Egda, Lorenzo-Luaces, Patricia, Suárez, Gisela María, Silva, Alexa, Crombet, Tania, Saavedra, Danay, and Lage, Agustin

Subjects
CENTENARIANS, T cells, SUCCESSFUL aging, FRAILTY, BODY mass index, BLOOD proteins
Abstract

Introduction: Centenarians are considered a model of successful aging. Cuba exhibits one of the oldest populations in Latin America with more than two thousand centenarians. Methods: This study aimed to evaluate the immune phenotype of forty-three Cuban centenarians, their clinical characteristics such as comorbidities, frailty, body mass index, and some hemochemical parameters. Results: Centenarians had normal body mass indexes, relatively good health status, and 21.95% of them had no comorbidities; 53.6% were classified as frail, and 7% were classified as robust. In addition, 17% of centenarians were independent, and 41.46% were moderately dependent. The seroprevalence against cytomegalovirus was 100%. Concerning pro-inflammatory markers, the majority of them had very low cytokine levels and serum C-reactive protein around the normal limit. We also found the predominance of memory subsets over naive compartments in CD4+ and CD8+ T cells. Terminally differentiated CD8+CD28− T cells were higher in frail centenarians than in pre-frail, while CD8+CD57+ and CD8+EMRA T cells were higher in moderately and severely dependent individuals than in independent individuals. Severely dependent centenarians had a lower CD4+/CD8+ ratio. Conclusion: This study describes for the first time the predominance of memory subsets over naive compartments in CD4+ and CD8+ T cells, as well as its relation to frailty and/or dependency in a group of Cuban centenarians. Further studies are needed to continue understanding the natural biological aging mechanism and the relationship between terminally differentiated lymphocytes and inflammaging in the context of extreme longevity. [ABSTRACT FROM AUTHOR]

Published
2023
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14. List of Contributors

Author

Achkar, Jean-Paul, primary, Amaral, Flavio A., additional, Arnò, Caterina, additional, Boraschi, Diana, additional, Calderaro, Debora C., additional, Comi, Giancarlo, additional, Crombet, Tania, additional, Duschl, Albert, additional, Elinav, Eran, additional, Ferreira, Gilda A., additional, Fiocchi, Claudio, additional, Massó, Julio Raúl Fernández, additional, Furlan, Roberto, additional, Gironi, Maira, additional, Gresnigt, Mark S., additional, Haines, David D., additional, Italiani, Paola, additional, Lage, Agustin, additional, Levi-Schaffer, Francesca, additional, Migliorini, Paola, additional, Oliveira, Thiago H.C., additional, Penton-Arias, Eduardo, additional, Penton-Rol, Giselle, additional, Pevsner-Fischer, Meirav, additional, Puxeddu, Ilaria, additional, Rot, Chagai, additional, Sinh, Preetika, additional, Teixeira, Mauro M., additional, Töpfer, Elfi, additional, Tuganbaev, Timur, additional, and van de Veerdonk, Frank L., additional

Published
2016
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15. Thymic Polypeptide Fraction Biomodulina T Decreases Exhausted and Terminally Differentiated EMRA T Cells in Advanced Lung Cancer Patients Treated With Platinum-Based Chemotherapy

Author

Suárez, Gisela María, primary, Catalá, Mauricio, additional, Peña, Yadira, additional, Portela, Susana, additional, Añé-Kourí, Ana Laura, additional, González, Amnely, additional, Lorenzo-Luaces, Patricia, additional, Díaz, Manuel, additional, Molina, María de los A., additional, Pereira, Karla, additional, Hernández, Jenysbel de la C., additional, Ramos, Raúl, additional, Reyes, Mary Carmen, additional, Ledón, Nuris, additional, Mazorra, Zaima, additional, Crombet, Tania, additional, Lage, Agustin, additional, and Saavedra, Danay, additional

Published
2022
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17. Safety and efficacy of CIMAvax-EGF vaccine for the treatment of real-world non-small cell lung cancer patients

Author

Hernandez, Maurenis, primary, A. Ortiz, Ramon, additional, Salomon, Eva, additional, Acosta, Soraida, additional, Santiesteban, Eduardo, additional, M. Amador, Rosa, additional, C. Mendoza, Ivis, additional, P. Guerra, Pedro, additional, Robaina, Maitee, additional, Sanchez, Carlos, additional, Viada, Carmen, additional, Torres, Olga, additional, Crombet, Tania, additional, and Lage, Agustin, additional

Published
2021
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20. COVID-19 and Cancer in Cuba

Author

Rubio, Maria Caridad, primary, Sanchez, Lizet, additional, Abreu-Ruíz, Gisela, additional, Bermejo-Bencomo, Walkiria, additional, Crombet, Tania, additional, and Lage, Agustin, additional

Published
2020
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22. How Mathematical Approaches Could Help Decision-Making to Epidemic Control? The Successful Experience against COVID-19 in Cuba

Author

Sanchez, Lizet, primary, Lorenzo-Luaces, Patricia, additional, Sebrango, Carlos, additional, Torres, Antonio, additional, Fonte, Claudia, additional, Crespo, Marelis, additional, Valdes, Jose E., additional, Baldoquin, Waldemar, additional, Fonte, Paula, additional, Almeida-Cruz, Yudivián, additional, Estévez-Velarde, Suilan, additional, Piad-Morffis, Alejandro, additional, Morales, Wilfredo, additional, Pérez, Nancy, additional, Araujo, Rafael, additional, del Carmen Pria, Maria, additional, Corral, Ariadna, additional, Noriega, Vivian, additional, Vidal, Maria, additional, Lage, Agustin, additional, Guinovart, Raul, additional, and Mas, Pedro, additional

Published
2020
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24. Differential effects of two therapeutic cancer vaccines on short- and long-term survival populations among patients with advanced lung cancer

Author

SANCHEZ, Lizet, MUCHENE, Leacky, Lorenzo-Luaces, Patricia, Viada, Carmen, Rodriguez, Pedro C., Alfonso, Sailyn, Crombet, Tania, Neninger, Elia, SHKEDY, Ziv, Lage, Agustin, SANCHEZ, Lizet, MUCHENE, Leacky, Lorenzo-Luaces, Patricia, Viada, Carmen, Rodriguez, Pedro C., Alfonso, Sailyn, Crombet, Tania, Neninger, Elia, SHKEDY, Ziv, and Lage, Agustin

Subjects
long-term survival, non–small cell lung cancer, immunotherapy, survival mixture models, non-small cell lung cancer
Abstract

Background: Progress in immunotherapy has revolutionized the treatment landscape for advanced lung cancer, with emerging evidence of patients experiencing long-term survivals. The goal of this study was to explore the existence of short- and long-term survival populations and to assess the effect of immunotherapy on them. Methods: Data from two randomized, multicenter, controlled clinical trials was used to evaluate the effect of two therapeutic vaccines (anti-idiotypic vaccine VAXIRA and anti-EGF vaccine CIMAVAX) on survival curves in advanced non-small cell lung cancer patients. Data were fitted to Kaplan-Meier, standard Weibull survival, and two-component Weibull mixture models. Bayesian Information Criterion was used for model selection. Results: VAXIRA did not modify, neither the fraction of patients with long-term survivals (0.18 in the control group v 0.19 with VAXIRA, P = .88), nor the median overall survival of the patients in the short-term survival subpopulation (6.8 v 7.8 months, P = .24). However, this vaccine showed great benefit for the patients belonging to the subpopulation of patients with long-term survival (33.8 v 76.6 months, P

Published
2018

28. Abstract CT088: Final results of the Phase I study of nivolumab in combination with CIMAvax, an epidermal growth factor(EGF)-depleting immunotherapy in patients (pts) with advanced non-small cell lung cancer (NSCLC): Focus on biomarker analyses

Author

Dy, Grace K., primary, Lee, Kelvin, additional, Groman, Adrienne, additional, Cinquino, Aileen, additional, Cedeno, Carlos, additional, Minderman, Hans, additional, Hutson, Alan, additional, Wallace, Paul, additional, Johnson, Candace, additional, Mazorra, Zaima, additional, Hernandez, Danay Saavedra, additional, Leon, Kalet, additional, Lage, Agustin, additional, and Crombet, Tania, additional

Published
2019
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33. A Phase III Clinical Trial of the Epidermal Growth Factor Vaccine CIMAvax-EGF as Switch Maintenance Therapy in Advanced Non–Small Cell Lung Cancer Patients

Author

Rodriguez, Pedro C., primary, Popa, Xitllaly, additional, Martínez, Odeth, additional, Mendoza, Silvia, additional, Santiesteban, Eduardo, additional, Crespo, Tatiana, additional, Amador, Rosa M., additional, Fleytas, Ricardo, additional, Acosta, Soraida C., additional, Otero, Yanine, additional, Romero, Gala N., additional, de la Torre, Ana, additional, Cala, Mireysi, additional, Arzuaga, Lina, additional, Vello, Loisel, additional, Reyes, Delmairis, additional, Futiel, Niurka, additional, Sabates, Teresa, additional, Catala, Mauricio, additional, Flores, Yoanna I., additional, Garcia, Beatriz, additional, Viada, Carmen, additional, Lorenzo-Luaces, Patricia, additional, Marrero, Maria A., additional, Alonso, Liuba, additional, Parra, Jenelin, additional, Aguilera, Nadia, additional, Pomares, Yaisel, additional, Sierra, Patricia, additional, Rodríguez, Gryssell, additional, Mazorra, Zaima, additional, Lage, Agustin, additional, Crombet, Tania, additional, and Neninger, Elia, additional

Published
2016
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37. Trial proactive: A prospective, randomized, multicenter, open label phase III study of active specific immunotherapy with racotumomab plus best support treatment versus best support treatment in patients with advanced non-small cell lung cancer.

Author

Gomez, Roberto E, primary, Macias, Amparo, additional, Crombet, Tania, additional, Vazquez, Ana Maria, additional, Perez, Rolando, additional, Ardigo, Maria Laura, additional, and Lage, Agustin, additional

Published
2013
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38. EGF-based cancer vaccine: Optimizing predictive and surrogate biomarkers.

Author

Crombet Ramos, Tania, primary, Neninger, Elia, additional, Gonzalez, Jorge, additional, Rodriguez, Pedro Camilo, additional, Garcia, Beatriz, additional, Popa, Xitlally, additional, Mazorra, Zaima, additional, Viada, Carmen, additional, Luaces, Patricia Lorenzo, additional, Gonzalez, Gisela, additional, and Lage, Agustin, additional

Published
2013
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41. EGF-based cancer vaccine for advanced NSCLC: Results from a phase III trial.

Author

Crombet Ramos, Tania, primary, Neninger, Elia, additional, Acosta, Soraida, additional, Amador, Rosa Mari­a, additional, Mendoza, Silvia, additional, Santiesteban, Eduardo Rafael, additional, Rodriguez, Pedro Camilo, additional, Garcia, Beatriz, additional, Popa, Xitlally, additional, Mazorra, Zaima, additional, Viada, Carmen, additional, Gonzalez, Gisela, additional, and Lage, Agustin, additional

Published
2012
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44. 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

Author

Rodriguez, Pedro C, primary, Neninger, Elia, additional, García, Beatriz, additional, Popa, Xitlally, additional, Viada, Carmen, additional, Luaces, Patricia, additional, González, Gisela, additional, Lage, Agustin, additional, Montero, Enrique, additional, and Crombet, Tania, additional

Published
2011
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45. Paradigma Cognitivo en Inmunología

Author

Montero, Enrique, Lage, Agustin, Montero, Enrique, and Lage, Agustin

Abstract

La práctica de la investigación científica opera con un enfoque esencialmente reduccionista. Del estudio reciente sobre los sistemas complejos en las ciencias biológicas se evidencia las limitaciones de este enfoque. Particularmente la Inmunología luego de un período de impresionantes avances y soluciones prácticas, principalmente en la obtención de vacunas, comenzó a hacerse lenta y limitada en sus capacidades explicativa, predictiva y transformativa en el campo de las enfermedades autoinmunes y el cáncer. Incluso en su propio campo originario de las enfermedades infecciosas, la aparición de nuevas vacunas ha sido cada vez más lenta y algunas de las enfermedades más importantes tales como la Malaria, el Cólera y varias parasiíosis, se han mostrado refractarias a las vacunas. Esto obliga a una revisión de fondo de los propios postulados básicos de la Inmunología y la evaluación de la potencial contribución a la inmunoterapia del paradigma cognitivo emergente

Published
2002

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