931 research outputs found

    Factores de incidencia en el consumo de alimentos con denominación de origen (DO) en México.

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    Food products with origin seals, such as Appellation of Origin (AO), have tangible and intangible characteristics that link them to both territory, and local culture; factors which may impact the consumption of AO goods. The objective of this article is to analyze the effect that sociocultural-environmental, nutritional-sensory-quality, and socioeconomic-accessibility factors have on the consumption level of AO foods in Mexico. It also aims to contribute to the understanding of changes in consumption that have occurred mainly due to exogenous and transitory factors, such as the health emergency (pandemic event). This is undertaken by applying 147 randomized surveys to consumers of AO products, whose information was analyzed using statistical tools and regression models. Results suggested that the socioeconomic factor, related to price and physical access to AO products, is the main incidence factor affecting level of consumption, followed by the perception of quality and safety that these foods have. Likewise, changes in level of income, and mobility restrictions derived from the health emergency, have also decreased the level of consumption of these goods.Los bienes alimenticios con sellos de procedencia como la Denominación de Origen (DO), poseen características tangibles e intangibles que les vinculan al territorio y a la cultura local; elementos que pueden influir en el consumo de estos bienes. El objetivo de este artículo es analizar el efecto que determinados factores pertenecientes a las categorías sociocultural-ambiental, nutricional-sensorial-calidad, y socioeconómico-accesibilidad, tienen sobre el consumo de alimentos con DO en México, así como abonar a entender los cambios que en este nivel consumo se han dado debido a factores exógenos y transitorios como la emergencia sanitaria (pandemia). Lo anterior, a través de la aplicación de 147 encuestas aleatorias a consumidores de productos con DO, cuya información fue analizada a través de herramientas estadísticas y modelos de regresión. Los resultados sugieren que el factor socioeconómico, relacionado con el precio y el acceso físico a estos productos se coloca como el principal factor de incidencia en el nivel de consumo, seguido de la percepción de la calidad e inocuidad que sobre estos alimentos se tiene. Asimismo, los cambios en el nivel de ingresos, y las restricciones de movilidad derivadas de la emergencia sanitaria han también disminuido el nivel de consumo de estos bienes

    Sustentabilidad en las Denominaciones de Origen Protegidas (DOP) en la Unión Europea. Aproximaciones desde una revisión sistemática de la literatura

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    Protected Designations of Origin (PDO) safeguard and recognize food products with specific qualities resulting from their origins. This topic has been of recent interest to academics. Nonetheless, research that addresses sustainability in PDOs is still scarce. Thus, this paper aimed to identify the way the link between PDO and sustainability topic has been approached in recent research, especially on geographical spaces with a great history of use and exploitation of PDO figures, such as the European Union (EU). A systematic literature review methodology was selected by applying the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) methodology, and by using Scopus, WoS, and Science Direct database between 2005 and 2021. From this screening process, 41 eligible studies were selected, and a qualitative and quantitative analysis was performed on the selected sample to address the following elements: (1) timeline growth on the field of knowledge; (2) food type product analyzed in the research; (3) research’s geographical location; (4) methodologies used, and (5) sustainability term’s combinations and its link to food type product. The results showed that sustainability in PDO’s research in the EU has experienced an upwards trend and is mostly carried out in those countries with the highest volume of PDOs registration, focusing mainly on dairy and oil products. Most of them applied mixed methodologies to assess an interdisciplinary sustainability perspective from its social, economic, and environmental dimension, being sustainable production systems the most common term used in the research.Las denominaciones de origen protegidas (DOP) salvaguardan y reconocen los productos alimenticios con cualidades específicas derivadas de su origen. Este tema ha sido de reciente interés para los académicos; no obstante, la investigación que aborda la sostenibilidad en las DOP es aún escasa. Por tanto, este trabajo tuvo como objetivo identificar la forma en que se ha abordado el vínculo entre DOP y sostenibilidad en investigaciones recientes, especialmente en espacios geográficos con una gran trayectoria en el uso y explotación de DOP, como la Unión Europea (UE). Se seleccionó una metodología de revisión sistemática de la literatura aplicando la metodología Preferred reporting items for systematic reviews and meta-analyzes (PRISMA) y se utilizó la base de datos de Scopus, WoS y Science Direct entre 2005 y 2021. De este proceso de selección, se escogieron 41 estudios elegibles y se realizó un análisis cualitativo y cuantitativo de la muestra para abordar los siguientes elementos: (1) tendencia temporal en el campo del conocimiento; (2) tipo de producto alimenticio analizado en la investigación; (3) ubicación geográfica de la investigación; (4) metodologías utilizadas; y (5) combinaciones de términos de sostenibilidad y su vínculo con el tipo de producto alimenticio. Los resultados mostraron que la investigación de la sostenibilidad en DOP en la UE presenta una tendencia creciente, y se lleva a cabo principalmente en aquellos países con el mayor volumen de registro de DOP, centrándose en productos lácteos y aceite, y aplicando metodologías mixtas para evaluar desde una perspectiva interdisciplinaria la dimensión social, económica y ambiental de la sostenibilidad, siendo los sistemas de producción sostenibles, el término más utilizado en la investigación

    Alternativas de organización económica para el desarrollo de productores rurales. Ejemplo práctico del municipio de Tecozautla, Hidalgo, 1994-2011

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    99 páginas. Maestría en Economía.El presenten trabajo, tiene como un primer objetivo la identificación de las instituciones y organismos de apoyo al sector productivo rural (capítulo primero), así como definir y proponer a la organización económica rural [acción y ente], como una alternativa de desarrollo para los productores rurales (capítulo segundo). Así mismo ejemplificar lo anterior con el análisis del sector productivo rural del municipio de Tecozautla, Hidalgo en el periodo de 1994 a 2011(capítulo tercero). Buscaremos definir a la organización, como acción colectiva de asociación y como ente, como una alternativa de desarrollo exitosa para productores del medio rural si se considera la estructura institucional y organismos de apoyo al medio rural adecuado a las necesidades de dichos agentes, definiendo y seleccionando la alternativa de organización económica rural más adecuada con base en las necesidades de los productores. Así mismo, esta organización para el productor rural constituirá una alternativa de mejora rural si, cuando la propuesta de organización se realice en una localidad, esta ha sido previamente analizada en lo general y en lo particular. Lo anterior con el fin de que la propuesta teórica mostrada en el presente trabajo [y potencialmente práctica] converja lo más posible con la compleja realidad agropecuaria.Consejo Nacional de Ciencia y Tecnología (México)

    Parques públicos de bolsillo en la Ciudad de México ¿alternativas sostenibles para el rescate de espacios urbanos vacíos?

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    Las recientes estrategias de ordenamiento urbano han dejado en el olvido elementos como la movilidad, el óptimo aprovechamiento de espacios y la sostenibilidad de las ciudades. En ciudades como la Ciudad de México, los “vacíos urbanos” son espacios públicos en desuso y residuales que tienden a deteriorar el estado general de bienestar en las localidades. La búsqueda de la sostenibilidad urbana da paso a estrategias de rescate para los espacios que, en franco abandono, existen dentro del espacio público. Dentro de las alternativas de rescate de espacios públicos están los Parques Públicos de Bolsillo, los cuales son iniciativas de transformación de estos espacios urbanos vacíos en zonas verdes para el mejoramiento visual y el desarrollo ambiental y social de la comunidad. Estas iniciativas pueden ser consideradas sostenibles debido al equilibrio entre los costos económicos de la implementación de los Parques Públicos de Bolsillo sus potenciales impactos sociales, y estímulos de acción colectiva, y sus virtuales beneficios ambientales. Con base en lo anterior es que el objetivo del presente artículo es identificar a los Parques Públicos de Bolsillo como alternativas de intervención urbana para la regeneración de la imagen del espacio público y establecer la pertinencia de estas iniciativas en la búsqueda de la sostenibilidad del espacio público

    Smart specialization for building up a regional innovation agenda: the case of San Luis Potosí, Mexico

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    The state of San Luis Potosí (SLP) is divided into four regions: “Altiplano, Centro, Huasteca and Media”. A large socioeconomic inequality is perceived among the regions, this is especially observed when comparing Centro with the other regions, mainly because Centro region shows greater economic dynamism and has a great amount of companies, educational institutions and research centers, which contributes to lower its socioeconomic lag. In order to reduce the social inequality and the economic development gap of SLP, a project for the construction of innovation agendas with a regional focus was formulated applying RIS3 methodology.Therefore, this article has as its main objective, to present and analyze the results of this project, through the identification of regional economic potential and their areas of smart specialization, as well as international technological trends in those areas. As an important component, a governance mechanism was organized in the four regions used to build consensus and legitimate the RIS3 process. In the framework of triple- helix participatory workshops, a portfolio of priority innovation projects was defined. This article offers an analysis of favorable factors and obstacles faced during the process; a series of recommendations for the promotion of regional innovation agendas (RIA) plus brief conclusions

    Gobernanza y factores críticos para la ejecución de estrategias de especialización inteligente en países en desarrollo. El caso del estado de México, México

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    Smart specialization strategies (RIS3) have been implemented in the State of Mexico, one of the most important regions in Mexico, this framework was used to create state innovation agendas (SIA). Therefore, the main objective of this document is to analyze the experience of a project using the RIS3 methodology to build up an SIA as the basis to structuring a regional innovation system (RIS). We conclude that RIS3 in lagging countries face difficulties to be successful, especially if in the region there is a weak governance structure, an adverse institutional framework, and a lack of funding for innovation activitiesLa estrategia de especialización inteligente ha sido implementada en uno de los estados más importantes del país, el Estado de México, este marco analítico fue usado para crear agendas estatales de innovación (AEI). Por lo tanto, el objetivo de este documento es analizar la experiencia de un proyecto que utilizó la metodología RIS3 para construir una AEI como base para estructurar un sistema regional de innovación. Concluimos que la RIS3 en países en desarrollo enfrenta dificultades para ser exitosa especialmente si en la región hay una débil estructura de gobernanza, adversos ambientes institucionales y se carece de financiamiento para innovació

    Governance and Critical Factors to Implement Smart Specialization Strategies in Developing Countries. The Case of the State of Mexico, Mexico

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    Smart specialization strategies (RIS3) have been implemented in the State of Mexico, one of the most important regions in Mexico; this framework was used to create state innovation agendas (SIA). Therefore, the main objective of this document is to analyze the experience of a project using the RIS3 methodology to build up an SIA as the basis to structuring a regional innovation system (RIS). We conclude that RIS3 in lagging countries face difficulties to be successful, especially if in the region there is a weak governance structure, an adverse institutional framework, and a lack of funding for innovation activities.

    Characterization of protons accelerated from a 3 TW table-top laser system

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    [EN] We report on benchmark tests of a 3 TW/50 fs, table-top laser system specifically developed for proton acceleration with an intrinsic pump rate up to 100 Hz. In two series of single-shot measurements differing in pulse energy and contrast the successful operation of the diode pumped laser is demonstrated. Protons have been accelerated up to 1.6 MeV in interactions of laser pulses focused on aluminium and mylar foils between 0.8 and 25 mu m thickness. Their spectral distributions and maximum energies are consistent with former experiments under similar conditions. These results show the suitability of our system and provide a reference for studies of laser targets at high repetition rate and possible applications.This project has been funded by Centro para el Desarrollo Tecnologico Industrial (CDTI, Spain) within the INNPRONTA program, grant no. IPT-20111027, by EUROSTARS project E9113, and by the Spanish Ministry for Economy and Competitiveness within the Retos-Colaboracion 2015 initiative, ref. RTC-2015-3278-1.Bellido-Millán, PJ.; Lera, R.; Seimetz, M.; Ruiz-De La Cruz, A.; Torres Peiró, S.; Galán, M.; Mur, P.... (2017). Characterization of protons accelerated from a 3 TW table-top laser system. Journal of Instrumentation. 12:1-12. https://doi.org/10.1088/1748-0221/12/05/T05001S11212Daido, H., Nishiuchi, M., & Pirozhkov, A. S. (2012). Review of laser-driven ion sources and their applications. Reports on Progress in Physics, 75(5), 056401. doi:10.1088/0034-4885/75/5/056401Macchi, A., Borghesi, M., & Passoni, M. (2013). Ion acceleration by superintense laser-plasma interaction. Reviews of Modern Physics, 85(2), 751-793. doi:10.1103/revmodphys.85.751Ledingham, K., Bolton, P., Shikazono, N., & Ma, C.-M. (2014). Towards Laser Driven Hadron Cancer Radiotherapy: A Review of Progress. Applied Sciences, 4(3), 402-443. doi:10.3390/app4030402Kraft, S. D., Richter, C., Zeil, K., Baumann, M., Beyreuther, E., Bock, S., … Pawelke, J. (2010). Dose-dependent biological damage of tumour cells by laser-accelerated proton beams. New Journal of Physics, 12(8), 085003. doi:10.1088/1367-2630/12/8/085003Yogo, A., Sato, K., Nishikino, M., Mori, M., Teshima, T., Numasaki, H., … Daido, H. (2009). Application of laser-accelerated protons to the demonstration of DNA double-strand breaks in human cancer cells. Applied Physics Letters, 94(18), 181502. doi:10.1063/1.3126452Fritzler, S., Malka, V., Grillon, G., Rousseau, J. P., Burgy, F., Lefebvre, E., … Ledingham, K. W. D. (2003). Proton beams generated with high-intensity lasers: Applications to medical isotope production. Applied Physics Letters, 83(15), 3039-3041. doi:10.1063/1.1616661Kishimura, H., Morishita, H., Okano, Y. H., Okano, Y., Hironaka, Y., Kondo, K., … Nemoto, K. (2004). Enhanced generation of fast protons from a polymer-coated metal foil by a femtosecond intense laser field. Applied Physics Letters, 85(14), 2736-2738. doi:10.1063/1.1803915Nakamura, S., Iwashita, Y., Noda, A., Shirai, T., Tongu, H., Fukumi, A., … Wada, Y. (2006). Real-Time Optimization of Proton Production by Intense Short-Pulse Laser with Time-of-Flight Measurement. Japanese Journal of Applied Physics, 45(No. 34), L913-L916. doi:10.1143/jjap.45.l913Nishiuchi, M., Fukumi, A., Daido, H., Li, Z., Sagisaka, A., Ogura, K., … Nakamura, S. (2006). The laser proton acceleration in the strong charge separation regime. Physics Letters A, 357(4-5), 339-344. doi:10.1016/j.physleta.2006.04.053Yogo, A., Daido, H., Fukumi, A., Li, Z., Ogura, K., Sagisaka, A., … Itoh, A. (2007). Laser prepulse dependency of proton-energy distributions in ultraintense laser-foil interactions with an online time-of-flight technique. Physics of Plasmas, 14(4), 043104. doi:10.1063/1.2721066Robinson, A. P. L., Foster, P., Adams, D., Carroll, D. C., Dromey, B., Hawkes, S., … Neely, D. (2009). Spectral modification of laser-accelerated proton beams by self-generated magnetic fields. New Journal of Physics, 11(8), 083018. doi:10.1088/1367-2630/11/8/083018Nemoto, K., Maksimchuk, A., Banerjee, S., Flippo, K., Mourou, G., Umstadter, D., & Bychenkov, V. Y. (2001). Laser-triggered ion acceleration and table top isotope production. Applied Physics Letters, 78(5), 595-597. doi:10.1063/1.1343845Lee, K., Park, S. H., Cha, Y.-H., Lee, J. Y., Lee, Y. W., Yea, K.-H., & Jeong, Y. U. (2008). Generation of intense proton beams from plastic targets irradiated by an ultraintense laser pulse. Physical Review E, 78(5). doi:10.1103/physreve.78.056403Yogo, A., Daido, H., Bulanov, S. V., Nemoto, K., Oishi, Y., Nayuki, T., … Tajima, T. (2008). Laser ion acceleration via control of the near-critical density target. Physical Review E, 77(1). doi:10.1103/physreve.77.016401Lee, K., Lee, J. Y., Park, S. H., Cha, Y.-H., Lee, Y. W., Kim, K. N., & Jeong, Y. U. (2011). Dominant front-side acceleration of energetic proton beams from plastic targets irradiated by an ultraintense laser pulse. Physics of Plasmas, 18(1), 013101. doi:10.1063/1.3496058OKIHARA, S., SENTOKU, Y., SUEDA, K., SHIMIZU, S., SATO, F., MIYANAGA, N., … SAKABE, S. (2002). Energetic Proton Generation in a Thin Plastic Foil Irradiated by Intense Femtosecond Lasers. Journal of Nuclear Science and Technology, 39(1), 1-5. doi:10.1080/18811248.2002.9715150McKenna, P., Ledingham, K. W. D., Spencer, I., McCany, T., Singhal, R. P., Ziener, C., … Clark, E. L. (2002). Characterization of multiterawatt laser-solid interactions for proton acceleration. Review of Scientific Instruments, 73(12), 4176-4184. doi:10.1063/1.1516855Spencer, I., Ledingham, K. W. D., McKenna, P., McCanny, T., Singhal, R. P., Foster, P. S., … Davies, J. R. (2003). Experimental study of proton emission from 60-fs, 200-mJ high-repetition-rate tabletop-laser pulses interacting with solid targets. Physical Review E, 67(4). doi:10.1103/physreve.67.046402Kaluza, M., Schreiber, J., Santala, M. I. K., Tsakiris, G. D., Eidmann, K., Meyer-ter-Vehn, J., & Witte, K. J. (2004). Influence of the Laser Prepulse on Proton Acceleration in Thin-Foil Experiments. Physical Review Letters, 93(4). doi:10.1103/physrevlett.93.045003Ceccotti, T., Lévy, A., Popescu, H., Réau, F., D’Oliveira, P., Monot, P., … Martin, P. (2007). Proton Acceleration with High-Intensity Ultrahigh-Contrast Laser Pulses. Physical Review Letters, 99(18). doi:10.1103/physrevlett.99.185002Neely, D., Foster, P., Robinson, A., Lindau, F., Lundh, O., Persson, A., … McKenna, P. (2006). Enhanced proton beams from ultrathin targets driven by high contrast laser pulses. Applied Physics Letters, 89(2), 021502. doi:10.1063/1.2220011Steinke, S., Henig, A., Schnürer, M., Sokollik, T., Nickles, P. V., Jung, D., … Habs, D. (2010). Efficient ion acceleration by collective laser-driven electron dynamics with ultra-thin foil targets. Laser and Particle Beams, 28(1), 215-221. doi:10.1017/s0263034610000157Strickland, D., & Mourou, G. (1985). Compression of amplified chirped optical pulses. Optics Communications, 56(3), 219-221. doi:10.1016/0030-4018(85)90120-8Yogo, A., Kondo, K., Mori, M., Kiriyama, H., Ogura, K., Shimomura, T., … Bolton, P. R. (2014). Insertable pulse cleaning module with a saturable absorber pair and a compensating amplifier for high-intensity ultrashort-pulse lasers. Optics Express, 22(2), 2060. doi:10.1364/oe.22.002060Trisorio, A., Grabielle, S., Divall, M., Forget, N., & Hauri, C. P. (2012). Self-referenced spectral interferometry for ultrashort infrared pulse characterization. Optics Letters, 37(14), 2892. doi:10.1364/ol.37.002892Seimetz, M., Bellido, P., Soriano, A., Garcia Lopez, J., Jimenez-Ramos, M. C., Fernandez, B., … Benlloch, J. M. (2015). Calibration and Performance Tests of Detectors for Laser-Accelerated Protons. IEEE Transactions on Nuclear Science, 62(6), 3216-3224. doi:10.1109/tns.2015.2480682Nürnberg, F., Schollmeier, M., Brambrink, E., Blažević, A., Carroll, D. C., Flippo, K., … Roth, M. (2009). Radiochromic film imaging spectroscopy of laser-accelerated proton beams. Review of Scientific Instruments, 80(3), 033301. doi:10.1063/1.3086424Oishi, Y., Nayuki, T., Fujii, T., Takizawa, Y., Wang, X., Yamazaki, T., … Andreev, A. A. (2005). Dependence on laser intensity and pulse duration in proton acceleration by irradiation of ultrashort laser pulses on a Cu foil target. Physics of Plasmas, 12(7), 073102. doi:10.1063/1.1943436Nishiuchi, M., Daito, I., Ikegami, M., Daido, H., Mori, M., Orimo, S., … Yoshiyuki, T. (2009). Focusing and spectral enhancement of a repetition-rated, laser-driven, divergent multi-MeV proton beam using permanent quadrupole magnets. Applied Physics Letters, 94(6), 061107. doi:10.1063/1.3078291Antici, P., Fuchs, J., d’ Humières, E., Lefebvre, E., Borghesi, M., Brambrink, E., … Pépin, H. (2007). Energetic protons generated by ultrahigh contrast laser pulses interacting with ultrathin targets. Physics of Plasmas, 14(3), 030701. doi:10.1063/1.2480610Green, J. S., Carroll, D. C., Brenner, C., Dromey, B., Foster, P. S., Kar, S., … Zepf, M. (2010). Enhanced proton flux in the MeV range by defocused laser irradiation. New Journal of Physics, 12(8), 085012. doi:10.1088/1367-2630/12/8/085012Zeil, K., Kraft, S. D., Bock, S., Bussmann, M., Cowan, T. E., Kluge, T., … Schramm, U. (2010). The scaling of proton energies in ultrashort pulse laser plasma acceleration. New Journal of Physics, 12(4), 045015. doi:10.1088/1367-2630/12/4/045015Nishiuchi, M., Daido, H., Yogo, A., Orimo, S., Ogura, K., Ma, J., … Azuma, H. (2008). Efficient production of a collimated MeV proton beam from a polyimide target driven by an intense femtosecond laser pulse. Physics of Plasmas, 15(5), 053104. doi:10.1063/1.2928161Macchi, A., Sgattoni, A., Sinigardi, S., Borghesi, M., & Passoni, M. (2013). Advanced strategies for ion acceleration using high-power lasers. Plasma Physics and Controlled Fusion, 55(12), 124020. doi:10.1088/0741-3335/55/12/124020Fuchs, J., Antici, P., d’ Humières, E., Lefebvre, E., Borghesi, M., Brambrink, E., … Audebert, P. (2005). Laser-driven proton scaling laws and new paths towards energy increase. Nature Physics, 2(1), 48-54. doi:10.1038/nphys199Schwoerer, H., Pfotenhauer, S., Jäckel, O., Amthor, K.-U., Liesfeld, B., Ziegler, W., … Esirkepov, T. (2006). Laser-plasma acceleration of quasi-monoenergetic protons from microstructured targets. Nature, 439(7075), 445-448. doi:10.1038/nature04492Margarone, D., Klimo, O., Kim, I. J., Prokůpek, J., Limpouch, J., Jeong, T. M., … Korn, G. (2012). 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    Asmase Regulates autophagy and lysosomal membrane permeabilization and its inhibition prevents early stage nonalcoholic steatohepatitis

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    Background & Aims: Acid sphingomyelinase (ASMase) is activated in nonalcoholic steatohepatitis (NASH). However, ASMase's contribution to NASH is poorly understood and limited to hepatic steatosis and glucose metabolism. Here we examined ASMase's role in high fat diet (HFD)-induced NASH. Methods: Autophagy, endoplasmic reticulum (ER) stress and lysosomal membrane permeabilization (LMP) were determined in ASMase-/- mice fed HFD. The impact of pharmacological ASMase inhibition on NASH was analyzed in wild type mice fed HFD. Results: ASMase deficiency determined resistance to HFD or methionine and choline deficient diet-mediated hepatic steatosis. ASMase-/- mice were resistant to HFD-induced hepatic ER stress, but sensitive to tunicamycin-mediated ER stress and steatosis, indicating selectivity in the resistance of ASMase-/- mice to ER stress. Autophagic flux determined in the presence of rapamycin and/or chloroquine was lower in primary mouse hepatocytes (PMH) from ASMase-/- mice and accompanied by increased p62 levels, suggesting autophagic impairment. Moreover, autophagy suppression by chloroquine and brefeldinA caused ER stress in PMH from ASMase+/+ mice but not ASMase-/- mice. ASMase-/- PMH exhibited increased lysosomal cholesterol loading, decreased LMP and apoptosis resistance induced by O-methyl-serine dodecylamide hydrochloride or palmitic acid, effects that were reversed by decreasing cholesterol levels by the oxysterol 25-hydroxycholesterol. In vivo pharmacological ASMase inhibition by amitriptyline, a widely used tricyclic antidepressant, protected wild type mice against HFD- induced hepatic steatosis, fibrosis, and liver damage, effects indicative of early-stage NASH. Conclusions: These findings underscore a critical role for ASMase in diet-induced NASH and suggest the potential of amitriptyline as a treatment for patients with NASH

    Phase III Trial of Adjuvant Capecitabine After Standard Neo-/Adjuvant Chemotherapy in Patients With Early Triple-Negative Breast Cancer (GEICAM/2003-11_CIBOMA/2004-01)

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    Altres ajuts: Agustí Barnadas: Honoraria: Pfizer. Consulting or Advisory Role: Pfizer, Novartis, Eli Lilly. Speakers'Bureau: Roche, Pfizer, Novartis, Genomic Health International. Travel, Accommodations, Expenses: Roche, Pfizer; Miguel A. Seguí: Consulting or Advisory Role: Roche, Pfizer, Novartis, Amgen, Eisai, Eli Lilly. Speakers' Bureau: Roche, Pfizer, Amgen. Research Funding: Roche (Inst), Novartis (Inst). Travel, Accommodations, Expenses: Roche, Pfizer, Novartis, Amgen.Operable triple-negative breast cancers (TNBCs) have a higher risk of relapse than non-TNBCs with standard therapy. The GEICAM/2003-11_CIBOMA/2004-01 trial explored extended adjuvant capecitabine after completion of standard chemotherapy in patients with early TNBC. Eligible patients were those with operable, node-positive-or node negative with tumor 1 cm or greater-TNBC, with prior anthracycline- and/or taxane-containing chemotherapy. After central confirmation of TNBC status by immunohistochemistry, patients were randomly assigned to either capecitabine or observation. Stratification factors included institution, prior taxane-based therapy, involved axillary lymph nodes, and centrally determined phenotype (basal v nonbasal, according to cytokeratins 5/6 and/or epidermal growth factor receptor positivity by immunohistochemistry). The primary objective was to compare disease-free survival (DFS) between both arms. Eight hundred seventy-six patients were randomly assigned to capecitabine (n = 448) or observation (n = 428). Median age was 49 years, 55.9% were lymph node negative, 73.9% had a basal phenotype, and 67.5% received previous anthracyclines plus taxanes. Median length of follow-up was 7.3 years. DFS was not significantly prolonged with capecitabine versus observation [hazard ratio (HR), 0.82; 95% CI, 0.63 to 1.06; P =.136]. In a preplanned subgroup analysis, nonbasal patients seemed to derive benefit from the addition of capecitabine with a DFS HR of 0.53 versus 0.94 in those with basal phenotype (interaction test P =.0694) and an HR for overall survival of 0.42 versus 1.23 in basal phenotype (interaction test P =.0052). Tolerance of capecitabine was as expected, with 75.2% of patients completing the planned 8 cycles. This study failed to show a statistically significant increase in DFS by adding extended capecitabine to standard chemotherapy in patients with early TNBC. In a preplanned subset analysis, patients with nonbasal phenotype seemed to obtain benefit with capecitabine, although this will require additional validation
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