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1. TB and COVID-19 co-infection: rationale and aims of a global study

Author

Casco, N., Jorge, A. L., Palmero, D., Alffenaar, J. -W., Fox, G., Ezz, W., Cho, J. -G., Skrahina, A., Solodovnikova, V., Bachez, P., Arbex, M. A., Galvao, T., Rabahi, M., Pereira, G. R., Sales, R., Silva, D. R., Saffie, M. M., Miranda, R. C., Cancino, V., Carbonell, M., Cisterna, C., Concha, C., Cruz, A., Salinas, N. E., Revillot, M. E., Farias, J., Fernandez, I., Flores, X., Gallegos, P., Garavagno, A., Guajardo, C., Bahamondes, M. H., Merino, L. M., Munoz, E., Munoz, C., Navarro, I., Navarro, J., Ortega, C., Palma, S., Pardenas, A. M., Pereira, G., Castillo, P. P., Pinto, M., Pizarro, R., Rivas, F., Rodriguez, P., Sanchez, C., Serrano, A., Soto, A., Taiba, C., Venegas, M., Vergara, M. S., Vilca, E., Villalon, C., Yucra, E., Li, Y., Guelvez, B., Plaza, R., Tello, K., Andrejak, C., Blanc, F. -X., Dourmane, S., Froissart, A., Izadifar, A., Riviere, F., Schlemmer, F., Gupta, N., Ish, P., Mishra, G., Sharma, S., Singla, R., Udwadia, Z. F., Manika, K., Diallo, B. D., Hassane-Harouna, S., Artiles, N., Mejia, L. A., Alladio, F., Calcagno, A., Centis, R., Codecasa, L. R., D'Ambrosio, L., Formenti, B., Gaviraghi, A., Giacomet, V., Goletti, D., Gualano, G., Matteelli, A., Migliori, G. B., Motta, I., Palmieri, F., Prestileo, T., Riccardi, N., Saderi, L., Saporiti, M., Sotgiu, G., Stochino, C., Tadolini, M., Torre, A., Visca, D., Villa, S., Kuksa, L., Danila, E., Diktanas, S., Miliauskas, S., Ridaura, R. L., Lopez, F. L. L., Torrico, M. M., Rendon, A., Akkerman, O. W., Piubello, A., Souleymane, M. B., Aizpurua, E., Gonzales, R., Jurado, J., Loban, A., Aguirre, S., De Egea, V., Irala, S., Medina, A., Sequera, G., Sosa, N., Vazquez, F., Manga, S., Villanueva, R., Araujo, D., Duarte, R., Marques, T. S., Grecu, V. I., Socaci, A., Barkanova, O., Bogorodskaya, M., Borisov, S., Mariandyshev, A., Kaluzhenina, A., Stosic, M., Beh, D., Ng, D., Ong, C. W. M., Solovic, I., Dheda, D., Gina, P., Caminero, J. A., Cardoso-Landivar, J., De Souza Galvao, M. L., Dominguez-Castellano, A., Garcia-Garcia, J. -M., Pinargote, I. M., Fernandez, S. Q., Sanchez-Montalva, A., Huguet, E. T., Murguiondo, M. Z., Bruchfeld, J., Bart, P. -A., Mazza-Stalder, J., Tiberi, S., Arrieta, F., Heysell, S., Logsdon, J., Young, L., Department of Physics [Glasgow], University of Strathclyde [Glasgow], Instituto de Fisica Corpuscular (IFIC), Consejo Superior de Investigaciones Científicas [Madrid] (CSIC)-Universitat de València (UV), Laboratoire d'Etude des Mécanismes Cognitifs (EMC), Université Lumière - Lyon 2 (UL2), Added Value Solutions (AVS), Universidade de Santiago de Compostela [Spain] (USC ), Departamento de Ingeniería Térmica y de Fluidos, Avda. Universidad 30, University Medical Center Göttingen (UMG), CHU Amiens-Picardie, Agents infectieux, résistance et chimiothérapie - UR UPJV 4294 (AGIR ), Université de Picardie Jules Verne (UPJV)-CHU Amiens-Picardie, Institut Mondor de Recherche Biomédicale (IMRB), Institut National de la Santé et de la Recherche Médicale (INSERM)-IFR10-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Réanimation Médicale [CHU Henri Mondor - APHP] (DHU A-TVB), CHU Henri Mondor-Université Paris-Est Créteil, Faculté de Médecine [Créteil] (UPEC-Médecine), Inter-University Centre for Astronomy and Astrophysics [Pune] (IUCAA), Alma Mater Studiorum University of Bologna (UNIBO), Laboratoire des EcoSystèmes et des Sociétés en Montagne (UR LESSEM), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Università degli Studi di Milano = University of Milan (UNIMI), Vilnius University [Vilnius], Instituto de Ciencias Nucleares [Mexico], Universidad Nacional Autónoma de México = National Autonomous University of Mexico (UNAM), Instituto Mexicano del Petróleo (IMP), University of Cadiz, Hospital Universitario Puerta de Hierro-Majadahonda [Madrid, Spain], Bart's and The London School of Medicine and Dentistry, Queen Mary University of London (QMUL), Southwest Research Institute [Boulder] (SwRI), BIOLOGICAL AND AGRICULTURAL ENGINEERING NORTH CAROLINA STATE UNIVERSITY RALEIGH USA, Partenaires IRSTEA, Institut national de recherche en sciences et technologies pour l'environnement et l'agriculture (IRSTEA)-Institut national de recherche en sciences et technologies pour l'environnement et l'agriculture (IRSTEA), Microbes in Health and Disease (MHD), Université Paris-Est Créteil, Faculté de Médecine [Créteil] (UPEC-Médecine)-CHU Henri Mondor, Università degli Studi di Milano [Milano] (UNIMI), and Universidad Nacional Autónoma de México (UNAM)

Subjects
Pulmonary and Respiratory Medicine, Research design, medicine.medical_specialty, Tuberculosis, Coronavirus disease 2019 (COVID-19), [SDV]Life Sciences [q-bio], MEDLINE, Global Health, medicine, Global health, Humans, Multicenter Studies as Topic, Prospective Studies, Intensive care medicine, Prospective cohort study, Tuberculosis, Pulmonary, ComputingMilieux_MISCELLANEOUS, business.industry, Coinfection, COVID-19, Pulmonary, medicine.disease, Infectious Diseases, Research Design, business, Co infection
Abstract

International audience

Published
2021
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2. nab-Paclitaxel plus carboplatin or gemcitabine versus gemcitabine plus carboplatin as first-line treatment of patients with triple-negative metastatic breast cancer: results from the tnAcity trial

Author

Yardley, D A, Coleman, R, Conte, P, Cortes, J, Brufsky, A, Shtivelband, M, Young, R, Bengala, C, Ali, H, Eakel, J, Schneeweiss, A, de la Cruz-Merino, L, Wilks, S, O'Shaughnessy, J, Glück, S, Li, H, Miller, J, Barton, D, Harbeck, N, and tnAcity investigators

Subjects
0301 basic medicine, medicine.medical_treatment, Triple Negative Breast Neoplasms, Kaplan-Meier Estimate, Deoxycytidine, Gastroenterology, Carboplatin, chemistry.chemical_compound, Triple-negative Breast cancer, 0302 clinical medicine, Breast Tumors, Antineoplastic Combined Chemotherapy Protocols, Mastectomy, Aged, 80 and over, Chemotherapy, Gemcitabine, Nab-paclitaxel, Hematology, Oncology, Hazard ratio, Middle Aged, Chemotherapy regimen, Metastatic breast cancer, Progression-Free Survival, Chemotherapy, Adjuvant, 030220 oncology & carcinogenesis, Female, medicine.drug, Adult, medicine.medical_specialty, Paclitaxel, Disease-Free Survival, 03 medical and health sciences, Breast cancer, Albumins, Internal medicine, medicine, Humans, Progression-free survival, Aged, business.industry, Original Articles, medicine.disease, 030104 developmental biology, chemistry, business
Abstract

Background Metastatic triple-negative breast cancer (mTNBC) has a poor prognosis and aggressive clinical course. tnAcity evaluated the efficacy and safety of first-line nab-paclitaxel plus carboplatin (nab-P/C), nab-paclitaxel plus gemcitabine (nab-P/G), and gemcitabine plus carboplatin (G/C) in patients with mTNBC. Patients and methods Patients with pathologically confirmed mTNBC and no prior chemotherapy for metastatic BC received (1 : 1 : 1) nab-P 125 mg/m2 plus C AUC 2, nab-P 125 mg/m2 plus G 1000 mg/m2, or G 1000 mg/m2 plus C AUC 2, all on days 1, 8 q3w. Phase II primary end point: investigator-assessed progression-free survival (PFS); secondary end points included overall response rate (ORR), overall survival (OS), percentage of patients initiating cycle 6 with doublet therapy, and safety. Results In total, 191 patients were enrolled (nab-P/C, n = 64; nab-P/G, n = 61; G/C, n = 66). PFS was significantly longer with nab-P/C versus nab-P/G [median, 8.3 versus 5.5 months; hazard ratio (HR), 0.59 [95% CI, 0.38–0.92]; P = 0.02] or G/C (median, 8.3 versus 6.0 months; HR, 0.58 [95% CI, 0.37–0.90]; P = 0.02). OS was numerically longer with nab-P/C versus nab-P/G (median, 16.8 versus 12.1 months; HR, 0.73 [95% CI, 0.47–1.13]; P = 0.16) or G/C (median, 16.8 versus 12.6 months; HR, 0.80 [95% CI, 0.52–1.22]; P = 0.29). ORR was 73%, 39%, and 44%, respectively. In the nab-P/C, nab-P/G, and G/C groups, 64%, 56%, and 50% of patients initiated cycle 6 with a doublet. Grade ≥3 adverse events were mainly hematologic. Conclusions First-line nab-P/C was active in mTNBC and resulted in a significantly longer PFS and improved risk/benefit profile versus nab-P/G or G/C.

Published
2018
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3. Traditional organic additives improve lime mortars: new old materials for restoration and building natural stone fabrics

Author

Ventola, L., Vendrell, M., Giraldez, P., and Merino, L.

Subjects
Mineralogy -- Analysis, Portland cement -- Mechanical properties -- Usage, Historic buildings -- Design and construction -- Materials, Business, Construction and materials industries
Abstract

ABSTRACT Portland cement has low chemical and physical affinity for traditional building materials. This hinders the restoration of historical buildings and modern rustic architecture where natural stone is used. Lime [...]

Published
2011
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4. Results of EAHP's 2018 Survey on Medicines Shortages

Author

Danzon, Patricia M., Kandolf Sekulovic, L., Guo, J., Agarwala, S., Hauschild, A., McArthur, G., Cinat, G., Wainstein, A., Caglevic, C., Lorigan, P., Gogas, H., Alvarez, M., Duncombe, R., Lebbe, C., Peris, K., Rutkowski, P., Stratigos, A., Forsea, A. M., De La Cruz Merino, L., Kukushkina, M., Dummer, R., Hoeller, C., Gorry, C., Bastholt, L., Herceg, D., Neyns, B., Vieira, R., Arenberger, P., Bylaite-Bucinskiene, M., Babovic, N., Banjin, M., Putnik, K., Todorovic, V., Kirov, K., Ocvirk, J., Zhukavets, A., Ymeri, A., Stojkovski, I., Garbe, C., Miljković, Nenad, Gibbons, Nicholas, Batista, Aida, Fitzpatrick, Raymond William, Underhill, Jonathan, and Horák, Petr

Subjects
medicine.medical_specialty, Metastatic melanoma, Innovative medicines, Economic shortage, 030226 pharmacology & pharmacy, Patient care, RS, Targeted therapy, 03 medical and health sciences, 0302 clinical medicine, Immunooncology, Medicine, medicines shortage, 030212 general & internal medicine, General Pharmacology, Toxicology and Pharmaceutics, Hospital pharmacy, Manchester Cancer Research Centre, business.industry, ResearchInstitutes_Networks_Beacons/mcrc, Public health, public health, Budgetary impact, antimicrobial drugs, Access, drug procurement, Treatment, hospital pharmacy, Family medicine, Original Article, business
Abstract

Aims and objectives: \ud The aim of the 2018 EAHP Survey on Medicines Shortages was to provide a clearer picture on the issue of medicines shortages, including the impact on hospital pharmacists' time, budgets and the effect on patient care. Methods: A survey was conducted by the EAHP, collecting information from European hospital pharmacists on the shortage situation in their respective countries. The survey ran from 19 March 2018 to 11 June 2018. Keele University, UK analysed and compared the results to those of the 2014 survey. \ud \ud Results: \ud There were 1666 responses to the 2018 survey, which represented a threefold increase from the 2014 survey which received 607 responses. Ninety per cent of respondents answered 'Yes' when asked if shortages of medicines are a current problem in delivering the best care to patients, while only 7% of respondents answered 'No', and 3% 'Unsure'.Problems with shortages of antimicrobials were most commonly reported (77% of respondents reporting this as an issue in 2018 vs 57% in 2014), followed by preventative medicines (43% in 2018 vs 20% in 2014) and anaesthetics (39% in 2018 vs 27% in 2014). Fifty-nine per cent of respondents have seen care delayed as a consequence of medication shortages, with cancellations of care (31% of respondents), medication errors (25% of respondents) and suboptimal treatment for patients (25% of respondents) also being frequently reported.Sixty-three per cent of respondents reported having had to pay a higher price to procure from alternate sources most of the time or always when there was a shortage of a medicine. \ud \ud Conclusions: \ud Medicines shortages is an increasing problem across Europe and is having an adverse impact on patient care. Medicines shortages are adding to hospital pharmacists' time pressures and have an adverse budgetary impact. More timely information about impending shortages and how long they will last is seen as necessary to help manage the problem.

Published
2019
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5. MEGARA, the new intermediate-resolution optical IFU and MOS for GTC: getting ready for the telescope

Author

Evans, Christopher J., Simard, Luc, Takami, Hideki, Gil de Paz, A., Carrasco, E., Gallego, J., Iglesias-Páramo, J., Cedazo, R., García Vargas, M. L., Arrillaga, X., Avilés, J. L., Cardiel, N., Carrera, M. A., Castillo-Morales, A., Castillo-Domínguez, E., de la Cruz García, J. M., Esteban San Román, S., Ferrusca, D., Gómez-Álvarez, P., Izazaga-Pérez, R., Lefort, B., López-Orozco, J. A., Maldonado, M., Martínez-Delgado, I., Morales Durán, I., Mujica, E., Páez, G., Pascual, S., Pérez-Calpena, A., Picazo, P., Sánchez-Penim, A., Sánchez-Blanco, E., Tulloch, S., Velázquez, M., Vílchez, J. M., Zamorano, J., Aguerri, A. L., Barrado y Naváscues, D., Bertone, E., Cava, A., Cenarro, J., Chávez, M., García, M., García-Rojas, J., Guichard, J., González-Delgado, R., Guzmán, R., Herrero, A., Huélamo, N., Hughes, D. H., Jiménez-Vicente, J., Kehrig, C., Marino, R. A., Márquez, I., Masegosa, J., Mayya, Y. D., Méndez-Abreu, J., Mollá, M., Muñoz-Tuñón, C., Peimbert, M., Pérez-González, P. G., Pérez Montero, E., Rodríguez, M., Rodríguez-Espinosa, J. M., Rodríguez-Merino, L., Rodríguez-Muñoz, L., Rosa-González, D., Sánchez-Almeida, J., Sánchez Contreras, C., Sánchez-Blázquez, P., Sánchez Moreno, F. M., Sánchez, S. F., Sarajedini, A., Silich, S., Simón-Díaz, S., Tenorio-Tagle, G., Terlevich, E., Terlevich, R., Torres-Peimbert, S., Trujillo, I., Tsamis, Y., Vega, O., and UAM. Departamento de Física Teórica

Subjects
Astrofísica, Optical fiber, Techniques: spectroscopic, Instrumentation: spectrographs, 01 natural sciences, spectroscopic [Techniques], Spiral, law.invention, 010309 optics, Telescope, Optics, Cosmic web, law, 0103 physical sciences, Local Group [Galaxies], spectrographs [Instrumentation], Galaxies: Local Group, Spectral resolution, 010303 astronomy & astrophysics, Spectrograph, ISM: kinematics and dynamics, Physics, business.industry, Resolution (electron density), Kinematics and dynamics, Física, Astronomía, kinematics and dynamics [ISM], business
Abstract

A. Gil de Paz... et al. "MEGARA, the new intermediate-resolution optical IFU and MOS for GTC: getting ready for the telescope". Ground-based and Airborne Instrumentation for Astronomy VI, Proc.SPIE 9908 ( (4 August 2016); doi: 10.1117/12.2231988. Copyright 2016 Society of Photo‑Optical Instrumentation Engineers. One print or electronic copy may be made for personal use only. Systematic reproduction and distribution, duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper are prohibited., Proceedings of the VI Ground-based and Airborne Instrumentation for Astronomy Conference (Edinburgh, United Kingdom), MEGARA (Multi-Espectrógrafo en GTC de Alta Resolución para Astronomía) is an optical Integral-Field Unit (IFU) and Multi-Object Spectrograph (MOS) designed for the GTC 10.4m telescope in La Palma that is being built by a Consortium led by UCM (Spain) that also includes INAOE (Mexico), IAA-CSIC (Spain), and UPM (Spain). The instrument is currently finishing AIV and will be sent to GTC on November 2016 for its on-sky commissioning on April 2017. The MEGARA IFU fiber bundle (LCB) covers 12.5x11.3 arcsec2 with a spaxel size of 0.62 arcsec while the MEGARA MOS mode allows observing up to 92 objects in a region of 3.5x3.5 arcmin 2 around the IFU. The IFU and MOS modes of MEGARA will provide identical intermediate-to-high spectral resolutions (RFWHM∼6,000, 12,000 and 18,700, respectively for the low-, mid- and high-resolution Volume Phase Holographic gratings) in the range 3700-9800 ÄA. An x-y mechanism placed at the pseudo-slit position allows (1) exchanging between the two observing modes and (2) focusing the spectrograph for each VPH setup. The spectrograph is a collimator-camera system that has a total of 11 VPHs simultaneously available (out of the 18 VPHs designed and being built) that are placed in the pupil by means of a wheel and an insertion mechanism. The custom-made cryostat hosts a 4kx4k 15-μm CCD. The unique characteristics of MEGARA in terms of throughput and versatility and the unsurpassed collecting are of GTC make of this instrument the most efficient tool to date to analyze astrophysical objects at intermediate spectral resolutions. In these proceedings we present a summary of the instrument characteristics and the results from the AIV phase. All subsystems have been successfully integrated and the system-level AIV phase is progressing as expected

Published
2016

6. Side loading - a cylinder's worst enemy!

Author

Merino, L.

Subjects
Hydraulic cylinders -- Installation, Pneumatic cylinders -- Installation, Business, Engineering and manufacturing industries
Abstract

Choosing the correct hydraulic and pneumatic cylinder and installing them properly prevents the occurrence of side loading, which is considered the leading cause of premature cylinder failure. If improperly applied, a cylinder will not only ruin itself but also the equipment to which it is installed. Designers must pay greater attention to mounting style, stop tube replacements and rod diameter when undertaking cylinder mounting., Don't just select basic design, bore size, and pressure in cylinder applications; a little attention to mounting style, rod diameter, and stop-tube requirements will improve the performance dramatically Properly applied [...]

Published
1993

7. Accurate fusion of robot, camera and wireless sensors for surveillance applications

Author

Gilbert, A, Illingworth, J, Bowden, R, Capitan, J, and Merino, L

Subjects
Computer science, business.industry, ComputingMethodologies_IMAGEPROCESSINGANDCOMPUTERVISION, Sensor fusion, Tracking (particle physics), Object detection, Robot, Wireless, Computer vision, Artificial intelligence, Image sensor, business, Mobile device, Wireless sensor network
Abstract

Often within the field of tracking people within only fixed cameras are used. This can mean that when the the illumination of the image changes or object occlusion occurs, the tracking can fail. We propose an approach that uses three simultaneous separate sensors. The fixed surveillance cameras track objects of interest cross camera through incrementally learning relationships between regions on the image. Cameras and laser rangefinder sensors onboard robots also provide an estimate of the person. Moreover, the signal strength of mobile devices carried by the person can be used to estimate his position. The estimate from all these sources are then combined using data fusion to provide an increase in performance. We present results of the fixed camera based tracking operating in real time on a large outdoor environment of over 20 non-overlapping cameras. Moreover, the tracking algorithms for robots and wireless nodes are described. A decentralized data fusion algorithm for combining all these information is presented.

Published
2009

8. More than 5000 patients with metastatic melanoma in Europe per year do not have access to recommended first-line innovative treatments

Author

Ketty Peris, Lev V. Demidov, Lars Bastholt, J.-J. Grob, Paul Nathan, M. Banjin, M. Kukushkina, Alexandros Stratigos, A.M. Forsea, A. Ymeri, Matilda Bylaite-Bucinskiene, Christoph Hoeller, A. Zhukavets, V. Todorovic, G. Weinlich, Claus Garbe, K. Putnik, L. Kandolf Sekulovic, Piotr Rutkowski, M. Risteski, K. Kirov, Iris Zalaudek, J. Ocvirk, Reinhard Dummer, D. Herceg, J. Maric-Brozic, Helen Gogas, Ricardo Vieira, Judit Oláh, Ivana Krajsová, N. Babovic, L. De La Cruz Merino, C. Blank, Johan Hansson, Bart Neyns, Axel Hauschild, C. Lebbé, Laboratory of Molecullar and Cellular Therapy, Laboratory for Medical and Molecular Oncology, Clinical sciences, [Sekulovic, L. Kandolf] Mil Med Acad, Fac Med, Dept Dermatol, Belgrade, Serbia, [Peris, K.] Univ Cattolica Sacro Cuore, Inst Dermatol, Rome, Italy, [Hauschild, A.] Univ Hosp Schleswig Holstein UKSH, Dept Dermatol, Campus Kiel, Kiel, Germany, [Stratigos, A.] Univ Athens, Athens, Greece, [Gogas, H.] Univ Athens, Athens, Greece, [Grob, J. -J.] Hop la Timone, Serv Dermatol & Cancerol Cutanee, Marseille, France, [Nathan, P.] Mt Vernon Canc Ctr, Northwood, Middx, England, [Dummer, R.] Univ Hosp, Univ Spital Zurich, Skin Canc Ctr, Zurich, Switzerland, [Forsea, A. -M.] Carol Davila Univ Med & Pharm, Elias Univ Hosp Bucharest, Bucharest, Romania, [Hoeller, C.] Med Univ Vienna, Dept Dermatol, Vienna, Austria, [Demidov, L.] NN Blokhin Russian Canc Res Ctr, Moscow, Russia, [Lebbe, C.] Hosp St Louis, APHP, Paris, France, [Blank, C.] Netherland Canc Inst, Amsterdam, Netherlands, [Olah, J.] Univ Szeged, Dept Dermatol & Allergol, Szeged, Hungary, [Bastholt, L.] Odense Univ Hosp, Dept Oncol, Odense, Denmark, [Herceg, D.] Univ Hosp Zagreb, Dept Oncol, Zagreb, Croatia, [Neyns, B.] VUB, Univ Ziekenhuis Brussel, Dept Med Oncol, Brussels, Belgium, [Vieira, R.] Univ Coimbra, Fac Med, Dept Dermatol, Coimbra, Portugal, [Hansson, J.] Karolinska Inst, Dept Oncol Pathol, Stockholm, Sweden, [Hansson, J.] Karolinska Univ Hosp Solna, Stockholm, Sweden, [Rutkowski, P.] Maria Sklodowska Curie Mem Canc Ctr, Warsaw, Poland, [Rutkowski, P.] Inst Oncol, Warsaw, Poland, [Krajsova, I.] Gen Teaching Hosp, Prague, Czech Republic, [Bylaite-Bucinskiene, M.] Vilnius Univ, Dept Dermatol, Vilnius, Lithuania, [Zalaudek, I.] Med Univ Graz, Div Dermatol & Venerol, Graz, Austria, [Maric-Brozic, J.] Univ Hosp Ctr Sestre Milosrdnice, Zagreb, Croatia, [Babovic, N.] Inst Oncol & Radiol Serbia, Belgrade, Serbia, [Banjin, M.] Univ Hosp Sarajevo, Dept Oncol, Sarajevo, Bosnia & Herceg, [Putnik, K.] North Estonia Med Ctr, Tallinn, Estonia, [Weinlich, G.] Med Univ Innsbruck, Dept Dermatol & Venerol & Allergy, Innsbruck, Austria, [Todorovic, V.] Clin Oncol & Radiotherapy, Podgorica, Montenegro, [Kirov, K.] Natl Canc Ctr, Clin Oncodermatol, Sofia, Bulgaria, [Ocvirk, J.] Inst Oncol Ljubljana, Ljubljana, Slovenia, [Zhukavets, A.] NN Alexandrov Natl Canc Ctr Belarus NCCB, Minsk, BELARUS, [Kukushkina, M.] Natl Canc Inst, Kiev, Ukraine, [De La Cruz Merino, L.] Hosp Univ Virgen Macarena, Dept Clin Oncol, Seville, Spain, [Ymeri, A.] Univ Hosp Mother Theresa, Tirana, Albania, [Risteski, M.] Univ Clin Radiotherapy & Oncol, Skopje, Macedonia, [Garbe, C.] Eberhard Karls Univ Tubingen, Dept Dermatol, Ctr Dermatooncol, Tubingen, Germany, Kandolf Sekulovic, L., Peris, K., Hauschild, A., Stratigos, A., Grob, J. -J., Nathan, P., Dummer, R., Forsea, A. -M., Hoeller, C., Gogas, H., Demidov, L., Lebbe, C., Blank, C., Olah, J., Bastholt, L., Herceg, D., Neyns, B., Vieira, R., Hansson, J., Rutkowski, P., Krajsova, I., Bylaite-Bucinskiene, M., Zalaudek, I., Maric-Brozic, J., Babovic, N., Banjin, M., Putnik, K., Weinlich, G., Todorovic, V., Kirov, K., Ocvirk, J., Zhukavets, A., Kukushkina, M., De La Cruz Merino, L., Ymeri, A., Risteski, M., and Garbe, C.

Subjects
Human development index, Male, Cancer Research, Skin Neoplasms, Survival, medicine.medical_treatment, Access, Health expenditure per capita, Immunooncology, Innovative medicines, Metastatic melanoma, Targeted therapy, Treatment, Acrylonitrile, Aniline Compounds, Antibodies, Monoclonal, Humanized, Europe, Female, Health Services Accessibility, Healthcare Disparities, Humans, Immunotherapy, Melanoma, Programmed Cell Death 1 Receptor, Proto-Oncogene Proteins B-raf, Reimbursement Mechanisms, Therapies, Investigational, Oncology, Investigational, Reimbursement Mechanism, Melanoma/economics, Disparities, Immuno oncology, Medicines, 0302 clinical medicine, Diagnosis, Health care, Monoclonal, 030212 general & internal medicine, Healthcare Disparities/economics, Acce, Acrylonitrile/analogs & derivatives, Humanized, Proto-Oncogene Proteins B-raf/antagonists & inhibitors, Reimbursement, Programmed Cell Death 1 Receptor/antagonists & inhibitors, Aniline Compound, Healthcare Disparitie, Health Services Accessibility/economics, 030220 oncology & carcinogenesis, Targeted therapy Health, Innovative medicine, Health-care, Settore MED/35 - MALATTIE CUTANEE E VENEREE, Treatment Immunooncology, Human, medicine.medical_specialty, Reimbursement Mechanisms/statistics & numerical data, Union, Antibodies, Europe/epidemiology, Malignant-melanoma, 03 medical and health sciences, Pharmacotherapy, Internal medicine, medicine, Skin Neoplasm, Human Development Index, Mortality, Therapies, Investigational/economics, Skin Neoplasms/economics, Health policy, business.industry, Cancer, medicine.disease, access, innovative medicines, metastatic melanoma, treatment, immunooncologytargeted therapyhealth expenditure per capita, human development index, Surgery, Immunotherapy/economics, Therapies, Aniline Compounds/economics, Skin cancer, business, Cancer incidence, Antibodies, Monoclonal, Humanized/economics
Abstract

Background. Despite the efficacy of innovative treatments for metastatic melanoma, their high costs has led to disparities in cancer care among different European countries. We analysed the availability of these innovative therapies in Europeand estimated the number of patients without access to first-line recommended treatment per current guidelines of professional entities such as the European Society for Medical Oncology (ESMO), the European Organisation for Research and Treatment of Cancer (EORTC), the European Association of Dermato-Oncology (EADO), and European Dermatology Forum (EDF). Materials and methods Web-based online survey was conducted in 30 European countries with questions about the treatment schedules from 1st May 2015 to 1st May 2016: number of metastatic melanoma patients, registration and reimbursement of innovative medicines (updated data, as of 1st October 2016), percentage of patients treated and availability of clinical studies and compassionate-use programmes. Results The recommended BRAF inhibitor (BRAFi)+MEK inhibitor (MEKi) combination was both registered and fully reimbursed in 9/30 (30%) countries, and in 13/30 (43%) (all from Eastern Europe) not reimbursed. First-line immunotherapy with anti-PD1 antibodies was registered and fully reimbursed in 14/30 (47%) countries, while in 13/30 (43%) (all from Eastern Europe) not reimbursed. It was estimated that in Europe 19,600 patients with metastatic melanoma are treated, and 5238 (27%) do not have access to recommended first-line therapy. Significant correlation was found between human development index (HDI, UNDP report 2015), (r=0.662; p Previous article in issue

Published
2017
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9. Pembrolizumab Plus Gemcitabine in the Subset of Triple-Negative Advanced Breast Cancer Patients in the GEICAM/2015-04 (PANGEA-Breast) Study

Author

Rosalia Caballero, Maribel Casas, Fernando Moreno, Massimo Chiesa, Natalia Palazón-Carrión, María Gion, Manuel Ramos, Javier Cortes, Josefina Cruz-Jurado, Isaac Ceballos, Raquel Andrés, Víctor Sánchez-Margalet, Jose L Alonso-Romero, Luis de la Cruz-Merino, Federico Rojo, Fernando Henao-Carrasco, Luz Milva Rodriguez Rodriguez, Elena López-Miranda, Esther Holgado, Vanesa Quiroga, Susana Bezares, Sara Benito, Carlos Jiménez-Cortegana, Institut Català de la Salut, [de la Cruz-Merino L] Medical Oncology Department, Virgen Macarena University Hospital, Medicine Department University of Seville, Seville, Spain. GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. [Gion M] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Universitario Ramón y Cajal, Madrid, Spain. [Cruz-Jurado J] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Universitario de Canarias, Santa Cruz de Tenerife, Spain. [Quiroga V] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Badalona Applied Research Group in Oncology (B-ARGO Group), Catalan Institute of Oncology, Badalona, Spain. [Andrés R] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Clínico Universitario Lozano Blesa, Zaragoza, Spain. [Moreno F] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. Medical Oncology Department, Hospital Clínico Universitario San Carlos, Madrid, Spain. [Cortés J] GEICAM Spanish Breast Cancer Group, San Sebastián de los Reyes, Spain. International Breast Cancer Center (IBCC), Quirón Teknon Hospital (Quironsalud Group), Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. Department of Medicine, Faculty of Biomedical and Health Sciences, Universidad Europea de Madrid, Madrid, Spain, and Vall d'Hebron Barcelona Hospital Campus

Subjects
Oncology, PD-L1, Cancer Research, medicine.medical_specialty, Mujer, MDSCs, Otros calificadores::Otros calificadores::/farmacoterapia [Otros calificadores], Pembrolizumab, Neutropenia, Other subheadings::Other subheadings::/drug therapy [Other subheadings], Article, Tratamiento médico, Breast cancer, breast cancer, Internal medicine, Medicine, TILs, RC254-282, triple-negative, business.industry, Tumor-infiltrating lymphocytes, Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], terapéutica::terapia biológica::inmunomodulación::inmunoterapia [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Cancer, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, biomarkers, phase II, Cáncer, medicine.disease, Gemcitabine, Discontinuation, neoplasias::neoplasias por localización::neoplasias de la mama::neoplasias de mama triple negativos [ENFERMEDADES], Anticuerpos monoclonales, Neoplasias de la mama, Mama - Càncer - Tractament, Neoplasms::Neoplasms by Site::Breast Neoplasms::Triple Negative Breast Neoplasms [DISEASES], Càncer - Immunoteràpia, pembrolizumab, immunotherapy, Quimioterapia, business, Progressive disease, medicine.drug
Abstract

The PANGEA-Breast trial evaluated a new chemo-immunotherapeutic combination that would synergistically induce long-term clinical benefit in HER2-negative advanced breast cancer patients. Treatment consisted of 21-day cycles of 200 mg of pembrolizumab (day 1) plus gemcitabine (days 1 and 8). The primary objective was the objective response rate (ORR). The tumor infiltrating lymphocytes (TILs) density and PD-L1 expression in tumor, and the myeloid-derived suppressor cells (MDSCs) level in peripheral blood, were analyzed to explore associations with treatment efficacy. Considering a two-stage Simon’s design, the study recruitment was stopped after its first stage as statistical assumptions were not met. A subset of 21 triple-negative breast cancer (TNBC) patients was enrolled. Their median age was 49 years, 15 patients had visceral involvement, and 16 had ≤3 metastatic locations. Treatment discontinuation due to progressive disease (PD) was reported in 16 patients. ORR was 15% (95% CI 3.2–37.9). Four patients were on treatment &gt, 6 months before PD. Grade ≥3 treatment-related adverse events were observed in 8 patients, where neutropenia was the most common. No association was found between TILs density, PD-L1 expression or MDSCs levels and treatment efficacy. ORR in TNBC patients also did not meet the assumptions, but 20% were on treatment &gt, 6 months.

Published
2021

10. Final results from the PERUSE study of first-line pertuzumab plus trastuzumab plus a taxane for HER2-positive locally recurrent or metastatic breast cancer, with a multivariable approach to guide prognostication

Author

D. Miles, E. Ciruelos, A. Schneeweiss, F. Puglisi, T. Peretz-Yablonski, M. Campone, I. Bondarenko, Z. Nowecki, H. Errihani, S. Paluch-Shimon, A. Wardley, J.-L. Merot, P. Trask, Y. du Toit, C. Pena-Murillo, V. Revelant, D. Klingbiel, T. Bachelot, K. Bouzid, I. Desmoulins, B. Coudert, I. Glogowska, E. Ciruelos Gil, F. Dalenc, F. Ricci, V. Dieras, B. Kaufman, A. Ferreira, M. Mano, H. Kalofonos, C. Andreetta, F. Montemurro, S. Barrett, Q. Zhang, D. Mavroudis, J. Matus, C. Villarreal Garza, C. Beato, G. Ismael, X. Hu, H. Abdel Azeem, R. Gaafar, C. Perrin, P. Kerbrat, J. Ettl, S. Paepke, E. Hitre, I. Lang, M. Trudeau, S. Verma, H. Li, O. Hoffmann, B. Aktas, A. Cariello, G. Cruciani, A. Tienghi, C. Tondini, T. Al-Twegieri, N. Loman, R. Laing, E. Brain, P. Fasching, M. Lux, A. Frassoldati, Z. Aziz, J. Salas, J. Streb, K. Krzemieniecki, A. Wronski, J. Garcia Garcia, S. Menjon Beltran, I. Cicin, P. Schmid, C. Gallagher, N. Turner, Z. Tong, K. Boer, B. Juhász, Z. Horvath, G. Bianchini, L. Gianni, G. Curigliano, A. Juarez Ramiro, S. Susnjar, E. Matos, E. Sevillano, L. Garcia Estevez, E. Gokmen, R. Uslu, H. Wildiers, F. Schutz, M. Cruz, H. Bourgeois, R. von Schumann, S. Stemmer, A. Dominguez, F. Morales-Vásques, M. Wojtukiewicz, J. Trifunovic, M.J. Echarri Gonzalez, J. Illarramendi Mañas, E. Martinez De Dueñas, N. Voitko, J. Hicks, S. Waters, P. Barrett-Lee, D. Wheatley, R. De Boer, V. Cocquyt, G. Jerusalem, C. Barrios, L. Panasci, J. Mattson, M. Tanner, M. Gozy, G. Vasilopoulos, C. Papandreou, J. Revesz, N. Battelli, G. Benedetti, L. Latini, C. Gridelli, J. Lazaro Leon, J. Alarcón Company, A. Arance Fernandez, A. Barnadas Molins, I. Calvo Plaza, R. Bratos, A. Gonzalez Martin, Y. Izarzugaza Peron, L. Klint, A. Kovalev, N. McCarthy, B. Yeo, D. Kee, J. Thomson, S. White, R. Greil, S. Wang, X. Artignan, I. Juhasz-Böess, A. Rody, R. Ngan, F. Dourleshter, H. Goldberg, L. Doni, F. Di Costanzo, F. Ferraù, M. Drobniene, E. Aleknavicius, K. Rashid, L. Costa, L. de la Cruz Merino, J. Garcia Saenz, R. López, O. Del Val Munoz, O. Ozyilkan, F. Azribi, H. Jaafar, R. Baird, M. Verrill, J. Beith, A. Petzer, J. Moreira de Andrade, V. Bernstein, N. Macpherson, D. Rayson, I. Saad Eldin, M. Achille, P. Augereau, V. Müller, A. Rasco, E. Evron, D. Katz, R. Berardi, S. Cascinu, A. De Censi, A. Gennari, N. El-Saghir, M. Ghosn, H.M. Oosterkamp, J. Van den Bosch, M. Kukulska, E. Kalinka, J. Alonso, E. Dalmau Portulas, M. Del Mar Gordon Santiago, I. Pelaez Fernandez, S. Aksoy, K. Altundag, H. Senol Coskun, H. Bozcuk, Y. Shparyk, L. Barraclough, N. Levitt, U. Panwar, S. Kelly, A. Rigg, M. Varughese, C. Castillo, L. Fein, L. Malik, R. Stuart-Harris, C. Singer, H. Stoeger, H. Samonigg, J. Feng, M. Cedeño, J. Ruohola, J.-F. Berdah, A. Goncalves, H. Orfeuvre, E.-M. Grischke, E. Simon, S. Wagner, G. Koumakis, K. Papazisis, N. Ben Baruch, G. Fried, D. Geffen, N. Karminsky, T. Peretz, L. Cavanna, P. Pedrazzioli, D. Grasso, E. Ruggeri, G. D’Auria, L. Moscetti, E. Juozaityte, J. Rodriguez Cid, H. Roerdink, N. Siddiqi, J. Passos Coelho, A. Arcediano Del Amo, E. Garcia Garre, M. García Gonzalez, A. Garcia-Palomo Perez, C. Herenandez Perez, P. Lopez Alvarez, M.H. Lopez De Ceballos, N. Martínez Jañez, M. Mele Olive, K. McAdam, T. Perren, G. Dunn, A. Humphreys, W. Taylor, R. Vera, L. Kaen, J. Andel, G. Steger, J. De Grève, M. Huizing, R. Hegg, A. Joy, P. Kuruvilla, S. Sehdev, S. Smiljanic, R. Kütner, J. Alexandre, J. Grosjean, P. Laplaige, R. Largillier, P. Maes, P. Martin, V. Pottier, B. Christensen, F. Khandan, H.-J. Lück, D.-M. Zahm, G. Fountzilas, V. Karavasilis, T. Safra, M. Inbar, L. Ryvo, A. Bonetti, E. Seles, A. Giacobino, Y. Chavarri Guerra, F. de Jongh, A. van der Velden, L. van Warmerdam, S. Vrijaldenhoven, C.H. Smorenburg, M. Cavero, R. Andres Conejero, A. Oltra Ferrando, A. Redondo Sanchez, N. Ribelles Entrena, S. Saura Grau, G. Viñas Vilaro, K. Bachmeier, M. Beresford, M. Butt, J. Joffe, C. Poole, P. Woodings, P. Chakraborti, G. Yordi, N. Woodward, A. Nobre, G. Luiz Amorim, N. Califaretti, S. Fox, A. Robidoux, E. Li, N. Li, J. Jiang, T. Soria, P. Padrik, O. Lahdenpera, H. Barletta, N. Dohollou, D. Genet, K. Prulhiere, D. Coeffic, T. Facchini, S. Vieillot, S. Catala, L. Teixeira, T. Hesse, T. Kühn, A. Ober, R. Repp, W. Schröder, D. Pectasides, G. Bodoky, Z. Kahan, I. Jiveliouk, O. Rosengarten, V. Rossi, O. Alabiso, M. Pérez Martínez, A.J. van de Wouw, J. Smok-Kalwat, M. Damasecno, I. Augusto, G. Sousa, A. Saadein, N. Abdelhafiez, O. Abulkhair, A. Antón Torres, M. Corbellas Aparicio, R. Llorente Domenech, J. Florián Jerico, J. Garcia Mata, M. Gil Raga, A. Galan Brotons, A. Llombart Cussac, C. Llorca Ferrandiz, P. Martinez Del Prado, C. Olier Garate, C. Rodriguez Sanchez, R. Sanchez Gomez, M. Santisteban Eslava, J. Soberino, M. Vidal Losada Garcia, D. Soto de Prado, J. Torrego Garcia, E. Vicente Rubio, M. Garcia, A. Murias Rosales, H. Granstam Björneklett, U. Narbe, M. Jafri, D. Rea, J. Newby, A. Jones, S. Westwell, A. Ring, I. Alonso, R. Rodríguez, Miles, D., Ciruelos, E., Schneeweiss, A., Puglisi, F., Peretz-Yablonski, T., Campone, M., Bondarenko, I., Nowecki, Z., Errihani, H., Paluch-Shimon, S., Wardley, A., Merot, J. -L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., Klingbiel, D., Bachelot, T., Bouzid, K., Desmoulins, I., Coudert, B., Glogowska, I., Ciruelos Gil, E., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Montemurro, F., Barrett, S., Zhang, Q., Mavroudis, D., Matus, J., Villarreal Garza, C., Beato, C., Ismael, G., Hu, X., Abdel Azeem, H., Gaafar, R., Perrin, C., Kerbrat, P., Ettl, J., Paepke, S., Hitre, E., Lang, I., Trudeau, M., Verma, S., Li, H., Hoffmann, O., Aktas, B., Cariello, A., Cruciani, G., Tienghi, A., Tondini, C., Al-Twegieri, T., Loman, N., Laing, R., Brain, E., Fasching, P., Lux, M., Frassoldati, A., Aziz, Z., Salas, J., Streb, J., Krzemieniecki, K., Wronski, A., Garcia Garcia, J., Menjon Beltran, S., Cicin, I., Schmid, P., Gallagher, C., Turner, N., Tong, Z., Boer, K., Juhasz, B., Horvath, Z., Bianchini, G., Gianni, L., Curigliano, G., Juarez Ramiro, A., Susnjar, S., Matos, E., Sevillano, E., Garcia Estevez, L., Gokmen, E., Uslu, R., Wildiers, H., Schutz, F., Cruz, M., Bourgeois, H., von Schumann, R., Stemmer, S., Dominguez, A., Morales-Vasques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M. J., Illarramendi Manas, J., Martinez De Duenas, E., Voitko, N., Hicks, J., Waters, S., Barrett-Lee, P., Wheatley, D., De Boer, R., Cocquyt, V., Jerusalem, G., Barrios, C., Panasci, L., Mattson, J., Tanner, M., Gozy, M., Vasilopoulos, G., Papandreou, C., Revesz, J., Battelli, N., Benedetti, G., Latini, L., Gridelli, C., Lazaro Leon, J., Alarcon Company, J., Arance Fernandez, A., Barnadas Molins, A., Calvo Plaza, I., Bratos, R., Gonzalez Martin, A., Izarzugaza Peron, Y., Klint, L., Kovalev, A., Mccarthy, N., Yeo, B., Kee, D., Thomson, J., White, S., Greil, R., Wang, S., Artignan, X., Juhasz-Boess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferrau, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., Lopez, R., Del Val Munoz, O., Ozyilkan, O., Azribi, F., Jaafar, H., Baird, R., Verrill, M., Beith, J., Petzer, A., Moreira de Andrade, J., Bernstein, V., Macpherson, N., Rayson, D., Saad Eldin, I., Achille, M., Augereau, P., Muller, V., Rasco, A., Evron, E., Katz, D., Berardi, R., Cascinu, S., De Censi, A., Gennari, A., El-Saghir, N., Ghosn, M., Oosterkamp, H. M., Van den Bosch, J., Kukulska, M., Kalinka, E., Alonso, J., Dalmau Portulas, E., Del Mar Gordon Santiago, M., Pelaez Fernandez, I., Aksoy, S., Altundag, K., Senol Coskun, H., Bozcuk, H., Shparyk, Y., Barraclough, L., Levitt, N., Panwar, U., Kelly, S., Rigg, A., Varughese, M., Castillo, C., Fein, L., Malik, L., Stuart-Harris, R., Singer, C., Stoeger, H., Samonigg, H., Feng, J., Cedeno, M., Ruohola, J., Berdah, J. -F., Goncalves, A., Orfeuvre, H., Grischke, E. -M., Simon, E., Wagner, S., Koumakis, G., Papazisis, K., Ben Baruch, N., Fried, G., Geffen, D., Karminsky, N., Peretz, T., Cavanna, L., Pedrazzioli, P., Grasso, D., Ruggeri, E., D'Auria, G., Moscetti, L., Juozaityte, E., Rodriguez Cid, J., Roerdink, H., Siddiqi, N., Passos Coelho, J., Arcediano Del Amo, A., Garcia Garre, E., Garcia Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M. H., Martinez Janez, N., Mele Olive, M., Mcadam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Greve, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kutner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Luck, H. -J., Zahm, D. -M., Fountzilas, G., Karavasilis, V., Safra, T., Inbar, M., Ryvo, L., Bonetti, A., Seles, E., Giacobino, A., Chavarri Guerra, Y., de Jongh, F., van der Velden, A., van Warmerdam, L., Vrijaldenhoven, S., Smorenburg, C. H., Cavero, M., Andres Conejero, R., Oltra Ferrando, A., Redondo Sanchez, A., Ribelles Entrena, N., Saura Grau, S., Vinas Vilaro, G., Bachmeier, K., Beresford, M., Butt, M., Joffe, J., Poole, C., Woodings, P., Chakraborti, P., Yordi, G., Woodward, N., Nobre, A., Luiz Amorim, G., Califaretti, N., Fox, S., Robidoux, A., Li, E., Li, N., Jiang, J., Soria, T., Padrik, P., Lahdenpera, O., Barletta, H., Dohollou, N., Genet, D., Prulhiere, K., Coeffic, D., Facchini, T., Vieillot, S., Catala, S., Teixeira, L., Hesse, T., Kuhn, T., Ober, A., Repp, R., Schroder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Perez Martinez, M., van de Wouw, A. J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Anton Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florian Jerico, J., Garcia Mata, J., Gil Raga, M., Galan Brotons, A., Llombart Cussac, A., Llorca Ferrandiz, C., Martinez Del Prado, P., Olier Garate, C., Rodriguez Sanchez, C., Sanchez Gomez, R., Santisteban Eslava, M., Soberino, J., Vidal Losada Garcia, M., Soto de Prado, D., Torrego Garcia, J., Vicente Rubio, E., Garcia, M., Murias Rosales, A., Granstam Bjorneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodriguez, R., Apollo - University of Cambridge Repository, Medical Genetics, Clinical sciences, and Laboratory for Medical and Molecular Oncology

Subjects
0301 basic medicine, Oncology, Receptor, ErbB-2, medicine.medical_treatment, chemistry.chemical_compound, paclitaxel, 0302 clinical medicine, Trastuzumab, Antineoplastic Combined Chemotherapy Protocols, Clinical endpoint, skin and connective tissue diseases, HER2 positive, hormone receptor, metastatic breast cancer, overall survival, pertuzumab, Hematology, Metastatic breast cancer, Receptor, ErbB-2/genetics, Neoplasm Recurrence, Local/drug therapy, Treatment Outcome, Docetaxel, Paclitaxel, 030220 oncology & carcinogenesis, Female, Taxoids, Pertuzumab, medicine.drug, medicine.medical_specialty, Taxoids/therapeutic use, Breast Neoplasms, Antibodies, Monoclonal, Humanized, 03 medical and health sciences, Breast Neoplasms/drug therapy, Internal medicine, medicine, Humans, Trastuzumab/adverse effects, neoplasms, Chemotherapy, Taxane, business.industry, Antineoplastic Combined Chemotherapy Protocols/adverse effects, medicine.disease, 030104 developmental biology, chemistry, Neoplasm Recurrence, Local, business
Abstract

Background The phase III CLinical Evaluation Of Pertuzumab And TRAstuzumab (CLEOPATRA) trial established the combination of pertuzumab, trastuzumab and docetaxel as standard first-line therapy for human epidermal growth factor receptor 2 (HER2)-positive locally recurrent/metastatic breast cancer (LR/mBC). The multicentre single-arm PERtUzumab global SafEty (PERUSE) study assessed the safety and efficacy of pertuzumab and trastuzumab combined with investigator-selected taxane in this setting. Patients and methods Eligible patients with inoperable HER2-positive LR/mBC and no prior systemic therapy for LR/mBC (except endocrine therapy) received docetaxel, paclitaxel or nab-paclitaxel with trastuzumab and pertuzumab until disease progression or unacceptable toxicity. The primary endpoint was safety. Secondary endpoints included progression-free survival (PFS) and overall survival (OS). Prespecified subgroup analyses included subgroups according to taxane, hormone receptor (HR) status and prior trastuzumab. Exploratory univariable analyses identified potential prognostic factors; those that remained significant in multivariable analysis were used to analyse PFS and OS in subgroups with all, some or none of these factors. Results Of 1436 treated patients, 588 (41%) initially received paclitaxel and 918 (64%) had HR-positive disease. The most common grade ≥3 adverse events were neutropenia (10%, mainly with docetaxel) and diarrhoea (8%). At the final analysis (median follow-up: 5.7 years), median PFS was 20.7 [95% confidence interval (CI) 18.9-23.1] months overall and was similar irrespective of HR status or taxane. Median OS was 65.3 (95% CI 60.9-70.9) months overall. OS was similar regardless of taxane backbone but was more favourable in patients with HR-positive than HR-negative LR/mBC. In exploratory analyses, trastuzumab-pretreated patients with visceral disease had the shortest median PFS (13.1 months) and OS (46.3 months). Conclusions Mature results from PERUSE show a safety and efficacy profile consistent with results from CLEOPATRA and median OS exceeding 5 years. Results suggest that paclitaxel is a valid alternative to docetaxel as backbone chemotherapy. Exploratory analyses suggest risk factors that could guide future trial design.

Published
2021

11. T-cells immune response controls the high incidence of adenovirus infection in adult allogenic hematopoietic transplantation recipients

Author

Virginia Escamilla-Gómez, Cecilia Martín-Gandul, Ildefonso Espigado, Jerónimo Pachón, Laura Merino, José Antonio Marrugal-Lorenzo, Manuela Aguilar-Guisado, José A. Pérez-Simón, Javier Sánchez-Céspedes, Enrique Montero-Mateos, Ana Serna-Gallego, Nancy Rodríguez-Torres, [Sánchez-Céspedes,J, Marrugal-Lorenzo,JA, Martín-Gandul,C, Montero-Mateos,E, Serna-Gallego,A, Merino,L, Aguilar-Guisado,M] Unit of Infectious Diseases, Microbiology and Preventive Medicine, Institute of Biomedicine of Seville (IBIS), University Hospital Virgen del Rocío (CSIC), University of Seville. [Rodríguez-Torres,N, Escamilla-Gómez,V, Espigado,I, Pérez-Simón,JA] Department of Hematology, University Hospital Virgen del Rocío, Institute of Biomedicine of Seville (IBIS/CSIC/CIBERONC), University of Seville. [Pachón,J, Pérez-Simón,JA] Department of Medicine, University of Seville. [Pachón,J] Institute of Biomedicine of Seville (IBIS), University Hospital Virgen del Rocío (CSIC), University of Seville, Seville, Spain, This work was supported by Plan Nacional de I+D+i 2013‐2016 and Instituto de Salud Carlos III, Subdirección General de Redes y Centros de Investigación Cooperativa, Ministerio de Ciencia, Innovación y Universidades, Spanish Network for Research in Infectious Diseases (REIPI RD16/0016/0009) - cofinanced by European Development Regional Fund 'A way to achieve Europe', Operative program Intelligent Growth 2014‐2020, the Instituto de Salud Carlos III, Subdirección General de Evaluación y Fomento de la Investigación (PI15/00489), and the Spanish Adenovirus Network (AdenoNet, BIO2015/68990-REDT). JSC is a researcher belonging to the program 'Nicolás Monardes' (C-0059-2018), Servicio Andaluz de Salud, Junta de Andalucía, Spain., and Ministerio de Economía y Competitividad (España)

Subjects
Adult, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Prospective Studies [Medical Subject Headings], Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Case-Control Studies::Retrospective Studies [Medical Subject Headings], Adenoviridae Infections, T-Lymphocytes, Hematopoietic stem cell transplantation, Phenomena and Processes::Chemical Phenomena::Biochemical Phenomena::Kinetics [Medical Subject Headings], Diseases::Virus Diseases::DNA Virus Infections::Adenoviridae Infections [Medical Subject Headings], Persons::Persons::Age Groups::Adolescent [Medical Subject Headings], Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings], Immune system, Text mining, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Data Collection::Vital Statistics::Morbidity::Incidence [Medical Subject Headings], Humans, Medicine, Persons::Persons::Age Groups::Child [Medical Subject Headings], Viremia, Adenovirus infection, Letters to the Editor, Persons::Persons::Age Groups::Adult [Medical Subject Headings], Anatomy::Cells::Blood Cells::Leukocytes::Leukocytes, Mononuclear::Lymphocytes::T-Lymphocytes [Medical Subject Headings], business.industry, Incidence, T-cell immune response, Hematopoietic Stem Cell Transplantation, Immunity, Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Cell Transplantation::Stem Cell Transplantation::Hematopoietic Stem Cell Transplantation [Medical Subject Headings], Diseases::Virus Diseases::Viremia [Medical Subject Headings], Hematology, Phenomena and Processes::Immune System Phenomena::Immunity [Medical Subject Headings], medicine.disease, Transplantation, Infecciones por adenovirus Humanos, Haematopoiesis, Organisms::Viruses::DNA Viruses::Adenoviridae::Mastadenovirus::Adenoviruses, Human [Medical Subject Headings], Adenovirus infections, Human, Immunology, High incidence, business, Inmunidad celular, Trasplante de células madre hematopoyéticas
Abstract

This work was supported by Plan Nacional de I+D+i 2013

Published
2021

12. Overall survival with ribociclib plus fulvestrant in advanced breast cancer

Author

Giulia Val Bianchi, Xavier Pivot, Guy Jerusalem, Luis de la Cruz-Merino, Stephen Chia, Tetiana Taran, Gabe S. Sonke, Seock-Ah Im, Arnd Nusch, Francisco J. Esteva, Patrick Neven, J. Thaddeus Beck, Michelino De Laurentiis, Miguel Martin, Arunava Chakravartty, Dennis J. Slamon, K. Petrakova, Yingbo Wang, Karen Rodriguez-Lorenc, Manu Sondhi, Peter A. Fasching, Slamon, D. J., Neven, P., Chia, S., Fasching, P. A., De Laurentiis, M., Im, S. -A., Petrakova, K., Bianchi, G. V., Esteva, F. J., Martin, M., Nusch, A., Sonke, G. S., De La Cruz-Merino, L., Beck, J. T., Pivot, X., Sondhi, M., Wang, Y., Chakravartty, A., Rodriguez-Lorenc, K., Taran, T., and Jerusalem, G.

Subjects
Oncology, medicine.medical_specialty, medicine.drug_class, Receptor, ErbB-2, Aminopyridines, Ribociclib, Breast Neoplasms, Kaplan-Meier Estimate, 030204 cardiovascular system & hematology, Drug Administration Schedule, law.invention, 03 medical and health sciences, 0302 clinical medicine, Randomized controlled trial, law, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Overall survival, Humans, 030212 general & internal medicine, Progression-free survival, Fulvestrant, Purine, Aged, Antineoplastic Combined Chemotherapy Protocol, business.industry, Cancer, General Medicine, Middle Aged, medicine.disease, Progression-Free Survival, Clinical trial, Postmenopause, Aminopyridine, Receptors, Estrogen, Estrogen, Purines, Female, business, Receptors, Progesterone, Breast Neoplasm, medicine.drug, Human
Abstract

In an earlier analysis of this phase 3 trial, ribociclib plus fulvestrant showed a greater benefit with regard to progression-free survival than fulvestrant alone in postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. Here we report the results of a protocol-specified second interim analysis of overall survival. Patients were randomly assigned in a 2:1 ratio to receive either ribociclib or placebo in addition to fulvestrant as first-line or second-line treatment. Survival was evaluated by means of a stratified log-rank test and summarized with the use of Kaplan-Meier methods. This analysis was based on 275 deaths: 167 among 484 patients (34.5%) receiving ribociclib and 108 among 242 (44.6%) receiving placebo. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant. The estimated overall survival at 42 months was 57.8% (95% confidence interval [CI], 52.0 to 63.2) in the ribociclib group and 45.9% (95% CI, 36.9 to 54.5) in the placebo group, for a 28% difference in the relative risk of death (hazard ratio, 0.72; 95% CI, 0.57 to 0.92; P = 0.00455). The benefit was consistent across most subgroups. In a descriptive update, median progression-free survival among patients receiving first-line treatment was 33.6 months (95% CI, 27.1 to 41.3) in the ribociclib group and 19.2 months (95% CI, 14.9 to 23.6) in the placebo group. No new safety signals were observed. Ribociclib plus fulvestrant showed a significant overall survival benefit over placebo plus fulvestrant in patients with hormone-receptor-positive, HER2-negative advanced breast cancer. (Funded by Novartis; MONALEESA-3 ClinicalTrials.gov number, NCT02422615.).

Published
2020

13. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor–Positive, Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer: MONALEESA-3

Author

Xavier Pivot, Michelle Miller, Seock-Ah Im, Francisco J. Esteva, Yingbo Wang, Miguel Martin, Arnd Nusch, Luis de la Cruz-Merino, Karen Rodriguez Lorenc, Patrick Neven, Dennis J. Slamon, K. Petrakova, Peter A. Fasching, J. Thaddeus Beck, Stephen Chia, Michelino De Laurentiis, Gena Vidam, Guy Jerusalem, Giulia Val Bianchi, Gabe S. Sonke, Tetiana Taran, Slamon, D. J., Neven, P., Chia, S., Fasching, P. A., De Laurentiis, M., Im, S. -A., Petrakova, K., Val Bianchi, G., Esteva, F. J., Martin, M., Nusch, A., Sonke, G. S., De La Cruz-Merino, L., Beck, J. T., Pivot, X., Vidam, G., Wang, Y., Lorenc, K. R., Miller, M., Taran, T., and Jerusalem, G.

Subjects
Adult, 0301 basic medicine, Oncology, Cancer Research, medicine.medical_specialty, Receptor, ErbB-2, Aminopyridines, Anastrozole, Breast Neoplasms, Kaplan-Meier Estimate, Palbociclib, Gene mutation, 03 medical and health sciences, 0302 clinical medicine, Double-Blind Method, Internal medicine, Antineoplastic Combined Chemotherapy Protocols, medicine, Humans, Progression-free survival, Fulvestrant, Purine, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocol, business.industry, Goserelin, Middle Aged, medicine.disease, Metastatic breast cancer, Progression-Free Survival, Aminopyridine, 030104 developmental biology, Receptors, Estrogen, Purines, 030220 oncology & carcinogenesis, Hormonal therapy, Female, Receptors, Progesterone, business, Breast Neoplasm, Human, medicine.drug
Abstract

Purpose This phase III study evaluated ribociclib plus fulvestrant in patients with hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer who were treatment naïve or had received up to one line of prior endocrine therapy in the advanced setting. Patients and Methods Patients were randomly assigned at a two-to-one ratio to ribociclib plus fulvestrant or placebo plus fulvestrant. The primary end point was locally assessed progression-free survival. Secondary end points included overall survival, overall response rate, and safety. Results A total of 484 postmenopausal women were randomly assigned to ribociclib plus fulvestrant, and 242 were assigned to placebo plus fulvestrant. Median progression-free survival was significantly improved with ribociclib plus fulvestrant versus placebo plus fulvestrant: 20.5 months (95% CI, 18.5 to 23.5 months) versus 12.8 months (95% CI, 10.9 to 16.3 months), respectively (hazard ratio, 0.593; 95% CI, 0.480 to 0.732; P < .001). Consistent treatment effects were observed in patients who were treatment naïve in the advanced setting (hazard ratio, 0.577; 95% CI, 0.415 to 0.802), as well as in patients who had received up to one line of prior endocrine therapy for advanced disease (hazard ratio, 0.565; 95% CI, 0.428 to 0.744). Among patients with measurable disease, the overall response rate was 40.9% for the ribociclib plus fulvestrant arm and 28.7% for placebo plus fulvestrant. Grade 3 adverse events reported in ≥ 10% of patients in either arm (ribociclib plus fulvestrant v placebo plus fulvestrant) were neutropenia (46.6% v 0%) and leukopenia (13.5% v 0%); the only grade 4 event reported in ≥ 5% of patients was neutropenia (6.8% v 0%). Conclusion Ribociclib plus fulvestrant might represent a new first- or second-line treatment option in hormone receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer.

Published
2018
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14. SEOM clinical guidelines in advanced and recurrent breast cancer (2018)

Author

M. Bellet Ezquerra, S. Antolin Novoa, Mafalda Oliveira, E. Martínez de Dueñas, S. López-Tarruella Cobo, M. A. Segui Palmer, L. de la Cruz Merino, J. Gavila Gregori, I. Álvarez López, J. I. Chacón López-Muñiz, Institut Català de la Salut, [Chacón López-Muñiz JI] Servicio de Oncología Médica, Hospital Virgen de la Salud, Avda. de Barber, 30, 45004 Toledo, Spain. GEICAM, Madrid, Spain. [de la Cruz Merino L] Servicio de Oncología Médica, Medicine Department, Hospital Virgen Macarena, University of Sevilla, Seville, Spain. [Gavilá Gregori J] Servicio de Oncología Médica, Fundación Instituto Valenciano de Oncología, Valencia, Spain. [Martínez Dueñas E] Servicio de Oncología Médica, Hospital Provincial de Castellón, Castellón, Spain. [Oliveira M, Bellet Ezquerra M] Vall d’Hebron Hospital Universitari, Barcelona, Spain. Vall d’Hebron Institute of Oncology (VHIO), Barcelona, Spain. [Seguí Palmer MA] Servicio de Oncología Médica, Corporació Sanitaria Parc Tauli, Sabadell, Barcelona, Spain, Vall d'Hebron Barcelona Hospital Campus, and Hospital Universitari Vall d'Hebron

Subjects
0301 basic medicine, Cancer Research, medicine.medical_specialty, Mama - Càncer - Prognosi, SEOM, Neoplasms::Neoplasms by Site::Breast Neoplasms [DISEASES], Clinical Guides in Oncology, Breast Neoplasms, Disease, Guidelines, Rational use, 03 medical and health sciences, 0302 clinical medicine, Breast cancer, Metàstasi, medicine, Overall survival, Humans, Intensive care medicine, Diagnosis::Prognosis [ANALYTICAL, DIAGNOSTIC AND THERAPEUTIC TECHNIQUES, AND EQUIPMENT], Recurrent breast cancer, diagnóstico::pronóstico [TÉCNICAS Y EQUIPOS ANALÍTICOS, DIAGNÓSTICOS Y TERAPÉUTICOS], Societies, Medical, Otros calificadores::/terapia [Otros calificadores], Clinical Trials as Topic, neoplasias::neoplasias por localización::neoplasias de la mama [ENFERMEDADES], Time to progression, business.industry, Task force, Neoplasms::Neoplastic Processes::Neoplasm Metastasis [DISEASES], Disease Management, General Medicine, Guideline, Other subheadings::/therapy [Other subheadings], medicine.disease, Prognosis, Combined Modality Therapy, 030104 developmental biology, Oncology, Loco-regional recurrence, neoplasias::procesos neoplásicos::metástasis neoplásica [ENFERMEDADES], 030220 oncology & carcinogenesis, Practice Guidelines as Topic, Female, Advanced, Neoplasm Recurrence, Local, business
Abstract

Recurrència loco-regional; Càncer de mama; Pautes Recurrencia loco-regional; Cáncer de mama; Pautas Loco-regional recurrence; Breast cancer; Guidelines Although the metastasic breast cancer is still an incurable disease, recent advances have increased significantly the time to progression and the overall survival. However, too much information has been produced in the last 2 years, so a well-based guideline is a valuable document in treatment decision making. The SEOM guidelines are intended to make evidence-based recommendations on how to manage patients with advanced and recurrent breast cancer to achieve the best patient outcomes based on a rational use of the currently available therapies. To assign a level of certainty and a grade of recommendation the United States Preventive Services Task Force guidelines methodology was selected as reference.

Published
2019

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