292 results on '"de la Cruz Merino, L."'
Search Results
2. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving first-line ribociclib plus fulvestrant
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Neven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S.-A., Petrakova, K., Bianchi, G. V., Martín, M., Nusch, A., Sonke, G. S., De la Cruz-Merino, L., Beck, J. T., Zarate, J. P., Wang, Y., Chakravartty, A., Wang, C., and Slamon, D. J.
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- 2023
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3. Pembrolizumab in combination with gemcitabine for patients with HER2-negative advanced breast cancer: GEICAM/2015–04 (PANGEA-Breast) study
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de la Cruz-Merino, L., Gion, M., Cruz, J., Alonso-Romero, JL., Quiroga, V., Moreno, F., Andrés, R., Santisteban, M., Ramos, M., Holgado, E., Cortés, J., López-Miranda, E., Cortés, A., Henao, F., Palazón-Carrión, N., Rodriguez, L. M., Ceballos, I., Soto, A., Puertes, A., Casas, M., Benito, S., Chiesa, M., Bezares, S., Caballero, R., Jiménez-Cortegana, C., Sánchez-Margalet, V., and Rojo, F.
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- 2022
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4. 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
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Bachelot, T., Bouzid, K., Campone, M., Desmoulins, I., Coudert, B., Bondarenko, I., Nowecki, Z., Glogowska, I., Ciruelos Gil, E., Errihani, H., Dalenc, F., Ricci, F., Dieras, V., Kaufman, B., Paluch-Shimon, S., Wardley, A., Schneeweiss, A., Ferreira, A., Mano, M., Kalofonos, H., Andreetta, C., Puglisi, F., 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., Miles, D., 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., Juhász, 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-Vásques, F., Wojtukiewicz, M., Trifunovic, J., Echarri Gonzalez, M.J., Illarramendi Mañas, J., Martinez De Dueñas, 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., Alarcón 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-Böess, I., Rody, A., Ngan, R., Dourleshter, F., Goldberg, H., Doni, L., Di Costanzo, F., Ferraù, F., Drobniene, M., Aleknavicius, E., Rashid, K., Costa, L., de la Cruz Merino, L., Garcia Saenz, J., López, 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., Müller, 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., Cedeño, 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., García Gonzalez, M., Garcia-Palomo Perez, A., Herenandez Perez, C., Lopez Alvarez, P., Lopez De Ceballos, M.H., Martínez Jañez, N., Mele Olive, M., McAdam, K., Perren, T., Dunn, G., Humphreys, A., Taylor, W., Vera, R., Kaen, L., Andel, J., Steger, G., De Grève, J., Huizing, M., Hegg, R., Joy, A., Kuruvilla, P., Sehdev, S., Smiljanic, S., Kütner, R., Alexandre, J., Grosjean, J., Laplaige, P., Largillier, R., Maes, P., Martin, P., Pottier, V., Christensen, B., Khandan, F., Lück, 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., Viñas 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., Kühn, T., Ober, A., Repp, R., Schröder, W., Pectasides, D., Bodoky, G., Kahan, Z., Jiveliouk, I., Rosengarten, O., Rossi, V., Alabiso, O., Pérez Martínez, M., van de Wouw, A.J., Smok-Kalwat, J., Damasecno, M., Augusto, I., Sousa, G., Saadein, A., Abdelhafiez, N., Abulkhair, O., Antón Torres, A., Corbellas Aparicio, M., Llorente Domenech, R., Florián 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 Björneklett, H., Narbe, U., Jafri, M., Rea, D., Newby, J., Jones, A., Westwell, S., Ring, A., Alonso, I., Rodríguez, R., Ciruelos, E., Peretz-Yablonski, T., Merot, J.-L., Trask, P., du Toit, Y., Pena-Murillo, C., Revelant, V., and Klingbiel, D.
- Published
- 2021
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5. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival
- Author
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Slamon, D.J., Neven, P., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S., Petrakova, K., Valeria Bianchi, G., Martín, M., Nusch, A., Sonke, G.S., De la Cruz-Merino, L., Beck, J.T., Ji, Y., Wang, C., Deore, U., Chakravartty, A., Zarate, J.P., Taran, T., and Fasching, P.A.
- Published
- 2021
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6. Development of a leakage monitoring system in isolated limb perfusion with portable gamma camera
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Agudo Martínez, A., Calvo Morón, C., Cambil Molina, T., García Gómez, F.J., de la Riva Perez, P.A., de la Cruz Merino, L., Araji Tiliani, O., Terrón León, J.A., and Castro Montaño, J.
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- 2021
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7. Desarrollo de un protocolo de monitorización de fuga en perfusión de miembro aislado con gammacámara portátil
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Agudo Martínez, A., Calvo Morón, C., Cambil Molina, T., García Gómez, F.J., de la Riva Pérez, P.A., de la Cruz Merino, L., Araji Tiliani, O., Terrón León, J.A., and Castro Montaño, J.
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- 2021
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8. SEOM clinical guideline for the management of cutaneous melanoma (2020)
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Majem, M., Manzano, J. L., Marquez-Rodas, I., Mujika, K., Muñoz-Couselo, E., Pérez-Ruiz, E., de la Cruz-Merino, L., Espinosa, E., Gonzalez-Cao, M., and Berrocal, A.
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- 2021
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9. Impact of intestinal dysbiosis-related drugs on the efficacy of immune checkpoint inhibitors in clinical practice
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Pérez-Ruiz, E., Jiménez-Castro, J., Berciano-Guerrero, M.-A., Valdivia, J., Estalella-Mendoza, S., Toscano, F., Rodriguez de la Borbolla Artacho, M., Garrido-Siles, M., Martínez-Bautista, M. J., Villatoro Roldan, R., Rivas-Ruiz, F., Nogales-Fernández, E., Morales, C., Pérez-Valderrama, B., De la Cruz-Merino, L., and Rueda, A.
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- 2020
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10. SEOM clinical guideline for the management of immune-related adverse events in patients treated with immune checkpoint inhibitors (2019)
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Majem, M., García-Martínez, E., Martinez, M., Muñoz-Couselo, E., Rodriguez-Abreu, D., Alvarez, R., Arance, A., Berrocal, A., de la Cruz-Merino, L., and Lopez-Martin, J. A.
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- 2020
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11. Access to innovative medicines for metastatic melanoma worldwide: Melanoma World Society and European Association of Dermato-oncology survey in 34 countries
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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., and Garbe, C.
- Published
- 2018
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12. 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
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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., and Harbeck, N.
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- 2018
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13. New horizons in breast cancer: the promise of immunotherapy
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de la Cruz-Merino, L., Palazón-Carrión, N., Henao-Carrasco, F., Nogales-Fernández, E., Álamo-de la Gala, M., Vallejo-Benítez, A., Chiesa, M., Sánchez-Margalet, V., and GEICAM (Spanish Breast Cancer Research Group) and GÉTICA (Spanish Group for Cancer Immuno-Biotherapy)
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- 2019
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14. SEOM clinical guidelines in advanced and recurrent breast cancer (2018)
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Chacón López-Muñiz, J. I., de la Cruz Merino, L., Gavilá Gregori, J., Martínez Dueñas, E., Oliveira, M., Seguí Palmer, M. A., Álvarez López, I., Antolin Novoa, S., Bellet Ezquerra, M., and López-Tarruella Cobo, S.
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- 2019
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15. Advances in the Immunobiological Therapies for Advanced Melanoma
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Gago, M.C. Pérez, Gadea, O. Saavedra Santa, and de la Cruz-Merino, L.
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- 2017
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16. Nuevos avances de tratamiento inmunobiológico en el melanoma avanzado
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Pérez Gago, M.C., Saavedra Santa Gadea, O., and de la Cruz-Merino, L.
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- 2017
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17. More than 5000 patients with metastatic melanoma in Europe per year do not have access to recommended first-line innovative treatments
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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.
- Published
- 2017
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18. 2018 consensus statement by the Spanish Society of Pathology and the Spanish Society of Medical Oncology on the diagnosis and treatment of cancer of unknown primary
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Losa, F., Iglesias, L., Pané, M., Sanz, J., Nieto, B., Fusté, V., de la Cruz-Merino, L., Concha, Á., Balañá, C., and Matías-Guiu, X.
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- 2018
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19. Matrix Metalloproteinase-9 Expression Is Associated with the Absence of Response to Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Patients
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Universitat Rovira i Virgili, Lejeune, M; Reverte, L; Gallardo, N; Sauras, E; Bosch, R; Mata, D; Roso, A; Petit, A; Peg, V; Riu, F; Garcia-Fontgivell, J; Relea, F; Vieites, B; de la Cruz-merino, L; Arenas, M; Rodriguez, V; Galera, J; Korzynska, A; Plancoulaine, B; Alvaro, T; Lopez, C, Universitat Rovira i Virgili, and Lejeune, M; Reverte, L; Gallardo, N; Sauras, E; Bosch, R; Mata, D; Roso, A; Petit, A; Peg, V; Riu, F; Garcia-Fontgivell, J; Relea, F; Vieites, B; de la Cruz-merino, L; Arenas, M; Rodriguez, V; Galera, J; Korzynska, A; Plancoulaine, B; Alvaro, T; Lopez, C
- Abstract
Triple-negative breast cancer (TNBC) is particularly challenging due to the weak or absent response to therapeutics and its poor prognosis. The effectiveness of neoadjuvant chemotherapy (NAC) response is strongly influenced by changes in elements of the tumor microenvironment (TME). This work aimed to characterize the residual TME composition in 96 TNBC patients using immunohistochemistry and in situ hybridization techniques and evaluate its prognostic implications for partial responders vs. non-responders. Compared with non-responders, partial responders containing higher levels of CD83+ mature dendritic cells, FOXP3+ regulatory T cells, and IL-15 expression but lower CD138+ cell concentration exhibited better OS and RFS. However, along with tumor diameter and positive nodal status at diagnosis, matrix metalloproteinase-9 (MMP-9) expression in the residual TME was identified as an independent factor associated with the impaired response to NAC. This study yields new insights into the key components of the residual tumor bed, such as MMP-9, which is strictly associated with the lack of a pathological response to NAC. This knowledge might help early identification of TNBC patients less likely to respond to NAC and allow the establishment of new therapeutic targets.
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- 2023
20. Prognostic Implications of the Residual Tumor Microenvironment after Neoadjuvant Chemotherapy in Triple-Negative Breast Cancer Patients without Pathological Complete Response
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Universitat Rovira i Virgili, Lejeune, M; Reverté, L; Sauras, E; Gallardo, N; Bosch, R; Roso, A; Petit, A; Peg, V; Riu, F; García-Fontgivell, J; Ibáñez, J; Relea, F; Vieites, B; Bor, C; de la Cruz-Merino, L; Arenas, M; Rodriguez, V; Galera, J; Korzynska, A; Belhomme, P; Plancoulaine, B; Alvaro, T; López, C, Universitat Rovira i Virgili, and Lejeune, M; Reverté, L; Sauras, E; Gallardo, N; Bosch, R; Roso, A; Petit, A; Peg, V; Riu, F; García-Fontgivell, J; Ibáñez, J; Relea, F; Vieites, B; Bor, C; de la Cruz-Merino, L; Arenas, M; Rodriguez, V; Galera, J; Korzynska, A; Belhomme, P; Plancoulaine, B; Alvaro, T; López, C
- Abstract
With a high risk of relapse and death, and a poor or absent response to therapeutics, the triple-negative breast cancer (TNBC) subtype is particularly challenging, especially in patients who cannot achieve a pathological complete response (pCR) after neoadjuvant chemotherapy (NAC). Although the tumor microenvironment (TME) is known to influence disease progression and the effectiveness of therapeutics, its predictive and prognostic potential remains uncertain. This work aimed to define the residual TME profile after NAC of a retrospective cohort with 96 TNBC patients by immunohistochemical staining (cell markers) and chromogenic in situ hybridization (genetic markers). Kaplan–Meier curves were used to estimate the influence of the selected TME markers on five-year overall survival (OS) and relapse-free survival (RFS) probabilities. The risks of each variable being associated with relapse and death were determined through univariate and multivariate Cox analyses. We describe a unique tumor-infiltrating immune profile with high levels of lymphocytes (CD4, FOXP3) and dendritic cells (CD21, CD1a and CD83) that are valuable prognostic factors in post-NAC TNBC patients. Our study also demonstrates the value of considering not only cellular but also genetic TME markers such as MUC-1 and CXCL13 in routine clinical diagnosis to refine prognosis modelling.
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- 2023
21. 42TiP A multicenter, randomized, double-blind phase III study of HBI-8000 combined with nivolumab versus placebo with nivolumab in patients with unresectable or metastatic melanoma not previously treated with PD-1 or PD-L1 inhibitors
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Khushalani, N.I., primary, Shue, H., additional, Gedye, C., additional, Mazumder, A., additional, Sharma, S., additional, Eastgate, M., additional, Majem Tarruella, M., additional, Antonanzas Basa, M., additional, Montaudie, H., additional, Marais-Nieman, R., additional, de la Cruz Merino, L., additional, Clements, A., additional, Mortier, L., additional, Jameson, M., additional, Shojaei, F., additional, Ning, J., additional, Aiyer, L., additional, Gillings, M., additional, Kabbinavar, F., additional, and Ascierto, P., additional
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- 2022
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22. Breast Cancer Immunology and Immunotherapy
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de la Cruz-Merino, L., primary, Chiesa, M., additional, Caballero, R., additional, Rojo, F., additional, Palazón, N., additional, Carrasco, F.H., additional, and Sánchez-Margalet, V., additional
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- 2017
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23. Safety of vemurafenib in patients with BRAF V600 mutated metastatic melanoma: the Spanish experience
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Arance, A. M., Berrocal, A., Lopez-Martin, J. A., de la Cruz-Merino, L., Soriano, V., Martín Algarra, S., Alonso, L., Cerezuela, P., La Orden, B., and Espinosa, E.
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- 2016
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24. Clinical use of ipilimumab for metastatic melanoma in Spain: towards a more consistent approach
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Martín-Algarra, S., de la Cruz-Merino, L., Soriano, V., Manzano, J. L., and Espinosa, E.
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- 2016
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25. 813P Time to development of central nervous system (CNS) metastases (mets) with atezolizumab (A) or placebo (P) combined with vemurafenib (V) + cobimetinib (C): Updated results from the phase III IMspire150 study
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Lewis, K., primary, Robert, C., additional, Ramella Munhoz, R., additional, Liszkay, G., additional, de la Cruz Merino, L., additional, Olah, J., additional, Queirolo, P., additional, Mackiewicz, J., additional, Li, H., additional, Zhu, Q., additional, Hertig, C., additional, Paranthaman, N., additional, McKenna, E.F., additional, Gutzmer, R., additional, McArthur, G., additional, and Ascierto, P.A., additional
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- 2022
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26. 823P A propensity score weighted comparison of tebentafusp or pembrolizumab versus combination ipilimumab and nivolumab in untreated metastatic uveal melanoma
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Piulats Rodriguez, J.M., primary, Piperno-Neumann, S., additional, Rutkowski, P., additional, Nathan, P., additional, Hassel, J.C., additional, Espinosa, E., additional, de la Cruz Merino, L., additional, Ochsenreither, S., additional, Shoushtari, A.N., additional, Orloff, M., additional, Salama, A.K.S., additional, Watkins, C., additional, Goodall, H., additional, and Baurain, J-F., additional
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- 2022
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27. Lenalidomide plus R-GDP (R2-GDP) in Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Final Results of the R2-GDP-GOTEL Trial and Immune Biomarker Subanalysis
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Universitat Rovira i Virgili, Palazón-Carrión N; Martín García-Sancho A; Nogales-Fernández E; Jiménez-Cortegana C; Carnicero-González F; Ríos-Herranz E; de la Cruz-Vicente F; Rodríguez-García G; Fernández-Álvarez R; Martínez-Banaclocha N; Gumà-Padrò J; Gómez-Codina J; Salar-Silvestre A; Rodríguez-Abreu D; Gálvez-Carvajal L; Labrador J; Guirado-Risueño M; García-Domínguez DJ; Hontecillas-Prieto L; Espejo-García P; Fernández-Román I; Provencio-Pulla M; Sánchez-Beato M; Navarro M; Marylene L; Álvaro-Naranjo T; Casanova-Espinosa M; Sánchez-Margalet V; Rueda-Domínguez A; de la Cruz-Merino L, Universitat Rovira i Virgili, and Palazón-Carrión N; Martín García-Sancho A; Nogales-Fernández E; Jiménez-Cortegana C; Carnicero-González F; Ríos-Herranz E; de la Cruz-Vicente F; Rodríguez-García G; Fernández-Álvarez R; Martínez-Banaclocha N; Gumà-Padrò J; Gómez-Codina J; Salar-Silvestre A; Rodríguez-Abreu D; Gálvez-Carvajal L; Labrador J; Guirado-Risueño M; García-Domínguez DJ; Hontecillas-Prieto L; Espejo-García P; Fernández-Román I; Provencio-Pulla M; Sánchez-Beato M; Navarro M; Marylene L; Álvaro-Naranjo T; Casanova-Espinosa M; Sánchez-Margalet V; Rueda-Domínguez A; de la Cruz-Merino L
- Abstract
New therapeutic options are needed in relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Lenalidomide-based schedules can reverse rituximab refractoriness in lymphoma.In the phase II R2-GDP trial, 78 patients unsuitable for autologous stem cell transplant received treatment with the following schedule: lenalidomide 10 mg Days (D)1-14, rituximab 375 mg/m2 D1, cisplatin 60 mg/m2 D1, gemcitabine 750 mg/m2 D1 and D8, and dexamethasone 20 mg D1-3, up to 6 cycles (induction phase), followed by lenalidomide 10 mg (or last lenalidomide dose received) D1-21 every 28 days (maintenance phase). Primary endpoint was overall response rate (ORR). Secondary endpoints included progression-free survival (PFS), overall survival (OS), safety, and monitorization of key circulating immune biomarkers (EU Clinical Trials Register number: EudraCT 2014-001620-29).After a median follow-up of 37 months, ORR was 60.2% [37.1% complete responses (CR) and 23.1% partial responses (PR)]. Median OS was 12 months (47 vs. 6 months in CR vs. no CR); median PFS was 9 months (34 vs. 5 months in CR vs. no CR). In the primary refractory population, ORR was 45.5% (21.2% CR and 24.3% PR). Most common grade 3-4 adverse events were thrombocytopenia (60.2%), neutropenia (60.2%), anemia (26.9%), infections (15.3%), and febrile neutropenia (14.1%). Complete responses were associated with a sharp decrease in circulating myeloid-derived suppressor cells and regulatory T cells.R2-GDP schedule is feasible and highly active in R/R DLBCL, including the primary refractory population. Immune biomarkers showed differences in responders versus progressors.©2022 The Authors; Published by the American Association for Cancer Research.
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- 2022
28. SEOM clinical guidelines for the treatment of follicular non-Hodgkin’s lymphoma
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Provencio Pulla, M., Alfaro Lizaso, J., de la Cruz Merino, L., Gumá i Padró, J., Quero Blanco, C., Gómez Codina, J., Llanos Muñoz, M., Martinez Banaclocha, N., Rodriguez Abreu, D., and Rueda Domínguez, A.
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- 2015
- Full Text
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29. SEOM clinical guidelines in metastatic breast cancer 2015
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Gavilá, J., Lopez-Tarruella, S., Saura, C., Muñoz, M., Oliveira, M., De la Cruz-Merino, L., Morales, S., Alvarez, I., Virizuela, J. A., and Martin, M.
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- 2015
- Full Text
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30. SEOM clinical guidelines for the treatment of Hodgkin’s lymphoma
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Rueda Domínguez, A., Alfaro Lizaso, J., de la Cruz Merino, L., Gumá i Padró, J., Quero Blanco, C., Gómez Codina, J., Llanos Muñoz, M., Martinez Banaclocha, N., Rodriguez Abreu, D., and Provencio Pulla, M.
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- 2015
- Full Text
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31. Adjuvant regimens with trastuzumab administered for small HER2-positive breast cancer in routine clinical practice
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Antolín-Novoa, S., Blanco-Campanario, E., Antón, A., Gallegos-Sancho, M. I., Pérez-Carrión, R., Peláez, I., Galán-Brotons, A., de la Cruz-Merino, L., and Murías-Rosales, A.
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- 2015
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32. LBA4 Updated overall survival (OS) results from the first-line (1L) population in the phase III MONALEESA-3 trial of postmenopausal patients (PTS) with HR+/HER2− advanced breast cancer (ABC) treated with ribociclib (RIB) + fulvestrant (FUL)
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Neven, P., primary, Fasching, P.A., additional, Chia, S., additional, Jerusalem, G., additional, De Laurentiis, M., additional, Im, S.-A., additional, Petrakova, K., additional, Bianchi, G.V., additional, Martin Jimenez, M., additional, Nusch, A., additional, Sonke, G.S., additional, de la Cruz Merino, L., additional, Beck, J.T., additional, Zarate, J.P., additional, Wang, Y., additional, Chakravartty, A., additional, Wang, C., additional, and Slamon, D., additional
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- 2022
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33. The complexity of cancer immunotherapy illustrated through skin tumors
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Vieco-Martí, I., primary, López-Carrasco, A., additional, de la Cruz-Merino, L., additional, Noguera, R., additional, and Álvaro Naranjo, T., additional
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- 2022
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34. Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2–advanced breast cancer: GEICAM/2014–12 (FLIPPER)
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Albanell, J., primary, Martínez, M.T., additional, Ramos, M., additional, O'Connor, M., additional, de la Cruz-Merino, L., additional, Santaballa, A., additional, Martínez-Jañez, N., additional, Moreno, F., additional, Fernández, I., additional, Alarcón, J., additional, Virizuela, J.A., additional, de la Haba-Rodríguez, J., additional, Sánchez-Rovira, P., additional, González-Cortijo, L., additional, Margelí, M., additional, Sánchez-Muñoz, A., additional, Antón, A., additional, Casas, M., additional, Bezares, S., additional, and Rojo, F., additional
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- 2022
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35. Clinical guideline SEOM: cancer of unknown primary site
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Collado Martín, R., García Palomo, A., de la Cruz Merino, L., Borrega García, P., and Barón Duarte, F. J.
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- 2014
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36. 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
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Miles, D., primary, Ciruelos, E., additional, Schneeweiss, A., additional, Puglisi, F., additional, Peretz-Yablonski, T., additional, Campone, M., additional, Bondarenko, I., additional, Nowecki, Z., additional, Errihani, H., additional, Paluch-Shimon, S., additional, Wardley, A., additional, Merot, J.-L., additional, Trask, P., additional, du Toit, Y., additional, Pena-Murillo, C., additional, Revelant, V., additional, Klingbiel, D., additional, Bachelot, T., additional, Bouzid, K., additional, Desmoulins, I., additional, Coudert, B., additional, Glogowska, I., additional, Ciruelos Gil, E., additional, Dalenc, F., additional, Ricci, F., additional, Dieras, V., additional, Kaufman, B., additional, Ferreira, A., additional, Mano, M., additional, Kalofonos, H., additional, Andreetta, C., additional, Montemurro, F., additional, Barrett, S., additional, Zhang, Q., additional, Mavroudis, D., additional, Matus, J., additional, Villarreal Garza, C., additional, Beato, C., additional, Ismael, G., additional, Hu, X., additional, Abdel Azeem, H., additional, Gaafar, R., additional, Perrin, C., additional, Kerbrat, P., additional, Ettl, J., additional, Paepke, S., additional, Hitre, E., additional, Lang, I., additional, Trudeau, M., additional, Verma, S., additional, Li, H., additional, Hoffmann, O., additional, Aktas, B., additional, Cariello, A., additional, Cruciani, G., additional, Tienghi, A., additional, Tondini, C., additional, Al-Twegieri, T., additional, Loman, N., additional, Laing, R., additional, Miles, D., additional, Brain, E., additional, Fasching, P., additional, Lux, M., additional, Frassoldati, A., additional, Aziz, Z., additional, Salas, J., additional, Streb, J., additional, Krzemieniecki, K., additional, Wronski, A., additional, Garcia Garcia, J., additional, Menjon Beltran, S., additional, Cicin, I., additional, Schmid, P., additional, Gallagher, C., additional, Turner, N., additional, Tong, Z., additional, Boer, K., additional, Juhász, B., additional, Horvath, Z., additional, Bianchini, G., additional, Gianni, L., additional, Curigliano, G., additional, Juarez Ramiro, A., additional, Susnjar, S., additional, Matos, E., additional, Sevillano, E., additional, Garcia Estevez, L., additional, Gokmen, E., additional, Uslu, R., additional, Wildiers, H., additional, Schutz, F., additional, Cruz, M., additional, Bourgeois, H., additional, von Schumann, R., additional, Stemmer, S., additional, Dominguez, A., additional, Morales-Vásques, F., additional, Wojtukiewicz, M., additional, Trifunovic, J., additional, Echarri Gonzalez, M.J., additional, Illarramendi Mañas, J., additional, Martinez De Dueñas, E., additional, Voitko, N., additional, Hicks, J., additional, Waters, S., additional, Barrett-Lee, P., additional, Wheatley, D., additional, De Boer, R., additional, Cocquyt, V., additional, Jerusalem, G., additional, Barrios, C., additional, Panasci, L., additional, Mattson, J., additional, Tanner, M., additional, Gozy, M., additional, Vasilopoulos, G., additional, Papandreou, C., additional, Revesz, J., additional, Battelli, N., additional, Benedetti, G., additional, Latini, L., additional, Gridelli, C., additional, Lazaro Leon, J., additional, Alarcón Company, J., additional, Arance Fernandez, A., additional, Barnadas Molins, A., additional, Calvo Plaza, I., additional, Bratos, R., additional, Gonzalez Martin, A., additional, Izarzugaza Peron, Y., additional, Klint, L., additional, Kovalev, A., additional, McCarthy, N., additional, Yeo, B., additional, Kee, D., additional, Thomson, J., additional, White, S., additional, Greil, R., additional, Wang, S., additional, Artignan, X., additional, Juhasz-Böess, I., additional, Rody, A., additional, Ngan, R., additional, Dourleshter, F., additional, Goldberg, H., additional, Doni, L., additional, Di Costanzo, F., additional, Ferraù, F., additional, Drobniene, M., additional, Aleknavicius, E., additional, Rashid, K., additional, Costa, L., additional, de la Cruz Merino, L., additional, Garcia Saenz, J., additional, López, R., additional, Del Val Munoz, O., additional, Ozyilkan, O., additional, Azribi, F., additional, Jaafar, H., additional, Baird, R., additional, Verrill, M., additional, Beith, J., additional, Petzer, A., additional, Moreira de Andrade, J., additional, Bernstein, V., additional, Macpherson, N., additional, Rayson, D., additional, Saad Eldin, I., additional, Achille, M., additional, Augereau, P., additional, Müller, V., additional, Rasco, A., additional, Evron, E., additional, Katz, D., additional, Berardi, R., additional, Cascinu, S., additional, De Censi, A., additional, Gennari, A., additional, El-Saghir, N., additional, Ghosn, M., additional, Oosterkamp, H.M., additional, Van den Bosch, J., additional, Kukulska, M., additional, Kalinka, E., additional, Alonso, J., additional, Dalmau Portulas, E., additional, Del Mar Gordon Santiago, M., additional, Pelaez Fernandez, I., additional, Aksoy, S., additional, Altundag, K., additional, Senol Coskun, H., additional, Bozcuk, H., additional, Shparyk, Y., additional, Barraclough, L., additional, Levitt, N., additional, Panwar, U., additional, Kelly, S., additional, Rigg, A., additional, Varughese, M., additional, Castillo, C., additional, Fein, L., additional, Malik, L., additional, Stuart-Harris, R., additional, Singer, C., additional, Stoeger, H., additional, Samonigg, H., additional, Feng, J., additional, Cedeño, M., additional, Ruohola, J., additional, Berdah, J.-F., additional, Goncalves, A., additional, Orfeuvre, H., additional, Grischke, E.-M., additional, Simon, E., additional, Wagner, S., additional, Koumakis, G., additional, Papazisis, K., additional, Ben Baruch, N., additional, Fried, G., additional, Geffen, D., additional, Karminsky, N., additional, Peretz, T., additional, Cavanna, L., additional, Pedrazzioli, P., additional, Grasso, D., additional, Ruggeri, E., additional, D’Auria, G., additional, Moscetti, L., additional, Juozaityte, E., additional, Rodriguez Cid, J., additional, Roerdink, H., additional, Siddiqi, N., additional, Passos Coelho, J., additional, Arcediano Del Amo, A., additional, Garcia Garre, E., additional, García Gonzalez, M., additional, Garcia-Palomo Perez, A., additional, Herenandez Perez, C., additional, Lopez Alvarez, P., additional, Lopez De Ceballos, M.H., additional, Martínez Jañez, N., additional, Mele Olive, M., additional, McAdam, K., additional, Perren, T., additional, Dunn, G., additional, Humphreys, A., additional, Taylor, W., additional, Vera, R., additional, Kaen, L., additional, Andel, J., additional, Steger, G., additional, De Grève, J., additional, Huizing, M., additional, Hegg, R., additional, Joy, A., additional, Kuruvilla, P., additional, Sehdev, S., additional, Smiljanic, S., additional, Kütner, R., additional, Alexandre, J., additional, Grosjean, J., additional, Laplaige, P., additional, Largillier, R., additional, Maes, P., additional, Martin, P., additional, Pottier, V., additional, Christensen, B., additional, Khandan, F., additional, Lück, H.-J., additional, Zahm, D.-M., additional, Fountzilas, G., additional, Karavasilis, V., additional, Safra, T., additional, Inbar, M., additional, Ryvo, L., additional, Bonetti, A., additional, Seles, E., additional, Giacobino, A., additional, Chavarri Guerra, Y., additional, de Jongh, F., additional, van der Velden, A., additional, van Warmerdam, L., additional, Vrijaldenhoven, S., additional, Smorenburg, C.H., additional, Cavero, M., additional, Andres Conejero, R., additional, Oltra Ferrando, A., additional, Redondo Sanchez, A., additional, Ribelles Entrena, N., additional, Saura Grau, S., additional, Viñas Vilaro, G., additional, Bachmeier, K., additional, Beresford, M., additional, Butt, M., additional, Joffe, J., additional, Poole, C., additional, Woodings, P., additional, Chakraborti, P., additional, Yordi, G., additional, Woodward, N., additional, Nobre, A., additional, Luiz Amorim, G., additional, Califaretti, N., additional, Fox, S., additional, Robidoux, A., additional, Li, E., additional, Li, N., additional, Jiang, J., additional, Soria, T., additional, Padrik, P., additional, Lahdenpera, O., additional, Barletta, H., additional, Dohollou, N., additional, Genet, D., additional, Prulhiere, K., additional, Coeffic, D., additional, Facchini, T., additional, Vieillot, S., additional, Catala, S., additional, Teixeira, L., additional, Hesse, T., additional, Kühn, T., additional, Ober, A., additional, Repp, R., additional, Schröder, W., additional, Pectasides, D., additional, Bodoky, G., additional, Kahan, Z., additional, Jiveliouk, I., additional, Rosengarten, O., additional, Rossi, V., additional, Alabiso, O., additional, Pérez Martínez, M., additional, van de Wouw, A.J., additional, Smok-Kalwat, J., additional, Damasecno, M., additional, Augusto, I., additional, Sousa, G., additional, Saadein, A., additional, Abdelhafiez, N., additional, Abulkhair, O., additional, Antón Torres, A., additional, Corbellas Aparicio, M., additional, Llorente Domenech, R., additional, Florián Jerico, J., additional, Garcia Mata, J., additional, Gil Raga, M., additional, Galan Brotons, A., additional, Llombart Cussac, A., additional, Llorca Ferrandiz, C., additional, Martinez Del Prado, P., additional, Olier Garate, C., additional, Rodriguez Sanchez, C., additional, Sanchez Gomez, R., additional, Santisteban Eslava, M., additional, Soberino, J., additional, Vidal Losada Garcia, M., additional, Soto de Prado, D., additional, Torrego Garcia, J., additional, Vicente Rubio, E., additional, Garcia, M., additional, Murias Rosales, A., additional, Granstam Björneklett, H., additional, Narbe, U., additional, Jafri, M., additional, Rea, D., additional, Newby, J., additional, Jones, A., additional, Westwell, S., additional, Ring, A., additional, Alonso, I., additional, and Rodríguez, R., additional
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- 2021
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37. Corrigendum to ‘Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival’
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Slamon, D.J., primary, Neven, P., additional, Chia, S., additional, Jerusalem, G., additional, De Laurentiis, M., additional, Im, S., additional, Petrakova, K., additional, Valeria Bianchi, G., additional, Martín, M., additional, Nusch, A., additional, Sonke, G.S., additional, De la Cruz-Merino, L., additional, Beck, J.T., additional, Ji, Y., additional, Wang, C., additional, Deore, U., additional, Chakravartty, A., additional, Zarate, J.P., additional, Taran, T., additional, and Fasching, P.A., additional
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- 2021
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38. Avoidance of Cancer Cell Destruction by the Immune System
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de la Cruz-Merino, L., primary, Illescas-Vacas, A., additional, and Sánchez-Escribano, R., additional
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- 2014
- Full Text
- View/download PDF
39. Contributors
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Abbasi, S., primary, Adolphi, N.L., additional, Aikawa, E., additional, Akbar, H., additional, Akilesh, S., additional, Aladjem, M.I., additional, Allocca, M., additional, Alpini, G., additional, Alroy, J., additional, Altman, B.J., additional, Andujar, P., additional, Antonello, Z.A., additional, Antsiferova, M., additional, Apica, B.S., additional, Ariel, I., additional, Aronow, B.J., additional, Ashley, J.W., additional, Badell, I.R., additional, Bagg, A., additional, Bajaj, M., additional, Banerjee, S., additional, Barbieri, J.S., additional, Bardes, E.E., additional, Barisoni, L., additional, Barletta, J.A., additional, Baskin, D.G., additional, Bastarrachea, R.A., additional, Bayat, A., additional, Bayrak-Toydemir, P., additional, Beck, A.H., additional, Beebe, D.C., additional, Beltran, H., additional, Benichou, G., additional, Bergman, M., additional, Bernard, S.A., additional, Bernardi, P., additional, Best, D.H., additional, Blair, H.C., additional, Bonaldo, P., additional, Bondy, J., additional, Bosman, F.T., additional, Bouma, B.E., additional, Brandi, M.L., additional, Bresler, S.C., additional, Brewer, M.T., additional, Britto, C.J., additional, Brock, J.E., additional, Brosens, L.A.A., additional, Budge, H., additional, Burd, E.M., additional, Burness, M.L., additional, Bushnell, T., additional, Byrd, J., additional, Calderone, A., additional, Campbell, M.J., additional, Cao, D., additional, Capell, W., additional, Cardigan, R., additional, Carey, P.M., additional, Carneiro, F., additional, Carp, S.A., additional, Carter, A.M., additional, Cascio, M.J., additional, Castellani, R.J., additional, Castellanos, J., additional, Caviglia, J.M., additional, Cecconi, F., additional, Chamarthy, S., additional, Chamma, E., additional, Chang, A., additional, Chang, A.Y., additional, Chang, N.C., additional, Chapman, D.G., additional, Charles, A.K., additional, Chen, D., additional, Chen, D.F., additional, Chen, P., additional, Cheng, J., additional, Chernock, R.D., additional, Cheruvu, S., additional, Chiang, J., additional, Childs, G.V., additional, Cho, Y.-B., additional, Choi, A.M.K., additional, Choi, J.K., additional, Cipriani, N.A., additional, Cleary, J.O.S.H., additional, Clementi, E., additional, Clines, G.A., additional, Cohen, M.L., additional, Coleman, W.B., additional, Coletta, D.K., additional, Collie, A.M.B., additional, Cooling, L., additional, Coron, E., additional, Côté, D., additional, Coussens, L.M., additional, Crielaard, B.J., additional, Cron, R.Q., additional, Crum, C.P., additional, Cruz, N.M., additional, Dairkee, S.H., additional, Daly, C.A., additional, Dang, C.V., additional, Danila, M.I., additional, Daradich, A., additional, Darnell, C.M., additional, Dartt, D.A., additional, Das, A., additional, D’Asta, F., additional, DeFronzo, R., additional, De Hertogh, G., additional, Dela Cruz, C.S., additional, de la Cruz-Merino, L., additional, De Palma, C., additional, Demetris, A.J., additional, DeMorrow, S., additional, Denechaud, P.-D., additional, Di Carli, M.F., additional, DiCarlo, E.F., additional, Dikic, I., additional, Dimberg, A., additional, Dowell, M.L., additional, Doyle, L.A., additional, Drachenberg, C.B., additional, Driskell, E., additional, Duda, D.G., additional, Duker, J., additional, Dyck, J.R.B., additional, Ecker, C., additional, Elifritz, J.M., additional, Elsheikh, T.M., additional, Ensari, A., additional, Ernst, L.M., additional, Esch, K.J., additional, Fajas-Coll, L., additional, Fang, Q., additional, Farhat, N.A., additional, Farshid, G., additional, Faye-Petersen, O.M., additional, Fehlings, M.G., additional, Fend, F., additional, Feng, X., additional, Fernandes, H., additional, Fernandez-Checa, J.C., additional, Ferreira, B.P., additional, Fidler, I.J., additional, Finn, J.A., additional, Fischer, A., additional, Fishbein, M.C., additional, Fleit, H.B., additional, Flomenbaum, M., additional, Folkins, A., additional, Francis, H., additional, Frank, K.M., additional, Frevert, C.W., additional, Frias, A.E., additional, Friedman, J.R., additional, Fukumura, D., additional, Furie, M.B., additional, Gaffo, A.L., additional, Galateau-Sallé, F., additional, Gallegos-Cabriales, E.C., additional, Gandhi, C.R., additional, Gannon, M., additional, García-Moliner, M.L., additional, Gardner, J.M., additional, Gasper, C.A., additional, Gaulard, P., additional, Gaut, J.P., additional, Gavia-García, G., additional, Gerrard, C., additional, Ghosh, A.P., additional, Giersch, A.B.S, additional, Gilbert, S.R., additional, Gill, J.R., additional, Giusti, F., additional, Glorioso, J.M., additional, González-Torres, M.C., additional, Goolsby, C.L., additional, Gora, M.J., additional, Gordon, I.O., additional, Gotlieb, A.I., additional, Gouw, A.M., additional, Goyal, A., additional, Grégoire, M., additional, Graham, B.B., additional, Granger, D.N., additional, Greene, A.K., additional, Greenlee, J.J., additional, Griffiths, R., additional, Guimarães, A.R., additional, Gulati, M., additional, Gullet, A., additional, Gupta, S., additional, Haider, N.B., additional, Halushka, M.K., additional, Hambuch, T.M., additional, Hamza, S.M., additional, Han, Y., additional, Hansen, W.P., additional, Hard, R., additional, Harris, B.T., additional, Harris, J.E., additional, Hartnett, M.E., additional, Hasserjian, R.P., additional, Hatch, G.M., additional, Hefti, M.M., additional, Heller, D.S., additional, Hemminger, J.A., additional, Hendrickson, J.E., additional, Henley, K.D., additional, Herzog, E., additional, Hess, J.R., additional, Hill, C.E., additional, Hipp, J., additional, Hobbs, R., additional, Höller, D., additional, Hodges, R.R., additional, Homer, R.J., additional, Horowitz, N., additional, Hsi, E.D., additional, Hsieh, A.L., additional, Hunt, J.M., additional, Hure, S., additional, Husain, A.N., additional, Hussey, S., additional, Hutcheson, J.D., additional, Hutson, R.M., additional, Illescas-Vacas, A., additional, Irvin, C.G., additional, Jaffer, F.A., additional, Jäger, R., additional, Jain, R.K., additional, Jain, S., additional, James, J., additional, Jansen, M., additional, Jarzembowski, J.A., additional, Jaurand, M.-C., additional, Jean, D., additional, Jegga, A.G., additional, Jellinger, K.A., additional, Jen, K.-Y., additional, Jo, V.Y., additional, Johnson, B., additional, Jones, R.L., additional, Kalfa, T.A., additional, Kamionek, M., additional, Kang, D., additional, Kantari, C., additional, Kantor, P.F., additional, Kanzaki, G., additional, Karns, R., additional, Katzman, P.J., additional, Kawai, T., additional, Kelley, T.W., additional, Kent, J.W., additional, Kerr, E.H., additional, Kew, R.R., additional, Khalighi, M., additional, Khanh Vu, T.H., additional, Khong, T.Y., additional, Kim, B.S., additional, Kim, J., additional, Klein, M.J., additional, Knechtle, S.J., additional, Konkle, B.A., additional, Kowalewska, J., additional, Kricka, L.J., additional, Krishnan, B., additional, Kumar, A., additional, Kumar, S., additional, Kvietys, P., additional, Kwong, R.Y., additional, Lafont, E., additional, Laga, A.C., additional, Lagarrigue, S., additional, Lakin, A., additional, Laszik, Z.G., additional, Lauwers, G.Y., additional, Laver, N.V., additional, Lawlor, M.W., additional, Lederer, J.A., additional, Lee, R.E., additional, Lee, W.M., additional, LeGallo, R., additional, Leich, E., additional, Lemmens, B., additional, Le Pimpec-Barthes, F., additional, Leval, L., additional, Levy, B.D., additional, Lewis, J.S., additional, Lewis, T.L., additional, Leyva-Illades, D., additional, Li, L., additional, Li, Y.-P., additional, Lianidou, E.S., additional, Liao, L., additional, Liapis, H., additional, Lin, J.B., additional, Lin, A.-L., additional, Lindsay, M.E., additional, Liu, E., additional, Longacre, T., additional, Lopez-Alvarenga, J.C., additional, Lopez-Mejía, I., additional, Lozanski, G., additional, Lucia, M.S., additional, Luk, E., additional, Lutty, G.A., additional, Maclellan, R.A., additional, Madabhushi, A., additional, Mahindra, A., additional, Malek, E., additional, Mammucari, C., additional, Mani, H., additional, Mao, S.A., additional, Marboe, C.C., additional, Marí, M., additional, Marini, F., additional, Markou, A., additional, Marshall, A.H., additional, Martin, S.J., additional, Marzioni, M., additional, Masli, S., additional, Matsukuma, K.E., additional, Matulonis, U.A., additional, Mayfield, J., additional, McCoy, J.P., additional, McDougle, C.J., additional, McGinnis, M.R., additional, McGuire, A., additional, McKinstry, K.K., additional, McManus, B.M., additional, Means, A.L., additional, Meny, G.M., additional, Merchant, N., additional, Meserve, E.E.K, additional, Mess, A.M., additional, Minervini, M.I., additional, Mitchell, R.N., additional, Monaco, S.E., additional, Monga, S.P., additional, Monica Way, H.-Y., additional, Montecucco, C., additional, Montone, K.T., additional, Morgan, E.A., additional, Morgan, T.K., additional, Morrissey, K., additional, Mortensen, R.M., additional, Moser, S.A., additional, Mosquera, J.M., additional, Mossman, B.T., additional, Motta, A.C.F., additional, Mullins, E., additional, Murphy, G.F., additional, Murray, L., additional, Mysorekar, I.U., additional, Nadel, B., additional, Nadon, A.S., additional, Nagathihalli, N., additional, Nájera-Medina, O., additional, Nalesnik, M.A., additional, Nast, C.C., additional, Natkunam, Y., additional, Nault, J.C., additional, Nava-González, E.J., additional, Nayar, R., additional, Nerenz, R.D., additional, Neumann, H., additional, Ni, H., additional, Nolte, K.B., additional, Norton, L., additional, Nowak, J., additional, Nucera, C., additional, Nyberg, S.L., additional, Oakes, S.A., additional, Offerhaus, G.J.A., additional, Ojha, S., additional, Okabe, H., additional, Oliveira, A.M., additional, Osborn, E.A., additional, O'Tierney-Ginn, P., additional, Ott, G., additional, Ozcan, A., additional, Padera, R.F., additional, Pagano, M.B., additional, Page, E.K., additional, Paintal, A.S., additional, Pairon, J.-C., additional, Papadimitriou, J.C., additional, Park, H.-J., additional, Park, J.Y., additional, Parsons, L.N., additional, Patra, D., additional, Peclovits, A., additional, Peeters, P.M., additional, Perkins, T.N., additional, Perry, G., additional, Perumbeti, A., additional, Petersen, C.A., additional, Petrache, I., additional, Petroff, M.G., additional, Pettus, J.R., additional, Picken, M.M., additional, Pierson, C.R., additional, Pittman, M.E., additional, Pogoriler, J., additional, Politi, K., additional, Pollack, S.M., additional, Quintanilla-Martínez, L., additional, Rai, M.F., additional, Ramkissoon, S., additional, Randhawa, P.S., additional, Rangel, J.R., additional, Rasola, A., additional, Reeves, B., additional, Reheman, A., additional, Remick, D.G., additional, Reynaert, N.L., additional, Richmond, J.M., additional, Rivella, S., additional, Rivenbark, A.G., additional, Rizzuto, R., additional, Roberts, K.A., additional, Robin, D.A., additional, Robinson, L.J., additional, Rockey, D.C., additional, Rosenwald, A., additional, Rossetto, O., additional, Roth, K.A., additional, Roy-Chowdhury, J., additional, Roy-Chowdhury, N., additional, Rubin, M.A., additional, Rudnicki, M.A., additional, Russell, D.S., additional, Ryter, S.W., additional, Saban, D.R., additional, Sacher, R.A., additional, Sacks, D.B., additional, Sagaert, X., additional, Sagdeo, A., additional, Sahay, B., additional, Sahin, A., additional, Samali, A., additional, Sampson, B., additional, Sánchez-Escribano, R., additional, Sandri, M., additional, Sanyal, A., additional, Sasatomi, E., additional, Sauer, V., additional, Scherpereel, A., additional, Schmidt, E.P., additional, Schwabe, R.F., additional, Scorrano, L., additional, Scott, M.G., additional, Scull, J.C., additional, Seidman, M.A., additional, Seki, A., additional, Sellati, T.J., additional, Serban, K., additional, Serhan, C.N., additional, Seshan, S.V., additional, Seth, A., additional, Seykora, J.T., additional, Sharma, N., additional, Shi, C., additional, Shi, S.-R., additional, Shimada, M., additional, Shimizu, A., additional, Singer, D.B., additional, Sitko, K., additional, Smallwood, R.F., additional, Smiraglia, D.J., additional, Smith, B.R., additional, Smola, H., additional, Soubeyrand, M., additional, Stahl, W.L., additional, Stajić, M., additional, Stanworth, S.J., additional, Stathatos, N., additional, Stemler, K.M., additional, Stevens, T.M., additional, Stine, Z.E., additional, Stoll, M.L., additional, Strati, A., additional, Strutt, T.M., additional, Sund, M., additional, Sung, M.M., additional, Symonds, M.E., additional, Tabar, S., additional, Takahashi, N., additional, Talmadge, J.E., additional, Tang, V., additional, Tangrea, M., additional, Tarango, C., additional, Tario, J.D., additional, Taylor, C.R., additional, Taylor, R., additional, Tearney, G.J., additional, Tefera, K., additional, Thomas, S., additional, Thornburg, K.L., additional, Tirado, C.A., additional, Tobian, A.A.R., additional, Tomaszewski, J.E., additional, Tormey, C.A., additional, Torres, R., additional, Tran, M.-H., additional, Tredget, E.E., additional, Treister, N.S., additional, Trotter, J., additional, Troyer, D., additional, Truong, L., additional, Tubbs, R.R., additional, Turakhia, S., additional, Unglert, C.I., additional, Utheim, T., additional, Vahabzadeh, A., additional, van Bokhoven, A., additional, Vanden Berghe, T., additional, Vandenabeele, P., additional, van der Klei, I.J., additional, Vanguri, V.K., additional, Van Noorden, C.J.F, additional, Van Poznak, C., additional, Vassallo, R.R., additional, Vawda, R., additional, Vieth, M., additional, Visscher, D.W., additional, Volk, S.W., additional, Vyas, G.N., additional, Waggoner, S.N., additional, Walczak, H., additional, Walker, D.H., additional, Wallace, P.K., additional, Wanat, K.A., additional, Wang, J., additional, Wang, Y., additional, Wang, Y.X., additional, Warger, W.C., additional, Wei, S., additional, Weinman, S.A., additional, Wenig, B.M., additional, Wentz, S.C., additional, Werner, S., additional, Wertheim, G., additional, Whitley, E.M., additional, Wooderchak-Donahue, W., additional, Woods, K., additional, Wouters, E.F.M., additional, Wu, Y., additional, Xing, W., additional, Yachimski, P., additional, Yan, P., additional, Yang, J., additional, Yang, L., additional, Yoshizawa, S., additional, Yuan, J., additional, Yun, S.-H., additional, Yvon, A., additional, Zhang, H., additional, Zhang, P., additional, Zhao, Z., additional, Zhu, G., additional, Zhu, R., additional, Zordoky, B.N., additional, Zou, J., additional, Zuccato, J.A., additional, and Zucman-Rossi, J., additional
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- 2014
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40. LBA3 Pembrolizumab versus placebo after complete resection of high-risk stage II melanoma: Efficacy and safety results from the KEYNOTE-716 double-blind phase III trial
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Luke, J.J., primary, Rutkowski, P., additional, Queirolo, P., additional, Del Vecchio, M., additional, Mackiewicz, J., additional, Chiarion Sileni, V., additional, de la Cruz Merino, L., additional, Khattak, M.A., additional, Schadendorf, D., additional, Long, G.V., additional, Ascierto, P.A., additional, Mandala, M., additional, De Galitiis, F., additional, Sondak, V., additional, Scolyer, R.A., additional, Kirkwood, J.M., additional, Chen, K., additional, Ibrahim, N., additional, Ahsan, S., additional, and Eggermont, A.M.M., additional
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- 2021
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41. Metabolic Classification and Intervention Opportunities for Tumor Energy Dysfunction
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Monferrer E, Vieco-Marti I, Lopez-Carrasco A, Farinas F, Abanades S, de la Cruz-Merino L, Noguera R, and Alvaro Naranjo T
- Abstract
A comprehensive view of cell metabolism provides a new vision of cancer, conceptualized as tissue with cellular-altered metabolism and energetic dysfunction, which can shed light on pathophysiological mechanisms. Cancer is now considered a heterogeneous ecosystem, formed by tumor cells and the microenvironment, which is molecularly, phenotypically, and metabolically reprogrammable. A wealth of evidence confirms metabolic reprogramming activity as the minimum common denominator of cancer, grouping together a wide variety of aberrations that can affect any of the different metabolic pathways involved in cell physiology. This forms the basis for a new proposed classification of cancer according to the altered metabolic pathway(s) and degree of energy dysfunction. Enhanced understanding of the metabolic reprogramming pathways of fatty acids, amino acids, carbohydrates, hypoxia, and acidosis can bring about new therapeutic intervention possibilities from a metabolic perspective of cancer.
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- 2021
42. Circulating myeloid-derived suppressor cells and regulatory T cells as immunological biomarkers in refractory/relapsed diffuse large B-cell lymphoma: translational results from the R2-GDP-GOTEL trial
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Jimenez-Cortegana C, Palazon-Carrion N, Garcia-Sancho A, Nogales-Fernandez E, Carnicero-Gonzalez F, Rios-Herranz E, de la Cruz-Vicente F, Rodriguez-Garcia G, Fernandez-Alvarez R, Dominguez A, Casanova-Espinosa M, Martinez-Banaclocha N, Guma-Padro J, Gomez-Codina J, Labrador J, Salar-Silvestre A, Rodriguez-Abreu D, Galvez-Carvajal L, Provencio M, Sanchez-Beato M, Guirado-Risueno M, Espejo-Garcia P, Lejeune M, Alvaro T, Sanchez-Margalet V, de la Cruz-Merino L, Spanish Lymphoma Oncology Grp GOTE, and Spanish Grp Immunobiotherapy Canc
- Subjects
tumor ,biomarkers ,immunotherapy ,Cellular ,immunomodulation ,myeloid-derived suppressor cells ,immunity - Abstract
Background The search for immunological markers with ability of predicting clinical outcome is a priority in lymphomas, and in cancer in general. It is well known that some immunomodulatory cells, such as myeloid derived suppressor cells (MDSCs) or regulatory T cells (Tregs), are recruited by tumors, jeopardizing antitumor immunosurveillance. In this work, we have studied blood levels of these immunosuppressive cells in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), prior to and along the course of the experimental rituximab, gemcitabine, dexamethasone, and cisplatin (R2-GDP) schedule, as a translational substudy of the R2-GDP-GOTEL trial (EudraCT Number: 2014-001620-29), which included lenalidomide as an immunomodulator. Methods Blood samples were taken before treatment, at cycle 3 and end of induction. Samples were analyzed by flow cytometry. Non-parametric tests were used. Mann-Whitney U test was used to compare basal cells distributions, and Wilcoxon test was considered to compare cells distribution at different times. Spearman test was performed to measure the degree of association between cell populations. Results In this study, MDSC and Treg circulating concentration was found increased in all patients compared with a healthy control group and decreased after treatment only in patients with longest overall survival (>24 months), reaching the levels of the healthy group. Likewise, the number of inhibited T lymphocytes expressing Programmed Death-1 (PD-1) were increased in peripheral blood from patients and decreased on the treatment, whereas activated T lymphocytes increased after therapy in those with better overall survival. Conclusions In conclusion, blood concentration of MDSCs and Treg cells may be good prognostic markers for overall survival after 2 years in R/R DLBCL. These results point to a possible role of these elements in the immunosuppression of these patients, as assessed by the circulating activated and inhibited T lymphocytes, and therefore, they may be considered as therapeutic targets in DLBCL.
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- 2021
43. Adjuvant nivolumab for stage III/IV melanoma: Evaluation of safety outcomes and association with recurrence-free survival
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Mandala, M. Larkin, J. Ascierto, P.A. Del Vecchio, M. Gogas, H. Cowey, C.L. Arance, A. Dalle, S. Schenker, M. Grob, J.-J. Chiarion-Sileni, V. Marquez, I. Butler, M.O. Di Giacomo, A.M. Lutzky, J. De La Cruz-Merino, L. Atkinson, V. Arenberger, P. Hill, A. Fecher, L. Millward, M. Khushalani, N.I. De Pril, V. Lobo, M. Weber, J.
- Abstract
Background Several therapeutic options are now available in the adjuvant melanoma setting, mandating an understanding of their benefit €'risk profiles in order to make informed treatment decisions. Herein we characterize adjuvant nivolumab select (immune-related) treatment-related adverse events (TRAEs) and evaluate possible associations between safety and recurrence-free survival (RFS) in the phase III CheckMate 238 trial. Methods Patients with resected stage IIIB-C or IV melanoma received nivolumab 3 mg/kg every 2 weeks (n=452) or ipilimumab 10 mg/kg every 3 weeks for four doses and then every 12 weeks (n=453) for up to 1 year or until disease recurrence, unacceptable toxicity, or consent withdrawal. First-occurrence and all-occurrence select TRAEs were analyzed within discrete time intervals: from 0 to 3 months of treatment, from >3-12 months of treatment, and from the last dose (regardless of early or per-protocol treatment discontinuation) to 100 days after the last dose. Possible associations between select TRAEs and RFS were investigated post randomization in 3-month landmark analyses and in Cox model analyses (including a time-varying covariate of select TRAE), within and between treatment groups. Results From the first nivolumab dose to 100 days after the last dose, first-occurrence select TRAEs were reported in 67.7% (306/452) of patients. First-occurrence select TRAEs were reported most frequently from 0 to 3 months (48.0%), during which the most common were pruritus (15.5%) and diarrhea (15.3%). Most select TRAEs resolved within 6 months. There was no clear association between the occurrence (or not) of select TRAEs and RFS by landmark analysis or by Cox model analysis within treatment arms or comparing nivolumab to the ipilimumab comparator arm. Conclusion Results of this safety analysis of nivolumab in adjuvant melanoma were consistent with its established safety profile. In the discrete time intervals evaluated, most first-occurrence TRAEs occurred early during treatment and resolved. No association between RFS and select TRAEs was evident. Trial registration number NCT02388906. ©
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- 2021
44. 5-Year Outcomes with Cobimetinib plus Vemurafenib in BRAFV600 Mutation-Positive Advanced Melanoma: Extended Follow-up of the coBRIM Study
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Ascierto, PA, Dreno, B, Larkin, J, Ribas, A, Liszkay, G, Maio, M, Mandala, M, Demidov, L, Stroyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Hsu, J, Jones, S, Li, H, McKenna, E, Voulgari, A, McArthur, GA, Ascierto, PA, Dreno, B, Larkin, J, Ribas, A, Liszkay, G, Maio, M, Mandala, M, Demidov, L, Stroyakovskiy, D, Thomas, L, de la Cruz-Merino, L, Atkinson, V, Dutriaux, C, Garbe, C, Hsu, J, Jones, S, Li, H, McKenna, E, Voulgari, A, and McArthur, GA
- Abstract
PURPOSE: The randomized phase III coBRIM study (NCT01689519) demonstrated improved progression-free survival (PFS) and overall survival (OS) with addition of cobimetinib to vemurafenib compared with vemurafenib in patients with previously untreated BRAFV600 mutation-positive advanced melanoma. We report long-term follow-up of coBRIM, with at least 5 years since the last patient was randomized. PATIENTS AND METHODS: Eligible patients were randomized 1:1 to receive either oral cobimetinib (60 mg once daily on days 1-21 in each 28-day cycle) or placebo in combination with oral vemurafenib (960 mg twice daily). RESULTS: 495 patients were randomized to cobimetinib plus vemurafenib (n = 247) or placebo plus vemurafenib (n = 248). Median follow-up was 21.2 months for cobimetinib plus vemurafenib and 16.6 months for placebo plus vemurafenib. Median OS was 22.5 months (95% CI, 20.3-28.8) with cobimetinib plus vemurafenib and 17.4 months (95% CI, 15.0-19.8) with placebo plus vemurafenib; 5-year OS rates were 31% and 26%, respectively. Median PFS was 12.6 months (95% CI, 9.5-14.8) with cobimetinib plus vemurafenib and 7.2 months (95% CI, 5.6-7.5) with placebo plus vemurafenib; 5-year PFS rates were 14% and 10%, respectively. OS and PFS were longest in patients with normal baseline lactate dehydrogenase levels and low tumor burden, and in those achieving complete response. The safety profile remained consistent with previously published reports. CONCLUSIONS: Extended follow-up of coBRIM confirms the long-term clinical benefit and safety profile of cobimetinib plus vemurafenib compared with vemurafenib monotherapy in patients with BRAFV600 mutation-positive advanced melanoma.
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- 2021
45. Circulating myeloid-derived suppressor cells and regulatory T cells as immunological biomarkers in refractory/relapsed diffuse large B-cell lymphoma: Translational results from the R2-GDP-GOTEL trial
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Universitat Rovira i Virgili, Jiménez-Cortegana C; Palazón-Carrión N; Martin Garcia-Sancho A; Nogales-Fernandez E; Carnicero-González F; Ríos-Herranz E; De La Cruz-Vicente F; Rodríguez-Garciá G; Fernández-Álvarez R; Rueda Dominguez A; Casanova-Espinosa M; Martínez-Banaclocha N; Gumà-Padrò J; Gómez-Codina J; Labrador J; Salar-Silvestre A; Rodriguez-Abreu D; Galvez-Carvajal L; Provencio M; Sánchez-Beato M; Guirado-Risueño M; Espejo-Garciá P; Lejeune M; Álvaro T; Sánchez-Margalet V; De La Cruz-Merino L, Universitat Rovira i Virgili, and Jiménez-Cortegana C; Palazón-Carrión N; Martin Garcia-Sancho A; Nogales-Fernandez E; Carnicero-González F; Ríos-Herranz E; De La Cruz-Vicente F; Rodríguez-Garciá G; Fernández-Álvarez R; Rueda Dominguez A; Casanova-Espinosa M; Martínez-Banaclocha N; Gumà-Padrò J; Gómez-Codina J; Labrador J; Salar-Silvestre A; Rodriguez-Abreu D; Galvez-Carvajal L; Provencio M; Sánchez-Beato M; Guirado-Risueño M; Espejo-Garciá P; Lejeune M; Álvaro T; Sánchez-Margalet V; De La Cruz-Merino L
- Abstract
Background The search for immunological markers with ability of predicting clinical outcome is a priority in lymphomas, and in cancer in general. It is well known that some immunomodulatory cells, such as myeloid derived suppressor cells (MDSCs) or regulatory T cells (Tregs), are recruited by tumors, jeopardizing antitumor immunosurveillance. In this work, we have studied blood levels of these immunosuppressive cells in patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL), prior to and along the course of the experimental rituximab, gemcitabine, dexamethasone, and cisplatin (R2-GDP) schedule, as a translational substudy of the R2-GDP-GOTEL trial (EudraCT Number: 2014-001620-29), which included lenalidomide as an immunomodulator. Methods Blood samples were taken before treatment, at cycle 3 and end of induction. Samples were analyzed by flow cytometry. Non-parametric tests were used. Mann-Whitney U test was used to compare basal cells distributions, and Wilcoxon test was considered to compare cells distribution at different times. Spearman test was performed to measure the degree of association between cell populations. Results In this study, MDSC and Treg circulating concentration was found increased in all patients compared with a healthy control group and decreased after treatment only in patients with longest overall survival (>24 months), reaching the levels of the healthy group. Likewise, the number of inhibited T lymphocytes expressing Programmed Death-1 (PD-1) were increased in peripheral blood from patients and decreased on the treatment, whereas activated T lymphocytes increased after therapy in those with better overall survival. Conclusions In conclusion, blood concentration of MDSCs and Treg cells may be good prognostic markers for ove
- Published
- 2021
46. 43O Pertuzumab/trastuzumab in early stage HER2-positive breast cancer: 5-year and final analysis of the BERENICE trial
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Dang, C., primary, Ewer, M.S., additional, Delaloge, S., additional, Ferrero, J-M., additional, Colomer, R., additional, de la Cruz Merino, L., additional, Dadswell, K., additional, Verrill, M., additional, Eiger, D., additional, Sarkar, S., additional, de Haas, S., additional, Restuccia, E., additional, and Swain, S.M., additional
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- 2021
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47. 94MO Quality of life (QoL) with fulvestrant (FUL)/palbociclib (PAL) versus FUL/placebo (PBO) in postmenopausal women with hormone receptor (HR)+/HER2- endocrine sensitive advanced breast cancer (ABC): Results from GEICAM/2014-12 (FLIPPER) study
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Tibau, A., primary, Martinez, M.T., additional, Ramos, M., additional, De la Cruz-Merino, L., additional, Santaballa, A., additional, Connor, M. O', additional, Martinez-Jañez, N., additional, Moreno, F., additional, Fernandez-Perez, I., additional, Virizuela, J.A., additional, Alarcón, J., additional, de la Haba-Rodríguez, J., additional, Sánchez-Rovira, P., additional, Albacar, C.R., additional, Bueno, C., additional, Kelly, C., additional, Casas, M., additional, Bezares, S., additional, Rosell, L., additional, and Albanell, J., additional
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- 2021
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48. Integrating the Tumor Microenvironment into Cancer Therapy
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Sanegre S, Lucantoni F, Burgos-Panadero R, de La Cruz-Merino L, Noguera R, and Alvaro Naranjo T
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biomarker discovery, immune therapy, mechanotransduction, metabolism, metformin, microbiota, mitochondria, prognostic tools, stromal reprogramming, vitamin D3 - Abstract
Tumor progression is mediated by reciprocal interaction between tumor cells and their surrounding tumor microenvironment (TME), which among other factors encompasses the extracellular milieu, immune cells, fibroblasts, and the vascular system. However, the complexity of cancer goes beyond the local interaction of tumor cells with their microenvironment. We are on the path to understanding cancer from a systemic viewpoint where the host macroenvironment also plays a crucial role in determining tumor progression. Indeed, growing evidence is emerging on the impact of the gut microbiota, metabolism, biomechanics, and the neuroimmunological axis on cancer. Thus, external factors capable of influencing the entire body system, such as emotional stress, surgery, or psychosocial factors, must be taken into consideration for enhanced management and treatment of cancer patients. In this article, we review prognostic and predictive biomarkers, as well as their potential evaluation and quantitative analysis. Our overarching aim is to open up new fields of study and intervention possibilities, within the framework of an integral vision of cancer as a functional tissue with the capacity to respond to different non-cytotoxic factors, hormonal, immunological, and mechanical forces, and others inducing stroma and tumor reprogramming.
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- 2020
49. Adjuvant nivolumab versus ipilimumab in resected stage IIIB–C and stage IV melanoma (CheckMate 238): 4-year results from a multicentre, double-blind, randomised, controlled, phase 3 trial
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Ascierto, P.A. Del Vecchio, M. Mandalá, M. Gogas, H. Arance, A.M. Dalle, S. Cowey, C.L. Schenker, M. Grob, J.-J. Chiarion-Sileni, V. Márquez-Rodas, I. Butler, M.O. Maio, M. Middleton, M.R. de la Cruz-Merino, L. Arenberger, P. Atkinson, V. Hill, A. Fecher, L.A. Millward, M. Khushalani, N.I. Queirolo, P. Lobo, M. de Pril, V. Loffredo, J. Larkin, J. Weber, J.
- Abstract
Background: Previously, findings from CheckMate 238, a double-blind, phase 3 adjuvant trial in patients with resected stage IIIB–C or stage IV melanoma, showed significant improvements in recurrence-free survival and distant metastasis-free survival with nivolumab versus ipilimumab. This report provides updated 4-year efficacy, initial overall survival, and late-emergent safety results. Methods: This multicentre, double-blind, randomised, controlled, phase 3 trial was done in 130 academic centres, community hospitals, and cancer centres across 25 countries. Patients aged 15 years or older with resected stage IIIB–C or IV melanoma and an Eastern Cooperative Oncology Group performance status of 0 or 1 were randomly assigned (1:1) to receive nivolumab or ipilimumab via an interactive voice response system and stratified according to disease stage and baseline PD-L1 status of tumour cells. Patients received intravenous nivolumab 3 mg/kg every 2 weeks or intravenous ipilimumab 10 mg/kg every 3 weeks for four doses, and then every 12 weeks until 1 year of treatment, disease recurrence, unacceptable toxicity, or withdrawal of consent. The primary endpoint was recurrence-free survival by investigator assessment, and overall survival was a key secondary endpoint. Efficacy analyses were done in the intention-to-treat population (all randomly assigned patients). All patients who received at least one dose of study treatment were included in the safety analysis. The results presented in this report reflect the 4-year update of the ongoing study with a database lock date of Jan 30, 2020. This study is registered with ClinicalTrials.gov, NCT02388906. Findings: Between March 30 and Nov 30, 2015, 906 patients were assigned to nivolumab (n=453) or ipilimumab (n=453). Median follow-up was 51·1 months (IQR 41·6–52·7) with nivolumab and 50·9 months (36·2–52·3) with ipilimumab; 4-year recurrence-free survival was 51·7% (95% CI 46·8–56·3) in the nivolumab group and 41·2% (36·4–45·9) in the ipilimumab group (hazard ratio [HR] 0·71 [95% CI 0·60–0·86]; p=0·0003). With 211 (100 [22%] of 453 patients in the nivolumab group and 111 [25%] of 453 patients in the ipilimumab group) of 302 anticipated deaths observed (about 73% of the originally planned 88% power needed for significance), 4-year overall survival was 77·9% (95% CI 73·7–81·5) with nivolumab and 76·6% (72·2–80·3) with ipilimumab (HR 0·87 [95% CI 0·66–1·14]; p=0·31). Late-emergent grade 3–4 treatment-related adverse events were reported in three (1%) of 452 and seven (2%) of 453 patients. The most common late-emergent treatment-related grade 3 or 4 adverse events reported were diarrhoea, diabetic ketoacidosis, and pneumonitis (one patient each) in the nivolumab group, and colitis (two patients) in the ipilimumab group. Two previously reported treatment-related deaths in the ipilimumab group were attributed to study drug toxicity (marrow aplasia in one patient and colitis in one patient); no further treatment-related deaths were reported. Interpretation: At a minimum of 4 years' follow-up, nivolumab demonstrated sustained recurrence-free survival benefit versus ipilimumab in resected stage IIIB–C or IV melanoma indicating a long-term treatment benefit with nivolumab. With fewer deaths than anticipated, overall survival was similar in both groups. Nivolumab remains an efficacious adjuvant treatment for patients with resected high-risk melanoma, with a safety profile that is more tolerable than that of ipilimumab. Funding: Bristol Myers Squibb and Ono Pharmaceutical. © 2020 Elsevier Ltd
- Published
- 2020
50. Adjuvant nivolumab (NIVO) vs ipilimumab (IPI) in resected stage III/IV melanoma: 4-y recurrence-free and overall survival (OS) results from CheckMate 238
- Author
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Weber, J. Del Vecchio, M. Mandala, M. Gogas, H. Arance Fernandez, A. M. Dalle, S. Cowey, C. L. Schenker, M. and Grob, J-J. Sileni, V. Chiarion Marquez-Rodas, I. Butler, M. O. Maio, M. Middleton, M. de la Cruz Merino, L. Lobo, M. and de Pril, V. Larkin, J. Ascierto, P. A.
- Published
- 2020
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