26 results on '"Vlassak, S"'
Search Results
2. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study
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Van Cutsem, E., Yoshino, T., Lenz, H.J., Lonardi, S., Falcone, A., Limón, M.L., Saunders, M., Sobrero, A., Park, Y.S., Ferreiro, R., Hong, Y.S., Tomasek, J., Taniguchi, H., Ciardiello, F., Stoehr, J., Oum’Hamed, Z., Vlassak, S., Studeny, M., and Argiles, G.
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- 2018
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3. EVITA—a double-blind, vehicle-controlled, randomized phase II trial of vitamin K1 cream as prophylaxis for cetuximab-induced skin toxicity
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Hofheinz, R.-D., Lorenzen, S., Trojan, J., Ocvirk, J., Ettrich, T.J., Al-Batran, S.-E., Schulz, H., Homann, N., Feustel, H.-P., Schatz, M., Kripp, M., Schulte, N., Tetyusheva, M., Heeger, S., Vlassak, S., and Merx, K.
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- 2018
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4. 33P Real-world experience of MET TKI-induced peripheral edema
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Ferrara, R., primary, Vansteenkiste, J.F., additional, Yang, X., additional, Grossi, F., additional, Melosky, B., additional, Ahn, M-J., additional, Calles, A., additional, Chan, O.S.H., additional, Han, B., additional, Bulusu, V.R., additional, Califano, R., additional, Nishino, K., additional, Ghori, V., additional, Ronga, P., additional, Berghoff, K., additional, Vlassak, S., additional, and Le, X., additional
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- 2023
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5. 364P Tepotinib with an EGFR-tyrosine kinase inhibitor (TKI) in patients with EGFR-mutant MET-amplified NSCLC: A case series
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Ahmad, A.R., primary, Tho, L.M., additional, Chik, Y.K.J., additional, Lee, W.C.K., additional, Yang, T-Y., additional, Le, X., additional, Eisert, A.K., additional, Himpe, U., additional, De Bondt, C., additional, Mazieres, J., additional, Petrini, I., additional, Lam, W-S., additional, Joshi, K., additional, Berghoff, K., additional, Vlassak, S., additional, Karachaliou, N., additional, Van Der Wekken, A.J., additional, and Hsia, T-C., additional
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- 2022
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6. EP08.02-162 Tepotinib with an EGFR-Tyrosine Kinase Inhibitor (TKI) in Patients with EGFR-mutant MET-amplified NSCLC: A Case Series
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Le, X., primary, Eisert, A., additional, Himpe, U., additional, De Bondt, C., additional, Mazieres, J., additional, Petrini, I., additional, Tho, L.M., additional, Ahmad, A., additional, Lam, W.-S., additional, Chik, Y.K.J., additional, Lee, W.C.K., additional, Yang, T.-Y., additional, Joshi, K., additional, Berghoff, K., additional, Vlassak, S., additional, Karachaliou, N., additional, and Wekken, A.v.d., additional
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- 2022
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7. Tepotinib with an EGFR-tyrosine kinase inhibitor (TKI) in patients with EGFR-mutant MET-amplified NSCLC: A case series
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Ahmad, A. R., Tho, L. M., Chik, Y. K. J., Lee, W. C. K., Yang, T-Y., Le, X., Eisert, A. K., Himpe, U., De Bondt, C., Mazieres, J., Petrini, I., Lam, W-S., Joshi, K., Berghoff, K., Vlassak, S., Karachaliou, N., Van der Wekken, A. J., Hsia, T-C., Ahmad, A. R., Tho, L. M., Chik, Y. K. J., Lee, W. C. K., Yang, T-Y., Le, X., Eisert, A. K., Himpe, U., De Bondt, C., Mazieres, J., Petrini, I., Lam, W-S., Joshi, K., Berghoff, K., Vlassak, S., Karachaliou, N., Van der Wekken, A. J., and Hsia, T-C.
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- 2022
8. 1380P Treatment (Tx) sequencing with tepotinib in previously treated patients (pts) with MET exon 14 (METex14) skipping NSCLC in the VISION trial
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Viteri, S., Felip, E., Griesinger, F., Garassino, M.C., Sakai, H., Le, X., Veillon, R., Smit, E.F., Raskin, J., Thomas, M., Ahn, M-J., Vlassak, S., Bruns, R., Johne, A., and Paik, P.K.
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- 2023
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9. 34P Treatment sequencing in the VISION study of tepotinib in patients with MET exon 14 (METex14) skipping NSCLC
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Griesinger, F., Garassino, M.C., Felip, E., Sakai, H., Le, X., Veillon, R., Smit, E.F., Raskin, J., Thomas, M., Ahn, M-J., Vlassak, S., Bruns, R., Johne, A., and Paik, P.K.
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- 2023
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10. Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study
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Van Cutsem, E, Yoshino, T, Lenz, H J, Lonardi, S, Falcone, A, Limón, M L, Saunders, M, Sobrero, A, Park, Y S, Ferreiro, R, Hong, Y S, Tomasek, J, Taniguchi, H, Ciardiello, F, Stoehr, J, Oum'Hamed, Z, Vlassak, S, Studeny, M, Argiles, G, Universitat Autònoma de Barcelona, Van Cutsem, E, Yoshino, T, Lenz, H J, Lonardi, S, Falcone, A, Limón, M L, Saunders, M, Sobrero, A, Park, Y S, Ferreiro, R, Hong, Y S, Tomasek, J, Taniguchi, H, Ciardiello, F, Stoehr, J, Oum'Hamed, Z, Vlassak, S, Studeny, M, and Argiles, G
- Subjects
0301 basic medicine ,Oncology ,Male ,Indoles ,chemorefractory metastatic colorectal cancer ,Placebo-controlled study ,Administration, Oral ,law.invention ,Placebos ,chemistry.chemical_compound ,0302 clinical medicine ,Randomized controlled trial ,law ,nintedanib ,angiogenesis inhibition ,Hematology ,Fatigue ,Hazard ratio ,Middle Aged ,Progression-Free Survival ,Angiogenesis inhibition ,Response Evaluation Criteria in Solid Tumors ,030220 oncology & carcinogenesis ,Disease Progression ,Nintedanib ,Female ,Chemical and Drug Induced Liver Injury ,Colorectal Neoplasms ,Adult ,medicine.medical_specialty ,Antineoplastic Agents ,Adenocarcinoma ,Placebo ,03 medical and health sciences ,Double-Blind Method ,Internal medicine ,Regorafenib ,Gastrointestinal Tumors ,medicine ,Humans ,Progression-free survival ,Protein Kinase Inhibitors ,neoplasms ,Aged ,business.industry ,Chemorefractory metastatic colorectal cancer ,Original Articles ,digestive system diseases ,030104 developmental biology ,Receptors, Vascular Endothelial Growth Factor ,chemistry ,business - Abstract
BACKGROUND: Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies. PATIENTS AND METHODS: Eligible patients (Eastern Cooperative Oncology Group performance status 0-1, with histologically/cytologically confirmed metastatic/locally advanced CRC adenocarcinoma unamenable to surgery and/or radiotherapy) were randomized 1 : 1 to receive nintedanib (200 mg twice daily) or placebo (twice daily), until disease progression or undue toxicity. Patients were stratified by previous regorafenib, time from onset of metastatic disease to randomization, and region. Co-primary end points were overall survival (OS) and progression-free survival (PFS) by central review. Secondary end points included objective tumor response and disease control by central review. RESULTS: From October 2014 to January 2016, 768 patients were randomized; 765 were treated (nintedanib n = 384; placebo n = 381). Median follow-up was 13.4 months (interquartile range 11.1-15.7). OS was not improved [median OS 6.4 months with nintedanib versus 6.0 months with placebo; hazard ratio (HR), 1.01; 95% confidence interval (CI), 0.86-1.19; P = 0.8659]. There was a significant but modest increase in PFS with nintedanib versus placebo (median PFS 1.5 versus 1.4 months, respectively; HR 0.58; 95% CI 0.49-0.69; P
- Published
- 2018
11. Vitamin K1 cream significantly reduces incidence and severity of cetuximab-related acneiform skin rash in women: a post hoc analysis of the EVITA trial
- Author
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Gaiser, M.R., Lorenzen, S., Merx, K., Trojan, J., Ocvirk, J., Ettrich, T.J., Al-Batran, S.-E., Schulz, H., Homann, N., Feustel, H.-P., Schatz, M., Kripp, M., Schulte, N., Heeger, S., Vlassak, S., Koch, W., and Hofheinz, R.-D.
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- 2018
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12. gastrointestinal tumours, colorectal Nintedanib plus best supportive care (BSC) versus placebo plus BSC for the treatment of patients (pts) with colorectal cancer (CRC) refractory to standard therapies: Results of the phase III LUME-colon 1 study
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Van Cutsem, E., primary, Yoshino, T., additional, Lenz, H.-J., additional, Lonardi, S., additional, Falcone, A., additional, Limon, M.L., additional, Saunders, M.P., additional, Sobrero, A., additional, Maiello, E., additional, Park, Y.S., additional, Monteagudo, R. Ferreiro, additional, Hong, Y.S., additional, Tomasek, J., additional, Taniguchi, H., additional, Ciardiello, F., additional, Hocke, J., additional, Oum'hamed, Z., additional, Vlassak, S., additional, Studeny, M., additional, and Tabernero, J., additional
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- 2016
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13. PD-005 Combined analysis of two randomised Phase II trials comparing the efficacy and safety of nintedanib versus sorafenib in Caucasian and Asian patients with advanced hepatocellular carcinoma
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Palmer, D., primary, Meyer, T., additional, Chao, Y., additional, Deptala, A., additional, Fartoux, L., additional, Feng, Y.-H., additional, Graham, J., additional, Lin, D.-Y., additional, Ma, Y.T., additional, Peck-Radosavljevic, M., additional, Ross, P., additional, Ryoo, B.-Y., additional, Yen, C.-J., additional, Hocke, J., additional, Vlassak, S., additional, Wenz, A., additional, Loembe, A.-B., additional, and Cheng, A.-L., additional
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- 2015
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14. Phase I clinical trial of nintedanib plus paclitaxel in early HER-2-negative breast cancer (CNIO-BR-01-2010/GEICAM-2010-10 study)
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Quintela-Fandino, M, primary, Urruticoechea, A, additional, Guerra, J, additional, Gil, M, additional, Gonzalez-Martin, A, additional, Marquez, R, additional, Hernandez-Agudo, E, additional, Rodriguez-Martin, C, additional, Gil-Martin, M, additional, Bratos, R, additional, Escudero, M J, additional, Vlassak, S, additional, Hilberg, F, additional, and Colomer, R, additional
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- 2014
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15. Efficacy and safety of tenecteplase in combination with enoxaparin, abciximab, or unfractionated heparin: the ASSENT-3 randomised trial in acute myocardial infarction
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Van de Werf, F., Armstrong, P. W., Granger, C., Wallentin, L., Adgey, A. A. J., Aylward, P., Binbrek, A. S., Califf, R., Cassim, S., Diaz, R., Fanebust, R., Fioretti, P. M., Huber, K., Husted, S., Lindahl, B., Lopez-Sendon, J. L., Makijarvi, M., Meyer, J., Navarro Robles, J., Pfisterer, M., Seabra-Gomes, R., Soares-Piegas, L., Sugrue, D., Tendera, M., Theroux, P., Toutouzas, P., Vahanian, A., Verheugt, F., Sarelin, H., Goetz, G., Bluhmki, E., Daclin, V., Danays, T., Houbracken, K., Kaye, J., Reilly, P., Hacke, W., von Kummer, R., Lesaffre, E., Bogaerts, K., Peeters, C., Fox, K. A. A., Brower, R., Hirsh, J., Maggioni, A., Tijssen, J., Weaver, D., Beernaert, A., Beysen, N., Broos, K., De Prins, E., D'Hollander, K., Dupon, L., Fomyna, N., Fransen, A., Genesse, D., Goffin, L., Hendrickx, R., Jansen, B., Jorissen, F., Luys, C., Luyten, A., Marschal, C., Moreira, M., Munsters, K., Salerno, R., Schoovaerts, C., Sinnaeve, P., Schildermans, C., Vandenberghe, K., Vandeschoot, K., Van Gucht, H., Van Rompaey, P., Vlassak, S., Watzeels, M., Wittockx, H., Galan, K., Humeniuk, L., Seidel, A., Molina, M., Hafley, G., Alexander, J., Pascual, A., Bestilny, S., Temple, T., Ahuad Guerrero, R., Albisu, J. P., Bassani Arrieta, C. A., Bono, J., Caccavo, A., Cagnolatti, A., Cartasegna, L. R., Castellanos, R., Chekerdemian, S., Covelli, G., Cuello, J. L., Cuneo, C. A., Fernandez, A., Ferrara, C., Ferro-Queirel, E., Gambarte, A., Garcia-Duran, R., Hasbani, E., Hrabar, A., Keller, L., Lobo Marquez, L. L., Luciardi, H., Macin, S. M., Marinig, A., Marzetti, E., Muntaner, J., Nordaby, R., Orlandini, A. D., Piombo, A. C., Pomposiello, J. C., Quijano, R. A., Amerena, J., Aroney, G., Buckmaster, N., Carroll, P., Fitzpatrick, M., Newman, R., Rowe, M., Singh, B., Thomson, A., Winter, C., Eber, B., Gaul, G. B., Klein, W., Leisch, F., Mayr, H., Mlczoch, J., Niessner, H., Pachinger, O., Pall, H., Pichler, M., Roggla, G., Schaflinger, E., Schreiber, W., Slany, J., Traindl, O., Zenker, G., Beckers, J., Bekaert, I., Berthe, C., Bodur, G., Carlier, B., Carlier, M., Carpentier, J., Celen, H., Charlier, F., Clement, A., Coenen, A., Crochelet, L., De Keyser, F., De Man, F., de Meester, A., Dendale, P., Dhondt, E., Dhooghe, G., El Allaf, D., Elshot, S., Emmerechts, C., Foret, F., Gatera, E., Geraedts, J., Gerardy, A. C., Gysbrechts, M., Hallemans, R., Hellemans, S., Herssens, H., Huygens, L., Janssens, L., Lalmand, J., Maamar, R., Marechal, P., Mertens, D., Michel, P., Morandini, E., Nannan, M., Nguyen, D., Odeurs, W., Peerenboom, P., Pirenne, B., Quinonez, M., Raymenants, E., Renard, M., Silance, P. G., Standaert, A. M., Striekwold, H., Thiels, H., Valadi, D., van Brabandt, H., Van Dormael, M., Van Iseghem, P., Van Walleghem, U., Vanden Bosch, H., Vandenbossche, J. L., Vermylen, J., Verstraete, S., Vo Ngoc, P., Willems, P., Zenner, R., Campos de Albuquerque, D., Coutinho, M., de Camargo Carvalho, A. C., Fernandes Manenti, E. R., Ferreira Azevedo, A., Golin, V., Gun, C., Marin Neto, J. A., Marino, R. L., Miranda Abrantes, J. A., Nicolau, J. C., Porto Alegre Dancini, E. M., Rabelo, A., Ramos, R. F., Rizzi Coelho, O., Alexander, D., Bata, I. R., Bhargava, R. K., Bogaty, P., D'Amours, G., Darcel, I., Finnie, K. J. C., Fowlis, R., Gupta, M. K., Henderson, M., Howlett, M. K., Javier, J. J., Kieu, C. V., Kumar, G., Lebouthillier, P., Leduc, F., Lepage, S., Mcavinue, T., Mcgillen, J. E., Mcmeekin, J. D., Morse, J. W., Pistawka, K., Raimondo, E. F., Sandrin, F., Smith, H., Smylie, P. C., Tran, K., Turabian, M., Wagner, K. R., Winkler, L. H., Woo, K. S., Falstie-Jensen, N., Lind Rasmussen, S., Lomholt, P., Markenvard, J., Nielsen, H., Petersen, J., Romer, F., Ahonen, J., Huttunen, M., Kokkonen, L., Luukkonen, J., Mantyla, P., Melin, J., Mustonen, J., Valli, J., Voutilainen, S., Agraou, B., Allam, S., Baradat, G., Battistella, P., Bazin, P., Bouvier, J. -M., Destrac, S., Fouche, R., Fournier, P. -Y., Funck, F., Garnier, H., Grall, J. -Y., Gully, C., Lallement, P. -Y., Loiselet, P., Mycinsky, C., Page, A., Parisot, M., Range, G., Rocher, R., Tafani, C., Thisse, J. -Y., Tibi, T., Tissot, M., Wahl, P., Backenkohler, U., Bavastro, P., Beckmann-Hiss, H., Behnke, M., Bermes, M., Bernsmeier, R., Bethge, K. P., Bethge, H., Block, M., Burkhardt, W., Cieslinski, G., Claus, G., Deetjen, A., Diefenbach, A., Diehm, C., Dietz, A., Dippold, W. G., Eichner, A., Erckenbrecht, J. F., Gawlick, L., Gerber, V., Goppel, L., Gottwik, M., Grosch, B., Hammer, B., Hanheide, M., Hanrath, P., Haspel, J., Hennersdorf, F., Hermanns, M., Hoffmeister, H. M., Holzapfel, P., Hubner, H., Jansen, W., Jung, S., Kaddatz, J., Kienbock, H., Klein, H. H., Konz, K. H., Kulschbach, M., Leschke, M., Liebau, G., Linnartz, M., Lockert, G., Loesbrock, R., Lollgen, H., Ludwig, N., Mudra, H., Munzer, K., Nebel, B., Nellessen, U., Neu, C., Olbrich, H. G., Pfeffer, A., Pfeiffer, P., Plate, V., Pollock, B., Rapp, H., Rommele, U., Sauer, K., Scheffler, N., Schlotterbeck, K., Schmidt-Salzmann, A., Schnitzler, G., Schumann, H., Schuster, C. J., Schuster, P., Schweizer, P., Seitz, K., Simon, R., Spes, C., Szabo, S., Terhardt-Kasten, E., Theuerkauf, B., Tigges, R., Tinnappel, J., Topp, H., Trockel, P., Unland, N., Veth, V., Vom Dahl, J., Vossbeck, G., Weindel, K., Weib, D., Wiewel, D., Wirtz, P., Zipp, C., Apostolou, T., Chalkidis, C., Exadaktylos, N., Foussas, S., Hatseras, D., Karas, S., Karydis, K., Lambrou, S., Louridas, G., Manolis, A., Nanas, J., Novas, I., Panagiotidou, T., Papadopoulos, C., Papakonstantinou, D., Papasteriadis, E., Pavlidis, P., Pyrgakis, V., Skoufas, P., Stavrati, A., Tyrologos, A., Vardas, P., Vrouchos, G., Zacharoulis, A., Zarifis, J., Brown, A., Daly, K., Fennell, W., Horgan, J., Mccann, H., Mcdonald, K., O'Reilly, M., Sullivan, P., Altamura, G., Ambrosio, G., Auteri, A., Aveta, P., Azzarito, M., Badano, L. P., Barbiero, M., Barletta, C., Biscosi, C., Boccanelli, A., Bottero, M., Brizio, E., Brunazzi, M. C., Brunelli, C., Bugatti, U., Capozi, A., Capucci, A., Carfora, A., Caronna, A., Carrone, M., Casazza, F., Cauticci, A., Ceci, V., Ciconte, V., Circo, A., Ciricugno, S., Comito, F., Cornacchia, D., Corsini, G., D'Andrea, F., De Rosa, P., De Simone, M., Del Citerna, F., Del Pinto, M., Dell'Ali, C., Della Casa, S., Della Monica, R., Delogu, G., Di Biase, M., Di Chiara, A., Di Guardo, G., Di Marco, S., Di Mario, F., Di Napoli, T., Di Palma, F., Fadin, B. M., Fazzari, M., Ferraiuolo, G., Fiaschetti, R., Fontanelli, A., Fresco, C., Gambelli, G., Gasbarri, F., Gemelli, M., Giani, P., Gigantino, A., Giomi, A., Giorgi, G., Greco, C., Gregorio, G., Guagnozzi, G., Guiducci, U., Guzzardi, G., Izzo, A., La Rosa, A., Leone, F., Leone, G., Lo Bianco, F., Locuratolo, N., Maggiolini, S., Malinconico, M., Mancone, C., Mangiameli, S., Marchi, S. M., Maresta, A., Mauri, F., Mazzini, C. A., Michisanti, M., Miracapillo, G., Modena, M. G., Morgagni, G. L., Mossuti, E., Nascimbeni, F., Negrelli, M., Notaristefano, A., Pardi, S., Peci, P., Pettinati, G., Pietropaolo, F., Pirelli, S., Pretolani, M., Prinzi, D., Proietti, F., Raganelli, L., Rapino, S., Re, F., Ricci, R., Rinaldi, G., Rusticali, G., Severi, S., Spallarossa, P., Tartagni, F., Terrosu, P., Tortorella, G., Tota, F., Tritto, I., Tuccilo, B., Turco, V., Uscio, G., Valagussa, F., Vergoni, W., Verzuri, M. S., Vetrano, A., Villani, R., Zanini, R., Boisante, L., Niclou, R., Alcocer, L., Castro, A., Fragoso, J., Gonzalez, V., Gonzalez-Pacheco, H., Hernandez-Santamaria, I., Huerta, R., Huerta, D., Martinez, A., Mendoza, M., Moguel, R., Navarro, J., Portos, J. M., Rodriguez, I., Sierra, L., Valencia, S., Vazquez, A., Arnold, A. E. R., Boehmer, A. G., de Graaf, J. J., Funke Kupper, A. J., Gobel, E. J. A. M., Janus, C. L., Linssen, G. C. M., Sedney, M. I., Slegers, L. C., Spierenburg, H. A. M., Strikwerda, S., Tans, J. G. M., Twisk, S. P. M., van der Heijden, R., van Kalmthout, P. M., Verheugt, F. W. A., Holt, E., Skogsholm, A., Thorshaug, R., Thybo, N. K., Wang, H., Maciejewicz, J., Piotrowski, W., Pluta, W., Ruminski, W., Skura, M., Smielak-Korombel, W., Carranca, J., Carvalho, M., Catarino, C., Cunha, D., Ferreira, D., Ferreira, J., Ferreira da Costa, A. F., Lopes de Carvalho, J., Martins, L., Mourao, L., Oliveira Carrageta, M., Prazeres de Sa, E., Puig, J., Ramalho Dos Santos, M. J. J., Resende, M., Seabra Gomes, R., Baig, M. M. E., Bayat, J., Benjamin, J. D., Ranjith, N., Routier, R., Wittmer, H., Abizanda Campos, R., Alonso Garcia, M. A., Amaro Cendon, A., Arboleda Sanchez, J. A., Blanco Varela, J., Bruguera I Cortada, J., Carpintero Avellaneda, J. L., Caturla Such, J., Civeira Murillo, E., Fernandez Aviles, F., Fernandez Fernandez, R., Figueras Bellot, J., Fiol Sala, M., Froufe Sanchez, J., Garcia Calabozo, R., Garcia Palacios, J. L., Gonzalez Maqueda, I., Kallmeyer Martin, C., Lopez Sendon, J. L., Manzano Ramirez, A., Marine Rebull, J., Monton Rodriguez, A., Pique Gilart, M., Reina Toral, A., Rodriguez Llorian, A., Ruano Marco, M., Sanchez Miralles, A., Sanjose Garagarza, J. M., Santalo Bel, M., Torres Ruiz, J. M., Valentin Segura, V., Ahlstrom, P., Ahremark, U., Bandh, S., Bellinetto, A., Dahlberg, A., Hansen, O., Hurtig, U., Jonasson, L., Karlsson, J. E., Larsson, L. E., Moller, B., Ohlin, H., Persson, H., Sandstedt, L., Soderberg, S., Svennberg, L., Swahn, E., Tygesen, H., Broccard, A. F., Estlinbaum, W., Follath, F., Frutiger, A., Hess, N., Maggiorini, M., Marti, D., Muller, P., Rickenbacher, P., Schaller, M. D., Weinbacher, M., Abdulali, S., Ahmad, G., George, S., Ghazi, A., Rao, K. N., Bishop, A., Bridges, A., Canepa-Anson, R., Cave, M., Clarck, R., Cooper, I., de Belder, A., Farrer, M., Kendall, J. M., Ludman, P., Mattu, R., Mcglinchey, P., Moriarty, A. J., Muthusamy, S., Nee, P. A., Nolan, J., Papouchado, M., Rose, E. L., Shahi, M., Stephens, J., Trevelyan, J., Abdul-Karim, A., Adler, L., Arunasalam, S., Avington, D., Baron, S., Beel, T., Bellamy, B., Bennett, J., Berndt, T., Berrick, A., Bersin, R. M., Bethala, V., Bharath, S., Bouchard, A., Boulet, J. E., Bowerman, R., Boyek, T., Brar, R. S., Brodell, G., Bryant, B., Buckner, J. K., Cage, J., Cannon, J. D., Carducci, B., Carr, K., Chang, M., Chelliah, N., Chin, W. L., Chin, J., Church, D. H., Clark, R., Coulis, L., Dadkhah, S., Dearing, B., Defranco, A., Dharawat, M., Dharawat, R., Dhruva, N., Dicola, J., Dykstra, G., Eisenberg, S., El-Bialy, A., Fera, S., Ford, K., Foreman, R. D., Friedman, S., Friedman, V., Garibian, G., Gelormini, J., Geninatti, M. R., Genovese, R., Ghazi, F., Gilchrist, I., Gitler, B., Glover, R., Gonzalez, J., Goulah, R., Graham, B., Gray, R., Grodman, R., Habib, G. B., Hack, T., Hamroff, G., Hanna, G., Hart, M., Haught, H., Hawkins, J., Hempel, R., Hiremath, Y., Hiser, W., Holland, E., Jaffe, N., Jamal, N., James, K. F., Kalla, S., Kates, M., Kemper, A. J., Kennedy, J. J., Kerut, E. K., Killpack, M., King, J., T. Y., Ko, Kollar, K., Kontos, M., Kugelmassluu, A., Kumar, A., Kutscher, A. H., Lambrecht, C., Lancaster, L., Layden, J., Lazar, A., Lebow, M., Lee, C., Lee, A. B., Lehr, J., Levin, F. L., Levitt, R., Levy, R. M., Lieberman, A., Litman, G. I., Lui, H., Luu, M. Q., Macdonald, G., Madyoon, H., Mancherje, C., Marmulstein, M., Mclaurin, B. T., Mcnellis, M., Mendelson, R., Micale, P. J., Miller, M. J., Miller, M. S., Miller, J., Millman, A., Millsaps, R., Minor, S., Modica, J., Morse, H., Moskovits, N., Nester, B. A., Newton, A. S., Niazi, I., Niederman, A., Oatfield, R., Painter, J. A., Pamfilis, S. M., Pamulapati, K. M., Patel, N., Payne, R., Pearson, C., Peizner, D. S., Petrovich, L., Piriz, J., Pollack, M., Pollock, S., Popkave, A., Puma, J. A., Quesada, R., Quigley-Malcolm, D., Raby, K., Ravindran, K., Rees, A. P., Reiner, J., Rivera, E., Rogers, F., Rosenthal, A., Rowe, W. W., Ryan, P. F., Ryman, K., Salacata, A., Santolin, C., Saucedo, J., Savage, R., Savage, W., Schumacher, R., Segarra, S., Sharkey, S., Shonkoff, D., Silver, M., Silver, S. L., Singh, G., Sinyard, R. D., Sporn, D., Srivastava, N. K., Stomel, R., Suresh, D. P., Tallman, M., Togioka, T., Varma, S., Verant, R. P., Wallach, R., Weinberg, M., Weinberg, D., Weinstein, J. M., Wesley, G., Westerman, J. H., Wheeling, J., Whitaker, J., Widmer, M., Yasin, M., and Zakrzewski, M. J.
- Subjects
Male ,medicine.medical_specialty ,Abciximab ,Ischemia ,Myocardial Infarction ,Tenecteplase ,Injections ,Immunoglobulin Fab Fragments ,Reperfusion therapy ,Fibrinolytic Agents ,Recurrence ,Internal medicine ,medicine ,Humans ,Myocardial infarction ,Enoxaparin ,Aged ,Intention-to-treat analysis ,Chi-Square Distribution ,business.industry ,Heparin ,Antibodies, Monoclonal ,General Medicine ,Middle Aged ,medicine.disease ,Survival Analysis ,Regimen ,Treatment Outcome ,Anesthesia ,Tissue Plasminogen Activator ,Cardiology ,Drug Therapy, Combination ,Female ,business ,Platelet Aggregation Inhibitors ,medicine.drug - Abstract
BACKGROUND: Current fibrinolytic therapies fail to achieve optimum reperfusion in many patients. Low-molecular-weight heparins and platelet glycoprotein IIb/IIIa inhibitors have shown the potential to improve pharmacological reperfusion therapy. We did a randomised, open-label trial to compare the efficacy and safety of tenecteplase plus enoxaparin or abciximab, with that of tenecteplase plus weight-adjusted unfractionated heparin in patients with acute myocardial infarction. METHODS: 6095 patients with acute myocardial infarction of less than 6 h were randomly assigned one of three regimens: full-dose tenecteplase and enoxaparin for a maximum of 7 days (enoxaparin group; n=2040), half-dose tenecteplase with weight-adjusted low-dose unfractionated heparin and a 12-h infusion of abciximab (abciximab group; n=2017), or full-dose tenecteplase with weight-adjusted unfractionated heparin for 48 h (unfractionated heparin group; n=2038). The primary endpoints were the composites of 30-day mortality, in-hospital reinfarction, or in-hospital refractory ischaemia (efficacy endpoint), and the above endpoint plus in-hospital intracranial haemorrhage or in-hospital major bleeding complications (efficacy plus safety endpoint). Analysis was by intention to treat. FINDINGS: There were significantly fewer efficacy endpoints in the enoxaparin and abciximab groups than in the unfractionated heparin group: 233/2037 (11.4%) versus 315/2038 (15.4%; relative risk 0.74 [95% CI 0.63-0.87], p=0.0002) for enoxaparin, and 223/2017 (11.1%) versus 315/2038 (15.4%; 0.72 [0.61-0.84], p
- Published
- 2001
16. LBA20_PR - gastrointestinal tumours, colorectal Nintedanib plus best supportive care (BSC) versus placebo plus BSC for the treatment of patients (pts) with colorectal cancer (CRC) refractory to standard therapies: Results of the phase III LUME-colon 1 study
- Author
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Van Cutsem, E., Yoshino, T., Lenz, H.-J., Lonardi, S., Falcone, A., Limon, M.L., Saunders, M.P., Sobrero, A., Maiello, E., Park, Y.S., Monteagudo, R. Ferreiro, Hong, Y.S., Tomasek, J., Taniguchi, H., Ciardiello, F., Hocke, J., Oum'hamed, Z., Vlassak, S., Studeny, M., and Tabernero, J.
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- 2016
- Full Text
- View/download PDF
17. Awareness and Understanding of Stratified/Personalized Medicine in Patients Treated for Cancer: A Multinational Survey
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Tejpar, S., primary, Teague, T., additional, Lake, J., additional, Tabernero, J., additional, Vansteenkiste, J.F., additional, Vlassak, S., additional, and Ciardiello, F., additional
- Published
- 2012
- Full Text
- View/download PDF
18. Prediction of pathological response to preoperative chemoradiotherapy with cetuximab in rectal cancer
- Author
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Machiels, J. H., primary, Debucquoy, A., additional, Gevaert, O., additional, Daemen, A., additional, Sempoux, C., additional, McBride, W., additional, Stroh, C., additional, Vlassak, S., additional, and Haustermans, K., additional
- Published
- 2008
- Full Text
- View/download PDF
19. 1382P - Awareness and Understanding of Stratified/Personalized Medicine in Patients Treated for Cancer: A Multinational Survey
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Tejpar, S., Teague, T., Lake, J., Tabernero, J., Vansteenkiste, J.F., Vlassak, S., and Ciardiello, F.
- Published
- 2012
- Full Text
- View/download PDF
20. Intrapatient Cetuximab Dose Escalation in Metastatic Colorectal Cancer According to the Grade of Early Skin Reactions: The Randomized EVEREST Study
- Author
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Markus Moehler, M. Schlichting, Eric Van Cutsem, Jan B. Vermorken, Soetkin Vlassak, Hans Gelderblom, Bengt Glimelius, Frédéric Viret, Yves Humblet, Dirk Vanbeckevoort, Xavier Sagaert, Elisa Gallerani, Sabine Tejpar, Marc Peeters, Fortunato Ciardiello, Annemieke Cats, A. Hendlisz, Van Cutsem, E, Tejpar, S, Vanbeckevoort, D, Peeters, M, Humblet, Y, Gelderblom, H, Vermorken, Jb, Viret, F, Glimelius, B, Gallerani, E, Hendlisz, A, Cats, A, Moehler, M, Sagaert, X, Vlassak, S, Schlichting, M, and Ciardiello, Fortunato
- Subjects
Male ,Cancer Research ,medicine.medical_specialty ,Population ,Cetuximab ,medicine.disease_cause ,Antibodies, Monoclonal, Humanized ,Irinotecan ,Gastroenterology ,Pharmacokinetics ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Dosing ,Adverse effect ,education ,neoplasms ,Aged ,education.field_of_study ,Dose-Response Relationship, Drug ,business.industry ,Antibodies, Monoclonal ,Middle Aged ,digestive system diseases ,Surgery ,Oncology ,Fluorouracil ,Camptothecin ,Female ,Human medicine ,KRAS ,Drug Eruptions ,business ,Colorectal Neoplasms ,medicine.drug - Abstract
Purpose Skin toxicity in patients receiving cetuximab has been associated positively with clinical outcome in several tumor types. This study investigated the effect of cetuximab dose escalation in patients with irinotecan-refractory metastatic colorectal cancer who had developed no or mild skin reactions after 21 days of treatment at the standard dose. This article reports clinical and pharmacokinetic (PK) data. Patients and Methods After 21 days of standard-dose cetuximab (400 mg/m2 initial dose, then 250 mg/m2 per week) plus irinotecan, patients with ≤ grade 1 skin reactions were randomly assigned to standard-dose (group A) or dose-escalated (to 500 mg/m2 per week; group B) cetuximab. Patients with ≥ grade 2 skin reactions continued on standard-dose cetuximab plus irinotecan (group C). Results The intent-to-treat population comprised 157 patients. PK profiles reflected the dose increase and were predictable across the dose range investigated. Weekly cetuximab doses of up to 500 mg/m2 were well tolerated, and grade 3 and 4 adverse events were generally comparable between treatment groups. Dose escalation (n = 44) was associated with an increase in skin reactions ≥ grade 2 compared with standard (n = 45) dosing (59% v 38%, respectively). Dose escalation, compared with standard dosing, showed some evidence for improved response rate (30% v 16%, respectively) and disease control rate (70% v 58%, respectively) but no indication of benefit in relation to overall survival. In an exploratory analysis, dose escalation seemed to increase response rate compared with standard dosing in patients with KRAS wild-type but not KRAS mutant tumors. Conclusion Cetuximab serum concentrations increased predictably with dose. Higher dose levels were well tolerated. The possible indication for improved efficacy in the dose-escalation group warrants further investigation.
- Published
- 2012
21. Prolonged complete response to adjuvant tepotinib in a patient with newly diagnosed disseminated glioblastoma harboring mesenchymal-epithelial transition fusion.
- Author
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Pham LC, Weller L, Gann CN, Schumacher KM, Vlassak S, Swanson T, Highsmith K, O'Brien BJ, Nash S, Aaroe A, de Groot JF, and Majd NK
- Abstract
The prognosis of patients with glioblastoma (GBM) remains poor despite current treatments. Targeted therapy in GBM has been the subject of intense investigation but has not been successful in clinical trials. The reasons for the failure of targeted therapy in GBM are multifold and include a lack of patient selection in trials, the failure to identify driver mutations, and poor blood-brain barrier penetration of investigational drugs. Here, we describe a case of a durable complete response in a newly diagnosed patient with GBM with leptomeningeal dissemination and PTPRZ1-MET fusion who was treated with tepotinib, a brain-penetrant MET inhibitor. This case of successful targeted therapy in a patient with GBM demonstrates that early molecular testing, identification of driver molecular alterations, and treatment with brain-penetrant small molecule inhibitors have the potential to change the outcome in select patients with GBM., (© The Author(s) 2024. Published by Oxford University Press.)
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- 2024
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22. Tepotinib: Management of Adverse Events in Patients With MET Exon 14 Skipping Non-Small Cell Lung Cancer.
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Ahn L, Alexander T, Vlassak S, Berghoff K, and Lemmens L
- Subjects
- Creatinine, Exons, Humans, Piperidines, Pyridazines, Pyrimidines, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics
- Abstract
Background: Tepotinib, a highly selective, oral, once-daily MET inhibitor, has been approved for treatment of metastatic MET exon 14 skipping non-small cell lung cancer., Objectives: This article provides nurse-specific recommendations for identification and management of tepotinib adverse events (AEs)., Methods: Guidance on monitoring and proactive/reactive AE management was developed based on published literature and real-world nursing experience. Case studies of VISION trial participants were summarized to illustrate key principles., Findings: Tepotinib AEs are generally mild to moderate and manageable, and can include peripheral edema, hypoalbuminemia, nausea, diarrhea, and creatinine increase. Alongside supportive care, tepotinib interruption and dose reduction is recommended for grade 3 AEs. For peripheral edema, proactive monitoring is crucial, and treatment interruption (including frequent, short treatment holidays) should be considered early. Nursing management of tepotinib AEs includes proactive monitoring, patient education, and interprofessional team coordination.
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- 2022
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23. Safety of MET Tyrosine Kinase Inhibitors in Patients With MET Exon 14 Skipping Non-small Cell Lung Cancer: A Clinical Review.
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Cortot A, Le X, Smit E, Viteri S, Kato T, Sakai H, Park K, Camidge DR, Berghoff K, Vlassak S, and Paik PK
- Subjects
- Exons genetics, Humans, Mutation genetics, Prospective Studies, Protein Kinase Inhibitors therapeutic use, Proto-Oncogene Proteins c-met genetics, Carcinoma, Non-Small-Cell Lung drug therapy, Carcinoma, Non-Small-Cell Lung genetics, Lung Neoplasms drug therapy, Lung Neoplasms genetics
- Abstract
MET exon 14 (METex14) skipping mutations occur in 3% to 4% of non-small cell lung cancer (NSCLC) cases. Currently, four oral MET tyrosine kinase inhibitors (TKIs) are in use for the treatment of patients with METex14 skipping NSCLC (tepotinib, capmatinib, savolitinib, and crizotinib). To support optimal management of METex14 skipping NSCLC in this typically older patient population, the safety profiles of these treatment options are reviewed here. Published safety data from prospective clinical trials with MET TKIs in patients with METex14 skipping NSCLC were reviewed. Treatment-related adverse events (TRAEs) occurring in ≥ 10% of patients were reported where feasible. Guidance on clinical monitoring and management of key MET TKI TRAEs and drug-drug interactions is provided. Across the clinical trials, safety data for MET TKIs were reported for 442 patients with METex14 skipping. Peripheral edema was the most reported TRAE (50%-63% of patients; grade ≥ 3: 1%-11%), followed by nausea (26%-46% of patients; grade ≥ 3: 0%-1%). TRAEs led to dose reductions in 33% to 38% of patients and to discontinuation in 7% to 14% of patients, across the MET TKIs. Considerations on interpreting available safety data are provided, along with insights into monitoring and managing specific MET TKI TRAEs of interest and drug-drug interactions. Overall, MET TKIs are tolerable treatment options for patients with METex14 skipping NSCLC, an older population for whom chemo- or immuno-therapy may not be an effective nor tolerable option. More data regarding the effectiveness of safety interventions and management strategies are needed., (Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
24. Evaluation of EGFR inhibitor-mediated acneiform skin toxicity within the double-blind randomized EVITA trial: A thorough gender-specific analysis using the WoMo score.
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Gaiser MR, Lorenzen S, Merx K, Trojan J, Ocvirk J, Ettrich TJ, Al-Batran SE, Schulz H, Homann N, Feustel HP, Schatz M, Kripp M, Schulte N, Heeger S, Vlassak S, Koch W, and Hofheinz RD
- Subjects
- Acneiform Eruptions chemically induced, Adult, Aged, Aged, 80 and over, Cetuximab adverse effects, Double-Blind Method, ErbB Receptors antagonists & inhibitors, Female, Humans, Male, Middle Aged, Neoplasm Metastasis, Protein Kinase Inhibitors adverse effects, Sex Characteristics, Skin Cream, Treatment Outcome, Vitamin K 1 therapeutic use, Acneiform Eruptions prevention & control, Cetuximab administration & dosage, Colorectal Neoplasms drug therapy, Protein Kinase Inhibitors administration & dosage, Vitamin K 1 administration & dosage
- Abstract
Acne-like skin reactions frequently occur in patients undergoing treatment with drugs inhibiting the epidermal growth factor receptor. Recently, the effects of vitamin K1 containing cream (Reconval K1) as prophylactic skin treatment in addition to doxycycline were explored in a double-blind randomized phase II trial (EVITA) in patients with metastatic colorectal cancer receiving cetuximab. EVITA demonstrated a trend towards less severe skin rash in Reconval K1-treated patients using the tripartite WoMo skin reaction grading score as a thorough tool for quantification of drug related skin reactions. This gender-specific analysis of the EVITA trial evaluated the application of the WoMo score for assessment of epidermal growth factor receptor (EGFR)-related skin toxicities according to treatment arm and gender. To show the robustness of results parametric and non-parametric statistical analyses were conducted. All three parts of the WoMo score independently demonstrated the superiority of the treatment arm (Reconval K1) regarding a significant reduction in acneiform skin reactions in women. Men did not benefit from Reconval K1 cream at any time point in none of the WoMo score analyses. The treatment effect in women was confirmed by the use of skin rash categories based on the final WoMo overall score and mixed effect longitudinal multiple linear regression analysis. The WoMo score represents a sensitive tool for studies exploiting treatments against EGFR mediated acne-like skin rash. Part C of the WoMo score seems to be sufficient for quantification of drug related skin toxicities in further studies. Standard WoMo skin reaction score values for future studies are provided., (© 2019 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.)
- Published
- 2019
- Full Text
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25. Intrapatient cetuximab dose escalation in metastatic colorectal cancer according to the grade of early skin reactions: the randomized EVEREST study.
- Author
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Van Cutsem E, Tejpar S, Vanbeckevoort D, Peeters M, Humblet Y, Gelderblom H, Vermorken JB, Viret F, Glimelius B, Gallerani E, Hendlisz A, Cats A, Moehler M, Sagaert X, Vlassak S, Schlichting M, and Ciardiello F
- Subjects
- Aged, Antibodies, Monoclonal adverse effects, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols adverse effects, Camptothecin administration & dosage, Camptothecin analogs & derivatives, Cetuximab, Colorectal Neoplasms secondary, Dose-Response Relationship, Drug, Drug Eruptions etiology, Female, Humans, Irinotecan, Male, Middle Aged, Antibodies, Monoclonal administration & dosage, Antineoplastic Combined Chemotherapy Protocols administration & dosage, Colorectal Neoplasms drug therapy, Drug Eruptions classification
- Abstract
Purpose: Skin toxicity in patients receiving cetuximab has been associated positively with clinical outcome in several tumor types. This study investigated the effect of cetuximab dose escalation in patients with irinotecan-refractory metastatic colorectal cancer who had developed no or mild skin reactions after 21 days of treatment at the standard dose. This article reports clinical and pharmacokinetic (PK) data., Patients and Methods: After 21 days of standard-dose cetuximab (400 mg/m(2) initial dose, then 250 mg/m(2) per week) plus irinotecan, patients with ≤ grade 1 skin reactions were randomly assigned to standard-dose (group A) or dose-escalated (to 500 mg/m(2) per week; group B) cetuximab. Patients with ≥ grade 2 skin reactions continued on standard-dose cetuximab plus irinotecan (group C)., Results: The intent-to-treat population comprised 157 patients. PK profiles reflected the dose increase and were predictable across the dose range investigated. Weekly cetuximab doses of up to 500 mg/m(2) were well tolerated, and grade 3 and 4 adverse events were generally comparable between treatment groups. Dose escalation (n = 44) was associated with an increase in skin reactions ≥ grade 2 compared with standard (n = 45) dosing (59% v 38%, respectively). Dose escalation, compared with standard dosing, showed some evidence for improved response rate (30% v 16%, respectively) and disease control rate (70% v 58%, respectively) but no indication of benefit in relation to overall survival. In an exploratory analysis, dose escalation seemed to increase response rate compared with standard dosing in patients with KRAS wild-type but not KRAS mutant tumors., Conclusion: Cetuximab serum concentrations increased predictably with dose. Higher dose levels were well tolerated. The possible indication for improved efficacy in the dose-escalation group warrants further investigation.
- Published
- 2012
- Full Text
- View/download PDF
26. Molecular response to cetuximab and efficacy of preoperative cetuximab-based chemoradiation in rectal cancer.
- Author
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Debucquoy A, Haustermans K, Daemen A, Aydin S, Libbrecht L, Gevaert O, De Moor B, Tejpar S, McBride WH, Penninckx F, Scalliet P, Stroh C, Vlassak S, Sempoux C, and Machiels JP
- Subjects
- Antibodies, Monoclonal therapeutic use, Antibodies, Monoclonal, Humanized, Antineoplastic Combined Chemotherapy Protocols, Capecitabine, Cetuximab, Deoxycytidine analogs & derivatives, Deoxycytidine therapeutic use, Drug Resistance, Neoplasm, Fluorouracil analogs & derivatives, Fluorouracil therapeutic use, Humans, Radiotherapy Dosage, Rectal Neoplasms drug therapy, Rectal Neoplasms pathology, Rectal Neoplasms radiotherapy, Treatment Outcome, Biomarkers analysis, Combined Modality Therapy, Gene Expression drug effects, Gene Expression radiation effects, Neoplasm Staging, Prognosis, Rectal Neoplasms metabolism
- Abstract
Purpose: To characterize the molecular pathways activated or inhibited by cetuximab when combined with chemoradiotherapy (CRT) in rectal cancer and to identify molecular profiles and biomarkers that might improve patient selection for such treatments., Patients and Methods: Forty-one patients with rectal cancer (T3-4 and/or N+) received preoperative radiotherapy (1.8 Gy, 5 days/wk, 45 Gy) in combination with capecitabine and cetuximab (400 mg/m2 as initial dose 1 week before CRT followed by 250 mg/m2 /wk for 5 weeks). Biopsies and plasma samples were taken before treatment, after cetuximab but before CRT, and at the time of surgery. Proteomics and microarrays were used to monitor the molecular response to cetuximab and to identify profiles and biomarkers to predict treatment efficacy., Results: Cetuximab on its own downregulated genes involved in proliferation and invasion and upregulated inflammatory gene expression, with 16 genes being significantly influenced in microarray analysis. The decrease in proliferation was confirmed by immunohistochemistry for Ki67 (P = .01) and was accompanied by an increase in transforming growth factor-alpha in plasma samples (P < .001). Disease-free survival (DFS) was better in patients if epidermal growth factor receptor expression was upregulated in the tumor after the initial cetuximab dose (P = .02) and when fibro-inflammatory changes were present in the surgical specimen (P = .03). Microarray and proteomic profiles were predictive of DFS., Conclusion: Our study showed that a single dose of cetuximab has a significant impact on the expression of genes involved in tumor proliferation and inflammation. We identified potential biomarkers that might predict response to cetuximab-based CRT.
- Published
- 2009
- Full Text
- View/download PDF
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