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12. The Atrial Fibrillation Ablation Pilot Study: an European Survey on Methodology and results of catheter ablation for atrial fibrillation conducted by the European Heart Rhythm Association

Author

Arbelo, Elena, Brugada, Josep, Hindricks, Gerhard, Maggioni, Aldo P., Tavazzi, Luigi, Vardas, Panos, Laroche, Cécile, Anselme, Frédéric, Inama, Giuseppe, Jais, Pierre, Kalarus, Zbigniew, Kautzner, Josef, Lewalter, Thorsten, Mairesse, Georges H., Perez-Villacastin, Julian, Riahi, Sam, Taborsky, Milos, Theodorakis, George, Trines, Serge A., Brugada, Josep, Arbelo, Elena, Hindriks, Gerhard, Maggioni, Aldo P., Morgan, John, Tavazzi, Luigi, Vardas, Panos, Alonso, Angeles, Ferrari, Roberto, Komajda, Michel, Tavazzi, Luigi, Wood, David, Vardas, Panos, Brugada, Josep, Mairesse, Georges, Taborsky, Milos, Kautzner, Josef, Lewalter, Thorsten, Riahi, Sam, Jais, Pierre, Anselme, Frédéric, Theodorakis, George, Inama, Giuseppe, Trines, Serge, Kalarus, Zbigniew, Villacastin, Julian Perez, Maggioni, Aldo P., Manini, Malika, Gracia, Gérard, Laroche, Cécile, Missiamenou, Viviane, Taylor, Charles, Konte, Marème, Fiorucci, Emanuela, Lefrancq, Elin Folkesson, Glémot, Myriam, McNeill, Patti-Ann, Bois, Timothée, Heidbüchel, H., Nuyens, D., Boland, J., Dinraths, V., Herzet, J.-M., Hoffer, E., Malmendier, D., Massoz, M., Pourbaix, S., Ballant, E., Blommaert, D., Deceuninck, O., Dormal, F., Xhaet, O., De Potter, T., Geelen, P., Derycker, K., Duytschaever, M., Tavernier, R., Vandekerckhove, Y., Vankats, D., Bulava, A., Hanis, J., Sitek, D., Blahova, M., Cihak, R., Hanyasova, L., Jansova, H., Peichl, P., Tanzerova, M., Wichterle, D., Duda, J., Haman, L., Parizek, P., Coling, L., Neuzil, P., Petru, J., Sediva, L., Skoda, J., Chovancik, J., Fiala, M., Neuwirth, R., Karlsdottir, A., Pehrson, S., Gerdes, C., Jensen, H.K., Lukac, P., Nielsen, J. C., Hansen, J., Johannessen, A., Hansen, P. S., Pedersen, A.K., Heath, F.P., Hjortshoj, S., Thogersen, A.M., Da Costa, A., Martel, I., Romeyer-Bouchard, C., Sadki, N., Schmid, A., Haissaguerre, M., Hocini, M., Knecht, S., Sacher, F., Ait Said, M., Cauchemez, B., Ledoux, F., Thomas, O., Cebron, J.-P., Decarsin, N., Gras, D., Hervouet, S., Durand, C., Durand-Dubief, A., Poty, H., Babuty, D., Pierre, B., Albenque, J.-P., Boveda, S., Combes, N., Mas, R., Hermida, J-S., Kubala, M., Godin, B., Savouré, A., Soublin, Y., Defaye, P., Jacon, P., Brigadeau, F., Corbut, S., Flament-Balzola, F., Kacet, S., Klug, D., Lacroix, D., Copie, X., Gilles, L., Hocine, Z., Paziaud, O., Piot, O., Crocq, C., Kaballu, G., Le Moal, V., Lotton, P., Mabo, P., Pavin, D., Andronache, M., De Chillou, C., Magnin-Poull, I., Deharo, J.-C., Durand, C., Franceschi, F., Peyrouse, E., Prevot, S., Etchegoin, M., Extramiana, F., Leenhardt, A., Messali, A., Heine, T., Schneider, A., Winter, N., Brachmann, J., Ritscher, G., Schertel-Gruenler, B., Simon, H., Sinha, A.-M., Turschner, O., Wystrach, A., Stemberg, M., Kuck, K.-H., Metzner, A., Tilz, R., Wissner, E., Heitmann, K., Willems, S., Andresen, D., Mueller, S., Volkmer, M., Schmidt, B., Kostopoulou, A., Livanis, E., Voudris, V., Efremidis, M., Letsas, K., Tsikrikas, S., Christoforatou, E., Ioannidis, P., Katsivas, A., Kourouklis, S., Andrikopoulos, G., Rassias, I., Tzeis, S., Dakos, G., Paraskevaidis, S., Stavropoulos, G., Theofilogiannakos, E., Vassilikos, V.P., Bongiorni, M.G., Zucchelli, G., Raviele, A., Themistoclakis, S., Pratola, C., Tritto, M., Della Bella, P., Mazzone, P., Moltrasio, M., Tondo, C., Calo, L., De Luca, L., Guarracini, F., Lioy, E., Dozza, L., Frigoli, E., Giannelli, L., Pappone, C., Saviano, M., Schiavina, G., Vicedomini, G.G., De Ponti, R., Doni, L. A., Marazzi, R., Salerno-Uriarte, J.A., Tamborini, C., Anselmino, M., Ferraris, F., Gaita, F., Bertaglia, E., Brandolino, G., Zoppo, F., De Groot, N., Janse, P., Jordaens, L., Pison, L., Roos, C., Van Gelder, I., Manusama, R., Meijer, A., Van der Voort, P., Trines, S., Compier, Marieke G., Kazmierczak, J., Kornacewicz-Jach, Z., Wielusinski, M., Baran, J., Kulakowski, P., Dzidowski, M., Fuglewicz, A., Nowak, K., Pruszkowska-Skrzep, P., Wozniak, A., Nowak, S., Trusz-Gluza, M., Almendral, J., Atienza, F., Castellanos, E., De Diego, C., Ortiz, M., Moreno Planas, J., Perez Castellano, N., Benezet, J., Farre Muncharaz, J., Rubio Campal, J.M., Hernandez Madrid, A., Matia, R., Arana, E., Pedrote, A., Cozar, R., Peinado, R., Valverde, I., Arbelo, E., Berruezo, A., Calvo, N., Guiu, E., Husseini, S., and Mont Girbau, L.

Published
2014
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14. Phase 1 study of mTORC1/2 inhibitor sapanisertib (TAK-228) in advanced solid tumours, with an expansion phase in renal, endometrial or bladder cancer

Author

Voss M, Gordon M, Mita M, Rini B, Makker V, Macarulla T, Smith D, Cervantes A, Puzanov I, Pili R, Wang D, Jalal S, Pant S, Patel M, Neuwirth R, Enke A, Shou Y, Sedarati F, Faller D, and Burris H

Abstract

Background This Phase 1 dose-escalation/expansion study assessed safety/tolerability of sapanisertib, an oral, highly selective inhibitor of mTORC1/mTORC2, in advanced solid tumours. Methods Eligible patients received increasing sapanisertib doses once daily (QD; 31 patients), once weekly (QW; 30 patients), QD for 3 days on/4 days off QW (QD x 3dQW; 33 patients) or QD for 5 days on/2 days off QW (QD x 5dQW; 22 patients). In expansion cohorts, 82 patients with renal cell carcinoma (RCC), endometrial or bladder cancer received sapanisertib 5 mg QD (39 patients), 40 mg QW (26 patients) or 30 mg QW (17 patients). Results Maximum tolerated doses of sapanisertib were 6 mg QD, 40 mg QW, 9 mg QD x 3dQW and 7 mg QD x 5dQW. Frequent dose-limiting toxicities (DLTs) included hyperglycaemia, maculo-papular rash (QD), asthenia and stomatitis (QD x 3dQW/QD x 5dQW); expansion phase doses of 5 mg QD and 30 mg QW were selected based on tolerability beyond the DLT evaluation period. One patient with RCC achieved complete response; nine experienced partial responses (RCC: seven patients; carcinoid tumour/endometrial cancer: one patient each). Sapanisertib pharmacokinetics were time-linear and supported multiple dosing. Pharmacodynamic findings demonstrated treatment-related reductions in TORC1/2 biomarkers. Conclusions Sapanisertib demonstrated a manageable safety profile, with preliminary antitumour activity observed in RCC and endometrial cancer.

Published
2020

23. Abstract PD1-09: Phase 2 safety and efficacy results of TAK-228 in combination with exemestane or fulvestrant in postmenopausal women with ER-positive/HER2-negative metastatic breast cancer previously treated with everolimus

Author

Diamond, JR, primary, Potter, D, additional, Salkeni, M, additional, Silverman, P, additional, Haddad, T, additional, Forget, F, additional, Awada, A, additional, Canon, J-L, additional, Danso, M, additional, Lortholary, A, additional, Bourgeois, H, additional, Tan-Chiu, E, additional, Patel, C, additional, Neuwirth, R, additional, Leonard, EJ, additional, and Lim, B, additional

Published
2019
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28. Das chemotaktische Verhalten von Alveolarmakrophagen und Blutmonozyten nach Expositionen mit unterschiedlichen NO2-Konzentrationen

Author

J. Müller-Quernheim, Gross S, Marli Maria Knorst, Fries B, Neuwirth R, Ferlinz R, and Kienast K

Subjects
Lung, Chemistry, Healthy subjects, Chemotaxis, General Medicine, respiratory system, Diagnostic Bronchoscopy, Andrology, medicine.anatomical_structure, Bronchial carcinoma, Air exposure, medicine, Cytotoxic T cell, Cytotoxicity
Abstract

The chemotaxis of alveolar macrophages (AM) and blood monocytes (BM) is important in the elimination of particles and microorganisms which have invaded the lung. The effect of nitrogen dioxide (NO2) on chemotaxis was tested on AM obtained by diagnostic bronchoscopy from five patients suspected of having bronchial carcinoma (four men, one woman; mean age 59 +/- 10 years). Blood monocytes were also studied with blood from seven healthy subjects (five men, two women; mean age 32 +/- 10 years). These cells were placed on polycarbonate membranes for 15 min each, exposed to NO2 concentrations between 1.0 and 5.0 parts per million (ppm), and then incubated with complement component C5a as chemotactically active agent. The number of AM or BM which actively migrated through the polycarbonate membrane under the influence of C5a was measured by means of a light microscope. The migration rate of AM (compared to air exposure) was reduced by 33% with 1.0 ppm NO2 and by 61% with 5.0 ppm. The migration rate of BM in similar conditions was reduced by as much as 55%. There was no significant cytotoxic effect of NO2 exposure at 1.0 and 3.0 ppm. With 5.0 ppm 13.0 +/- 3.0 cells were no longer viable. These results indicate that NO2 concentrations relevant to indoor conditions affect the chemotaxis of AM and BM after short-time NO2 exposures. The data further suggest that NO2 exposures of these cells depressed chemotactic mechanisms without relevant cytotoxicity.

Published
2008

29. A phase 2 study of investigational TORC1/2 inhibitor TAK-228 and TAK-228 plus investigational PI3Kα-selective inhibitor TAK-117 vs everolimus in adults with advanced or metastatic clear-cell renal cell carcinoma (ccRCC) that has progressed on VEGF-targeted therapy

Author

Choueiri, T.K., primary, Porta, C., additional, Suarez Rodriguez, C., additional, Alter, R., additional, Czaykowski, P., additional, Duran, I., additional, Gross-Goupil, M., additional, Kalinka-Warzocha, E., additional, Melichar, B., additional, Patel, C., additional, Neuwirth, R., additional, Enke, A., additional, Zohren, F., additional, and Powles, T., additional

Published
2017
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30. A phase 1b multicenter, open-label study of investigational TAK-228 (MLN0128) plus TAK-117 (MLN1117) in adult patients with advanced nonhematologic malignancies

Author

Juric, D., primary, Lopez, J., additional, Rasco, D., additional, Macarulla Mercadé, T., additional, Xu, Q., additional, Brittany, B., additional, Kuida, K., additional, Patel, C., additional, Neuwirth, R., additional, Enke, A., additional, Zohren, F., additional, and Burris, H.A., additional

Published
2016
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32. Phase 1b/2 safety and efficacy of TAK-228 (MLN0128), plus exemestane (E) or fulvestrant (F) in postmenopausal women with ER + /HER2- metastatic breast cancer (MBC)

Author

Diamond, J., primary, Borges, V.F., additional, Kabos, P., additional, Krill-Jackson, E., additional, Graham, R., additional, Hoffman, A., additional, Lim, B., additional, Richards, D.A., additional, Salkeni, M.A., additional, Wilks, S., additional, Patel, C., additional, Neuwirth, R., additional, Kneissl, M., additional, and Zohren, F., additional

Published
2016
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39. 354 Phase I study of investigational oral mTORC1/2 inhibitor MLN0128: Expansion phase in patients with renal, endometrial, or bladder cancer

Author

Voss, M., primary, Gordon, M.S., additional, Mita, M., additional, Rini, B., additional, Makker, V., additional, Macarulla, T., additional, Smith, D., additional, Kwak, E.L., additional, Cervantes, A., additional, Puzanov, I., additional, Pili, R., additional, Wang, D., additional, Jalal, S., additional, Pant, S., additional, Patel, M., additional, Neuwirth, R., additional, Zohren, F., additional, and Infante, J., additional

Published
2015
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41. Mutation of NRAS but not KRAS significantly reduces myeloma sensitivity to single-agent bortezomib therapy

Author

Mulligan, G. (George), Lichter, D.I. (David), Bacco, A.D. (Alessandra Di), Blakemore, S.J. (Stephen), Berger, A. (Allison), Koenig, E. (Erik), Bernard, H. (Hugues), Trepicchio, W.L. (William), Li, B. (Bin), Neuwirth, R. (Rachel), Chattopadhyay, N. (Nibedita), Bolen, J.B. (Joseph), Dorner, A.J. (Andrew), Velde, H. (Helgi) van de, Ricci, D. (Deborah), Jagannath, S. (Sundar), Berenson, J.R. (James), Richardson, P.G. (Paul Gerard), Stadtmauer, E.A. (Edward), Orlowski, R.Z. (Robert), Lonial, S. (Sagar), Anderson, K.C. (Kenneth), Sonneveld, P. (Pieter), San Miguel, J.F. (Jesús Fernando), Esseltine, D.-L. (Dixie-Lee), Schu, M. (Matthew), Mulligan, G. (George), Lichter, D.I. (David), Bacco, A.D. (Alessandra Di), Blakemore, S.J. (Stephen), Berger, A. (Allison), Koenig, E. (Erik), Bernard, H. (Hugues), Trepicchio, W.L. (William), Li, B. (Bin), Neuwirth, R. (Rachel), Chattopadhyay, N. (Nibedita), Bolen, J.B. (Joseph), Dorner, A.J. (Andrew), Velde, H. (Helgi) van de, Ricci, D. (Deborah), Jagannath, S. (Sundar), Berenson, J.R. (James), Richardson, P.G. (Paul Gerard), Stadtmauer, E.A. (Edward), Orlowski, R.Z. (Robert), Lonial, S. (Sagar), Anderson, K.C. (Kenneth), Sonneveld, P. (Pieter), San Miguel, J.F. (Jesús Fernando), Esseltine, D.-L. (Dixie-Lee), and Schu, M. (Matthew)

Abstract

Various translocations and mutations have been identified in myeloma, and certain aberrations, such as t(4;14) and del17, are linked with disease prognosis. To investigate mutational prevalence in myeloma and associations between mutations and patient outcomes, we tested a panel of 41 known oncogenes and tumor suppressor genes in tumor samples from 133 relapsed myeloma patients participating in phase 2 or 3 clinical trials of bortezomib. DNA mutations were identified in 14 genes. BRAF as well as RAS genes were mutated in a large proportion of cases (45.9%) and these mutations were mutually exclusive. New recurrent mutations were also identified, including in the PDGFRA and JAK3 genes. NRAS mutations were associated with a significantly lower response rate to single-agent bortezomib (7% vs 53% in patients with mutant vs wildtype NRAS, P 5 .00116, Bonferroni-corrected P 5 .016), as well as shorter time to progression in bortezomib-treated patients (P 5 .0058, Bonferroni-corrected P 5 .012). However, NRAS mutation did not impact outcome in patients treated with high-dose dexamethasone. KRAS mutation did not reduce sensitivity to bortezomib or dexamethasone. These findings identify a significant clinical impact of NRAS mutation in myeloma and demonstrate a clear example of functional differences between the KRAS and NRAS oncogenes. (Blood. 2014; 123(5):632-639).

Published
2014
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44. 925TiP - A phase 2 study of investigational TORC1/2 inhibitor TAK-228 and TAK-228 plus investigational PI3Kα-selective inhibitor TAK-117 vs everolimus in adults with advanced or metastatic clear-cell renal cell carcinoma (ccRCC) that has progressed on VEGF-targeted therapy

Author

Choueiri, T.K., Porta, C., Suarez Rodriguez, C., Alter, R., Czaykowski, P., Duran, I., Gross-Goupil, M., Kalinka-Warzocha, E., Melichar, B., Patel, C., Neuwirth, R., Enke, A., Zohren, F., and Powles, T.

Published
2017
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48. Cancer testis antigens in newly diagnosed and relapse multiple myeloma: Prognostic markers and potential targets for immunotherapy

Author

Duin, M. (Mark) van, Broyl, A. (Annemiek), Knegt, Y. (Yvonne) de, Goldschmidt, H. (Hartmut), Richardson, P.G. (Paul Gerard), Holt, B. (Bronno) van der, Hop, W.C.J. (Wim), Joseph-Pietras, D. (Debora), Mulligan, G. (George), Neuwirth, R. (Rachel), Sahota, S.S. (Surinder), Sonneveld, P. (Pieter), Duin, M. (Mark) van, Broyl, A. (Annemiek), Knegt, Y. (Yvonne) de, Goldschmidt, H. (Hartmut), Richardson, P.G. (Paul Gerard), Holt, B. (Bronno) van der, Hop, W.C.J. (Wim), Joseph-Pietras, D. (Debora), Mulligan, G. (George), Neuwirth, R. (Rachel), Sahota, S.S. (Surinder), and Sonneveld, P. (Pieter)

Abstract

Background In multiple myeloma, expression of cancer testis antigens may provide prognostic markers and potential targets for immunotherapy. Expression at relapse has not yet been evaluated for a large panel of cancer testis antigens which can be classified by varying expression in normal tissue: restricted to testis, expressed in testis and brain and not restricted but selectively expressed in testis. Design and Methods Evaluation of cancer testis antigen expression was made in newly diagnosed multiple myeloma cases (HOVON-65/GMMG-HD4 trial; n=320) and in relapse cases (APEX, SUMMIT, CREST trials; n=264). Presence of expression using Affymetrix GeneChips was determined for 123 cancer testis antigens. Of these 87 had a frequency of more than 5% in the newly diagnosed and relapsed patients, and were evaluated in detail. Results Tissue restriction was known for 58 out of 87 cancer testis antigens. A significantly lower frequency of presence calls in the relapsed compared to newly diagnosed cases was found for 3 out of 13 testis restricted genes, 2 out of 7 testis/brain restricted genes, and 7 out of 38 testis selective genes. MAGEC1, MAGEB2 and SSX1 were the most frequent testis-restricted cancer testis antigens in both data sets. Multivariate analysis demonstrated that presence of MAGEA6 and CDCA1 were clearly associated with shorter progression free survival, and presence of MAGEA9 with shorter overall survival in the set of newly diagnosed cases. In the set of relapse cases, presence of CTAG2 was associated with shorter progression free survival and presence of SSX1 with shorter overall survival. Conclusions Relapsed multiple myeloma reveals extensive cancer testis antigen expression. Cancer testis antigens are confirmed as useful prognostic markers in newly diagnosed multiple myeloma patients and in relapsed multiple myeloma patients.

Published
2011
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