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3. Anastrozole versus tamoxifen for the prevention of locoregional and contralateral breast cancer in postmenopausal women with locally excised ductal carcinoma in situ (IBIS-II DCIS): A double-blind, randomised controlled trial

Author

Forbes, John F, Sestak, Ivana, Howell, Anthony, Bonanni, Bernardo, Bundred, Nigel, Levy, Christelle, von Minckwitz, Gunter, Eiermann, Wolfgang, Neven, Patrick, Stierer, Michael, Holcombe, Chris, Coleman, Robert E, Jones, Louise, Ellis, Ian, Cuzick, Jack, Sainsbury, Richard, Garber, Judy, Warwick, Jane, Buchanan, Mary, Buser, Katharina, Cawthorn, Simon, Coleman, Robert, Dowsett, Mitch, Eastell, Richard, Ejlertsen, Bent, Forbes, John, Kahan, Zsuzsanna, Baclesse, François, Mansel, Robert, Palva, Tiina, Rydén, Lisa, Stuart, Mary, Vaz, Fatima, Marsiglia, Hugo, Benyoucef, Ahmed, Berton-Rigaud, Dominique, Loustalot, Catherine, Serin, Daniel, Kerbrat, Pierre, Eymard, Jean-Christophe, Giard-Lefevre, Sylvia, Bonichon-Lamichhane, Nathalie, Monnier, Alain, Tubiana-Mathieu, Nicole, Piot, Gilles, de Lara, Christine Tunon, Bernard, Olivier, Simon-Swirski, Hélène, Gladieff, Laurence, Regaud, I Claudius, Fouchet-Goudier, Marie-Joseph, Dohollou, Nadine, Aquitaine, Nord, Elgard-Maitre, Anne-Marie, Bergerat, Jean-Pierre, Petit, Thierry, Marti, Adina, Toussaint, Caroline, Del Piano, Francesco, Ibrahim, Mahmoud, Fric, Danièle, Hönig, Arnd, Müller, Volkmar, Marmé, Frederik, Rautenberg, Beate, Schmidt, Marcus, Hanusch, Claus, Paepke, Stefan, Kaltenecker, Gabriele, Lemster, Sabine, Tio, Joke, Reimer, Toralf, Schnappauf, Benjamin, Baumann, Klaus, Schrader, Iris, Mundhenke, Christoph, Liedtke, Cornelia, Meinerz, Wolfgang, Thomssen, Christoph, Christl, Klaus, Hitschold, Thomas, Goerke, Kay, Kast, Karin, Runnebaum, Ingo, Lindner, Christoph, Scheidel, Peter, Herwig, Uwe, Bangemann, Nikola, Sommer, Harald, Göhring, Kornelia, Tulusan, Augustinus, Stauß, Eva, Köhler, Günter, Zahm, Dirk, Augustin, Doris, Hocke, Andrea, Neunhöffer, Tanja, Schmatloch, Sabine, Heinrich, Georg, Groß, Sabine, Breitbach, G P, Scharl, Anton, Klare, Peter, Stefek, Andrea, Hoffmann, Gerald, Martignoni, Franca, Weiss, Erich, Emons, Günter, Tesch, Hans-Christian, Beckmann, Matthias, Schmutzler, Rita, Schütte, Martin, Aktas, Bahriye, Hille-Betz, Ursula, Deryal, Mustafa, Dan Costa, Serban, Blümel, Beate, Göhring, Uwe-Jochen, Kleine-Tebbe, Anke, Schumacher, Claudia, Jasmin, Pourfard, Christoph, Uleer, Kullmer, Uwe, Krabisch, Petra, Gätje, Regine, Schwenzer, Thomas, Hindenburg, Hans-Joachim, Rempen, Andreas, Höffkes, Heinz-Gert, Stickeler, Elmar, Reffert, Christian, Seitz, Stephan, Splitt, Gerd, Böhne, Petra, Gnauert, Karsten, Strittmatter, Hans-Joachim, Baake, Gerold, Rezai, Mahdi, Noesselt, Thomas, Köhne, C-H, Hanf, Volker, Strumberg, Dirk, Dall, Peter, Schleicher, Peter, Schleicher, Bernd, Beldermann, Frank, Berghorn, Michael, Baerens, Dirk-Thoralf, Kolberg, Hans-Christian, Bauer, Lelia, Brucker, Cosima, Steck, Thomas, Boyle, Frances, Chaudhuri, Anupam, Wagga, Wagga, Moylan, Eugene, Donovan, Jenny, Della-Fiorentina, Stephen, Abdi, Ehtesham, Marx, Gavin, Beadle, Geoffrey, Donovan, Michael, Bennett, Ian, Gill, Peter Grantley, Baker, Caroline, Masters, Richard, Blum, Robert, Collins, John, Law, Michael, Hart, Stewart, Kannourakis, George, Snyder, Raymond, Joseph, David, McCrystal, Michael, Campbell, Ian, Jakesz, Raimund, Selim, Ursula, Singer, Christian, Heck, Dietmar, Greil, Richard, Ramoni, Angela, Bjelic-Radisic, Vesna, Reichenauer, Arno, Horvath, Wilfried, Thaler, Josef, Fridrik, Michael, Keckstein, Joerg, Jan, Lamote, L'Hermitte, Marc, Roelstrate, Heidi, Dirix, Luc, Bambust, Inneke, Seret, Monique, Liebens, Fabienne, Maerevoet, Maria, D'Hondt, Lionel, Berliere, Martine, Nogaret, Jean-Marie, Simon, Phillipe, O'Hanlon, Deirdre, Redmond, Henry Paul, Hill, Arnold, Evoy, Denis, Kerin, Michael, Gupta, Rajnish, Martin, Michael J, Fritis, Marcela, Schwartz, Ricardo, Yañez, Maria Loreto, Peralta, Octavio, Graiff, Claudio, Artioli, Fabrizio, Generali, Daniele, Orzalesi, Lorenzo, Visini, Marilena, Michiara, Maria, Pavesi, Lorenzo, Ravaioli, Alberto, Porpiglia, Mauro, Puglisi, Fabio, Pinotti, Graziella, Brincat, Stephen, Buser, Katharina S, Rabaglio, Manuela, Rauch, Daniel, Chappuis, Pierre O, Zaman, Khalil, Bucher, Susanne, Bolliger, Barbara, Pagani, Olivia, Falck, Anna-Karin, Kaij, Jakob, Margolin, Sara, Muslumanoglum, Mahmut, Bertelli, Gianfilippo, Bramley, Maria, Bristol, James, Chandrasekharan, Sankaran, Crellin, Perric, Daoud, Raouf, Dodwell, David, Drew, Philip, Dubey, Sidharth, Evans, Abigail, Ferguson, Douglas, Gendy, Raafat, Hamed, Hisham, Harding-McKean, Claudia, Horgan, Kieran, Iqbal, Shabana, Jibril, Jibril A, Kokan, Jalal, Kneeshaw, Peter, Lansdown, Mark, Lennard, Tom, Linforth, Rick, McIntosh, Stuart, Mitra, Sankha, Neades, Glyn, Ooi, Jane Louise, Patel, Ashraf, Rayter, Zenon, Reichert, Robert, Roberts, Fiona, Roche, Nicola, Rogers, Colin, Royle, Gavin, Shah, Elizabeth, Sibbering, Mark, Skene, Anthony Iain, Smith, Simon, Sparrow, Geoffrey, Thompson, Alastair, Vaidya, Jayant, Wolstenholme, Virginia, Wood, Jeremy, Yiangou, Constantinos, Zammit, Charles, Thornton, Rochelle, Probert, Flonda, Fong, Akiko, Francis, Nicole, Gili, Manuela, Eigenberger, Rosita, Supply, Daisy, Lefever, Inge, Muller, Bettina, Zlatar, Zdenka, Feer, Petra, Gkantiragas, Ioannis, Virkki, Marjo, Everhard, Sibille, Lemonnier, Jerome, Garcia, Sara, Ghanem, Saliha, Cole, Anna, O'Hare, Debra, Cronin, Elaine, Roche, Trudi, Kennedy, Emer, Ballot, Jo, Killilea, Niamh, Jennings, Marian, Lowry, Laura, Maxwell, Moira, Burke, Margaret, Gonzaga, Aliana Guerrieri, Bollani, Giorgia, Bianchetti, Andrea, Scalvini, Anna, Cretella, Elisabetta, Pasqualini, Antonella, Gobbi, Angela, Roselli, Jenny, Lagati, Angelita, Rapacchi, Elena, Lanza, Annalisa, Pini, Emanuela, Picardo, Elisa, Maggiorotto, Furio, Sottile, Roberta, Vallini, Ilaria, Cilia, Nadia, Patel, Mital, Bamford, Linda, Robertshaw, Helen, Inman, Hayle, Hill, Naomi, Dexter, Jane, Peasgood, Emily, Batty, Imogen, Cocks, Shirley, Mistry, Raksha, Sidders, Mary, Foulstone, Emily, Garlicka, Helen, Dawe, Catherine, Elliott, Jackie, Rooke, Kathy, Morris, Christine, Lester, Yvonne, Gibson, Sian, Chittock, Jill, Skelton, Amy, Gallimore, Elizabeth, Downes, Charlotte, Billett, Lynn, Caddy, Simone, Cumming, Helen, Cowell-Smith, Sharon, Turner, Caroline, Fernando, Sunjalee, Goodwin, Sarah, Taylor, Jo-Anne, Baines, Kizzy, Downer, Susan, Pilcher, Alice, Dobson, Tracey, Osborne, Lynn, Kuenzig, Greg, Hancock, Denise, Melia, Deborah, Gullaksen, Elaine, Hartup, Susan, Henson, Amy, Gibb, Jane, Coombs, Sarah, Taylor, Caroline, Kirkby, Amy, Thomas, Issy, Makinson, Karen, Kano, Yukie, Shah, Zoheb, Hardstaff, Lisa, Townley, Barbara, Hill, Philippa, McCurrie, Marilyn, Grassby, Sue, Henderson, Pamela, Talbot, Elizabeth, Bell, Ashley, Kanani, Reshma, Johnson, Joanne, Jones, Richard, Foster, Mel, Troke, Becky, Congdon, Hilary, Pascoe, Julie, Whelan, Sian, Edwards, Jenna, Brinkworth, Elaine, Blizard, Sheila, Clarke, Alison, Stevens, Kim, Harvey, Carol, Stacey, Jill, Mitchell, Sadie, Lowry, Tracey, Buckley, Sarah, Collins, Clare, Green, Liz, Jones, Helen, Conteh, Veronica, Ducket, Tracey, Kotze, Michelle, Strider, Paula, Stouraitis, Marina, Sundberg, Jan, Babiker, Abdel, Collins, Rory, Klijn, Jan, Ralston, Stuart, Tattersall, Martin, Weller, Ian, De Sousa, Andreia, Edwards, Rob, Ferguson, Sheila, Hickman, Jane, Johnson, Damian, Haidar, Nadia, Hammond, Victoria, Heighway, Emma, Ndoutoumou, Amalia, Sahota, Navdip, White, Laura, Aigret, Benoit, Batra, Priyanka, Knox, Jill, Oke, Adedayo, Ostler, Richard, and Sasieni, Peter

Subjects
Medicine (all), Medizin, skin and connective tissue diseases
Abstract

Third-generation aromatase inhibitors are more effective than tamoxifen for preventing recurrence in postmenopausal women with hormone-receptor-positive invasive breast cancer. However, it is not known whether anastrozole is more effective than tamoxifen for women with hormone-receptor-positive ductal carcinoma in situ (DCIS). Here, we compare the efficacy of anastrozole with that of tamoxifen in postmenopausal women with hormone-receptor-positive DCIS.In a double-blind, multicentre, randomised placebo-controlled trial, we recruited women who had been diagnosed with locally excised, hormone-receptor-positive DCIS. Eligible women were randomly assigned in a 1:1 ratio by central computer allocation to receive 1 mg oral anastrozole or 20 mg oral tamoxifen every day for 5 years. Randomisation was stratified by major centre or hub and was done in blocks (six, eight, or ten). All trial personnel, participants, and clinicians were masked to treatment allocation and only the trial statistician had access to treatment allocation. The primary endpoint was all recurrence, including recurrent DCIS and new contralateral tumours. All analyses were done on a modified intention-to-treat basis (in all women who were randomised and did not revoke consent for their data to be included) and proportional hazard models were used to compute hazard ratios and corresponding confidence intervals. This trial is registered at the ISRCTN registry, number ISRCTN37546358.Between March 3, 2003, and Feb 8, 2012, we enrolled 2980 postmenopausal women from 236 centres in 14 countries and randomly assigned them to receive anastrozole (1449 analysed) or tamoxifen (1489 analysed). Median follow-up was 7·2 years (IQR 5·6-8·9), and 144 breast cancer recurrences were recorded. We noted no statistically significant difference in overall recurrence (67 recurrences for anastrozole vs 77 for tamoxifen; HR 0·89 [95% CI 0·64-1·23]). The non-inferiority of anastrozole was established (upper 95% CI

Published
2016

4. Vergleich der Pharmakokinetik von Erlotinib bei zwei verschiedenen Dosierungen

Author

Gili, Manuela

Abstract

Die vorliegende Diplomarbeit befasst sich mit der Auswertung von Plasmaproben von Pankreaskarzinompatienten, die eine Kombinationschemotherapie der Substanzen Erlotinib, Capecitabin und Bevacizumab unterliefen. Hauptziel der Arbeit war der Vergleich der Pharmakokinetik zweier unterschiedlicher Dosierungen des Tyrosinkinasehemmers Erlotinib (Tarceva®). Dazu wurden drei Dose-Levels einer klinischen Studie zum Vergleich herangezogen, wobei sieben Patienten eine 100-mg-Dosis (Dose-Level 3) und 6 Patienten eine 150-mg-Dosis erhielten (Dose-Levels 7 und 8). Untersucht wurden einerseits die Einzelgabe (0-24 Stunden aus Tag 1) sowie die Tage 1-8 (entsprechende Woche 1 der Studie) und die Langzeitgabe über Monate andererseits. Die Untersuchungen der Woche 1 zeigten, dass die Patienten, die eine 150-mg-Dosis erhielten durchschnittlich höhere Plasmakonzentrationen erreichten und es konnten auch Unterschiede wichtiger pharmakokinetischer Parameter zwischen den beiden Dosierungen festgestellt werden. Jedoch konnten auch Unterschiede innerhalb der Dose-Levels beobachtet werden. Die Schwankungen zwischen den Dose-Levels 7 und 8 könnten auf eine Interaktion mit Bevacizumab hinweisen, da sich die Dosierung dieses Arzneistoffes in diesen Dose-Levels unterschied. Die Literatur liefert aber keine Angaben zu möglichen Wechselwirkungen. Daher kann auch die variable Pharmakokinetik, die der Substanz Erlotinib zugeschrieben wird, Grund für die Verschiedenheiten sein. Die Ergebnisse der Langzeitgabe zeigten sehr starke Schwankungen der Konzentrationen innerhalb der Dose-Levels und somit auch im Vergleich der beiden Dosierungen. Im weiteren Verlauf der Arbeit wurden Peak-Interferenzen zwischen Erlotinib und ausgewählten Substanzen der Prämedikation und Comedikation untersucht. Darunter die Substanzen Diclofenac, Dexamethason, Metamizol, Pantoprazol, Metoclopramid, Famotidin und Enoxaparin. Es wurden keine Peak-Interferenzen beobachtet. Schließlich wurde noch die Plasmaproteinbindung von Erlotinib mittels Ultrafiltration untersucht. Unter Verwendung der Ultrafiltrationsröhrchen (Centrisart®) konnte die Plasmaproteinbindung, die laut Literatur 98 % beträgt, bestätigt werden., The present diploma thesis focuses on the evaluation of blood samples of patients with diagnosed pancreatic carcinoma, who have undergone a chemotherapy including the substances erlotinib, capecitabine and bevacizumab. The principal aim of this thesis was the comparison of the pharmacokinetics between two different dosages of the tyrosine kinase inhibitor erlotinib (Tarceva®). Three different dose levels were examined in a clinical trial. Seven patients were treated with a 100 mg dose (dose level 3) and six further patients received a 150 mg dose (dose level 7 and 8). An examination of a single dose (0-24 hours of day 1) and the days 1-8 (first week of the study) as well as a long-term supplementation (months) was performed. The investigations of the first week showed higher average concentrations in patients receiving a 150 mg dose und there were further differences between the pharmacokinetic parameters of the two dosages to be found. However, there were differences within the dose levels as well. The fluctuations between dose level 7 and 8 could suggest a possible interaction between bevacizumab and erlotinb, as the doses of this substance tell apart within dose level 7 and 8. But there are no interactions between the two substances to be found in literature. Thus the interindividual pharmokokinetics of erlotinib also could be the reason for those results. The examination of the long-term supplementation resulted in strong fluctuations of the concentration within the dose levels and the two different dosages respectively. Furthermore this diploma thesis examined the analytical interferences between erlotinib and premedicated or comedicated drugs, including the substances diclofenac, dexamethasone, metamizol, pantoprazole, metoclopramide, famotidine and enoxaparin. It could be shown that there are no interactions between the drugs and erlotinib. Finally the plasma protein binding of erlotinb was examined by means of ultrafiltration. The results of this examination corresponded with the data from the literature.

Published
2013
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