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372 results on '"Bogaerts, Jan"'

2. Tumor Size Is Not Everything: Advancing Radiomics as a Precision Medicine Biomarker in Oncology Drug Development and Clinical Care. A Report of a Multidisciplinary Workshop Coordinated by the RECIST Working Group

Author

Nakajima, Erica C., Simpson, Amber, Bogaerts, Jan, de Vries, Elisabeth G.E., Do, Richard, Garalda, Elena, Goldmacher, Greg, Kinahan, Paul E., Lambin, Philippe, LeStage, Barbara, Li, Qin, Lin, Frank, Litière, Saskia, Perez-Lopez, Raquel, Petrick, Nicholas, Schwartz, Lawrence, Seymour, Lesley, Shankar, Lalitha, and Laurie, Scott A.

Published
2024
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5. Defining the role of real-world data in cancer clinical research: The position of the European Organisation for Research and Treatment of Cancer

Author

Saesen, Robbe, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M., Cornelissen, Jan J., Dekker, Andre, Eisenhauer, Elizabeth A., Freitas, André, Gronchi, Alessandro, Hernán, Miguel A., Hulstaert, Frank, Ost, Piet, Szturz, Petr, Verkooijen, Helena M., Weller, Michael, Wilson, Roger, Lacombe, Denis, and van der Graaf, Winette T.

Published
2023
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6. Standard Anthracycline Based Versus Docetaxel-Capecitabine in Early High Clinical and/or Genomic Risk Breast Cancer in the EORTC 10041/BIG 3-04 MINDACT Phase III Trial.

Author

Delaloge, Suzette, Piccart, Martine, Rutgers, Emiel, Litière, Saskia, van 't Veer, Laura J, van den Berkmortel, Franchette, Brain, Etienne, Dudek-Peric, Aleksandra, Gil-Gil, Miguel, Gomez, Patricia, Hilbers, Florentine S, Khalil, Zaman, Knox, Susan, Kuemmel, Sherko, Kunz, Georg, Lesur, Anne, Pierga, Jean-Yves, Ravdin, Peter, Rubio, Isabel T, Saghatchian, Mahasti, Smilde, Tineke J, Thompson, Alastair M, Viale, Giuseppe, Zoppoli, Gabriele, Vuylsteke, Peter, Tryfonidis, Konstantinos, Poncet, Coralie, Bogaerts, Jan, and Cardoso, Fatima

Subjects
Genetics, Rare Diseases, Breast Cancer, Clinical Trials and Supportive Activities, Human Genome, Cancer, Clinical Research, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Adult, Aged, Aged, 80 and over, Anthracyclines, Antineoplastic Combined Chemotherapy Protocols, Breast Neoplasms, Capecitabine, Docetaxel, Female, Humans, Middle Aged, Prospective Studies, MINDACT investigators and the TRANSBIG Consortium, Clinical Sciences, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

PurposeMINDACT demonstrated that 46% of patients with early breast cancer at high clinical but low genomic risk on the basis of MammaPrint may safely avoid adjuvant chemotherapy. A second random assignment (R-C) compared docetaxel-capecitabine with an anthracycline-based regimen.Patients and methodsR-C randomly assigned patients 1:1 between standard anthracycline-based regimens, with or without taxanes (control) and experimental docetaxel 75 mg/m2 intravenously plus oral capecitabine 825 mg/m2 two times per day for 14 days (DC) every 3 weeks for 6 cycles. The primary end point was disease-free survival (DFS). Secondary end points included overall survival and safety.ResultsOf 2,832 patients, 1,301 (45%) were randomly assigned, and 97% complied with R-C assignment. In the control arm, 29.6% only received taxanes (0.5% of N0 patients). DFS events (n = 148) were much less than required (n = 422) as a result of a lower-than-expected accrual and event rate. At 5 years of median follow-up, DFS was not different between DC (n = 652) and control (n = 649; 90.7% [95% CI, 88% to 92.8%] v 88.8% [95% CI, 85.9% to 91.1%]; hazard ratio [HR], 0.83 [95% CI, 0.60 to 1.15]; P = .26). Overall survival (HR, 0.91 [95% CI, 0.54 to 1.53]) and DFS in the clinical high and genomic high-risk subgroup (86.1% v 88.1%; HR, 0.83 [95% CI, 0.58 to 1.21]) were similar in both arms. DC led to more grade 1 neuropathy (27.1% v 11.2%) and more grade 2 hand/foot syndrome (28.5% v 3.3%) and diarrhea (13.7% v 5.8%). Serious cardiac events occurred in 9 patients (control, n = 4; DC, n = 5). Fifty-three patients developed second cancers (control, n = 32; DC, n = 21; leukemia: 2 v 1). Five treatment-related deaths occurred (control, 2 [0.3%]; DC, 3 [0.5%]).ConclusionAlthough underpowered, this second randomization in MINDACT did not show any improvement in outcome or safety with the use of DC compared with anthracycline-based chemotherapy.

Published
2020

7. Controlling technical variation amongst 6693 patient microarrays of the randomized MINDACT trial

Author

Jacob, Laurent, Witteveen, Anke, Beumer, Inès, Delahaye, Leonie, Wehkamp, Diederik, van den Akker, Jeroen, Snel, Mireille, Chan, Bob, Floore, Arno, Bakx, Niels, Brink, Guido, Poncet, Coralie, Bogaerts, Jan, Delorenzi, Mauro, Piccart, Martine, Rutgers, Emiel, Cardoso, Fatima, Speed, Terence, van ’t Veer, Laura, and Glas, Annuska

Subjects
Biological Sciences, Bioinformatics and Computational Biology, Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Human Genome, Clinical Trials and Supportive Activities, Cancer, Breast Cancer, Clinical Research, Biotechnology, Genetics, Adult, Aged, Biomarkers, Tumor, Breast Neoplasms, Female, Gene Expression Regulation, Neoplastic, Humans, Middle Aged, Neoplasm Proteins, Prognosis, Protein Array Analysis, Randomized Controlled Trials as Topic, Transcriptome, Biological sciences, Biomedical and clinical sciences
Abstract

Gene expression data obtained in large studies hold great promises for discovering disease signatures or subtypes through data analysis. It is also prone to technical variation, whose removal is essential to avoid spurious discoveries. Because this variation is not always known and can be confounded with biological signals, its removal is a challenging task. Here we provide a step-wise procedure and comprehensive analysis of the MINDACT microarray dataset. The MINDACT trial enrolled 6693 breast cancer patients and prospectively validated the gene expression signature MammaPrint for outcome prediction. The study also yielded a full-transcriptome microarray for each tumor. We show for the first time in such a large dataset how technical variation can be removed while retaining expected biological signals. Because of its unprecedented size, we hope the resulting adjusted dataset will be an invaluable tool to discover or test gene expression signatures and to advance our understanding of breast cancer.

Published
2020

8. Anthracycline-containing and taxane-containing chemotherapy for early-stage operable breast cancer: a patient-level meta-analysis of 100 000 women from 86 randomised trials

Author

Braybrooke, Jeremy, Bradley, Rosie, Gray, Richard, Hills, Robert K, Pan, Hongchao, Peto, Richard, Dodwell, David, McGale, Paul, Taylor, Carolyn, Aihara, Tomohiko, Anderson, Stewart, Blum, Joanne, Cardoso, Fatima, Chen, Xiaosong, Crown, John P, Ejlertsen, Bent, Friedl, Thomas W P, Harbeck, Nadia, Janni, Wolfgang, Jensen, Maj-Britt, Mamounas, Eleftherios, Narui, Kazutaka, Nitz, Ulrike, Norton, Larry, O'Shaughnessy, Joyce, Piccart, Martine, Robert, Nicholas, Shao, Zhi-Ming, Slamon, Dennis, Sparano, Joseph, Watanabe, Toru, Yothers, Greg, Yu, Ke-Da, Berry, Richard, Boddington, Clare, Clarke, Mike, Davies, Christina, Davies, Lucy, Duane, Fran, Evans, Vaughan, Gay, Jo, Gettins, Lucy, Godwin, Jon, James, Sam, Lui, Hui, Lui, Zulian, MacKinnon, Elizabeth, Mannu, Gurdeep, McHugh, Theresa, Morris, Philip, Read, Simon, Straiton, Ewan, Buzdar, Aman, Suman, Vera J, Hunt, Kelly K, Leonard, Robert C F, Mansi, Janine, Delbaldo, Catherine, Piedbois, Pascal, Quinaux, Emmanuel, Fesl, Christian, Gnant, Michael, Sölkner, Lidija, Steger, Guenther, Eikesdal, Hans Petter, Lønning, Per Eystein, Bee, Valerie, Fung, Helena, Mackey, John, Martin, Miguel, Press, Michael, De Azambuja, Evandro, Gelber, Richard, Regan, Meredith, Di Leo, Angelo, Van Dooren, Veerle, Nogaret, Jean Marie, Bartlett, John, Chen, Bingshu E, Gelmon, Karen, Goss, Paul E, Levine, Mark N, Parulekar, Wendy, Pritchard, Kathleen I, Shepherd, Lois, Berry, Donald, Cirrincione, Constance, Shulman, Lawrence N, Winer, Eric, Gelman, Rebecca S, Harris, Jay R, Henderson, Craig, Shapiro, Charles L, Christiansen, Peer, Ewertz, Marianne, Mouridsen, Henning T, Van Leeuwen, Elise, Linn, Sabine, Van Rossum, Annelot G J, Van Tinteren, Harm, Van Werkhoven, Erik, Goldstein, Lori, Gray, Robert, Eiermann, Wolfgang, Gianni, Luca, Valagussa, Pinuccia, Bogaerts, Jan, Bonnefoi, Herve, Poncet, Coralie, Huovinen, Riikka, Joensuu, Heikki, Bonneterre, Jacques, Fargeot, Pierre, Fumoleau, Pierre, Kerbrat, Pierre, Luporsi, Elisabeth, Namer, Moïse, Carrasco, Eva M, Segui, Miguel Angel, Meisner, Christoph, Loibl, Sibylle, Nekljudova, Valentina, Thomssen, Christoph, Von Minckwitz, Gunter, Kümmel, Sherko, Lopez, Massimo, Vici, Patrizia, Fountzilas, George, Koliou, Georgia, Mavroudis, Dimitrios, Saloustros, Emmanouil, Brain, Etienne, Delaloge, Suzette, Michiels, Stefan, Mathoulin-Pelissier, Simone, Bines, Jose, Sarmento, Roberta M B, Bonadonna, Gianni, Brambilla, Cristina, Rossi, Anna, Bliss, Judith, Coombes, Raoul Charles, Kilburn, Lucy, Marty, Michel, Amadori, Dino, Boccardo, Francesco, Nanni, Oriana, Rubagotti, Alessandra, Scarpi, Emanuela, Masuda, Norikazu, Toi, Masakazu, Ueno, Takayuki, Ishikawa, Takashi, Matsumoto, Koji, Takao, Shintaro, Sommer, Harald, Foroglou, Pericles, Giokas, George, Kondylis, D, Lissaios, Byron, Reinisch, Mattea, Lee, Keun Seok, Nam, Byung-Ho, Ro, Jung Sil, De Matteis, Andrea, Perrone, Francesco, Tang, Gong, Wolmark, Norman, Hozumi, Yasuo, Nomura, Yasuo, Earl, Helena, Hiller, Louise, Vallier, Anne-Laure, De Mastro, Lucia, Venturini, Macro, Delozier, Thierry, Lemonnier, Jerome, Martin, Anne-Laure, Roché, Henri, Spielmann, Marc, Chen, Xiasong, Shen, Kunwei, Albain, Kathy, Barlow, William, Budd, George T, Gralow, Julie, Hayes, Dan, Bartlett-Lee, Peter, Ellis, Paul, Bianco, Angelo Raffaele, De Laurentiis, Michelino, De Placido, Sabino, Wildiers, Hans, Hsu, Limin, Eremin, Oleg, Walker, Leslie G, Ahlgren, Johan, Blomqvist, Carl, Holmberg, Lars, Lindman, Henrik, Asmar, Lina, Jones, Stephen E, Gluz, Oleg, Liedtke, Cornelia, Arriagada, Rodrigo, Bergsten-Nordström, Elizabeth, Carey, Lisa, Coleman, Robert, Cuzick, Jack, Davidson, Nancy, Dignam, James, Dowsett, Mitch, Francis, Prudence A, Goetz, Matthew P, Goodwin, Pam, Halpin-Murphy, Pat, Hill, Catherine, Jagsi, Reshma, Mukai, Hirofumi, Ohashi, Yasuo, Pierce, Lori, Poortmans, Philip, Raina, Vinod, Rea, Daniel, Robertson, John, Rutgers, Emiel, Salgado, Roberto, Spanic, Tanja, Tutt, Andrew, Viale, Giuseppe, Wang, Xiang, Whelan, Tim, Wilcken, Nicholas, Cameron, David, Bergh, Jonas, and Swain, Sandra M

Published
2023
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9. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age

Author

Piccart, Martine, van 't Veer, Laura J, Poncet, Coralie, Lopes Cardozo, Josephine M N, Delaloge, Suzette, Pierga, Jean-Yves, Vuylsteke, Peter, Brain, Etienne, Vrijaldenhoven, Suzan, Neijenhuis, Peter A, Causeret, Sylvian, Smilde, Tineke J, Viale, Giuseppe, Glas, Annuska M, Delorenzi, Mauro, Sotiriou, Christos, Rubio, Isabel T, Kümmel, Sherko, Zoppoli, Gabriele, Thompson, Alastair M, Matos, Erika, Zaman, Khalil, Hilbers, Florentine, Fumagalli, Debora, Ravdin, Peter, Knox, Susan, Tryfonidis, Konstantinos, Peric, Aleksandra, Meulemans, Bart, Bogaerts, Jan, Cardoso, Fatima, and Rutgers, Emiel J T

Published
2021
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12. Societal challenges of precision medicine: Bringing order to chaos

Author

Becker, Robert, Beer, Philip, Bergh, Jonas, Bogaerts, Jan, Dovedi, Simon, Fojo, Antonio T., Gerstung, Moritz, Golfinopoulos, Vassilis, Hewitt, Stephen, Hochhauser, Daniel, Juhl, Hartmut, Kinders, Robert, Lillie, Thomas, Herbert, Kim Lyerly, Maheswaran, Shyamala, Mesri, Mehdi, Nagai, Sumimasa, Norstedt, Irene, O'Connor, Daniel, Oliver, Kathy, Oyen, Wim J.G., Pignatti, Francesco, Polley, Eric, Rosenfeld, Nitzan, Schellens, Jan, Schilsky, Richard, Schneider, Erasmus, Senderowicz, Adrian, Tenhunen, Olli, van Dongen, Augustinus, Vietz, Christine, Wilking, Nils, Salgado, Roberto, Moore, Helen, Martens, John W.M., Lively, Tracy, Malik, Shakun, McDermott, Ultan, Michiels, Stefan, Moscow, Jeffrey A., Tejpar, Sabine, McKee, Tawnya, and Lacombe, Denis

Published
2017
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15. Supplementary Data1 from Meta-Analysis of the Test–Retest Repeatability of [18F]-Fluorodeoxyglucose Standardized Uptake Values: Implications for Assessment of Tumor Response

Author

Shankar, Lalitha K., primary, Huang, Erich, primary, Litiere, Saskia, primary, Hoekstra, Otto S., primary, Schwartz, Larry, primary, Collette, Sandra, primary, Boellaard, Ronald, primary, Bogaerts, Jan, primary, Seymour, Lesley, primary, and deVries, Elisabeth G.E., primary

Published
2023
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16. Defining the role of real-world data in cancer clinical research:The position of the European Organisation for Research and Treatment of Cancer

Author

Saesen, Robbe, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M., Cornelissen, Jan J., Dekker, Andre, Eisenhauer, Elizabeth A., Freitas, André, Gronchi, Alessandro, Hernán, Miguel A., Hulstaert, Frank, Ost, Piet, Szturz, Petr, Verkooijen, Helena M., Weller, Michael, Wilson, Roger, Lacombe, Denis, van der Graaf, Winette T., Saesen, Robbe, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M., Cornelissen, Jan J., Dekker, Andre, Eisenhauer, Elizabeth A., Freitas, André, Gronchi, Alessandro, Hernán, Miguel A., Hulstaert, Frank, Ost, Piet, Szturz, Petr, Verkooijen, Helena M., Weller, Michael, Wilson, Roger, Lacombe, Denis, and van der Graaf, Winette T.

Abstract

The emergence of the precision medicine paradigm in oncology has led to increasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the uncertainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non-randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treatment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients.

Published
2023

17. Defining the role of real-world data in cancer clinical research: The position of the European Organisation for Research and Treatment of Cancer

Author

Trialbureau Beeld, Cancer, Saesen, Robbe, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M, Cornelissen, Jan J, Dekker, Andre, Eisenhauer, Elizabeth A, Freitas, André, Gronchi, Alessandro, Hernán, Miguel A, Hulstaert, Frank, Ost, Piet, Szturz, Petr, Verkooijen, Helena M, Weller, Michael, Wilson, Roger, Lacombe, Denis, van der Graaf, Winette T, Trialbureau Beeld, Cancer, Saesen, Robbe, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M, Cornelissen, Jan J, Dekker, Andre, Eisenhauer, Elizabeth A, Freitas, André, Gronchi, Alessandro, Hernán, Miguel A, Hulstaert, Frank, Ost, Piet, Szturz, Petr, Verkooijen, Helena M, Weller, Michael, Wilson, Roger, Lacombe, Denis, and van der Graaf, Winette T

Published
2023

18. Defining the role of real-world data in cancer clinical research: The position of the European Organisation for Research and Treatment of Cancer

Author

Saesen, Robbe; https://orcid.org/0000-0003-4460-0860, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M, Cornelissen, Jan J, Dekker, Andre; https://orcid.org/0000-0002-0422-7996, Eisenhauer, Elizabeth A, Freitas, André, Gronchi, Alessandro; https://orcid.org/0000-0002-4703-3534, Hernán, Miguel A, Hulstaert, Frank; https://orcid.org/0000-0003-2879-9910, Ost, Piet, Szturz, Petr, Verkooijen, Helena M, Weller, Michael; https://orcid.org/0000-0002-1748-174X, Wilson, Roger; https://orcid.org/0000-0002-6043-7306, Lacombe, Denis, van der Graaf, Winette T, Saesen, Robbe; https://orcid.org/0000-0003-4460-0860, Van Hemelrijck, Mieke, Bogaerts, Jan, Booth, Christopher M, Cornelissen, Jan J, Dekker, Andre; https://orcid.org/0000-0002-0422-7996, Eisenhauer, Elizabeth A, Freitas, André, Gronchi, Alessandro; https://orcid.org/0000-0002-4703-3534, Hernán, Miguel A, Hulstaert, Frank; https://orcid.org/0000-0003-2879-9910, Ost, Piet, Szturz, Petr, Verkooijen, Helena M, Weller, Michael; https://orcid.org/0000-0002-1748-174X, Wilson, Roger; https://orcid.org/0000-0002-6043-7306, Lacombe, Denis, and van der Graaf, Winette T

Abstract

The emergence of the precision medicine paradigm in oncology has led to increasing interest in the integration of real-world data (RWD) into cancer clinical research. As sources of real-world evidence (RWE), such data could potentially help address the uncertainties that surround the adoption of novel anticancer therapies into the clinic following their investigation in clinical trials. At present, RWE-generating studies which investigate antitumour interventions seem to primarily focus on collecting and analysing observational RWD, typically forgoing the use of randomisation despite its methodological benefits. This is appropriate in situations where randomised controlled trials (RCTs) are not feasible and non-randomised RWD analyses can offer valuable insights. Nevertheless, depending on how they are designed, RCTs have the potential to produce strong and actionable RWE themselves. The choice of which methodology to employ for RWD studies should be guided by the nature of the research question they are intended to answer. Here, we attempt to define some of the questions that do not necessarily require the conduct of RCTs. Moreover, we outline the strategy of the European Organisation for Research and Treatment of Cancer (EORTC) to contribute to the generation of robust and high-quality RWE by prioritising the execution of pragmatic trials and studies set up according to the trials-within-cohorts approach. If treatment allocation cannot be left up to random chance due to practical or ethical concerns, the EORTC will consider undertaking observational RWD research based on the target trial principle. New EORTC-sponsored RCTs may also feature concurrent prospective cohorts composed of off-trial patients.

Published
2023

19. ESMO / ASCO Recommendations for a Global Curriculum in Medical Oncology Edition 2016

Author

Dittrich, Christian, Kosty, Michael, Jezdic, Svetlana, Pyle, Doug, Berardi, Rossana, Bergh, Jonas, El-Saghir, Nagi, Lotz, Jean-Pierre, Österlund, Pia, Pavlidis, Nicholas, Purkalne, Gunta, Awada, Ahmad, Banerjee, Susana, Bhatia, Smita, Bogaerts, Jan, Buckner, Jan, Cardoso, Fatima, Casali, Paolo, Chu, Edward, Close, Julia Lee, Coiffier, Bertrand, Connolly, Roisin, Coupland, Sarah, De Petris, Luigi, De Santis, Maria, de Vries, Elisabeth G.E., Dizon, Don S., Duff, Jennifer, Duska, Linda R., Eniu, Alexandru, Ernstoff, Marc, Felip, Enriqueta, Fey, Martin F., Gilbert, Jill, Girard, Nicolas, Glaudemans, Andor W.J.M., Gopalan, Priya K., Grothey, Axel, Hahn, Stephen M., Hanna, Diana, Herold, Christian, Herrstedt, Jørn, Homicsko, Krisztian, Jones, Dennie V., Jr, Jost, Lorenz, Keilholz, Ulrich, Khan, Saad, Kiss, Alexander, Köhne, Claus-Henning, Kunstfeld, Rainer, Lenz, H.einz-Josef, Lichtman, Stuart, Licitra, Lisa, Lion, Thomas, Litière, Saskia, Liu, Lifang, Loehrer, Patrick J., Markham, Merry Jennifer, Markman, Ben, Mayerhoefer, Marius, Meran, Johannes G., Michielin, Olivier, Moser, Elizabeth Charlotte, Mountzios, Giannis, Moynihan, Timothy, Nielsen, Torsten, Ohe, Yuichiro, Öberg, Kjell, Palumbo, Antonio, Peccatori, Fedro Alessandro, Pfeilstöcker, Michael, Raut, Chandrajit, Remick, Scot C., Robson, Mark, Rutkowski, Piotr, Salgado, Roberto, Schapira, Lidia, Schernhammer, Eva, Schlumberger, Martin, Schmoll, Hans-Joachim, Schnipper, Lowell, Sessa, Cristiana, Shapiro, Charles L., Steele, Julie, Sternberg, Cora N., Stiefel, Friedrich, Strasser, Florian, Stupp, Roger, Sullivan, Richard, Tabernero, Josep, Travado, Luzia, Verheij, Marcel, Voest, Emile, Vokes, Everett, Von Roenn, Jamie, Weber, Jeffrey S., Wildiers, Hans, and Yarden, Yosef

Published
2016
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22. Meta-Analysis of the Test–Retest Repeatability of [18F]-Fluorodeoxyglucose Standardized Uptake Values: Implications for Assessment of Tumor Response

Author

Shankar, Lalitha K., primary, Huang, Erich, additional, Litiere, Saskia, additional, Hoekstra, Otto S., additional, Schwartz, Larry, additional, Collette, Sandra, additional, Boellaard, Ronald, additional, Bogaerts, Jan, additional, Seymour, Lesley, additional, and deVries, Elisabeth G.E., additional

Published
2022
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23. Radiotherapy or surgery of the axilla after a positive sentinel node in breast cancer (EORTC 10981-22023 AMAROS): a randomised, multicentre, open-label, phase 3 non-inferiority trial

Author

Donker, Mila, van Tienhoven, Geertjan, Straver, Marieke E, Meijnen, Philip, van de Velde, Cornelis J H, Mansel, Robert E, Cataliotti, Luigi, Westenberg, A Helen, Klinkenbijl, Jean H G, Orzalesi, Lorenzo, Bouma, Willem H, van der Mijle, Huub C J, Nieuwenhuijzen, Grard A P, Veltkamp, Sanne C, Slaets, Leen, Duez, Nicole J, de Graaf, Peter W, van Dalen, Thijs, Marinelli, Andreas, Rijna, Herman, Snoj, Marko, Bundred, Nigel J, Merkus, Jos W S, Belkacemi, Yazid, Petignat, Patrick, Schinagl, Dominic A X, Coens, Corneel, Messina, Carlo G M, Bogaerts, Jan, and Rutgers, Emiel J T

Published
2014
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25. Pathological complete response and long-term clinical benefit in breast cancer: the CTNeoBC pooled analysis

Author

Cortazar, Patricia, Zhang, Lijun, Untch, Michael, Mehta, Keyur, Costantino, Joseph P, Wolmark, Norman, Bonnefoi, Hervé, Cameron, David, Gianni, Luca, Valagussa, Pinuccia, Swain, Sandra M, Prowell, Tatiana, Loibl, Sibylle, Wickerham, D Lawrence, Bogaerts, Jan, Baselga, Jose, Perou, Charles, Blumenthal, Gideon, Blohmer, Jens, Mamounas, Eleftherios P, Bergh, Jonas, Semiglazov, Vladimir, Justice, Robert, Eidtmann, Holger, Paik, Soonmyung, Piccart, Martine, Sridhara, Rajeshwari, Fasching, Peter A, Slaets, Leen, Tang, Shenghui, Gerber, Bernd, Geyer, Charles E, Jr, Pazdur, Richard, Ditsch, Nina, Rastogi, Priya, Eiermann, Wolfgang, and von Minckwitz, Gunter

Published
2014
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26. Discordant assessment of tumor biomarkers by histopathological and molecular assays in the EORTC randomized controlled 10041/BIG 03-04 MINDACT trial breast cancer: Intratumoral heterogeneity and DCIS or normal tissue components are unlikely to be the cause of discordance

Author

Viale, Giuseppe, Slaets, Leen, de Snoo, Femke A., Bogaerts, Jan, Russo, Leila, van’t Veer, Laura, Rutgers, Emiel J. T., Piccart-Gebhart, Martine J., Stork-Sloots, Lisette, Dell’Orto, Patrizia, Glas, Annuska M., and Cardoso, Fatima

Published
2016
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35. TP53 status for prediction of sensitivity to taxane versus non-taxane neoadjuvant chemotherapy in breast cancer (EORTC 10994/BIG 1-00): a randomised phase 3 trial

Author

Bonnefoi, Hervé, Piccart, Martine, Bogaerts, Jan, Mauriac, Louis, Fumoleau, Pierre, Brain, Etienne, Petit, Thierry, Rouanet, Philippe, Jassem, Jacek, Blot, Emmanuel, Zaman, Khalil, Cufer, Tanja, Lortholary, Alain, Lidbrink, Elisabet, André, Sylvie, Litière, Saskia, Lago, Lissandra Dal, Becette, Véronique, Cameron, David A, Bergh, Jonas, and Iggo, Richard

Published
2011
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38. Biases in study design, implementation, and data analysis that distort the appraisal of clinical benefit and ESMO-Magnitude of Clinical Benefit Scale (ESMO-MCBS) scoring

Author

Gyawali, Bishal, de Vries, E.G.E., Dafni, U., Amaral, Teresa, Barriuso, Jorge, Bogaerts, Jan, Calles, Antonio, Curigliano, Giuseppe, Gomez-Roca, Carlos, Kiesewetter, Barbara, Oosting, Sjoukje, Passaro, Antonio, Pentheroudakis, George, Piccart-Gebhart, Martine, Roitberg, Felipe Santa Rosa, Tabernero, Josep, Tarazona, Noelia, Trapani, Dario, Wester, Ruth, Zarkavelis, George, Zielinski, Christoph, Zygoura, Panagiota, Cherny, N.I., Gyawali, Bishal, de Vries, E.G.E., Dafni, U., Amaral, Teresa, Barriuso, Jorge, Bogaerts, Jan, Calles, Antonio, Curigliano, Giuseppe, Gomez-Roca, Carlos, Kiesewetter, Barbara, Oosting, Sjoukje, Passaro, Antonio, Pentheroudakis, George, Piccart-Gebhart, Martine, Roitberg, Felipe Santa Rosa, Tabernero, Josep, Tarazona, Noelia, Trapani, Dario, Wester, Ruth, Zarkavelis, George, Zielinski, Christoph, Zygoura, Panagiota, and Cherny, N.I.

Abstract

BACKGROUND: The European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) is a validated, widely used tool developed to score the clinical benefit from cancer medicines reported in clinical trials. ESMO-MCBS scores assume valid research methodologies and quality trial implementation. Studies incorporating flawed design, implementation, or data analysis may generate outcomes that exaggerate true benefit and are not generalisable. Failure to either indicate or penalise studies with bias undermines the intention and diminishes the integrity of ESMO-MCBS scores. This review aimed to evaluate the adequacy of the ESMO-MCBS to address bias generated by flawed design, implementation, or data analysis and identify shortcomings in need of amendment. METHODS: As part of a refinement of the ESMO-MCBS, we reviewed trial design, implementation, and data analysis issues that could bias the results. For each issue of concern, we reviewed the ESMO-MCBS v1.1 approach against standards derived from Helsinki guidelines for ethical human research and guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, the Food and Drugs Administration, the European Medicines Agency, and European Network for Health Technology Assessment. RESULTS: Six design, two implementation, and two data analysis and interpretation issues were evaluated and in three, the ESMO-MCBS provided adequate protections. Seven shortcomings in the ability of the ESMO-MCBS to identify and address bias were identified. These related to (i) evaluation of the control arm, (ii) crossover issues, (iii) criteria for non-inferiority, (iv) substandard post-progression treatment, (v) post hoc subgroup findings based on biomarkers, (vi) informative censoring, and (vii) publication bias against quality-of-life data. CONCLUSION: Interpretation of the ESMO-MCBS scores requires critical appraisal of trials to understand caveats in trial design, imp, SCOPUS: re.j, info:eu-repo/semantics/published

Published
2021

45. A stroma-related gene signature predicts resistance to neoadjuvant chemotherapy in breast cancer

Author

Farmer, Pierre, Bonnefoi, Herve, Anderle, Pascale, Cameron, David, Wirapati, Pratyakasha, Becette, Veronique, Andre, Sylvie, Piccart, Martine, Campone, Mario, Brain, Etienne, MacGrogan, Gaetan, Petit, Thierry, Jassem, Jacek, Bibeau, Frederic, Blot, Emmanuel, Bogaerts, Jan, Aguet, Michel, Bergh, Jonas, Iggo, Richard, and Delorenzi, Mauro

Subjects
Breast cancer -- Drug therapy, Breast cancer -- Research, Neoadjuvant therapy -- Health aspects, Drug resistance -- Genetic aspects, Drug resistance -- Research, Genes -- Physiological aspects, Genes -- Research
Abstract

To better understand the relationship between tumor-host interactions and the efficacy of chemotherapy, we have developed an analytical approach to quantify several biological processes observed in gene expression data sets. We tested the approach on tumor biopsies from individuals with estrogen receptor-negative breast cancer treated with chemotherapy. We report that increased stromal gene expression predicts resistance to preoperative chemotherapy with 5-fluorouracil, epirubicin and cyclophosphamide (FEC) in subjects in the EORTC 10994/131G 00-01 trial. The predictive value of the stromal signature was successfully validated in two independent cohorts of subjects who received chemotherapy but not in an untreated control group, indicating that the signature is predictive rather than prognostic. The genes in the signature are expressed in reactive stroma, according to reanalysis of data from microdissected breast tumor samples. These findings identify a previously undescribed resistance mechanism to FEC treatment and suggest that antistromal agents may offer new ways to overcome resistance to chemotherapy., &&&& Preoperative chemotherapy leads to the disappearance of the primary tumor (pathological complete response; pCR) in less than 10% of estrogen receptor-positive breast tumors and in 20-30% of estrogen receptor-negative [...]

Published
2009

47. Total dose and displacement damage effects in a radiation-hardened CMOS APS

Author

Bogaerts, Jan, Dierickx, Bart, Meynants, Guy, and Uwaerts, Dirk

Subjects
Ionizing radiation -- Structure, Ionizing radiation -- Analysis, Pixels -- Structure, Pixels -- Analysis, Complementary metal oxide semiconductors -- Structure, Complementary metal oxide semiconductors -- Analysis, Business, Electronics, Electronics and electrical industries
Abstract

The design and fabrication of a 512*512 CMOS active pixel sensor (APS) in a standard 0.5-mu m technology is described. The increase of the dark current is the most pronounced radiation effect.

Published
2003

48. 70-Gene Signature as an Aid to Treatment Decisions in Early Breast Cancer: Updated Results MINDACT

Author

Piccart, Martine, primary, van't Veer, Laura, additional, Poncet, Coralie, additional, Cardozo, Josephine M.N. Lopes, additional, Delaloge, Suzette, additional, Pierga, Jean-Yves, additional, Vuylsteke, Peter, additional, Brain, Etienne, additional, Vrijaldenhoven, Suzan, additional, Neijenhuis, Peter A., additional, Causeret, Sylvian, additional, Smilde, Tineke J., additional, Viale, Guiseppe, additional, Glas, Annuska M., additional, Delorenzi, Mauro, additional, Sotiriou, Christos, additional, Rubio, Isabel T., additional, Kümmel, Sherko, additional, Zoppoli, Gabrielle, additional, Thompson, Alastair M., additional, Matos, Erika, additional, Zaman, Khalil, additional, Hilbers, Florentine, additional, Fumagalli, Debora, additional, Ravdin, Peter, additional, Knox, Susan, additional, Tryfonidis, Konstantinos, additional, Peric, Aleksandra, additional, Meulemans, Bart, additional, Bogaerts, Jan, additional, Cardoso, Fatima, additional, and Rutgers, Emiel J.Th., additional

Published
2020
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