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14 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. 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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7. 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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8. 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

9. 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

10. 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

12. 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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13. Plasma ctDNA as a treatment response biomarker in metastatic cancers: evaluation by the RECIST working group.

Author

Wyatt AW, Litière S, Bidard FC, Cabel L, Dyrskjøt L, Karlovich CA, Pantel K, Petrie J, Philip R, Andrews HS, Vellanki PJ, Tolmeijer SH, Villalobos Alberu X, Alfano C, Bogaerts J, Calvo E, Chen AP, Toledo RA, de Vries EGE, Seymour L, Laurie SA, and Garralda E

Abstract

Early indicators of metastatic cancer response to therapy are important for evaluating new drugs and stopping ineffective treatment. The Response Evaluation Criteria in Solid Tumors (RECIST) based on repeat cancer imaging are widely adopted in clinical trials, are used to identify active regimens that may change practice, and contribute to regulatory approvals. However, these criteria do not provide insight before 6 - 12 weeks of treatment and typically require that patients have measurable disease. Recent data suggests that measuring on-treatment changes in the amount or proportion of circulating tumor DNA (ctDNA) in peripheral blood plasma may accurately identify responding and non-responding cancers at earlier time points. Over the past year, the RECIST working group has evaluated current evidence for plasma ctDNA kinetics as a treatment response biomarker in metastatic cancers and early endpoint in clinical trials, to identify areas of focus for future research and validation. Here, we outline the requirement for large standardized trial datasets, greater scrutiny of optimal ctDNA collection time points and assay thresholds, and consideration of regulatory body guidelines and patient opinions. In particular, clinically-meaningful changes in plasma ctDNA abundance are likely to differ by cancer type and therapy class, and must be assessed before ctDNA can be considered as a potential pan-cancer response evaluation biomarker. Despite the need for additional data, minimally-invasive on-treatment ctDNA measurements hold promise to build upon existing response assessments such as RECIST, and offer opportunities for developing novel early endpoints for modern clinical trials.

Published
2024
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14. Meta-Analysis of the Test-Retest Repeatability of [18F]-Fluorodeoxyglucose Standardized Uptake Values: Implications for Assessment of Tumor Response.

Author

Shankar LK, Huang E, Litiere S, Hoekstra OS, Schwartz L, Collette S, Boellaard R, Bogaerts J, Seymour L, and deVries EGE

Subjects
Humans, Positron Emission Tomography Computed Tomography methods, Reproducibility of Results, Positron-Emission Tomography methods, Radiopharmaceuticals, Fluorodeoxyglucose F18 metabolism, Neoplasms diagnostic imaging, Neoplasms metabolism
Abstract

Purpose: Currently, guidelines for PET with 18F-fluorodeoxyglucose (FDG-PET) interpretation for assessment of therapy response in oncology primarily involve visual evaluation of FDG-PET/CT scans. However, quantitative measurements of the metabolic activity in tumors may be even more useful in evaluating response to treatment. Guidelines based on such measurements, including the European Organization for Research and Treatment of Cancer Criteria and PET Response Criteria in Solid Tumors, have been proposed. However, more rigorous analysis of response criteria based on FDG-PET measurements is needed to adopt regular use in practice., Experimental Design: Well-defined boundaries of repeatability and reproducibility of quantitative measurements to discriminate noise from true signal changes are a needed initial step. An extension of the meta-analysis from de Langen and colleagues (2012) of the test-retest repeatability of quantitative FDG-PET measurements, including mean, maximum, and peak standardized uptake values (SUVmax, SUVmean, and SUVpeak, respectively), was performed. Data from 11 studies in the literature were used to estimate the relationship between the variance in test-retest measurements with uptake level and various study-level, patient-level, and lesion-level characteristics., Results: Test-retest repeatability of percentage fluctuations for all three types of SUV measurement (max, mean, and peak) improved with higher FDG uptake levels. Repeatability in all three SUV measurements varied for different lesion locations. Worse repeatability in SUVmean was also associated with higher tumor volumes., Conclusions: On the basis of these results, recommendations regarding SUV measurements for assessing minimal detectable changes based on repeatability and reproducibility are proposed. These should be applied to differentiate between response categories for a future set of FDG-PET-based criteria that assess clinically significant changes in tumor response., (©2022 American Association for Cancer Research.)

Published
2023
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