Suchergebnisse - "Buyse, Marc"

Generalized pairwise comparisons of prioritized outcomes in the two-sample problem von Buyse, Marc

“… This paper extends the idea behind the U‐statistic of the Wilcoxon–Mann–Whitney test to perform generalized pairwise comparisons between two groups of …”
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Combination of everolimus with trastuzumab plus paclitaxel as first-line treatment for patients with HER2-positive advanced breast cancer (BOLERO-1): a phase 3, randomised, double-blind, multicentre trial von Hurvitz, Sara A, Andre, Fabrice, Jiang, Zefei, Shao, Zhimin, Mano, Max S, Neciosup, Silvia P, Tseng, Ling-Min, Zhang, Qingyuan, Shen, Kunwei, Liu, Donggeng, Dreosti, Lydia M, Burris, Howard A, Toi, Masakazu, Buyse, Marc E, Cabaribere, David, Lindsay, Mary-Ann, Rao, Shantha, Pacaud, Lida Bubuteishvili, Taran, Tetiana, Slamon, Dennis

“… mTOR inhibition reverses trastuzumab resistance via the hyperactivated PIK/AKT/mTOR pathway due to PTEN loss, by sensitising PTEN-deficient tumours to …”
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Time to Review the Role of Surrogate End Points in Health Policy: State of the Art and the Way Forward von Ciani, Oriana, Buyse, Marc, Drummond, Michael, Rasi, Guido, Saad, Everardo D., Taylor, Rod S.

“… The efficacy of medicines, medical devices, and other health technologies should be proved in trials that assess final patient-relevant outcomes such as …”
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Surrogacy Beyond Prognosis: The Importance of “Trial-Level” Surrogacy von Buyse, Marc, Saad, Everardo D, Burzykowski, Tomasz, Regan, Meredith M, Sweeney, Christopher S

“… Abstract Many candidate surrogate endpoints are currently assessed using a 2-level statistical approach, which consists in checking whether (1) the potential …”
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Use of early tumor shrinkage to predict long-term outcome in metastatic colorectal cancer treated with cetuximab von Piessevaux, Hubert, Buyse, Marc, Schlichting, Michael, Van Cutsem, Eric, Bokemeyer, Carsten, Heeger, Steffen, Tejpar, Sabine

“… Early tumor shrinkage (ETS) is associated with long-term outcome in patients with chemorefractory metastatic colorectal cancer (mCRC) receiving cetuximab. This …”
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Circulating tumor cell biomarker panel as an individual-level surrogate for survival in metastatic castration-resistant prostate cancer von Scher, Howard I, Heller, Glenn, Molina, Arturo, Attard, Gerhardt, Danila, Daniel C, Jia, Xiaoyu, Peng, Weimin, Sandhu, Shahneen K, Olmos, David, Riisnaes, Ruth, McCormack, Robert, Burzykowski, Tomasz, Kheoh, Thian, Fleisher, Martin, Buyse, Marc, de Bono, Johann S

“… Trials in castration-resistant prostate cancer (CRPC) need new clinical end points that are valid surrogates for survival. We evaluated circulating tumor cell …”
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Biological processes associated with breast cancer clinical outcome depend on the molecular subtypes von Desmedt, Christine, Haibe-Kains, Benjamin, Wirapati, Pratyaksha, Buyse, Marc, Larsimont, Denis, Bontempi, Gianluca, Delorenzi, Mauro, Piccart, Martine, Sotiriou, Christos

“… Recently, several prognostic gene expression signatures have been identified; however, their performance has never been evaluated according to the previously …”
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Understanding and Communicating Measures of Treatment Effect on Survival: Can We Do Better? von Saad, Everardo D, Zalcberg, John R, Péron, Julien, Coart, Elisabeth, Burzykowski, Tomasz, Buyse, Marc

“… Time-to-event end points are the most frequent primary end points in phase III oncology trials, both in the adjuvant and advanced settings. The evaluation of …”
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Data Sharing, Year 1 — Access to Data from Industry-Sponsored Clinical Trials von Strom, Brian L, Buyse, Marc, Hughes, John, Knoppers, Bartha M

“… Since May 2013, researchers have been able to request access to deidentified patient-level data from GlaxoSmithKline–sponsored clinical trials, subject to …”
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Data Sharing — Is the Juice Worth the Squeeze? von Strom, Brian L, Buyse, Marc E, Hughes, John, Knoppers, Bartha M

“… Making clinical trial data widely available is ethically imperative and scientifically justified, but the experience with clinicalstudydatarequest.com suggests …”
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Neratinib after trastuzumab-based adjuvant therapy in patients with HER2-positive breast cancer (ExteNET): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial von Chan, Arlene, Delaloge, Suzette, Holmes, Frankie A, Moy, Beverly, Iwata, Hiroji, Harvey, Vernon J, Robert, Nicholas J, Silovski, Tajana, Gokmen, Erhan, von Minckwitz, Gunter, Ejlertsen, Bent, Chia, Stephen K L, Mansi, Janine, Barrios, Carlos H, Gnant, Michael, Buyse, Marc, Gore, Ira, Smith, John, Harker, Graydon, Masuda, Norikazu, Petrakova, Katarina, Zotano, Angel Guerrero, Iannotti, Nicholas, Rodriguez, Gladys, Tassone, Pierfrancesco, Wong, Alvin, Bryce, Richard, Ye, Yining, Yao, Bin, Martin, Miguel

“… Neratinib, an irreversible tyrosine-kinase inhibitor of HER1, HER2, and HER4, has clinical activity in patients with HER2-positive metastatic breast cancer. We …”
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Biomarkers and surrogate end points—the challenge of statistical validation von Buyse, Marc, Sargent, Daniel J., Grothey, Axel, Matheson, Alastair, de Gramont, Aimery

“… The validation of predictive and prognostic biomarkers and surrogate end points requires robust statistical analysis of data gathered from multiple, large, …”
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Outcome measures in multimodal rectal cancer trials von Fokas, Emmanouil, Glynne-Jones, Robert, Appelt, Ane, Beets-Tan, Regina, Beets, Geerard, Haustermans, Karin, Marijnen, Corrie, Minsky, Bruce D, Ludmir, Ethan, Quirke, Phil, Sebag-Montefiore, David, Garcia-Aguilar, Julio, Gambacorta, Maria Antonietta, Valentini, Vincenzo, Buyse, Marc, Rödel, Claus

“… There is a large variability regarding the definition and choice of primary endpoints in phase 2 and phase 3 multimodal rectal cancer trials, resulting in …”
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Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials von Saad, Everardo D, Katz, Artur, Buyse, Marc

“… With the availability of several lines of therapy, overall survival (OS) has been progressively substituted by progression-free survival (PFS) and other …”
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Radiographic Progression-Free Survival and Clinical Progression-Free Survival as Potential Surrogates for Overall Survival in Men With Metastatic Hormone-Sensitive Prostate Cancer von Halabi, Susan, Roy, Akash, Rydzewska, Larysa, Guo, Siyuan, Godolphin, Peter, Hussain, Maha, Tangen, Catherine, Thompson, Ian, Xie, Wanling, Carducci, Michael A, Smith, Matthew R, Morris, Michael J, Gravis, Gwenaelle, Dearnaley, David P, Verhagen, Paul, Goto, Takayuki, James, Nick, Buyse, Marc E, Tierney, Jayne F, Sweeney, Christopher

“… Despite major increases in the longevity of men with metastatic hormone-sensitive prostate cancer (mHSPC), most men still die of prostate cancer. Phase III …”
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Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen von Dowsett, Mitch, Cuzick, Jack, Ingle, Jim, Coates, Alan, Forbes, John, Bliss, Judith, Buyse, Marc, Baum, Michael, Buzdar, Aman, Colleoni, Marco, Coombes, Charles, Snowdon, Claire, Gnant, Michael, Jakesz, Raimund, Kaufmann, Manfred, Boccardo, Francesco, Godwin, Jon, Davies, Christina, Peto, Richard

“… To conduct meta-analyses of randomized trials of aromatase inhibitors (AIs) compared with tamoxifen either as initial monotherapy (cohort 1) or after 2 to 3 …”
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The tyranny of non-inferiority trials von Tannock, Ian F, Buyse, Marc, De Backer, Mickael, Earl, Helena, Goldstein, Daniel A, Ratain, Mark J, Saltz, Leonard B, Sonke, Gabe S, Strohbehn, Garth W

“… Opportunities to decrease the toxicity and cost of approved treatment regimens with lower dose, less frequent, or shorter duration alternative regimens have …”
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Disease-free survival as a surrogate for overall survival in patients with HER2-positive, early breast cancer in trials of adjuvant trastuzumab for up to 1 year: a systematic review and meta-analysis von Saad, Everardo D, Squifflet, Pierre, Burzykowski, Tomasz, Quinaux, Emmanuel, Delaloge, Suzette, Mavroudis, Dimitris, Perez, Edith, Piccart-Gebhart, Martine, Schneider, Bryan P, Slamon, Dennis, Wolmark, Norman, Buyse, Marc

“… Although frequently used as a primary endpoint, disease-free survival has not been validated as a surrogate for overall survival in early breast cancer. We …”
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Dose optimisation to improve access to effective cancer medicines von Tannock, Ian F, de Vries, Elisabeth G E, Fojo, Antonio, Buyse, Marc, Moja, Lorenzo

“… Access to many cancer medicines on WHO's Essential Medicines List (EML) is restricted because of price, especially in low-income and middle-income countries …”
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Regional variation in clinical-trial risks: a large-scale analysis of 585 clinical trials von de Viron, Sylviane, Young, Steve, Trotta, Laura, Buyse, Marc

“… ObjectivesTo assess 10 common indicators of clinical trial risks across regions.DesignRetrospective pooled analysis of routine central-monitoring outputs.Data …”
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