The broad experience of IDDI is reflected by its publications in medical and statistical journals and by its presence at major conferences.
Click on the links/year under to view the list of archived publications.
- 2011
Michael F Press, Guido Sauter, Marc Buyse, Leslie Bernstein, Roberta Guzman, Angela Santiago, Ivonne E Villalobos, Wolfgang Eiermann, Tadeusz Pienkowski, Miguel Martin, Nicholas Robert, John Crown, Valerie Bee, Henry Taupin, Kerry J Flom, Isabelle Tabah-F
Alteration of topoisomerase II-alpha gene in human breast cancer: association with responsiveness to anthracycline-based chemotherapy.
Marc Buyse, Pierre Squifflet, Beverly J Lange, Todd A Alonzo, Richard A Larson, Jonathan E Kolitz, Stephen L George, Clara D Bloomfield, Sylvie Castaigne, Sylvie Chevret, Didier Blaise, Dominique Maraninchi, Kathryn J Lucchesi, Tomasz Burzykowski
Individual patient data meta-analysis of randomized trials evaluating interleukin-2 monotherapy as remission maintenance therapy in acute myeloid leukemia.
Marc Buyse, Stefan Michiels, Pierre Suqifflet, Kathryn Lucchesi, Kristoffer Hellstrand, Mats L Brune, Sylvie Castaigne, Jacob M Rowe
Leukemia-free survival as a surrogate endpoint for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission.
Vicente Valero, John Forbes, Mark D Pegram, Tadeusz Pienkowski, Wolfgang Eiermann, Gunter von Minckwitz, Henri Roche, Miguel Martin, John Crown, John R Mackey, Pierre Fumoleau, Janusz Rolski, Zrinka Mrsic-Krmpotic, Agnieszka Jagiello-Gruszfeld, Alessandro
Multicenter phase III randomized trial comparing docetaxel and trastuzumab with docetaxel, carboplatin, and trastuzumab as first-line chemotherapy for patients with HER2-gene-amplified metastatic breast cancer: two highly active therapeutic regimens.
Marc Buyse, Emmanuel Quinaux, Alain Hendlisz, Vassilis Golfinopoulos, Christophe Tournigand, Rosemarie Mick
Progression-Free Survival Ratio As End Point for Phase II Trials in Advanced Solid Tumors.
Marc Buyse, Pierre Squifflet, Kathryn J Lucchesi, Mats L Brune, Sylvie Castaigne, Jacob M Rowe
Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia.
Marc Buyse, Ian C Marschner
Assessment of Statistical Heterogeneity in the PLATO Trial.
D Sargent, Q Shi, G Yothers, E Van Cutsem, J Cassidy, L Saltz, N Wolmark, B Bot, A Grothey, M Buyse, A de Gramont
Two or three year disease-free survival (DFS) as a primary end-point in stage III adjuvant colon cancer trials with fluoropyrimidines with or without oxaliplatin or irinotecan: Data from 12,676 patients from MOSAIC, X-ACT, PETACC-3, C-06, C-07 and C89803.
Marc Buyse, Stefan Michiels, Daniel J Sargent, Axel Grothey, Alastair Matheson, Aimery de Gramont
Integrating biomarkers in clinical trials.
Christine Desmedt, Angelo Di Leo, Evandro de Azambuja, Denis Larsimont, Benjamin Haibe-Kains, Jean Selleslags, Suzette Delaloge, Caroline Duhem, Jean-Pierre Kains, Birgit Carly, Marie Maerevoet, Anita Vindevoghel, Ghislane Rouas, Françoise Lallemand, Virg
Multifactorial approach to predicting resistance to anthracyclines.
- 2010
Geert Molenberghs, Tomasz Burzykowski, Ariel Alonso, Pryseley Assam, Abel Tilahun, Marc Buyse
A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials
Pascal Piedbois, Marc Buyse
Meta-analysis based on individual patient data: example of advanced colorectal cancer
Isabelle Baumgaertner, Emmanuel Quinaux, Ahmed Khalil, Christophe Louvet, Marc Buyse, Aimery de Gramont, Thierry André
Comparison of the levogyre and dextro-levogyre forms of leucovorin in a phase III trial of bimonthly LV5FU2 versus monthly 5-fluorouracil and high-dose leucovorin for patients with stage II and III colon cancer (GERCOR C96.1).
Tomasz Burzykowski, M Buyse
The correlation structure of longitudinal measurements of vision in patients with macular degeneration
E D Saad, A Katz, P M Hoff, M Buyse
Progression-free survival as surrogate and as true end point: insights from the breast and colorectal cancer literature
Everardo D Saad, Artur Katz, Marc Buyse
Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials
Aimery de Gramont, Joleen Hubbard, Qian Shi, Michael J O'Connell, Marc Buyse, Jacqueline Benedetti, Brian Bot, Chris O'Callaghan, Greg Yothers, Richard M Goldberg, Charles D Blanke, Al Benson, Qiqi Deng, Steven R Alberts, Thierry Andre, Norman Wolmark, Ax
Association between disease-free survival and overall survival when survival is prolonged after recurrence in patients receiving cytotoxic adjuvant therapy for colon cancer: simulations based on the 20,800 patient ACCENT data set.
Mitch Dowsett, Jack Cuzick, Jim Ingle, Alan Coates, John Forbes, Judith Bliss, Marc Buyse, Michael Baum, Aman Buzdar, Marco Colleoni, Charles Coombes, Claire Snowdon, Michael Gnant, Raimund Jakesz, Manfred Kaufmann, Francesco Boccardo, Jon Godwin, Christi
Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen.
Marc Buyse, Daniel J Sargent, Axel Grothey, Alastair Matheson, Aimery de Gramont
Biomarkers and surrogate end points--the challenge of statistical validation.
Xavier Paoletti, Koji Oba, Tomasz Burzykowski, Stefan Michiels, Yasuo Ohashi, Jean-Pierre Pignon, Philippe Rougier, Junichi Sakamoto, Daniel Sargent, Mitsuru Sasako, Eric Van Cutsem, Marc Buyse
Benefit of adjuvant chemotherapy for resectable gastric cancer: a meta-analysis.
Marc Buyse
Generalized pairwise comparisons of prioritized outcomes in the two-sample problem.
Karime K Machado, Artur Katz, Marc Buyse, Everardo Delforge Saad
Article in Rev Assoc Med Bras
Rev Assoc Med Bras 56: 5. 514-516.
Michael F Press, Guido Sauter, Marc Buyse, Leslie Bernstein, Roberta Guzman, Angela Santiago, Ivonne E Villalobos, Wolfgang Eiermann, Tadeusz Pienkowski, Miguel Martin, Nicholas Robert, John Crown, Valerie Bee, Henry Taupin, Kerry J Flom, Isabelle Tabah-F
Alteration of Topoisomerase II-Alpha Gene in Human Breast Cancer: Association With Responsiveness to Anthracycline-Based Chemotherapy
Vicente Valero, John Forbes, Mark D Pegram, Tadeusz Pienkowski, Wolfgang Eiermann, Gunter von Minckwitz, Henri Roche, Miguel Martin, John Crown, John R Mackey, Pierre Fumoleau, Janusz Rolski, Zrinka Mrsic-Krmpotic, Agnieszka Jagiello-Gruszfeld, Alessandro
Multicenter Phase III Randomized Trial Comparing Docetaxel and Trastuzumab With Docetaxel, Carboplatin, and Trastuzumab As First-Line Chemotherapy for Patients With HER2-Gene-Amplified Metastatic Breast Cancer (BCIRG 007 Study): Two Highly Active Therapeu
- 2009
Buyse M
Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials
H Piessevaux, M Buyse, W De Roock, H Prenen, M Schlichting, E Van Cutsem, S Tejpar
Radiological tumor size decrease at week 6 is a potent predictor of outcome in chemorefractory metastatic colorectal cancer treated with cetuximab (BOND trial).
B Chibaudel, C Tournigand, P Artru, T André, A Cervantes, A Figer, G Lledo, M Flesch, M Buyse, L Mineur, E Carola, F Rivera, N Perez-Staub, C Louvet, A de Gramont
FOLFOX in patients with metastatic colorectal cancer and high alkaline phosphatase level: an exploratory cohort of the GERCOR OPTIMOX1 study.
Molenbergh, Burzykowski, Alonso, Tilahun, Buyse M
A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials
Stefan Michiels, Aurélie Le Maître, Marc Buyse, Tomasz Burzykowski, Emilie Maillard, Jan Bogaerts, Jan B Vermorken, Wilfried Budach, Thomas F Pajak, Kian K Ang, Jean Bourhis, Jean-Pierre Pignon
Surrogate endpoints for overall survival in locally advanced head and neck cancer: meta-analyses of individual patient data.
Daniel Sargent, Alberto Sobrero, Axel Grothey, Michael J O'Connell, Marc Buyse, Thierry Andre, Yan Zheng, Erin Green, Roberto Labianca, Chris O'Callaghan, Jean Francois Seitz, Guido Francini, Daniel Haller, Greg Yothers, Richard Goldberg, Aimery de Gramon
Evidence for cure by adjuvant therapy in colon cancer: observations based on individual patient data from 20,898 patients on 18 randomized trials.
Buyse M
Contributions of meta-analyses based on individual patient data to therapeutic progress in colorectal cancer.
Christine Desmedt, Jeff Sperinde, Fanny Piette, Weidong Huang, Xueguang Jin, Yuping Tan, Virginie Durbecq, Denis Larsimont, Rosa Giuliani, Colombe Chappey, Marc Buyse, John Winslow, Martine Piccart, Christos Sotiriou, Christos Petropoulos, Michael Bates
Quantitation of HER2 expression or HER2:HER2 dimers and differential survival in a cohort of metastatic breast cancer patients carefully selected for trastuzumab treatment primarily by FISH.
Di Leo A., Isola J., Piette F., Ejlertsen B., Pritchard KI., Bartlett JMS., Desmedt C., Larsimont D., Tanner M., Mouridsen H., O’Malley FP., Twelves C., Cardoso F., Poole CJ., Piccart MJ., Buyse M
A meta-analysis of phase III trials evaluating the predictive vale of HER2 and topoisomerase II alpha in early breast cancer patients treated with CMF or anthracyclines-based adjuvant therapy.
Cancer Res 69, Supplement 2: Abstract 705, 2009
Buyse M
Les biomarquers en recherche clinique.
Journal du Réseau Cancer de l’Université Libre de Bruxelles, 2009.
Buyse M
Why are biomarkers and surrogate endpoints proving difficult to validate?
The Oncologist, 2009.
- 2008
N Speybroeck, T Marcotty, M Aerts, T Dolan, B Williams, J Lauer, G Molenberghs, T Burzykowski, M Mulumba, D Berkvens
Titrating Theileria parva: single stocks against combination of stocks
Marc Buyse
Reformulating the hazard ratio to enhance communication with clinical investigators.
Clin Trials 5: 6. 641-642 .
Dowsett M., Cuzick J., Ingle J., Coates A., Forbes J., Bliss J., Buyse M., Baum M., Buzdar A., Mouridsen H., Colleoni M., Coombes C., Gnant M., Jakesz R., Kaufmann M., Boccardo F., Godwin J., Davies C., Peto R.
Meta-analysis of breast cancer outcomes in adjuvant trials of aromatase inhibitors versus tamoxifen.
The Lancet 2008 (in press)
Land S.R., Abrams J., Buyse M., Chappell R.J.
Statistics in Oncology
J Clin Oncol 26: 22, 2008.
Haibe-Kains B., Desmedt C., Piette F., Buyse M., Cardoso F., van’t Veer L., Piccart M., Bontempi G., Sotiriou C.
Comparison of prognostic gene expression signatures for breast cancer
BMC Genomics 9: 394, 2008
Marc Buyse, Tomasz Burzykowski, Stefan Michiels, Kevin Carroll
Individual and trial-level surrogacy in colorectal cancer
Stat Methods MedRes 2008; 17: 5 467–475
Ignatiadis M., Perraki M., Apostolaki S., Xenidis N., Stathopoulos E., Lianidiou E., Buyse M.E., Sotiriou C., Georgoulias V., Mavroudis D.
Circulating tumor cells (CTCs) monitoring in HER2-negative early breast cancer: implications for secondary anti-HER2 adjuvant treatment strategies.
Proc Am Soc Clin Oncol 26: Abstract 11502, 2008.
Burzykowski T., Buyse M., Sargent D., Sakamoto J., Yothers G.
Exploring and validating surrogate endpoints in colorectal cancer.
Lifetime Data Analysis 14:1.54-64, 2008
Baigent C., Harrell F., Buyse M., Emberson J., Altman D.
Ensuring trial validity by data quality assurance and diversification of monitoring methods.
Clinical Trials 5: 1.49-55, 2008
Francis P., Crown J., Di Leo A., Buyse M., Balil A., Andersson M., Nordenskjöld B., Lang I., Jakesz R., Vorobiof D., Gutiérrez J., van Hazel G., Dolci S., Jamin S., Bendahmane B., Gelber R.D., Goldhirsch A., Castiglone-Gertsch M. & Piccart-Gebhart M. for
Adjuvant chemotherapy with Sequential or Concurrent Anthracycline and Docetaxel: Breast International Group 02-98 Randomized Trial.
J Natl Cancer Instit 100:2. 121-133, 2008
Molenberghs G., Burzykowski T, Alonso A., Assam P., Tilahun A., Buyse M.
The meta-analytic framework for the evaluation of surrogate endpoints in clinical trials.
J Statist Plann Inference 138: 432-449, 2008.
Desmedt C., Sperinde J., Piette F., Huang W., Jin X., Tan Y., Durbecq V., Larsimont D., Giuliani R., Chappey C., Buyse M., Winslow J., Piccart M., Sotiriou C., Petropoulos C., Bates M.
Quantitation of HER2 expression and HER2:HER2 dimers and differential survival in a cohort of metastatic breast cancer patients selected for trastuzumab treatment primarily by FISH
Diagnostic Molecular Path., 2008 (in press)
Desmedt C., Haibe-Kains B., Wirapati P., Buyse M., Larsimont D., Bontemps G., Delorenzi M., Piccart M., Sotiriou C.
Biological processes associated with breast cancer clinical outcome depend on the molecular subtypes
Clin Cancer Res, 14:16. 5158-5165, 2008.
Piedbois P., Buyse M.
Endpoints and surrogate endpoints in colorectal cancer : a review of recent developments.
Current Opinion Oncol, 20: 466-471, 2008.
Clarke M., Coates A.S., Darby S.C., Davies C., Gelber R.D., Godwin J., Goldhirsch A., Gray R., Peto R., Pritchard K.I., Wood W.C.
Adjuvant chemotherapy in oestrogen-receptor-poor breast cancer: patient-level meta-analysis of randomized trials.
Lancet 371 : 29-40, 2008. Early Breast Cancer Trialists’ Collaborative Group (EBCTCG)
Buyse M., Laporte S., Squifflet P., Baroux N., Fossella F., Georgoulias V., Pujol J.L., Kubota K., Monnier A., Kudoh S., Douillard J.Y.
Benefits of using individual patient data (IPD) in meta-analysis: example of docetaxel compared with vinca-alkaloids in the first-line treatment of NSCLC.
Paper accepted as poster discussion at the 1st European Lung Cancer Conference, Geneva, Switzerland, April 25, 2008.
Laporte S., Buyse M., Baroux N., Fossella F., Georgoulias V., Pujol J.L., Kubota K., Monnier A., Kudoh S., Douillard J.Y.
Lack of predictors for the survival benefit of docetaxel in the first-line treatment of non-small cell lung cancer. Results from a meta-analysis on individual patient data.
Paper submitted to the Annual Meeting of the American Society for Clinical Oncology, Chicago, Il, US, May 30-June 3, 2008.
Buyse M., Squifflet P., Allard E., Bhagwat D., Rowe J.M.
Leukemia-free survival as a surrage for overall survival (OS) in AML patients in remission 5CR): A trial of a novel immunotherapy with histamine dihydrochlofide plus low-dose IL-2 (HDC/IL-2).
Hematologica 93 (Suppl. 1): Abstract 0519, 2008.
Hughes S., Keene O., Howitt N., Roes K., Ashby D., Beltangady M., Bird S.M., Burton C., Buyse M., Day S., van Ewijk P., Fletcher C., Grieve A.P., Guinot C., Hemmings R., Holt D., Hothorn L., Jagers P., Keiding N., Korhonen P., Lesaffre E., Lewis J.A., Mol
European regulatory agencies should employ full time statisticians.
Brit Med J 336:250, 2008.
Burzykowski T., Buyse M., Piccart-Gebhart M.J., Sledge G., Carmichael J., Lück H.J., Mackey J.R., Nabholtz J.M., Paridaens R., Biganzoli L., Jassem J., Bontenbal M., Bonneterre J., Chan S., Atalay Basaran G., Therasse P.
Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate endpoints in metastatic breast cancer
J Clin Oncol 26:12.1987-1992, 2008.
Piccart-Gebhart M.J., Burzykowski T., Buyse M., Sledge G., Carmichael J., Lück H.J., Mackey J.R., Nabholtz J.M., Paridaens R., Biganzoli L., Jassem J., Blohmer J.-U., Bontenbal M., Bonneterre J., Chan S., Atalay G., Therasse P.
Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer
J Clin Oncol 26: 12.1980-1986, 2008
- 2007
Sherene Loi, Benjamin Haibe-Kains, Christine Desmedt, Françoise Lallemand, Andrew M Tutt, Cheryl Gillet, Paul Ellis, Adrian Harris, Jonas Bergh, John A Foekens, Jan G M Klijn, Denis Larsimont, Marc Buyse, Gianluca Bontempi, Mauro Delorenzi, Martine J Picc
Definition of clinically distinct molecular subtypes in estrogen receptor-positive breast carcinomas through genomic grade.
J Clin Oncol 25: 10. 1239-1246
Desmedt C., Piette F., Loi S., Wang Y., Lallemand F., Haibe-Kains B., Viale G., Delorenzi M., Zhang Y., Saghatchian d’Assignies M., Bergh J., Lidereau R., Ellis P., Harris A.L., Klijn J.G.M., Foekens J.A., Cardoso F., Piccart M.J., Buyse M., Sotiriou C. o
Strong time-dependency of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multi-centre independent validation series.
Clin Cancer Research 13: 3207-3214, 2007
Zelefsky J.R., Srinivasan M., Lietman T., Whitcher J.P., Wang K., Buyse M., Cunningham E.T.
Hookworm infestation as a risk factor for Mooren’s ulcer in South India.
Ophthalmology 114: 450-453, 2007.
Lassere M., Johnson K., Boers M., Tugwell P., Brooks P., Simon L., Strand V., Conaghan P., Østergaard M., Maksymowych W.P., Landewé R., Bresnihan B., Tak P.P., Wakefield R., Mease P., Bingham C.O. III, Hughes M., Altman D., Buyse M., Galbraith S., Wells G
Definitions and validation criteria for biomarkers and surrogate endpoints: development and testing of a quantitative hierarchical levels of evidence schema.
J Rheumatol 34: 607-615, 2007.
Lassere M., Johnson K., Hughes M., Altman D., Buyse M., Galbraith S., Wells G.
Simulation studies of surrogate endpoint validation using single trial and multi-trial statistical approaches.
J Rheumatol 34: 616-619, 2007.
Buyse M., Burzykowski T., Carroll K., Michiels S., Sargent D., Miller L.L., Elfring G.L., Pignon J.P., Piedbois P.
Progression-free survival as a surrogate for survival in advanced colorectal cancer.
J Clin Oncol 25, 33: 5218-5224, 2007.
de Gramont A., Buyse M., Cervantes A., Figer A., Lledo G., Flesh M., Mineur L., Carola E., Etienne P.L., Rivera F., Chirivella I., Perez-Staub N., Louvet C., André T., Tabah-Fisch I., Cortinas Abrahantes J., Quinaux E., Tournigand C.
Reintroduction of oxaliplatin improves survival in advanced colorectal cancer.
J Clin Oncol 25: 3224-3229, 2007.
Buyse M.
Towards the validation of statistically reliable biomarkers.
Eur J Cancer 41 Suppl 1: 2007.
Punt C.J.A., Buyse M., Köhne C.H., Hohenberger P., Labianca R., Sobrero A., Schmoll H.J., Pahlman L., Douillard J.Y.
A proposal for the definition of endpoints for adjuvant trials in colorectal cancer.
J Natl Cancer Inst 99: 998-1003, 2007
Buyse M.
Signature dish.
International Clinical Trials, Summer 2007: 58-60, 2007.
Allegra C., Venook P., Goldberg R., Grothey A., Blanke C., Buyse M., Sargent D.
Endpoints in advanced colon cancer clinical trials: a review and proposal.
J Clin Oncol 25: 3572-3575, 2007.
André T., Quinaux E., Louvet C., Colin P., Gamelin E., Bouche O., Achille E., Piedbois P., Tubiana-Mathieu N., Boutan-Laroze A., Flesch M., Lledo G., Raoul Y., Debrix I., Buyse M., de Gramont A.
Phase III study comparing a semimonthly with a monthly regimen of fluorouracil and leucovorin as adjuvant treatment for stage II and III colon cancer patients: final results of GERCOR C96.1.
J Clin Oncol 25: 3732-3738, 2007
Collette L., Burzykowski T., Buyse M
Are Prostate-Specific Antigen Changes Valid Surrogates for Survival in Hormone-Refractory Cancer? A Meta-Analysis Is Needed!
{Letter to the Editor} J Clin Oncol 25 (35) 5673-5674, 2007.
Press MF, Sauter G, Buyse M, Bernstein L, Eiermann W, Pienkowski T, Bee V, Taupin H, Seelig S, Slamon DJ.
Alteration of topoisomerase II-alpha gene in human breast cancer and its association with responsiveness to anthracycline-based chemotherapy.
Proc Am Soc Clin Oncol 25: Abstract 524, 2007.
Velero V, Roche H, Pienkowski T, Canon J, Zhao Y, Carney W, Mackey J, Taupin H, Buyse M, Slamon D.
BCIRG 007: Serum HER2 levels in women with metastatic HER2-amplified breast cancer.
Proc Am Soc Clin Oncol 25: Abstract 1020, 2007.
Buyse ME, Punt KJ, Köhne CH, Hohenberger P, Labianca R, Schmoll HJ, Pahlman L, Sobrero AF, Douillard JP.
Endpoints in adjuvant trials: A systematic review of the literature in colon cancer and proposed definitions for future trials.
Proc Am Soc Clin Oncol 25: Abstract 4018, 2007.
Sotiriou C, Desmedt C, Haibe-Kains B, Harris A, Larsimont D, Buyse M, Wirapati P, Delorenzi M, Bontempi G, Piccart M.
Biological mechanisms that trigger breast cancer (BC) tumor progression are molecular subtype dependent
Proc Am Soc Clin Oncol 25: Abstract 10581, 2007.
Durbecq V, Toussaint J, Haibe-Kains B, Desmedt C, Rouas G, Larsimont D, Bontempi G, Buyse M, Piccart M, Sotiriou C.
Transforming genomic grade index (GGI) into a user-friendly qRT-PCR tool which will assist clinicians in optimizing treatment of early breast cancer(BC).
Proc Am Soc Clin Oncol 25: Abstract 21058, 2007.
Laporte S., Buyse M., ., Baroux N., Fossella F., Georgoulias V., Pujol J.L., Kubota K., Monnier A., Kudoh S., Douillard J.Y.,
Meta-analysis comparing docetaxel and vinca-alkaloids in the first-line treatment of NSCLC. Comparison of results based on individual patient data, study report data, and published data.
Eur J Cancer Suppl. 1: Abstract 4, 2007.
Buyse M., Nicolas S. (editors)
Statistical innovations in clinical trials: opening remarks.
Statist in Med 27: 4843-4844, 2007.
Sargent D.J., Patiyil S., Yothers G., Haller D.G., Gray R., BenedettiJ., M. Buyse M., Labianca R., Seitz J.F., O’Callaghan C.J., Francini G., Grothey A., O’Connell M., Catalano K P.J., Kerr D., Green E., Wieand S., Goldberg R.M., de Gramont A. for the Adj
Endpoints for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients on 18 randomized trials.
J Clin Oncol 25: 4569-4574, 2007.
Buyse M., Nicolas S.
Statistical innovations in clinical trials: opening remarks.
Statist in Med 27:4843-4844
- 2006
Alonso A., Molenberghs G., Geys H., Buyse M., Vangeneugden T. A
Unifying approach for surrogate marker validation based on Prentice’s criteria.
Statist in Med 25: 205-221, 2006.
Harris A., Fox S., Smeds J., Nordgren H., Farmer P., Praz V., Haibe-Kains B., Desmedt C., Larsimont D., Cardoso F., Peterse H., Nuyten D., Buyse M., Van de Vijver M., Bergh J., Piccart M., Delorenzi M. Sotiriou C., Wirapati P., Loi S.
Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis.
J Natl Cancer Instit 98: 262?272, 2006.
Buyse M.
L’Héparine de bas poids moléculaire, un agent anti-cancéreux inattendu?
Journal du Réseau Cancer de l’Université Libre de Bruxelles 4: 4, 2006.
Tournigand C., Cervantes A., Figer A., Lledo G., Flesh M., Buyse M., Mineur L., Carola E., Etienne P.L., Rivera F., Chirivella I., Perez-Staub N., Louvet C., André T., Tabah-Fisch I., de Gramont A.
FOLFOX4 or FOLOFOX7 with oxaliplatin stop-and-go in advanced colorectal cancer. Optimox1, a randomized GERCOR study.
J Clin Oncol 24: 394-400, 2006.
Glynn-Jones R., Mawdsley S., Pearce T., Buyse M.
Alternative clinical end points in rectal cancer – are we getting closer?
Annals Oncol 17: 1239-1248, 2006.
André T., Sargent D., Tabernero J., O’Connell M., Buyse M., Sobrero A., Misset J.L., Boni C., Vanhoeffer U., de Gramont A.
Current issues in adjuvant treatment of stage II colon cancer.
Annals Surgical Oncol 13: 887-898, 2006.
Loi S., Sotiriou C., Buyse M., Rutgers E.J.T., Van't Veer L.J., Piccart M.J. and Cardoso F.
Molecular forecasting of breast cancer: time to move forward with clinical testing.
J Clin Oncol 24: 721-722, 2006.
Eisenhauer E., Twelves C., Buyse M. (editors).
Phase I Clinical Trials in Cancer.
Oxford University Press (329 p.), Oxford, 2006.
Buyse M.
Meta-Analysis
Encyclopedia of Life Support Systems, EOLSS Publishing Co Ltd, Oxford, 2006.
Buyse M.
Banques de tumeurs et recherche clinique – les nouveaux enjeux.
Bull Cancer 93: S237-S240, 2006.
Boucher P., Buyse M., Amalric F ., Le Chevalier T., Rixe O.
Visibilité nationale des tumorothèques et cadre d’interopérabilité. 2. Le projet de tumorothèque virtuelle nationale.
Bull Cancer 93: S246-S248, 2006.
Burzykowski T., Buyse M.
Surrogate threshold effect: An alternative measure for meta-analytic surrogate endpoint validation.
Pharmaceutical Statist 5: 173-186, 2006.
Buyse M., Loi S., van’t Veer L., Viale G., Delorenzi M., Glas A., Saghatchian d’Assignies M., Bergh J., Lidereau R., Ellis P., Harris A., Bogaerts J., Therasse P., Amakrane M., Piette F., Rutgers E., Sotiriou C., Cardoso F., Piccart M. on behalf of the TR
Independent validation and clinical utility of a 70-gene prognostic signature for patients with node-negative breast cancer.
J Natl Cancer Instit: 98: 1183-1192, 2006.
Liénard J.L., Quinaux E., Piedbois P., Jouhaud A., Decoster G., Buyse M.
Impact of on-site initiation visits on patient recruitment and data quality in a randomized trial of adjuvant chemotherapy for breast cancer.
Clinical Trials 3: 1-7, 2006.
Bogaerts J., Cardoso F., Buyse M., Braga S., Loi S., Harrison J., Bines J., Mook S., Decker N., Therasse P., Rutgers E., van’t Veer L., Piccart M. on behalf of the TRANSBIG Consortium.
Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial.
Nature Clinical Practice Oncol 3: 540-551, 2006.
Piedbois P., Priou F., Serin D., Greget S., Laplaige P., Angellier E., Tessier E., Berdah J.F., Fabro M., Valenza B., Jehl V., Buyse M.
Dose-dense adjuvant chemotherapy in node-positive breast cancer: docetaxel followed by epirubicin/cyclophosphamide (T/EC), or the reverse sequence (EC/T), every 2 weeks, versus docetaxel, epirubicin and cyclophosphamide (TEC) every 3 weeks.AERO B03 random
Annals Oncol: 2006.
Douillard J.Y., Rosell R., De Lena M., Carpagnano F., Ramlau R., Gonzales-Larriba J.L., Grodzki T., Pereira J.R., Le Groumellec A., Lorusso V., Clary C., Torres A.J., Dahabreh J., Souquet P.J., Astudillo J., Fournel P., Artal-Cortes A., Jassem J., Koubkov
Adjuvant vinorelbine plus cisplatin versus observation in patients with completely resected stage IB-IIIA non-small cell lung cancer (Adjuvant Navelbine International Trialist Association [ANITA]): a randomised controlled trial.
Lancet Oncol 7: 719-727, 2006. (Statistical Expert).
- 2005
F Boelaert, N Speybroeck, A de Kruif, M Aerts, T Burzykowski, G Molenberghs, D L Berkvens
Risk factors for bovine herpesvirus-1 seropositivity
Burzykowski T., Molenberghs G., Buyse M. (editors).
Evaluation of surrogate endpoints. Springer (408 p.),
Heidelberg, 2005.
Buyse M.
Fraud detection. In: Encyclopaedic Companion to Medical Statistics
(Everitt B., Palmer C., eds.), Arnold Publishers Ltd, London, 2005.
Buyse M.
Multicenter trials.
In: Encyclopaedic Companion to Medical Statistics (Everitt B., Palmer C., eds.), Arnold Publishers Ltd, London, 2005.
Buyse M.
Outliers
In: Encyclopaedic Companion to Medical Statistics (Everitt B., Palmer C., eds.), Arnold Publishers Ltd, London, 2005.
Buyse M.
Placebo effet, placebo run-in.
In: Encyclopaedic Companion to Medical Statistics (Everitt B., Palmer C., eds.), Arnold Publishers Ltd, London, 2005.
Sargent D., Wieand S., Haller D.G., Gray R., Benedetti J., Buyse M., Labianca R., Seitz J.F., O'Callaghan C.J., Francini G., Grothey A., O'Connell M., Catalano P.J., Blanke C.D., Kerr D., Green E., Wolmark N., Andre T., Goldberg R.M., de Gramont A.
Disease-free Survival (DFS) vs. Overall Survival (OS) as a Primary Endpoint for Adjuvant Colon Cancer Studies: individual patient data from 20,898 patients on 18 Randomized Trials
J Clin Oncol 23: 8664-8670, 2005.
- 2004
Tournigand C., André T., Achille E., Lledo G., Flesh M., Mery-Mignard D., Quinaux E., Couteau C., Buyse M., Ganem G., Landi B., Colin P., Louvet C., de Gramont A.
FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer. A randomised GERCOR study.
J Clin Oncol 22: 1-9, 2004
DiLeo A., Bleiberg H., Buyse M.
Is overall survival a realistic primary endpoint in advanced colorectal cancer? A critical assessment based on four clinical trials comparing fluorouracil plus leucovorin with the same treatment combined either with oxaliplatin or with irinotecan.
Annals Oncol 14: 545-549, 2004.
Zelek L., Bugat R., Cherqui D., Ganem G., Valleur P., Guimbaud R., Dupuis O., Aziza T., Fagniez P.L., Auroux J., Kobeiter H., Braud A.C., Haddad E., Piolot A., Buyse M., Piedbois P.
Multimodal therapy with intravenous biweekly leucovorin, fluorouracil, and irinotecan combined with hepatic arterial infusion pirarubicin in non-resectable hepatic metastases from colorectal cancer (an AERO trial).
Annals Oncol 14: 1537-1542, 2004.
Molenberghs G., Alonso A., Burzykowski T., Buyse M.
A Perspective on surrogate endpoints in controlled clinical trials. Statist
Methods in Medical Research 13: 177-206, 2004.
Meta-Analysis Group of the Japanese Society of Colorectal Cancer and Meta-Analysis Group In Cancer.
Efficacy of oral fluorinated pyrimidines as adjuvant therapy after resection of colorectal cancer: 5-year results from three randomised trials in 5,233 patients.
J Clin Oncol 22: 484-492, 2004.
Molenberghs G., Buyse M., Burzykowski T.
Surrogate endpoints.
Bulletin Int Chinese Stat Assoc: 2004.
Meta-Analysis Group In Cancer.
Modulation of fluorouracil by leucovorin in patients with advanced colorectal cancer: an updated meta-analysis.
J Clin Oncol 22: 3766-3775, 2004.
Burzykowski T., Molenberghs G., Buyse M., Geys H., Renard D.
The Validation of surrogate endpoints using data from randomized clinical trials: a case-study in advanced colorectal cancer.
J Royal Statist Soc A 167: 103-124, 2004.
Buyse M., McEntegart D.
Achieving balance in clinical trials: an unbalanced view from the European regulators.
Applied Clin Trials 13: 36-40, 2004.
Alonso A., Molenberghs G., Burzykowski T., Renard D., Geys H., Shkedy Z., Tibaldi F., Abrahantes J., Buyse M.
Prentice's approach and the meta-analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints.
Biometrics 60: 724-728, 2004.
Piedbois P., Buyse M. [Editorial]
Meta-Analyses based on abstracted data: a step in the right direction, but only a first step
J Clin Oncol 22: 3839-3841, 2004.
Buyse M., McEntegart D.
More nonSENNse about balance in clinical trials [Letter to the Editor].
Applied Clin Trials 13: 14-15, 2004.
Buyse M.
Traitements hormonaux substitutifs de la ménopause et cancers du sein: la tyrannie des chiffres.
In: Sein, hormones et antihormones. 26èmes Journées de la Société Française de Sénologie et de Pathologie Mammaire (Lesur A., Kessler Y., Verhaeghe J.L., eds.): 115-122, DeTeBe SAS, Puteaux, 2004.
Loi S., Buyse M., Sotiriou C., Cardoso F.
Challenges in breast cancer trial design in the post-genomic era.
Current Opinion Oncol 16: 536-541, 2004.
Diéras V., Fumoleau P., Romieu G., Tubiana-Hulin M., Namer M., Mauriac L., Guastalla J.P., Pujade-Lauraine E., Kerbrat P., Maillart P., Pénault-Llorca F., Buyse M., Pouillart P.
A Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer.
J Clin Oncol 22: 4958-4965, 2004.
- 2003
N Speybroeck, F Boelaert, D Renard, T Burzykowski, K Mintiens, G Molenberghs, D L Berkvens
Design-based analysis of surveys: a bovine herpesvirus 1 case study
Tibaldi F.S., Abrahantes J.C., Molenberghs G., Renard D., Burzykowski T., Buyse M., Parmar M., Stijnen T., Wolfinger R.
Simplified hierarchical linear models for the evaluation of surrogate endpoints.
J Statist Computation and Simulation 73: 643-658, 2003.
Buyse M.
Phase III clinical trials in oncology
Idrugs 6: 187-190, 2003.
DiLeo A., Bleiberg H., Buyse M.
Overall survival is not a realistic endpoint for clinical trials in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer [Letter to the Editor]
J Clin Oncol 21: 2045-2047, 2003.
André T., Colin P., Louvet C., Gamelin E., Bouche O., Achille E., Colbert N., Boaziz C., Piedbois P., Tubiana-Mathieu N., Boutan-Laroze A., Flesch M., Billau V., Buyse M., de Gramont A.
Bi-monthly regimen of 5-fluorouracil and leucovorin (LV5FU2) as adjuvant therapy in stage II and III colon cancer: 4-year results of a randomised trial.
J Clin Oncol 21: 2896-2903, 2003.
Buyse M., Vangeneugden T., Bijnens L., Geys H., Renard D., Burzykowski T., Molenberghs G.
Validation of Biomarkers as Surrogates for Clinical Endpoints.
Drugs and the Pharmaceutical Sciences 132: 149-168, 2003.
Buyse M., Burzykowski T., Parmar M.,Torri V., Omura G., Colombo N., Williams C., Conte P.F., Bertelsen K., Vermorken J., for the ICON Collaborators and the Ovarian Cancer Meta-Analysis Project.
Using the "expected" survival to explain differences between the results of randomized trials: a case in advanced ovarian cancer.
J Clin Oncol 21: 1682-1687, 2003.
Buyse M.
Cornerstones of a well-designed phase III trial.
Eur J Cancer 39 Suppl 1: S66-S76, 2003.
Fabre-Guillevin E., Piedbois P., Buyse M.
Progress in the treatment of advanced colorectal cancer.
Expert Rev Anticancer Ther 21: 89-94, 2003.
Autier P., Boyle P., Buyse M., Bleiberg H.
Is FOB screening really the answer for lowering mortality in colorectal cancer?
Recent Results Cancer Res 163: 254-263, 2003.
Molenberghs G., Buyse M., Geys H., Renard D., Burzykowski T.
Challenges in the methodology for the validation of surrogate endpoints in randomized trials.
In: Proceedings of the 17th International Workshop on Statistical Modelling, Crete. (Stasinopoulos M., ed.): 475-484, 2002.
- 2002
Piedbois P., Buyse M.
Fluoropyrimidines in advanced colorectal cancer: a review of six consecutive meta-analyses.
In: Fluoropyrimidines in the treatment of colorectal cancer (Rustum Y.M., ed.): 183-190, Humana Press, Totowa, NJ, 2002
DiLeo A., Buyse M.
Equivalence between ovarian suppression and chemotherapy in the adjuvant treatment of endocrine-responsive breast cancer [Letter to the Editor].
J Clin Oncol 20: 1954-1955, 2002.
Levy E., Piedbois P., Buyse M., Pignon J.P., Rougier P., Ryan L., Hansen R., Zee B., Weinerman B., Pater J., Leichman C., Macdonald J., Benedetti J., Lokich J., Fryer J., Brufman G., Isacson R., Laplanche A., Quinaux E., Thirion P., for the Meta-Analysis
Toxicity of 5-fluororuracil in patients with advanced colorectal cancer: effect of administration schedule and prognostic factors.
J Clin Oncol Classic Papers and Current Comments 6: 860-866, 2002.
Zelek L., Piedbois P., Buyse M.
Contribution of meta-analyses to the evaluation of treatments for advanced colorectal cancer.
Expert Rev Anticancer Ther 2: 417-425, 2002.
Trillet-Lenoir V., Piedbois P., Buyse M.
The Role of colony stimulating factors in small cell cancer: why the question is still unresolved [Letter to the Editor].
Lung Cancer 37: 125-126, 2002.
Renard D., Geys H., Molenberghs G., Burzykowski T., Buyse M., Vangeneugden T. and Bijnens L.
Validation of a longitudinally measured surrogate marker for a time-to-event endpoint.
J Applied Statist 30: 235-247, 2002.
Renard D., Geys H., Molenberghs G., Burzykowski T., Buyse M.
Validation of surrogate endpoints in multiple randomized clinical trials with discrete outcomes.
Biometrical J 44: 921-935, 2002.
Molenberghs G., Buyse M., Geys H., Renard D., Burzykowski T.
Statistical challenges in the evaluation of surrogate endpoints in randomized trials.
Controlled Clin Trials 23: 607-625, 2002.
- 2001
Buyse M.
Biostatistique.
In: Thérapeutique du cancer (Morère J.F., Mornex F., Piccart M., Nabholtz J.M., eds.): 1119-1137, Springer-Verlag, Paris, 2001.
Buyse M., Piedbois P.
Should Dukes' B patients receive adjuvant chemotherapy? A statistical perspective.
Seminars Oncol 28 Suppl 1: 20-24, 2001.
André T., Colin P., Louvet C., Gamelin E., Bouche O., Achille E., Colbert N., Boaziz C., Piedbois P., Tubiana-Mathieu N., Boutan-Laroze A., Flesch M., Billau V., Buyse M., de Gramont A.
Randomized adjuvant study comparing two schemes of 5-fluorouracil and leucovorin in stage B2 and C colon adenocarcinoma: study design and preliminary safety results.
Seminars Oncol 28 Suppl 1: 35-40, 2001.
Molenberghs G., Geys H., Buyse M.
Evaluation of surrogate end-points in randomized experiments with mixed discrete and continuous outcomes.
Stat Med 20: 3023-3038, 2001.
Buyse M., Evans S.
Fraud in clinical trials. In: Biostatistics in Clinical Trials
(Colton T., Redmond C., eds.), New York, Wiley, 2001.
Buyse M., Thirion P., Carlson R.W., Burzykowski T., Molenberghs G., Piedbois P., for the Meta-Analysis Group In Cancer.
A Model to select chemotherapy regimens for phase III trials for extensive-stage small-cell lung cancer [Letter to the Editor].
J Natl Cancer Inst 93: 399-400, 2001.
Burzykowski T., Molenberghs G., Buyse M., Geys H., Renard D.
Validation of surrogate endpoints in multiple randomized clinical trials with failure-time endpoints.
J Royal Stat Soc C (Applied Statist) 50: 405-422 , 2001.
Thirion P., Piedbois P., Buyse M., O'Dwyer P.J., Cunningham D., Man A., Greco F.A., Colucci G., Köhne C.H., Di Costanzo F., Piga A., Palmeri S., Dufour P., Cassano A., Pajkos G., Pensel R.A., Aykan N.F., Marsh J., Seymour M.T., for the Meta-Analysis Group
Alpha-interferon does not increase the efficacy of 5-fluorouracil in advanced colorectal cancer.
Br J Cancer 84: 611-620, 2001.
Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomized trials. Lancet 358: 1291-1304, 2001.
Colorectal Cancer Collaborative Group. Adjuvant radiotherapy for rectal cancer: a systematic overview of 8507 patients from 22 randomized trials.
Lancet 358: 1291-1304, 2001.
Piccart M.J., Lohrisch C., Duchateau L., Buyse M.
Taxanes in the adjuvant treatment of breast cancer: why not yet?
J Natl Cancer Inst Monographs 93: 88-95, 2001.
Pastorino U., Infante M., Maioli M., Chiesa G., Buyse M., Firket P., Rotmensz N., Clerici M., Soresi E., Valente M., Belloni P.A., Ravasi G.
Adjuvant treatment of stage I lung cancer with high dose Vitamin A.
J Clin Oncol Classic Papers and Current Comments 5: 2001.
Methodology for the validation of surrogate endpoints in multiple randomized experiments.
Molenberghs G., Alsonso Abad A., Burzykowski T., Cortinas Abrahantes J., Geys H., Renard D., Shkedy Z., Tibaldi F., Buyse M.
In: Proceedings of the 16th International Workshop on Statistical Modelling, Odense, Denmark. (Jorgensen B., ed.): 297-304, 2001.
- 2000
Buyse M., Piedbois P., Piedbois Y., Carlson R.
Meta-Analysis: methods, strengths and weaknesses.
Oncology 14: 437-443, 2000.
Buyse M.
R² : a useful measure of model performance when predicting a dichotomous outcome [Letter to the Editor].
Stat Med 19: 271-274, 2000.
Buyse M., Molenberghs G., Burzykowski T., Renard D., Geys H.
The Validation of surrogate endpoints in meta-analyses of randomized experiments.
Biostatistics 1: 49-68, 2000
Buyse M.
Randomized designs in early trials of new cancer treatments: an overview.
Drug Inf J 34: 387-396, 2000
Buyse M., Molenberghs G., Burzykowski T., Renard D., Geys H.
Statistical validation of surrogate endpoints: problems and proposals.
Drug Inf J 34: 447-454, 2000.
Piedbois P., Buyse M.
Recent meta-analyses in colorectal cancer.
Curr Opin Oncol 12: 362-367, 2000.
Pignon J.P., Buyse M., Piedbois P.
Critical issues in colorectal cancer randomized trials and meta-analyses.
In: Management of Colorectal Cancer (Second Edition) (Bleiberg H., Rougier P., Wilke H.J. , eds.), Martin Dunitz Publishers, London, 2000.
Buyse M., Molenberghs G., Burzykowski T
Corrigendum to ".The validation of surrogate endpoints in randomized experiments"
Biometrics 56: 324, 2000.
Buyse M., Piedbois P., Piedbois Y., Carlson R.
Meta-Analysis: methods, strengths and weaknesses.
Oncology 14: 437-443, 2000.
Losartan Heart Failure Mortality Meta-analysis Study Group.
Meta-analysis of observed mortality data from all-controlled, double-blind, multiple-dose studies of losartan in heart failure.
Am J Cardiol 85: 187-192, 2000.
Buyse M.
Centralized treatment allocation in comparative clinical trials.
Applied Clin Trials 9: 32-37, 2000.
Buyse M., Thirion P., Carlson R.W., Burzykowski T., Molenberghs G., Piedbois P., for the Meta-Analysis Group In Cancer.
Relation between tumour response to first-line chemotherapy and survival in advanced colorectal cancer
Lancet 356: 373-378, 2000.
Ranstam J., Buyse M., George S.L., Evans S., Geller N., Scherrer B., Lesaffre E., Murray G., Edler L., Hutton J., Colton T., Lachenbruch P., for the ISCB Subcommittee on Fraud.
Fraud in medical research: an international survey of biostatisticians.
Controlled Clin Trials 21: 415-427, 2000.
Buyse M., Piedbois P., Piedbois Y., Gray R.
Tumour site, sex, and survival in colorectal cancer [Letter to the Editor].
Lancet 356: 858, 2000.
Meta-Analysis Group In Cancer.
Tumour response and survival in advanced colorectal cancer [Letter to the Editor].
Lancet 356: 1771, 2000.