Marc Buyse

Summary

Publications

  1. ncbi request reprint Phase III clinical trials in oncology. 20-21 January 2003, London, UK
    Marc Buyse
    International Drug Development Institute, Brussels, Belgium
    IDrugs 6:187-90. 2003
  2. doi request reprint Integrating biomarkers in clinical trials
    Marc Buyse
    International Institute for Drug Development, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Expert Rev Mol Diagn 11:171-82. 2011
  3. pmc Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial
    Lynnette Fernández-Cuesta
    Molecular Carcinogenesis Group, International Agency for Research on Cancer, 150 cours Albert Thomas, 69372 Lyon Cedex 8, France
    Breast Cancer Res 14:R70. 2012
  4. doi request reprint Omics-based clinical trial designs
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    Curr Opin Oncol 25:289-95. 2013
  5. doi request reprint Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials
    Marc Buyse
    From the International Drug Development Institute, Louvain la Neuve, Belgium
    Cancer J 15:421-5. 2009
  6. pmc Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    Blood 117:7007-13. 2011
  7. ncbi request reprint Progression-free survival is a surrogate for survival in advanced colorectal cancer
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    J Clin Oncol 25:5218-24. 2007
  8. doi request reprint Biomarkers and surrogate end points--the challenge of statistical validation
    Marc Buyse
    International Drug Development Institute, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Nat Rev Clin Oncol 7:309-17. 2010
  9. doi request reprint Generalized pairwise comparisons of prioritized outcomes in the two-sample problem
    Marc Buyse
    International Drug Development Institute, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Stat Med 29:3245-57. 2010
  10. pmc Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia
    Marc Buyse
    International Drug Development Institute, Department of Biostatistics, Louvain la Neuve, Belgium
    Trials 12:86. 2011

Detail Information

Publications54

  1. ncbi request reprint Phase III clinical trials in oncology. 20-21 January 2003, London, UK
    Marc Buyse
    International Drug Development Institute, Brussels, Belgium
    IDrugs 6:187-90. 2003
  2. doi request reprint Integrating biomarkers in clinical trials
    Marc Buyse
    International Institute for Drug Development, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Expert Rev Mol Diagn 11:171-82. 2011
    ..Contemporary biomarker-based clinical trials in oncology are used as examples...
  3. pmc Prognostic and predictive value of TP53 mutations in node-positive breast cancer patients treated with anthracycline- or anthracycline/taxane-based adjuvant therapy: results from the BIG 02-98 phase III trial
    Lynnette Fernández-Cuesta
    Molecular Carcinogenesis Group, International Agency for Research on Cancer, 150 cours Albert Thomas, 69372 Lyon Cedex 8, France
    Breast Cancer Res 14:R70. 2012
    ....
  4. doi request reprint Omics-based clinical trial designs
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    Curr Opin Oncol 25:289-95. 2013
    ..In this review, we investigate the clinical trial designs for the validation of prognostic and predictive signatures...
  5. doi request reprint Use of meta-analysis for the validation of surrogate endpoints and biomarkers in cancer trials
    Marc Buyse
    From the International Drug Development Institute, Louvain la Neuve, Belgium
    Cancer J 15:421-5. 2009
    ..Data from several meta-analyses suggest that progression-free survival is an acceptable surrogate in advanced colorectal and ovarian cancer, but not in breast and prostate cancer...
  6. pmc Individual patient data meta-analysis of randomized trials evaluating IL-2 monotherapy as remission maintenance therapy in acute myeloid leukemia
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    Blood 117:7007-13. 2011
    ..We conclude that IL-2 alone is not an effective remission maintenance therapy for AML patients in CR1...
  7. ncbi request reprint Progression-free survival is a surrogate for survival in advanced colorectal cancer
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    J Clin Oncol 25:5218-24. 2007
    ..We investigated whether progression-free survival (PFS) could be considered a valid surrogate for OS in advanced colorectal cancer...
  8. doi request reprint Biomarkers and surrogate end points--the challenge of statistical validation
    Marc Buyse
    International Drug Development Institute, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Nat Rev Clin Oncol 7:309-17. 2010
    ..No consensus yet exists on processes or standards for pragmatic evaluation and adoption of biomarkers and surrogate end points in the absence of robust statistical validation...
  9. doi request reprint Generalized pairwise comparisons of prioritized outcomes in the two-sample problem
    Marc Buyse
    International Drug Development Institute, 30 Avenue Provinciale, 1340 Louvain la Neuve, Belgium
    Stat Med 29:3245-57. 2010
    ..We also show that they lead to a general measure of the difference between the groups called the 'proportion in favor of treatment', denoted Δ, which is related to traditional measures of treatment effect for a single variable...
  10. pmc Assessment of the consistency and robustness of results from a multicenter trial of remission maintenance therapy for acute myeloid leukemia
    Marc Buyse
    International Drug Development Institute, Department of Biostatistics, Louvain la Neuve, Belgium
    Trials 12:86. 2011
    ....
  11. doi request reprint Individual- and trial-level surrogacy in colorectal cancer
    Marc Buyse
    IDDI International Drug Development Institute, Louvain la Neuve, Belgium and Center for Statistics, Hasselt University, Diepenbeek, Belgium
    Stat Methods Med Res 17:467-75. 2008
    ..86. One trial with a large treatment effect on PFS and OS had a strong influence on the results in advanced disease. DFS (and PFS in advanced disease) are acceptable surrogates for OS in colorectal cancer...
  12. pmc Leukemia-free survival as a surrogate end point for overall survival in the evaluation of maintenance therapy for patients with acute myeloid leukemia in complete remission
    Marc Buyse
    International Drug Development Institute, 30 Avenue Provinciale, Louvain la Neuve, Belgium
    Haematologica 96:1106-12. 2011
    ..We aimed to assess whether leukemia-free survival is an acceptable statistical surrogate for overall survival when applied to remission maintenance therapy for acute myeloid leukemia...
  13. ncbi request reprint Using the expected survival to explain differences between the results of randomized trials: a case in advanced ovarian cancer
    Marc Buyse
    ScD, International Drug Development Institute Inc, American Twine Office Park, 222 Third St, Suite 0342, Cambridge, MA 02142, USA
    J Clin Oncol 21:1682-7. 2003
    ..98). In this article, we show how these discrepant results can be reconciled through the estimation of expected survival curves...
  14. doi request reprint Contributions of meta-analyses based on individual patient data to therapeutic progress in colorectal cancer
    Marc Buyse
    International Drug Development Institute, Louvain la Neuve, Belgium
    Int J Clin Oncol 14:95-101. 2009
    ..All of these potential contributions are illustrated with examples in early and advanced colorectal cancer...
  15. pmc Comparison of prognostic gene expression signatures for breast cancer
    Benjamin Haibe-Kains
    Functional Genomics Unit, Jules Bordet Institute, Universite Libre de Bruxelles, Brussels, Belgium
    BMC Genomics 9:394. 2008
    ..However, signatures were never compared on an independent population of untreated breast cancer patients, where risk assessment was computed using the original algorithms and microarray platforms...
  16. ncbi request reprint Strong time dependence of the 76-gene prognostic signature for node-negative breast cancer patients in the TRANSBIG multicenter independent validation series
    Christine Desmedt
    Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium
    Clin Cancer Res 13:3207-14. 2007
    ..The aims of this study conducted by TRANSBIG were to independently validate these results and to compare the outcome with clinical risk assessment...
  17. ncbi request reprint Validation and clinical utility of a 70-gene prognostic signature for women with node-negative breast cancer
    Marc Buyse
    International Drug Development Institute, Brussels, Belgium
    J Natl Cancer Inst 98:1183-92. 2006
    ..A 70-gene signature was previously shown to have prognostic value in patients with node-negative breast cancer. Our goal was to validate the signature in an independent group of patients...
  18. ncbi request reprint A unifying approach for surrogate marker validation based on Prentice's criteria
    Ariel Alonso
    Center for Statistics, Hasselt University, Campus Diepenbeek, Agoralaan Building D, BE 3590 Diepenbeek, Belgium
    Stat Med 25:205-21. 2006
    ..We apply the previous methodology using data from two clinical studies in psychiatry and ophthalmology...
  19. ncbi request reprint Prentice's approach and the meta-analytic paradigm: a reflection on the role of statistics in the evaluation of surrogate endpoints
    Ariel Alonso
    Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium
    Biometrics 60:724-8. 2004
    ..We briefly present a hierarchical framework that incorporates ideas from Prentice's work and is uniformly applicable to different types of surrogate and true clinical outcomes...
  20. ncbi request reprint Definition of clinically distinct molecular subtypes in estrogen receptor-positive breast carcinomas through genomic grade
    Sherene Loi
    Jules Bordet Institute Machine Learning Group, Universite Libre de Bruxelles, Brussels, Belgium
    J Clin Oncol 25:1239-46. 2007
    ..However, although the basal and the ErbB2 subtypes are repeatedly recognized, identification of estrogen receptor (ER) -positive subtypes has been inconsistent. Therefore, refinement of their molecular definition is needed...
  21. doi request reprint Evaluation of tumor response, disease control, progression-free survival, and time to progression as potential surrogate end points in metastatic breast cancer
    Tomasz Burzykowski
    Hasselt University, Center for Statistics, Agoralaan, Bldg D, 3590 Diepenbeek, Belgium
    J Clin Oncol 26:1987-92. 2008
    ....
  22. doi request reprint A unified framework for the evaluation of surrogate endpoints in mental-health clinical trials
    Geert Molenberghs
    I Biostat, Hasselt University, Diepenbeek, Belgium
    Stat Methods Med Res 19:205-36. 2010
    ..Implications for design and for predicting the effect of treatment in a new trial, based on the surrogate, are discussed. A case study in schizophrenia is analysed...
  23. ncbi request reprint A perspective on surrogate endpoints in controlled clinical trials
    Geert Molenberghs
    Center for Statistics, Limburgs Universitair Centrum, Diepenbeek, Belgium
    Stat Methods Med Res 13:177-206. 2004
    ..Clearly statistical evidence should only be seen as a component in a decision making process that also involves a number of clinical and biological considerations...
  24. ncbi request reprint Surrogate threshold effect: an alternative measure for meta-analytic surrogate endpoint validation
    Tomasz Burzykowski
    Center for Statistics, Hasselt University, Agoralaan bldg D, B3590 Diepenbeek, Belgium
    Pharm Stat 5:173-86. 2006
    ..One of its interesting features, apart from providing information relevant to the practical use of a surrogate endpoint, is its natural interpretation from a clinical point of view...
  25. doi request reprint Progression-free survival as a surrogate for overall survival in advanced/recurrent gastric cancer trials: a meta-analysis
    Xavier Paoletti
    Affiliations of authors Biostatistics Department, INSEM U900 Institut Curie, Paris, France XP Translational Research and Clinical Trial Center, Hokkaido University Hospital, Hokkaido, Japan KO Seoul National University College of Medicine, Oncology Division, Seoul, Korea Y JB Jules Bordet Hospital, Brussels, Belgium HB St Marianna University School of Medicine, Kawasaki, Japan NB Hôpital Robert Debré, Reims, Department of Clinical Oncology, France OB Dana Farber Cancer Institute and Harvard School of Public Health, Department of Biostatistics, Boston, MA PC National Cancer Center Hospital East, Department of Gastrointestinal Oncology, Kashiwa, Japan NF, AO Institut Gustave Roussy, Universite Paris XI, Biostatistics and Epidemiology Department, Villejuif, France SMi Johannes Gutenberg University, Medical Department, Mainz, Germany MM Yokohama City University, Department of Biostatistics and Epidemiology, Kanagawa, Japan SMo University of Tokyo, Tokyo, Japan YO University Hospital, Department of Surgery, Geneva, Switzerland AR University Hospital Europeen Georges Pompidou, Gastro enterology Department, Paris,
    J Natl Cancer Inst 105:1667-70. 2013
    ..61 (95% CI = 0.04 to 1.00). Treatment effects on PFS and on OS were only moderately correlated, and we could not confirm the validity of PFS as a surrogate endpoint for OS in advanced/recurrent gastric cancer. ..
  26. doi request reprint Exploring and validating surrogate endpoints in colorectal cancer
    Tomasz Burzykowski
    Center for Statistics, Hasselt University, Agoralaan D, 3590 Diepenbeek, Belgium
    Lifetime Data Anal 14:54-64. 2008
    ..J Clin Oncol 22:484-492, 2004). Our analysis supports the conclusion of Sargent et al. and shows that using DFS at 2 or 3 years would be the best option for the prediction of OS at 5 years...
  27. ncbi request reprint Impact of cyclins E, neutrophil elastase and proteinase 3 expression levels on clinical outcome in primary breast cancer patients
    Christine Desmedt
    Translational Research Unit, Department of Medical Oncology, Jules Bordet Institute, Universite Libre de Bruxelles, Brussels, Belgium
    Int J Cancer 119:2539-45. 2006
    ....
  28. ncbi request reprint Gene expression profiling in breast cancer: understanding the molecular basis of histologic grade to improve prognosis
    Christos Sotiriou
    Functional Genomics and Translational Research Unit, Universite Libre de Bruxelles, Brussels, Belgium
    J Natl Cancer Inst 98:262-72. 2006
    ..We examined whether histologic grade was associated with gene expression profiles of breast cancers and whether such profiles could be used to improve histologic grading...
  29. pmc Predicting treatment effect from surrogate endpoints and historical trials: an extrapolation involving probabilities of a binary outcome or survival to a specific time
    Stuart G Baker
    National Cancer Institute, EPN 3131, Bethesda, Maryland 20892 7354, USA
    Biometrics 68:248-57. 2012
    ..To summarize the additional uncertainty from using a predicted instead of true result for the estimated treatment effect, we compute its multiplier of standard error. Software is available for download...
  30. ncbi request reprint Statistical challenges in the evaluation of surrogate endpoints in randomized trials
    Geert Molenberghs
    Limburgs Universitair Centrum, TUL, Center for Statistics, Biostatistics, Diepenbeek, Belgium
    Control Clin Trials 23:607-25. 2002
    ..In this paper, we argue that such a multiunit approach should be adopted because it overcomes difficulties that necessarily surround validation efforts based on a single trial. These difficulties are highlighted...
  31. pmc Genomic Grade Index (GGI): feasibility in routine practice and impact on treatment decisions in early breast cancer
    Otto Metzger-Filho
    Institut Jules Bordet, Universite Libre de Bruxelles, Brussels, Belgium
    PLoS ONE 8:e66848. 2013
    ..In this prospective study we sought to evaluate the feasibility of performing GGI in routine clinical practice and its impact on treatment recommendations...
  32. ncbi request reprint Randomized parallel study of doxorubicin plus paclitaxel and doxorubicin plus cyclophosphamide as neoadjuvant treatment of patients with breast cancer
    Veronique Dieras
    Institut Curie, Department of Medical Oncology, 26 Rue d Ulm, 75005 Paris, France
    J Clin Oncol 22:4958-65. 2004
    ....
  33. ncbi request reprint Equivalence between ovarian suppression and chemotherapy in the adjuvant treatment of endocrine-responsive breast cancer
    Angelo Di Leo
    J Clin Oncol 20:1954-5. 2002
  34. ncbi request reprint Efficacy of oral adjuvant therapy after resection of colorectal cancer: 5-year results from three randomized trials
    Junichi Sakamoto
    Department of Epidemiological and Clinical Research Information Management, Graduate School of Medicine, Kyoto University, Yoshidakonoe cho, Sakyo ku, Kyoto 606 8501, Japan
    J Clin Oncol 22:484-92. 2004
    ..The purpose of this meta-analysis is to assess the survival and disease-free survival benefits of treating patients after surgical resection of a primary colorectal tumor with oral fluoropyrimidines for 1 year...
  35. ncbi request reprint FOLFIRI followed by FOLFOX6 or the reverse sequence in advanced colorectal cancer: a randomized GERCOR study
    Christophe Tournigand
    Hopital Saint Antoine, 184 rue du Faubourg Saint Antoine, 75571 Paris, Cedex 12, France
    J Clin Oncol 22:229-37. 2004
    ..This phase III study investigated two sequences: folinic acid, FU, and irinotecan (FOLFIRI) followed by folinic acid, FU, and oxaliplatin (FOLFOX6; arm A), and FOLFOX6 followed by FOLFIRI (arm B)...
  36. ncbi request reprint Semimonthly versus monthly regimen of fluorouracil and leucovorin administered for 24 or 36 weeks as adjuvant therapy in stage II and III colon cancer: results of a randomized trial
    Thierry Andre
    Hopital Tenon, Groupe d Etude et de Recherche Clinique en Oncologie Radioitherapie, Paris
    J Clin Oncol 21:2896-903. 2003
    ....
  37. ncbi request reprint Contribution of meta-analyses to the evaluation of treatments for advanced colorectal cancer
    Laurent Zelek
    Department of Medical Oncology, Henri Mondor Hospital, Creteil, France
    Expert Rev Anticancer Ther 2:417-25. 2002
    ..The interested reader can refer to the statistical appendix for details on the methodology used for all meta-analyses...
  38. ncbi request reprint OPTIMOX1: a randomized study of FOLFOX4 or FOLFOX7 with oxaliplatin in a stop-and-Go fashion in advanced colorectal cancer--a GERCOR study
    Christophe Tournigand
    Hopital Saint Antoine, Paris, France
    J Clin Oncol 24:394-400. 2006
    ..This study evaluates a new strategy of intermittent oxaliplatin treatment that is based on FOLFOX7, a simplified leucovorin and fluorouracil regimen with high-dose oxaliplatin...
  39. ncbi request reprint Reintroduction of oxaliplatin is associated with improved survival in advanced colorectal cancer
    Aimery de Gramont
    Hopital Saint Antoine, Paris Cedex 12, France
    J Clin Oncol 25:3224-9. 2007
    ....
  40. ncbi request reprint 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
    Thierry Andre
    Public Hôpitaux de Paris and CancerEst, Hopital Tenon, Paris, France
    J Clin Oncol 25:3732-8. 2007
    ....
  41. doi request reprint Adjuvant chemotherapy with sequential or concurrent anthracycline and docetaxel: Breast International Group 02-98 randomized trial
    Prudence Francis
    Division of Haematology and Medical Oncology, Peter MacCallum Cancer Centre, Melbourne 8006, Australia
    J Natl Cancer Inst 100:121-33. 2008
    ..The Breast International Group 02-98 randomized trial tested the effect of incorporating docetaxel into anthracycline-based adjuvant chemotherapy and compared sequential vs concurrent administration of doxorubicin and docetaxel...
  42. doi request reprint Statistics in oncology
    Stephanie R Land
    J Clin Oncol 26:3668. 2008
  43. ncbi request reprint End points in advanced colon cancer clinical trials: a review and proposal
    Carmen Allegra
    University of Florida, Gainsville, FL, USA
    J Clin Oncol 25:3572-5. 2007
  44. ncbi request reprint Gene signature evaluation as a prognostic tool: challenges in the design of the MINDACT trial
    Jan Bogaerts
    Medical Oncology and Translational Research, Jules Bordet Institute, Boulevard de Waterloo 125, 1000 Brussels, Belgium
    Nat Clin Pract Oncol 3:540-51. 2006
    ..We hope that this article will trigger further discussion about the difficulties of setting up and analyzing trials aimed at establishing the worth of new methods for better selection of patients for cancer treatment...
  45. ncbi request reprint End points for colon cancer adjuvant trials: observations and recommendations based on individual patient data from 20,898 patients enrolled onto 18 randomized trials from the ACCENT Group
    Daniel J Sargent
    Department of Health Sciences Research, North Central Cancer Treatment Group, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 25:4569-74. 2007
    ..We previously validated disease-free survival (DFS) after 3-year follow-up as an excellent predictor of 5-year OS results. Here we explore shorter term DFS and OS end points, as well as stage dependency...
  46. ncbi request reprint Overall survival is not a realistic end point for clinical trials of new drugs in advanced solid tumors: a critical assessment based on recently reported phase III trials in colorectal and breast cancer
    Angelo Di Leo
    J Clin Oncol 21:2045-7. 2003
  47. ncbi request reprint Are prostate-specific antigen changes valid surrogates for survival in hormone-refractory prostate cancer? A meta-analysis is needed!
    Laurence Collette
    J Clin Oncol 25:5673-4; author reply 5674. 2007
  48. ncbi request reprint Is FOB screening really the answer for lowering mortality in colorectal cancer?
    Philippe Autier
    Centre for Research in Epidemiology CRESIS, Luxembourg Health Institute, Luxembourg, Luxembourg
    Recent Results Cancer Res 163:254-63; discussion 264-6. 2003
    ..Therefore, recommending general population screening with biennial FOBT is still an open question...
  49. ncbi request reprint Progress in the medical treatment of advanced colorectal cancer
    Elizabeth Fabre-Guillevin
    Department of Medical Oncology, Assistance Publique Hopitaux de Paris, Henri Mondor Hospital, Creteil, France
    Expert Rev Anticancer Ther 3:711-6. 2003
    ..This review describes the research carried out in this field through randomized trials and meta-analyses aimed at optimizing the efficacy of front-line chemotherapy...
  50. doi request reprint Effect of rimonabant on progression of atherosclerosis in patients with abdominal obesity and coronary artery disease: the STRADIVARIUS randomized controlled trial
    Steven E Nissen
    Department of Cardiovascular Medicine and Cleveland Clinic Lerner School of Medicine, Cleveland, Ohio, USA
    JAMA 299:1547-60. 2008
    ..Abdominal obesity is associated with metabolic abnormalities and increased risk of atherosclerotic cardiovascular disease. However, no obesity management strategy has demonstrated the ability to slow progression of coronary disease...
  51. doi request reprint Taxanes alone or in combination with anthracyclines as first-line therapy of patients with metastatic breast cancer
    Martine J Piccart-Gebhart
    Institut Jules Bordet, 121 Boulevard de Waterloo, 1000 Brussels, Belgium
    J Clin Oncol 26:1980-6. 2008
    ..This meta-analysis uses data from all relevant trials to detect any advantages of taxanes in terms of tumor response, progression-free survival (PFS), and survival...
  52. ncbi request reprint Disease-free survival versus overall survival as a primary end point for adjuvant colon cancer studies: individual patient data from 20,898 patients on 18 randomized trials
    Daniel J Sargent
    North Central Cancer Treatment Group, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 23:8664-70. 2005
    ..A shorter-term end point providing convincing evidence to allow treatment comparisons could significantly speed the translation of advances into practice...
  53. doi request reprint Endpoints and surrogate endpoints in colorectal cancer: a review of recent developments
    Pascal Piedbois
    Department of Medical Oncology, Henri Mondor Hospital, Creteil, France
    Curr Opin Oncol 20:466-71. 2008
    ..The purpose of this review is to discuss recently published work on endpoints for early and advanced colorectal cancer, as well as the statistical approaches used to validate surrogate endpoints...
  54. ncbi request reprint Endpoints in adjuvant treatment trials: a systematic review of the literature in colon cancer and proposed definitions for future trials
    Cornelis J A Punt
    Department of Medical Oncology, Radboud University Nijmegen Medical Center, PO Box 9101 6500 HB Nijmegen, The Netherlands
    J Natl Cancer Inst 99:998-1003. 2007
    ..The proposed guidelines may add to the quality and cross-comparability of future studies of adjuvant treatments for cancer...