Sumithra J Mandrekar

Summary

Affiliation: Mayo Clinic
Country: USA

Publications

  1. ncbi request reprint Are our data symmetric?
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Stat Methods Med Res 12:505-13. 2003
  2. pmc A review of phase II trial designs for initial marker validation
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States Electronic address
    Contemp Clin Trials 36:597-604. 2013
  3. pmc Model-based phase I designs incorporating toxicity and efficacy for single and dual agent drug combinations: methods and challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Stat Med 29:1077-83. 2010
  4. pmc Clinical trial designs for predictive biomarker validation: one size does not fit all
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Biopharm Stat 19:530-42. 2009
  5. pmc Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 27:4027-34. 2009
  6. pmc Genomic advances and their impact on clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Genome Med 1:69. 2009
  7. pmc Endpoints in phase II trials for advanced non-small cell lung cancer
    Sumithra J Mandrekar
    Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic Rochester, Rochester, Minnesota 55905, USA
    J Thorac Oncol 5:3-9. 2010
  8. pmc Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data
    Jayawant N Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 4:1447-9. 2009
  9. pmc Predictive biomarker validation in practice: lessons from real trials
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA
    Clin Trials 7:567-73. 2010
  10. pmc Randomized phase II trials: time for a new era in clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 5:932-4. 2010

Detail Information

Publications51

  1. ncbi request reprint Are our data symmetric?
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Stat Methods Med Res 12:505-13. 2003
    ..With this work, we provide easy-to-implement S-PLUS functions as well as discuss the advantages and shortcomings of each technique...
  2. pmc A review of phase II trial designs for initial marker validation
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN, United States Electronic address
    Contemp Clin Trials 36:597-604. 2013
    ..Systematic evaluation and implementation of these design strategies in the phase II setting are essential for accelerating the clinical validation of biomarker guided-therapy. ..
  3. pmc Model-based phase I designs incorporating toxicity and efficacy for single and dual agent drug combinations: methods and challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Stat Med 29:1077-83. 2010
    ..We review and offer practical solutions to potentially overcome some of these challenges. The acceptance and integration of these designs in practice may be quicker and easier if they are developed in concert with a clinical paradigm...
  4. pmc Clinical trial designs for predictive biomarker validation: one size does not fit all
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Biopharm Stat 19:530-42. 2009
    ..The review and evaluation of these designs represents an essential step toward the goal of personalized medicine because we explicitly seek to explore and evaluate the methodology for the clinical validation of biomarker guided therapy...
  5. pmc Clinical trial designs for predictive biomarker validation: theoretical considerations and practical challenges
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 27:4027-34. 2009
    ..We discuss and evaluate various clinical trial designs for the validation of biomarker-guided therapy...
  6. pmc Genomic advances and their impact on clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    Genome Med 1:69. 2009
    ..Here, we highlight the impact of genomic advances on various aspects of clinical trial design...
  7. pmc Endpoints in phase II trials for advanced non-small cell lung cancer
    Sumithra J Mandrekar
    Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic Rochester, Rochester, Minnesota 55905, USA
    J Thorac Oncol 5:3-9. 2010
    ....
  8. pmc Biostatistics: a toolkit for exploration, validation, and interpretation of clinical data
    Jayawant N Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 4:1447-9. 2009
    ..In this brief report, we will put in perspective the general analytical framework for exploring and validating prognostic factors using data from large databases...
  9. pmc Predictive biomarker validation in practice: lessons from real trials
    Sumithra J Mandrekar
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA
    Clin Trials 7:567-73. 2010
    ..Biomarker validation has therefore become a central topic of discussion in the field of medicine, primarily due to the changing landscape of therapies for treatment of a disease and these therapies purported mechanism(s) of action...
  10. pmc Randomized phase II trials: time for a new era in clinical trial design
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 5:932-4. 2010
    ....
  11. pmc All-comers versus enrichment design strategy in phase II trials
    Sumithra J Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, MN 55905, USA
    J Thorac Oncol 6:658-60. 2011
    ..In this report, we discuss the parameters under which the enrichment or an all-comers design strategy would be appropriate for Phase II trials...
  12. ncbi request reprint Impact of pretreatment factors on adverse events: a pooled analysis of North Central Cancer Treatment Group advanced stage non-small cell lung cancer trials
    Sumithra J Mandrekar
    Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA
    J Thorac Oncol 1:556-63. 2006
    ..This pooled analysis was performed to examine the impact of pretreatment factors on severe (grade 3 or higher) adverse events (AE) in patients with advanced stage non-small cell lung cancer (NSCLC)...
  13. ncbi request reprint An adaptive phase I design for identifying a biologically optimal dose for dual agent drug combinations
    Sumithra J Mandrekar
    Division of Biostatistics, Mayo Clinic, Rochester, MN 55905, USA
    Stat Med 26:2317-30. 2007
    ..The proposed approach allowing the incorporation of both the toxicity and efficacy of each agent into the identification of an optimal dosing region for a combination is novel and warrants further consideration...
  14. ncbi request reprint Statistical modelling of the differences between successive R-R intervals
    Sumithra J Mandrekar
    The Ohio State University, Columbus, OH 43210, USA
    Stat Med 24:437-51. 2005
    ....
  15. ncbi request reprint A prognostic model for advanced stage nonsmall cell lung cancer. Pooled analysis of North Central Cancer Treatment Group trials
    Sumithra J Mandrekar
    Mayo Clinic College of Medicine, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA
    Cancer 107:781-92. 2006
    ....
  16. pmc Pomalidomide plus low-dose dexamethasone in myeloma refractory to both bortezomib and lenalidomide: comparison of 2 dosing strategies in dual-refractory disease
    Martha Q Lacy
    Mayo Clinic College of Medicine, Rochester, MN, USA
    Blood 118:2970-5. 2011
    ..Pomalidomide overcomes resistance in myeloma refractory to both lenalidomide and bortezomib. This trial is registered at http://ClinicalTrials.gov, number NCT00558896...
  17. pmc Pretreatment quality of life is an independent prognostic factor for overall survival in patients with advanced stage non-small cell lung cancer
    Yingwei Qi
    Mayo Clinic Rochester, Rochester, Minnesota 55905, USA
    J Thorac Oncol 4:1075-82. 2009
    ..We conducted this pooled analysis to assess the prognostic value of pretreatment Quality of Life (QOL) assessments on overall survival (OS) in advanced non-small cell lung cancer (NSCLC)...
  18. pmc Prognostic factors differ by tumor stage for small cell lung cancer: a pooled analysis of North Central Cancer Treatment Group trials
    Nathan R Foster
    Division of Biomedical Statistics and Informatics, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA
    Cancer 115:2721-31. 2009
    ....
  19. ncbi request reprint Population pharmacokinetic model for cancer chemoprevention with sulindac in healthy subjects
    Alexander K Berg
    Mayo Clinic, Rochester, MN 55905, USA
    J Clin Pharmacol 53:403-12. 2013
    ....
  20. ncbi request reprint The value of combined-modality therapy in elderly patients with stage III nonsmall cell lung cancer
    Steven E Schild
    Department of Radiation Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota, USA
    Cancer 110:363-8. 2007
    ....
  21. pmc UGT1A1 genotype-guided phase I study of irinotecan, oxaliplatin, and capecitabine
    Matthew P Goetz
    Department of Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN, 55905, USA
    Invest New Drugs 31:1559-67. 2013
    ..We performed a UGT1A1 genotype-guided study to determine the maximum tolerated dose (MTD) and evaluate the toxicities and pharmacokinetics of the combination of capecitabine (CAP), oxaliplatin (OX), and irinotecan (IRIN)...
  22. ncbi request reprint A limited sample model to predict area under the drug concentration curve for 17-(allylamino)-17-demethoxygeldanamycin and its active metabolite 17-(amino)-17-demethoxygeldanomycin
    Alfred F Furth
    Division of Biostatistics, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    Cancer Chemother Pharmacol 61:39-45. 2008
    ..Our goal was to develop a simple limited sampling model (LSM) for AUC of 17-AAG and its active metabolite, 17-(amino)-17-demethoxygeldanomycin (17-AG) using drug concentrations from a few time points...
  23. pmc Evaluation of glutathione metabolic genes on outcomes in advanced non-small cell lung cancer patients after initial treatment with platinum-based chemotherapy: an NCCTG-97-24-51 based study
    Ping Yang
    College of Medicine, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 4:479-85. 2009
    ....
  24. ncbi request reprint Phase I trial of sirolimus combined with radiation and cisplatin in non-small cell lung cancer
    Jann N Sarkaria
    Department of Radiation Oncology, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 2:751-7. 2007
    ..The safety and tolerability of sirolimus combined with thoracic radiation and cisplatin was evaluated in patients with lung cancer. In parallel, the effects of sirolimus were studied in a murine model of radiation pneumonitis...
  25. pmc Tumor response and progression-free survival as potential surrogate endpoints for overall survival in extensive stage small-cell lung cancer: findings on the basis of North Central Cancer Treatment Group trials
    Nathan R Foster
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota
    Cancer 117:1262-71. 2011
    ....
  26. pmc Evaluation of alternate categorical tumor metrics and cut points for response categorization using the RECIST 1.1 data warehouse
    Sumithra J Mandrekar
    Sumithra J Mandrekar, Jeffrey Meyers, Axel Grothey, and Daniel J Sargent, Mayo Clinic, Rochester, MN Ming Wen An, Vassar College, Poughkeepsie, NY and Jan Bogaerts, European Organisation for Research and Treatment of Cancer, Brussels, Belgium
    J Clin Oncol 32:841-50. 2014
    ..The data warehouse assembled to guide the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 was used...
  27. ncbi request reprint Randomized phase II trial of three schedules of pemetrexed and gemcitabine as front-line therapy for advanced non-small-cell lung cancer
    Cynthia X Ma
    Department of Oncology and Medicine, Mayo Clinic and Foundation, 200 First St SW, Rochester, MN 55905, USA
    J Clin Oncol 23:5929-37. 2005
    ..A randomized three-arm phase II study was undertaken to evaluate the optimum administration schedule of pemetrexed and gemcitabine in chemotherapy-naïve patients with non-small-cell lung cancer...
  28. pmc Impact of disease progression date determination on progression-free survival estimates in advanced lung cancer
    Yingwei Qi
    Department of Health Sciences Research, Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN 55905, USA
    Cancer 118:5358-65. 2012
    ..Because progression-free survival (PFS)-based endpoints are controversial, the authors evaluated the impact of the progression date (PD) determination approach on PFS estimates...
  29. ncbi request reprint A phase I trial of twice-weekly 17-allylamino-demethoxy-geldanamycin in patients with advanced cancer
    Grzegorz S Nowakowski
    Department of Oncology, Cancer Center Statistics, Mayo Clinic, Rochester, Minnesota 55905, USA
    Clin Cancer Res 12:6087-93. 2006
    ....
  30. pmc Randomized phase II trial of sulindac for lung cancer chemoprevention
    Paul J Limburg
    Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States
    Lung Cancer 79:254-61. 2013
    ..We conducted a randomized, phase II chemoprevention trial involving current or former cigarette smokers (≥30 pack-years) utilizing the multi-center, inter-disciplinary infrastructure of the Cancer Prevention Network (CPN)...
  31. pmc Idiopathic systemic capillary leak syndrome (Clarkson's disease): the Mayo clinic experience
    Prashant Kapoor
    Division of Hematology, Mayo Clinic, 200 First St SW, Rochester, MN 55905, USA
    Mayo Clin Proc 85:905-12. 2010
    ..To determine clinical features, natural history, and outcome of a well-defined cohort of 25 consecutive patients with idiopathic systemic capillary leak syndrome (SCLS) evaluated at a tertiary care center...
  32. pmc Evaluation of the value of attribution in the interpretation of adverse event data: a North Central Cancer Treatment Group and American College of Surgeons Oncology Group investigation
    Shauna L Hillman
    Mayo Clinic, Rochester, MN 55905, USA
    J Clin Oncol 28:3002-7. 2010
    ..In March 1998, Common Toxicity Criteria (CTC) version 2.0 introduced the collection of attribution of adverse events (AEs) to study drug. We investigate whether attribution adds value to the interpretation of AE data...
  33. ncbi request reprint Clinical trial designs for prospective validation of biomarkers
    Sumithra J Mandrekar
    Division of Biostatistics, Mayo Clinic, Rochester, Minnesota, USA
    Am J Pharmacogenomics 5:317-25. 2005
    ..Additional research is clearly warranted to achieve the goal of 'predictive oncology'...
  34. ncbi request reprint Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer
    Yolanda I Garces
    Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA
    Int J Radiat Oncol Biol Phys 67:995-1001. 2007
    ..The primary goal was to identify the maximum tolerable dose (MTD) of thoracic radiation therapy (TRT) that can be given with chemotherapy and amifostine for patients with limited-stage small-cell lung cancer (LSCLC)...
  35. pmc Phase 0 clinical chemoprevention trial of the Akt inhibitor SR13668
    Joel M Reid
    Mayo Clinic Comprehensive Cancer Center, Rochester, MN, USA
    Cancer Prev Res (Phila) 4:347-53. 2011
    ..Our findings support application of the phase 0 trial paradigm to accelerate chemoprevention agent development...
  36. pmc Effect of cigarette smoking on quality of life in small cell lung cancer patients
    Jun Chen
    Department of Medical Oncology, The Second Affiliated Hospital, Dalian Medical University, 467 Zhongshan Road, ShaHeKou District, Dalian 116023, PR China
    Eur J Cancer 48:1593-601. 2012
    ..In this study, we sought to evaluate the relationship between cigarette smoking and QOL profiles in SCLC patients...
  37. doi request reprint Predictive biomarkers in colorectal cancer: usage, validation, and design in clinical trials
    Qian Shi
    Department of Health Science Research, Mayo Clinic, Rochester, MN 55905, USA
    Scand J Gastroenterol 47:356-62. 2012
    ..We conclude that the combination of scientific, clinical, statistical, ethical, and practical considerations provides guidance for the choice of the clinical trial design for validation of each proposed predictive biomarker...
  38. ncbi request reprint A pooled analysis of quality of life measures and adverse events data in north central cancer treatment group lung cancer clinical trials
    Mashele M Huschka
    Division of Biostatistics, Mayo Clinic, Rochester, Minnesota 55905, USA
    Cancer 109:787-95. 2007
    ....
  39. pmc Comparative bioavailability of sulindac in capsule and tablet formulations
    Joel M Reid
    Mayo Clinic, College of Medicine, 200 First Street SW, Rochester, MN 55905, USA
    Cancer Epidemiol Biomarkers Prev 17:674-9. 2008
    ..These data support the use of sulindac capsules, which can be readily prepared with matching placebos, in future blinded chemoprevention trials...
  40. ncbi request reprint Pomalidomide (CC4047) plus low-dose dexamethasone as therapy for relapsed multiple myeloma
    Martha Q Lacy
    Division of Hematology, Mayo Clinic College of Medicine, Rochester, MN 55905, USA
    J Clin Oncol 27:5008-14. 2009
    ..We report, to our knowledge, the first phase II trial of pomalidomide administered in combination with low-dose dexamethasone for the treatment of relapsed or refractory multiple myeloma...
  41. pmc Randomized phase II trial of sulindac, atorvastatin, and prebiotic dietary fiber for colorectal cancer chemoprevention
    Paul J Limburg
    Mayo Clinic Rochester, Rochester, MN 55905, USA
    Cancer Prev Res (Phila) 4:259-69. 2011
    ....
  42. ncbi request reprint Combining symptom and survival data
    Pamela J Atherton
    Department of Health Science Research, Mayo Clinic, Rochester, Minnesota, USA
    Curr Probl Cancer 30:307-18. 2006
  43. ncbi request reprint Phase III randomized, double-blind study of maintenance CAI or placebo in patients with advanced non-small cell lung cancer (NSCLC) after completion of initial therapy (NCCTG 97-24-51)
    Elizabeth A Johnson
    Mayo Clinic Jacksonville, Jacksonville, FL 32224, USA
    Lung Cancer 60:200-7. 2008
    ....
  44. ncbi request reprint Statistical issues in the validation of prognostic, predictive, and surrogate biomarkers
    Daniel J Sargent
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, MN, USA
    Clin Trials 10:647-52. 2013
    ..Biomarkers have many distinct purposes, and depending on their intended use, the validation process varies substantially...
  45. ncbi request reprint A phase I and pharmacologic study of sequences of the proteasome inhibitor, bortezomib (PS-341, Velcade), in combination with paclitaxel and carboplatin in patients with advanced malignancies
    Cynthia Ma
    Division of Medical Oncology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Cancer Chemother Pharmacol 59:207-15. 2007
    ..Two different treatment schedules of bortezomib in combination with paclitaxel and carboplatin were tested in this phase I study to evaluate the effects of scheduling on toxicities, pharmacodynamics and clinical activity...
  46. pmc Systematic reviews and meta-analysis of published studies: an overview and best practices
    Jayawant N Mandrekar
    Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota 55905, USA
    J Thorac Oncol 6:1301-3. 2011
    ..As with any research, following a set of established guidelines is essential for quality and consistency of the findings across studies and for assessment of clinical utility...
  47. ncbi request reprint CT screening for lung cancer: five-year prospective experience
    Stephen J Swensen
    Department of Radiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, USA
    Radiology 235:259-65. 2005
    ..To report results of a 5-year prospective low-dose helical chest computed tomographic (CT) study of a cohort at high risk for lung cancer...
  48. pmc Residual serum monoclonal protein predicts progression-free survival in patients with previously untreated multiple myeloma
    Eric W Schaefer
    Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota 55905, USA
    Cancer 116:640-6. 2010
    ..The authors hypothesized that metrics incorporating the serial trend of M-protein would be better predictors of progression-free survival (PFS)...
  49. ncbi request reprint Impact of Brachytherapy on Local Recurrence Rates After Sublobar Resection: Results From ACOSOG Z4032 (Alliance), a Phase III Randomized Trial for High-Risk Operable Non-Small-Cell Lung Cancer
    Hiran C Fernando
    Hiran C Fernando, Boston Medical Center, Boston, MA Rodney J Landreneau, Dwight E Heron, and Benedict D T Daly, University of Pittsburgh, Pittsburgh, PA Sumithra J Mandrekar, Francis C Nichols, Shauna L Hillman, and Angelina D Tan, Mayo Clinic, Rochester, MN Bryan F Meyers, Washington University of St Louis, St Louis, MO Thomas A DiPetrillo, Rhode Island Hospital, Providence, RI David R Jones, University of Virginia, Charlottesville, VA Sandra L Starnes, University of Cincinnati, Cincinnati, OH and Joe B Putnam Jr, Vanderbilt University Medical Center, Nashville, TN
    J Clin Oncol 32:2456-62. 2014
    ..A major concern with sublobar resection (SR) for non-small-cell lung cancer (NSCLC) is high local recurrence (LR). Adjuvant brachytherapy may reduce LR This multicenter randomized trial compares SR to SR with brachytherapy (SRB)...
  50. ncbi request reprint Phase I trial of sorafenib in combination with gefitinib in patients with refractory or recurrent non-small cell lung cancer
    Alex A Adjei
    Roswell Park Cancer Institute, Buffalo, New York 14263, USA
    Clin Cancer Res 13:2684-91. 2007
    ..To evaluate the combination of sorafenib and gefitinib in patients with advanced non-small cell lung cancer...
  51. ncbi request reprint Pick the winner designs in phase II cancer clinical trials
    Sumithra J Mandrekar
    J Thorac Oncol 1:5-6. 2006