Sumithra J Mandrekar

Summary

Affiliation: Mayo Clinic
Country: USA

Publications

  1. ncbi 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. ncbi 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
  3. ncbi 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
  4. ncbi 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
  5. ncbi 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
  6. ncbi 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
  7. ncbi 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
  8. ncbi 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
  9. ncbi 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
  10. ncbi 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

Publications45

  1. ncbi 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. ncbi 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)...
  3. ncbi 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
    ....
  4. ncbi 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...
  5. ncbi 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...
  6. ncbi 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...
  7. ncbi 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...
  8. ncbi 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...
  9. ncbi 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...
  10. ncbi 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. ncbi 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
    ....
  12. ncbi 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
    ....
  13. ncbi 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...
  14. ncbi 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...
  15. ncbi 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...
  16. ncbi 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)...
  17. ncbi 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
    ....
  18. ncbi 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
    ....
  19. ncbi 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
    ....
  20. ncbi 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...
  21. ncbi 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...
  22. ncbi 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
    ..CONCLUSION: Pemetrexed and gemcitabine administered as outlined for schedule A met the protocol-defined efficacy criteria, was less toxic compared with the other treatment schedules, and should be further evaluated...
  23. ncbi 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
    ....
  24. ncbi 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...
  25. ncbi 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
    ..This raises the possibility that HSP70 induction as part of the stress response may contribute to resistance to 17-AAG...
  26. ncbi 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...
  27. ncbi 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...
  28. ncbi 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...
  29. ncbi 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'...
  30. ncbi 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)...
  31. ncbi 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...
  32. ncbi 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...
  33. ncbi 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...
  34. ncbi 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...
  35. ncbi 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
    ....
  36. ncbi 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
  37. ncbi 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
    ....
  38. ncbi 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
    ....
  39. ncbi 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...
  40. ncbi 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...
  41. ncbi Randomized phase II trial of sulindac for lung cancer chemoprevention
    Paul J Limburg
    Mayo Clinic, Rochester, MN, United States Electronic address
    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)...
  42. ncbi 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)...
  43. ncbi 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...
  44. ncbi Pick the winner designs in phase II cancer clinical trials
    Sumithra J Mandrekar
    J Thorac Oncol 1:5-6. 2006
  45. ncbi 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...