Mei-Yin Polley

Associate Professor
Research Summary
Dr. Polley’s primary research involves the design, conduct, and analysis of all phases of cancer clinical trials. She is the Head of the Statistics Division and Senior Statistician of the Brain Tumor Committee for NRG Oncology, a National Cancer Institute sponsored member of the national clinical trials network group. Previously, she served as the Director of the Biostatistics and Bioinformatics Core of the Mayo Clinic Breast Cancer Specialized Program of Research Excellence (SPORE). Dr. Polley had served on many scientific governing or advisory bodies including the National Cancer Institute Steering Committees (breast, lymphoma, head and neck cancer, and pediatric and adolescent solid tumor), the Scientific Program Committee of American Society of Clinical Oncology (ASCO) annual meetings, and the US Veterans Affairs (VA) Oncology A Study Section. Dr. Polley’s methodological interests include early-phase clinical trial designs, biomarker reproducibility, innovative group sequential methods for biomarker validation, prognostic and predictive modeling, design and analysis of biomarker-based clinical trials, and design and monitoring of late phase clinical trials.
clinical trials, cancer biomarker, prognostic modeling, biomarker reproducibility, breast cancer, brain cancer
  • Harvard University, Cambridge, Massachusetts, MA Statistics 06/1999
  • Columbia University, New York, New York, MS Biostatistics 05/2001
  • Columbia University, New York, New York, PhD Biostatistics 06/2006
Biosciences Graduate Program Association
Awards & Honors
  • 2001 - 2004 Merck & Co., Inc. Fellowship Columbia University
  • 2006 - The Joseph L. Fleiss Memorial Prize in Biostatistics for an Outstanding Dissertation Columbia University
  • 2008 - Travel Award - Biostatistics Workshop American Association for Cancer Research (AACR)
  • 2009 - Award for Excellence in Clinical Research The American Brain Tumor Association
  • 2009 - REAC Pilot Research Award in Basic and Clinical/Translational Sciences University of California San Francisco
  • 2012 - Distinguished Achievement Award Kelly Government Solutions, National Cancer Institute
  • 2017 - The Fraternal Order of Eagles Cancer Research Award Mayo Clinic Cancer Center
  • 2018 - Breast Cancer Specialized Program of Research Excellence - Developmental Research Program Award Mayo Clinic
  • 2021 - 2025 Appointee - Special Government Employee (SGE) member, Federal Advisory Committee Act (FACA) US Department of Veterans Affairs (VA)
  1. Leveraging external data in the design and analysis of clinical trials in neuro-oncology. Lancet Oncol. 2021 10; 22(10):e456-e465. View in: PubMed

  2. A clinical calculator to predict disease outcomes in women with hormone receptor-positive advanced breast cancer treated with first-line endocrine therapy. Breast Cancer Res Treat. 2021 Aug; 189(1):15-23. View in: PubMed

  3. Characteristics and Spatially Defined Immune (micro)landscapes of Early-stage PD-L1-positive Triple-negative Breast Cancer. Clin Cancer Res. 2021 10 15; 27(20):5628-5637. View in: PubMed

  4. On the Quest of Risk Stratification in HER2-Positive Breast Cancer. J Natl Cancer Inst. 2022 03 08; 114(3):345-346. View in: PubMed

  5. Statistical Considerations in the Evaluation of Continuous Biomarkers. J Nucl Med. 2021 05 10; 62(5):605-611. View in: PubMed

  6. A clinical calculator to predict disease outcomes in women with triple-negative breast cancer. Breast Cancer Res Treat. 2021 Feb; 185(3):557-566. View in: PubMed

  7. Assessment of Ki67 in Breast Cancer: Updated Recommendations From the International Ki67 in Breast Cancer Working Group. J Natl Cancer Inst. 2021 07 01; 113(7):808-819. View in: PubMed

  8. Survival, Pathologic Response, and Genomics in CALGB 40601 (Alliance), a Neoadjuvant Phase III Trial of Paclitaxel-Trastuzumab With or Without Lapatinib in HER2-Positive Breast Cancer. J Clin Oncol. 2020 12 10; 38(35):4184-4193. View in: PubMed

  9. Early-Phase Platform Trials: A New Paradigm for Dose Finding and Treatment Screening in the Era of Precision Oncology. JCO Precis Oncol. 2019; 3. View in: PubMed

  10. Phase III Precision Medicine Clinical Trial Designs That Integrate Treatment and Biomarker Evaluation. JCO Precis Oncol. 2019; 3. View in: PubMed

  11. A Validated T Cell Radiomics Score Is Associated With Clinical Outcomes Following Multisite SBRT and Pembrolizumab. Int J Radiat Oncol Biol Phys. 2020 09 01; 108(1):189-195. View in: PubMed

  12. Prognostic value of interim FDG-PET in diffuse large cell lymphoma: results from the CALGB 50303 Clinical Trial. Blood. 2020 06 18; 135(25):2224-2234. View in: PubMed

  13. The CCND1 c.870G risk allele is enriched in individuals of African ancestry with plasma cell dyscrasias. Blood Cancer J. 2020 03 16; 10(3):39. View in: PubMed

  14. Folate receptor alpha expression associates with improved disease-free survival in triple negative breast cancer patients. NPJ Breast Cancer. 2020; 6:4. View in: PubMed

  15. Two may be better than one: PD-1/PD-L1 blockade combination approaches in metastatic breast cancer. NPJ Breast Cancer. 2019; 5:34. View in: PubMed

  16. Bleomycin use in the treatment of Hodgkin lymphoma (HL): toxicity and outcomes in the modern era. Leuk Lymphoma. 2020 02; 61(2):298-308. View in: PubMed

  17. Randomized Trial of Standard Adjuvant Chemotherapy Regimens Versus Capecitabine in Older Women With Early Breast Cancer: 10-Year Update of the CALGB 49907 Trial. J Clin Oncol. 2019 09 10; 37(26):2338-2348. View in: PubMed

  18. Randomized trial of ofatumumab and bendamustine versus ofatumumab, bendamustine, and bortezomib in previously untreated patients with high-risk follicular lymphoma: CALGB 50904 (Alliance). Cancer. 2019 10 01; 125(19):3378-3389. View in: PubMed

  19. Dose-Adjusted EPOCH-R Compared With R-CHOP as Frontline Therapy for Diffuse Large B-Cell Lymphoma: Clinical Outcomes of the Phase III Intergroup Trial Alliance/CALGB 50303. J Clin Oncol. 2019 07 20; 37(21):1790-1799. View in: PubMed

  20. Mass Cytometry Analysis Reveals that Specific Intratumoral CD4+ T Cell Subsets Correlate with Patient Survival in Follicular Lymphoma. Cell Rep. 2019 02 19; 26(8):2178-2193.e3. View in: PubMed

  21. Hyperhaploid plasma cell myeloma characterized by poor outcome and monosomy 17 with frequently co-occurring TP53 mutations. Blood Cancer J. 2019 02 19; 9(3):20. View in: PubMed

  22. Differences in genomic abnormalities among African individuals with monoclonal gammopathies using calculated ancestry. Blood Cancer J. 2018 10 10; 8(10):96. View in: PubMed

  23. Impact of histopathology, tumor-infiltrating lymphocytes, and adjuvant chemotherapy on prognosis of triple-negative breast cancer. Breast Cancer Res Treat. 2018 01; 167(1):89-99. View in: PubMed

  24. Power estimation in biomarker studies where events are already observed. Clin Trials. 2017 Dec; 14(6):621-628. View in: PubMed

  25. An international study to increase concordance in Ki67 scoring. Mod Pathol. 2015 Jun; 28(6):778-86. View in: PubMed

  26. Comparison of confidence interval methods for an intra-class correlation coefficient (ICC). BMC Med Res Methodol. 2014 Nov 22; 14:121. View in: PubMed

  27. Two-stage adaptive cutoff design for building and validating a prognostic biomarker signature. Stat Med. 2014 Dec 20; 33(29):5097-110. View in: PubMed

  28. Immunotherapy and radiation therapy: considerations for successfully combining radiation into the paradigm of immuno-oncology drug development. Radiat Res. 2014 Aug; 182(2):252-7. View in: PubMed

  29. Criteria for the use of omics-based predictors in clinical trials: explanation and elaboration. BMC Med. 2013 Oct 17; 11:220. View in: PubMed

  30. An international Ki67 reproducibility study. J Natl Cancer Inst. 2013 Dec 18; 105(24):1897-906. View in: PubMed

  31. Statistical and practical considerations for clinical evaluation of predictive biomarkers. J Natl Cancer Inst. 2013 Nov 20; 105(22):1677-83. View in: PubMed

  32. Criteria for the use of omics-based predictors in clinical trials. Nature. 2013 Oct 17; 502(7471):317-20. View in: PubMed

  33. Development of omics-based clinical tests for prognosis and therapy selection: the challenge of achieving statistical robustness and clinical utility. Clin Trials. 2013 Oct; 10(5):653-65. View in: PubMed

  34. Circulating levels of immune and inflammatory markers and long versus short survival in early-stage lung cancer. Ann Oncol. 2013 Aug; 24(8):2073-9. View in: PubMed

  35. Randomized phase II trial designs with biomarkers. J Clin Oncol. 2012 Sep 10; 30(26):3304-9. View in: PubMed

  36. Heparan sulfate sulfatase SULF2 regulates PDGFRa signaling and growth in human and mouse malignant glioma. J Clin Invest. 2012 Mar; 122(3):911-22. View in: PubMed

  37. Conditional probability of survival in patients with newly diagnosed glioblastoma. J Clin Oncol. 2011 Nov 01; 29(31):4175-80. View in: PubMed

  38. Phase II and pharmacogenomics study of enzastaurin plus temozolomide during and following radiation therapy in patients with newly diagnosed glioblastoma multiforme and gliosarcoma. Neuro Oncol. 2011 Dec; 13(12):1331-8. View in: PubMed

  39. Pediatric intracranial ependymoma: the roles of surgery, radiation and chemotherapy. J Neurooncol. 2012 Jan; 106(2):367-75. View in: PubMed

  40. Practical modifications to the time-to-event continual reassessment method for phase I cancer trials with fast patient accrual and late-onset toxicities. Stat Med. 2011 Jul 30; 30(17):2130-43. View in: PubMed

  41. Cooperation of the HDAC inhibitor vorinostat and radiation in metastatic neuroblastoma: efficacy and underlying mechanisms. Cancer Lett. 2011 Jul 28; 306(2):223-9. View in: PubMed

  42. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul; 115(1):3-8. View in: PubMed

  43. Inhibition of PI3K/mTOR pathways in glioblastoma and implications for combination therapy with temozolomide. Neuro Oncol. 2011 Apr; 13(4):384-92. View in: PubMed

  44. Identifying the needs of brain tumor patients and their caregivers. J Neurooncol. 2011 Sep; 104(3):737-44. View in: PubMed

  45. Serial analysis of imaging parameters in patients with newly diagnosed glioblastoma multiforme. Neuro Oncol. 2011 May; 13(5):546-57. View in: PubMed

  46. Impact of bevacizumab chemotherapy on craniotomy wound healing. J Neurosurg. 2011 Jun; 114(6):1609-16. View in: PubMed

  47. Assessment of perfusion MRI-derived parameters in evaluating and predicting response to antiangiogenic therapy in patients with newly diagnosed glioblastoma. Neuro Oncol. 2011 Jan; 13(1):119-31. View in: PubMed

  48. Assessment of morbidity following resection of cingulate gyrus gliomas. Clinical article. J Neurosurg. 2011 Mar; 114(3):640-7. View in: PubMed

  49. Ex vivo MR spectroscopic measure differentiates tumor from treatment effects in GBM. Neuro Oncol. 2010 Nov; 12(11):1152-61. View in: PubMed

  50. En bloc resection for primary and metastatic tumors of the spine: a systematic review of the literature. Neurosurgery. 2010 Aug; 67(2):435-44; discussion 444-5. View in: PubMed

  51. Functional mapping-guided resection of low-grade gliomas in eloquent areas of the brain: improvement of long-term survival. Clinical article. J Neurosurg. 2011 Mar; 114(3):566-73. View in: PubMed

  52. Effect of imaging and catheter characteristics on clinical outcome for patients in the PRECISE study. J Neurooncol. 2011 Jan; 101(2):267-77. View in: PubMed

  53. Evaluation of diffusion parameters as early biomarkers of disease progression in glioblastoma multiforme. Neuro Oncol. 2010 Sep; 12(9):908-16. View in: PubMed

  54. Six-month progression-free survival as an alternative primary efficacy endpoint to overall survival in newly diagnosed glioblastoma patients receiving temozolomide. Neuro Oncol. 2010 Mar; 12(3):274-82. View in: PubMed

  55. Enzastaurin plus temozolomide with radiation therapy in glioblastoma multiforme: a phase I study. Neuro Oncol. 2010 Jun; 12(6):608-13. View in: PubMed

  56. Oncogenic BRAF mutation with CDKN2A inactivation is characteristic of a subset of pediatric malignant astrocytomas. Cancer Res. 2010 Jan 15; 70(2):512-9. View in: PubMed

  57. Activation of PI3K/mTOR pathway occurs in most adult low-grade gliomas and predicts patient survival. J Neurooncol. 2010 Mar; 97(1):33-40. View in: PubMed

  58. Insular glioma resection: assessment of patient morbidity, survival, and tumor progression. J Neurosurg. 2010 Jan; 112(1):1-9. View in: PubMed

  59. Quality of life in low-grade glioma patients receiving temozolomide. Neuro Oncol. 2009 Feb; 11(1):59-68. View in: PubMed

  60. Two-stage designs for dose-finding trials with a biologic endpoint using stepwise tests. Biometrics. 2008 Mar; 64(1):232-41. View in: PubMed

  61. Two-Stage Adaptive Design for Prognostic Biomarker Signatures With a Survival Endpoint. Statistics in Biopharmaceutical Research. 2020.::::

  62. A simulation based evaluation of sample size methods for biomarker studies. Int J Stat Med Res. 2018; 4(7):106-116.::::