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U.S. National Institutes of Health
Cancer Diagnosis Program Cancer Imaging Program Cancer Therapy Evaluation Program Developmental Therapeutics Program Radiation Research Program Translational Research Program Biometric Research Branch Office of Cancer Complementary and Alternative Medicine
Last Updated: 04/25/2012


Contributed by Dr. Lisa McShane

Dr. Lisa McShane conducts research in the areas of cancer diagnostics, genomic profiling, and clinical trial design for molecularly targeted therapies. She has published numerous papers and is invited to give many lectures on these topics. Her expertise is highly valued and she provides advice to many groups both within the NCI and internationally. She has served for several years as a member of the tutorial planning committee and tutorial faculty for the EORTC-NCI-ASCO Meeting on Molecular Markers in Cancer Diagnostic Development and was a leading developer of the REporting recommendations for tumour MARKer prognostic studies (REMARK) for reporting results of tumor marker studies. In collaboration with an international group of researchers, Dr. McShane has completed a follow-up paper to the REMARK guidelines paper that provides further explanations and examples for the REMARK reporting items. She has collaborated with members of the NCI Office of Biorepositories and Biospecimen Research to write guidelines for information that should be reported about biospecimen characteristics and handling in publications of scientific studies involving the use of biospecimens. In addition, she serves on numerous scientific review committees within DCTD and has contributed statistical advice and participated in scientific collaborations with groups in DCTD and in other divisions throughout NCI.

Dr. McShane provides statistical expertise to both CDP and CTEP through participation in planning meetings, reviews of protocols, concepts, and grants involving correlative science studies, and membership on several correlative science committees. Dr. McShane played a major role in CDP activities such as the Program for the Assessment of Clinical Cancer Tests (PACCT) and in the development and recent launch of the Clinical Assay Development Program. In addition, Dr. McShane continues to serve the NIH community as one of the lecturers in the “Statistical Analysis of Microarray Data” course taught through NIH Center for Information Technology.

Dr. McShane also has interacted with other programs in NCI and the wider cancer research community. She served on the ASCO Panel charged with developing clinical guidance on epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small cell lung cancer considering EGFR TKI therapy and on the ASCO/College of American Pathologists panel that developed guidelines for hormone receptor testing in breast cancer. These projects have resulted in the publication or submission of several important papers. Dr. McShane also led the planning committee for the 2010 ASCO-NCI-EORTC Diagnostic Development Tutorial. She is regularly invited to speak to national and international audiences on a variety of topics related to statistical design, analysis, and reporting of studies involving tumor markers and genomic profiling.

Dr. McShane’s extensive efforts in re-analyzing data associated with genomic predictors developed by from Duke University investigators were instrumental in the detection of serious flaws in several of the predictors and subsequent closure of trials using those predictors. Dr. McShane was appointed by the NCI director’s office to present NCI’s perspective to the Institute of Medicine Panel convened to review the Duke genomic predictors and, more generally, to review the processes by which “omics” predictors are developed and validated for fitness for use in clinical trials.

Dr. McShane has participated in several collaborations with colleagues in BRB, with other NCI scientists, and with international research groups. These collaborations have been highly productive, resulting in several important papers, published or submitted, covering a range of topics including design of trials involving biomarkers, reporting guidelines for tumor marker studies, gene expression pathway analysis to predict response to neoadjuvant therapy for breast cancer, microRNA profiling of lung cancers, and recommendations for the use of Ki67 in breast cancer.

Altman DG, McShane LM, Sauerbrei W, Taube SE. Reporting recommendations for tumor marker prognostic studies (REMARK): Explanation and elaboration. (Submitted).

Andre F, McShane LM, Michiels S, Ransohoff DF, Altman DG, Reis-Filho JS, Hayes DF, Pusztai L. Reporting cancer biomarker studies in their appropriate landscape: A call for a comprehensive biomarker study registry. Nat Rev Clin Oncol 2011:8;171-6.

Clark GM, McShane LM. Biostatistical considerations in development of biomarker-based tests to guide treatment decisions. (Submitted).

Dowsett M, Nielsen TO, A’Hern RA, Bartlett J, Coombes RC, Cuzick J, Ellis M, Henry L, Lively T, McShane L, Paik S, Prudkin L, Regan M, Salter J, Sotiriou C, Smith I, Viale G, Zujewski J, Hayes DF. Ki67 in breast cancer: Recommendations from the international Ki67 in Breast Cancer Working Group. (Submitted).

Freidlin B, McShane LM, Korn EL. Randomized clinical trials with biomarkers: Design issues. J Natl Cancer Inst 2010:102;152-60.

Hammond MEH, Allred DC, Dowsett M, Hagerty KL, Hayes DF, Schwartz JN, Badve S, Fitzgibbons PL, Frances G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Sweep FCG, Taube S, Torlakovic EE, Viale G, Valenstein P, Bischer D, Wheeler T, Whitliff JL, Williams RB, Wolff AC. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen/progesterone receptors in breast cancer. J Clin Oncol 2010:28;2784-95. (Co-published in Arch Pathol Lab Med 2010:134;907-22). and

Keedy VL, Temin S, Somerfield MR, Beasley MB, Johnson DH, McShane LM, Milton DT, Strawn JR, Wakelee HA, Giaccone G. American Society of Clinical Oncology Provisional Clinical Opinion: Epidermal growth factor receptor (EGFR) mutation testing for patients with advanced non-small cell lung cancer considering first-line EGFR tyrosine kinase inhibitor therapy. J Clin Oncol 2011:29;2121-7.

Korde LA, Lusa L, McShane LM, Lebowitz PF, Lukes L, Camphausen K, Parker JS, Swain SM, Hunter K, Zujewski J. Gene expression pathway analysis to predict response to neoadjuvant docetaxel and capecitabine for breast cancer. Breast Cancer Res Treat 2010:119;685-699.

Koshiol J, Gulley ML, Zhao Y, Rubagotti M, Marincola FM, Rotunno M, Tang W, Bergen AW, Bertazzi PA, Roy D, Pesatori AC, Linnoila RI, Dittmer D, Goldstein AM, Caporaso NE, McShane LM, Wang E, Landi MT. Epstein-Barr virus microRNAs and lung cancer. (Submitted).

Landi MT, Zhao Y, Rotunno M, Koshiol J, Liu H, Bergen AW, Rubagotti M, Goldstein AM, Linnoila I, Marincola FM, Tucker MA, Bertazzi PA, Pesatori AC, Caporaso NE, McShane LM, Wang E. MicroRNA expression differentiates histology and predicts survival of lung cancer. Clin Cancer Res 2010:16;430-41.

McShane LM, Hunsberger S, Adjei AA. Effective incorporation of biomarkers into phase II trials. Clin Cancer Res 2009:15;1898-1905.

Moore HM, Kelly AB, Jewell SD, McShane LM, Clark DP, Greenspan R, Hayes DF, Hainaut P, Kim P, Mansfield EA, Potapova O, Riegman P, Rubinstein Y, Seijo E, Somiari S, Watson P, Weier H-U, Zhu C, Vaught J. Biospecimen reporting for improved study quality (BRISQ). Cancer Cytopathol 2011:119;92-101.

Oyelaran O, McShane LM, Dodd L, Gildersleeve JC. Profiling serum antibodies with a carbohydrate antigen microarray. J Proteome Res 2009:8;4301-10.

Rotunno M, Zhao Y, Bergen AW, Koshiol J, Burdette L, Rubagotti M, Linnoila RI, Marincola FM, Bertazzi PA, Pesatori AC, Caporaso NE, McShane LM, Wang E, Landi MT. Inherited polymorphisms in the RNA-mediated interference machinery affect microRNA expression and lung cancer survival. Br J Cancer 2010:103;1870-74.

Taube SE, Clark GM, Dancey JE, McShane LM, Sigman CC, Gutman SI. A perspective on challenges and issues in biomarker development and drug and biomarker codevelopment. J Natl Cancer Inst 2009:101;1453-63.

Zhao Y, Wang E, Liu H, Rotunno M, Koshiol J, Marincola FM, Landi MT, McShane LM. Evaluation of normalization methods for two-channel microRNA microarrays. J Transl Med 2010:8;69-75.