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Dr. Lisa Meier McShane

Associate Director, Division of Cancer Treatment and Diagnosis

Biosketch

Lisa Meier McShane, Ph.D., is Associate Director, Division of Cancer Treatment and Diagnosis, National Cancer Institute, U.S. National Institutes of Health, where she heads the Biometric Research Program, comprising Biostatistics and Computational and Systems Biology Branches. She earned a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She is an internationally recognized expert on precision medicine clinical trial design; development of tumor markers and omics predictors for prognosis, therapy selection, and disease monitoring; and reporting guidelines for health research studies. She is a frequent invited speaker at national and international oncology and statistics meetings.

Dr. McShane has served in editorial roles for several biomedical and statistics journals and has been invited to serve on several national committees. Currently, she is an Editor-in-Chief of Statistics in Medicine and serves on the Scientific Advisory Board for Science Translational Medicine. She has served on American Society of Clinical Oncology committees that developed guidelines for HER2 and hormone receptor testing in breast cancer, EGFR mutation testing in lung cancer, biomarkers in early-stage breast cancer, and biomarkers to inform therapy for metastatic breast cancer. She interacts frequently with the U.S. Food and Drug Administration (FDA) on biomarker-based initiatives and has served on FDA Molecular and Clinical Genetics and Clinical Chemistry and Clinical Toxicology Panels. She has served as a member of several Institute of Medicine committees, including Committee for Management of the Air Force Health Study Data and Specimens, Consensus Committee on Management of the Air Force Health Study Data and Specimens-Report to Congress, and Committee on the State of the Science in Ovarian Cancer Research.

Research Interests

Dr. McShane's statistical research interests include biomarker-driven clinical trial design, analysis of high-dimensional omics data, multiple comparisons methods, surrogate endpoints, and biomarker assay analytical performance and clinical utility assessment. She co-led efforts to develop "Reporting guidelines for tumor marker prognostic studies (REMARK)" and "Criteria for the use of omics-based predictors in clinical trials". She has coauthored numerous statistical and biomedical papers and book chapters in addition to coauthoring the book Statistical Design and Analysis of DNA Microarray Investigations.

CV (Updated on January, 2024)

Selected peer-reviewed publications (within last 5 years):

1. Tsimberidou AM, Levit LA, Schilsky RL, Averbuch SD, Chen D, Kirkwood JM, McShane L, Sharon E, Mileham KF, Postow MA. Trial Reporting in Immuno-Oncology (TRIO): an American Society of Clinical Oncology - Society for Immunotherapy of Cancer Statement. Journal of Clinical Oncology 37(1): 72-80, 2019. [doi:10.1200/JCO.18.00145]. Co-publication: Journal for Immunotherapy of Cancer 6: 108, 2018.

2. Rimm DL, Leung SCY, McShane LM, Bai Y, Bane AL, Bartlett JMS, Bayani J, Chang MC, Dean M, Denkert C, Enwere EK, Galderisi C, Gholap A, Hugh JC, Jadhav A, Kornaga EN, Laurinavicius A, Levenson R, Lima J, Miller K, Pantanowitz L, Piper T, Ruan J, Srinivasan M, Virk S, Wu Y, Yang H, Hayes DF, Nielsen TO, Dowsett M. An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer. Modern Pathology 32(1): 59-69, 2019. [doi: /10.1038/s41379-018-0109-4].

3. Leung SCY, Nielsen TO, Zabaglo LA, Arun I, Badve SS, Bane AL, Bartlett JMS, Borgquis S, Chang MC, Dodson A, Ehinger A, Fineberg S, Focke CM, Gao D, Gown AM, Gutierrez C, Hugh JC, Kos Z, Lænkholm A-V, Mastropasqua MG, Moriya T, Nofech-Mozes S, Osborne CK, Penault-Llorca FM, Piper T, Sakatani T, Salgado R, Starczynski J, Sugie T, van der Vegt B, Viale G, Hayes DF, McShane LM, Dowsett M on behalf of the International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group (BIG-NABCG). Analytical validation of a standardized scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections: an international multicenter collaboration. Histopathology 75(2): 225-235, 2019.

4. Yee LM, McShane LM, Freidlin B, Mooney MM, Korn EL. Biostatistical and logistical considerations in the development of basket and umbrella clinical trials. The Cancer Journal 25(4): 254-263, 2019.

5. Jhaveri KL, Wang XV, Makker V, Luoh S-W, Mitchell EP, Zwiebel JA, Sharon E, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Ado-trastuzumab emtansine (T-DM1) in patients with HER2 amplified tumors excluding breast and gastric/gastro-esophageal junction (GEJ) adenocarcinomas: results from the NCI-MATCH trial (EAY131) sub-protocol Q. Annals of Oncology 30: 1821-1830, 2019.

6. Ji L, McShane L, Krailo M, Sposto R. Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial. Clinical Trials, 16(6): 599-609, 2019.

7. Azad N, Gray R, Overman MJ, Schoenfeld JD, Mitchell EP, Zwiebel JA, Sharon E, Streicher H, Li S, McShane LM, Rubinstein L, Patton DR, Williams PM, Coffey B, Hamilton SR, Bahary N, Suga JM, Hatoum H, Abrams JS, Conley BA, Arteaga CL, Harris L, O'Dwyer PJ, Chen AP, Flaherty KT. Nivolumab is effective in mismatch repair-deficient non-colorectal cancers: results from arm Z1D - the first subprotocol of the NCI-MATCH (EAY131). Journal of Clinical Oncology 38(3): 214-222, 2019.

8. Johnson DB, Zhao F, Noel M, Riely GJ, Mitchell EP, Wright JJ, Chen HX, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Trametinib in cancers harboring BRAF non-V600 mutations or fusions: results from NCI-MATCH (EAY131). Clinical Cancer Research 26(8): 1812-1819, 2020.

9. Flaherty KT, Gray R, Chen A, Li S, Patton D, Hamilton SR, Williams PM, Mitchell EP, Iafrate AJ, Sklar J, Harris LN, McShane LM, Rubinstein LV, Sims DJ, Routbort M, Coffey B, Fu A, Zwiebel JA, Little RF, Marinucci D, Catalano R, Magnan R, Kibbe W, Weil C, Tricoli JV, Alexander B, Kumar S, Schwartz GK, Meric-Bernstam F, Lih C-J, McCaskill-Stevens W, Caimi P, Takebe N, Datta V, Arteaga CL, Abrams JS, Comis R, O'Dwyer PJ, Conley BA. The Molecular Analysis for Therapy CHoice (NCI-MATCH) Trial: lessons for genomic trial design. Journal of the National Cancer Institute 112(10): djz245, 2020. [ doi: 10.1093/jnci/djz245].

10. Allison KH, Hammond MEH, Dowsett M, McKernin SE, Carey LA, Fitzgibbons PL, Hayes DF, Lakhani SR, Chavez-MacGregor M, Perlmutter J, Perou CM, Regan MM, Rimm DL, Symmans WF, Torlakovic EE, Varella L, Viale G, Weisberg TF, McShane LM, Wolff AC. Estrogen and progesterone receptor testing in breast cancer: ASCO/CAP guideline update. Journal of Clinical Oncology 38(12): 1356-1366, 2020. Co-published in the journal: Archives of Pathology and Laboratory Medicine 144(5): 545-563, 2020.

11. Merino DM, McShane LM, Fabrizio D, Funari V, Chen S-J, White JR, Wenz P, Baden J, Barrett JC, Chaudhary R, Chen L, Chen W, Cheng J-H, Cyanam D, Dickey JS, Gupta V, Hellmann MD, Helman E, Li Y, Maas J, Papin A, Patidar R, Quinn KJ, Rizvi NA, Tae H, Ward CK, Xie M, Zehir A, Zhao C, Dietel M, Stenzinger A, Stewart M, Allen J on behalf of the TMB Harmonization Consortium. Establishing guidelines to harmonize tumor mutational burden (TMB): in silico assessment of variation in TMB quantification across diagnostic platforms - phase 1 of the Friends of Cancer Research TMB Harmonization Project. Journal for ImmunoTherapy of Cancer 8: e000147, 2020. [doi:10.1136/ jitc-2019-000147]

12. Chae YK, Hong FX, Vaklavas C, Cheng HH, Hammerman P, Mitchell EP, Zwiebel JA, Ivy SP, Gray RJ, Li SL, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Mansfield A, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II study of AZD4547 in patients with tumors harboring aberrations in the FGFR pathway: results from the NCI-MATCH trial (EAY131) subprotocol W). Journal of Clinical Oncology 38(21): 2407-2417, 2020.

13. Godsey JH, Silvestro A, Barrett JC, Bramlett K, Chudova D, Deras I, Dickey J, Hicks J, Johann DJ, Leary R, Lee JSH, McMullen J, McShane L, Nakamura K, Richardson AO, Ryder M, Simmons J, Tanzella K, Yee L, Leiman LC, on behalf of the BloodPAC Consortium. Generic protocols for the analytical validation of next-generation sequencing-based ctDNA assays: a joint consensus recommendation of the BloodPAC's Analytical Variables Working Group. Clinical Chemistry 66(9): 1156-1166, 2020.

14. Flaherty KT, Gray RJ, Chen AP, Li S, McShane LM, Patton D, Hamilton SR, Williams PM, Iafrate AJ, Sklar J, Mitchell EP, Harris LN, Sims DJ, Coffey B, Fu A, Routbort M, Zwiebel JA, Rubinstein LV, Little RF, Arteaga CL, Comis R, Abrams JS, O'Dwyer PJ, Conley BA, for the NCI-MATCH team. Molecular landscape and actionable alterations in a genomically guided cancer clinical trial: NCI-MATCH (Molecular Analysis for Therapy Choice). Journal of Clinical Oncology 38: 3883-3894, 2020.

15. Salama AK, Li S, Macrae ER, Park J-I, Mitchell EP, Zwiebel JA, Chen HX, Gray RJ, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Armstrong DK, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Dabrafenib and trametinib in patients with tumors with BRAFV600E mutations: results of the NCI-MATCH Trial subprotocol H. Journal of Clinical Oncology 38: 3895-3904, 2020.

16. Conley BA, Staudt L, Takebe N, Wheeler DA, Wang L, Cardenas MF, Korchina V, Zenklusen JC, McShane LM, Tricoli JV, Williams PM, Lubensky I, O'Sullivan-Coyne G, Kohn E, Little RF, White J, Malik S, Harris LN, Mann B, Weil C, Tarnuzzer R, Karlovich C, Rodgers B, Shankar L, Jacobs PM, Nolan T, Berryman SM, Gastier-Foster J, Bowen J, Leraas K, Shen H, Laird PW, Esteller M, Miller V, Johnson A, Edmondson EF, Ivy SP. The Exceptional Responders Initiative: a National Cancer Institute pilot study. Journal of the National Cancer Institute 113(1): 27-37, 2021.

17. Wheeler DA, Takebe N, Hinoue T, Hoadley KA, Cardenas MF, Hamilton AM, Laird PW, Wang L, Johnson A, Dewal N, Miller V, Pineyro D, Castro de Moura M, Esteller M, Shen H, Zenklusen JC, Tarnuzzer R, McShane LM, Tricoli JV, Williams PM, Lubensky I, O'Sullivan-Coyne G, Kohn EC, Little R, White J, Malik S, Harris L, Weil C, Chen AP, Karlovich C, Rodgers B, Shankar L, Jacobs P, Nolan T, Muzny DM, Doddapaneni H, Korchina V, Gastier-Foster J, Bowen J, Leraas K, Edmondson EF, Doroshow JH, Conley BA, Ivy SP, Staudt LM. Molecular features of cancers exhibiting exceptional responses to treatment. Cancer Cell 39: 38-53, 2021.

18. Krushkal J, Negi S, Yee LM, Evans JR, Grkovic T, Palmisano A, Fang J, Sankaran H, McShane LM, Zhao Y, O'Keefe BR. Molecular genomic features associated with in vitro response of the NCI-60 cancer cell line panel to natural products. Molecular Oncology, published online November 2020. [doi:10.1002/1878-0261.12849]

19. Kalinsky K, Hong FX, McCourt CK, Sachdev JC, Mitchell EP, Zwiebel JA, Doyle LA, McShane LM, Li S, Gray RJ, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Conley BA, O'Dwyer PJ, Harris LN, Arteaga CL, Chen AP, Flaherty KT. Effect of capivasertib in patients with an AKT1 E17K-mutated tumor NCI-MATCH subprotocol EAY131-Y nonrandomized trial. JAMA Oncology, published online December 30, 2020. [doi:10.1001/jamaoncol.2020.6741]

20. Cleary JM, Wang V, Heist RS, Kopetz ES, Mitchell EP, Zwiebel JA, Kapner KS, Chen HX, Li S, Gray RJ, McShane LM, Rubinstein LV, Patton DR, Meric-Bernstam F, Dillmon MS, Williams PM, Hamilton SR, Conley BA, Aguirre AJ, O'Dwyer PJ, Harris LN, Arteaga CL, Chen AP, Flaherty KT. Differential outcomes in codon 12/13 and codon 61 NRAS-mutated cancers in the phase 2 NCI-Molecular Analysis for Therapy Choice (NCI-MATCH) Trial of binimetinib in patients with NRAS-mutated tumors. Clinical Cancer Research 27: 2996-3004, 2021. [doi: 0.1158/1078-0432.CCR-21-0066]

21. Hendrix S, Mogg R, Wang S-J, Chakravarty A, Romero K, Sauer J-M, McShane L. Perspectives on statistical strategies for the regulatory biomarker qualification process. Biomarkers in Medicine 15(9): 669-684, 2021. [doi: 10.2217/bmm-2020-0523]

22. Zhao Y, Li M-C, Konate MM, McShane LM. TPM, FPKM, or normalized counts? A comparative study of quantification measures for the analysis of RNA-seq data from the NCI Patient-Derived Models Repository. Journal of Translational Medicine 19: 269, 2021. [doi: 10.1186/s12967-021-02936-w]

23. Nielsen TO, Leung SCY, Rimm DL, Dodson A, Acs B, Badve S, Denkert C, Ellis MJ, Fineberg S, Flowers M, Kreipe HH, Laenkholm A-V, Pan H, Penault-Llorca FM, Polley M-Y, Salgado R, Smith IE, Sugie T, Bartlett JMS, McShane LM, Dowsett M, Hayes DF. Assessment of Ki67 in breast cancer: updated recommendations from the International Ki67 in Breast Cancer Working Group. Journal of the National Cancer Institute 113(7): djaa201, 2021.

24. Vega DM, Yee LM, McShane LM, Williams PM, Chen L, Vilimas T, Fabrizio D, Funari V, Newberg J, Bruce LK, Chen S-J, Baden J, Barret C, Beer P, Butler M, Cheng J-H, Conroy J, Cyanam D, Eyring K, Garcia E, Green G, Gregersen VR, Hellmann MD, Keefer LA, Lazar AJ, Li M-C, Macconaill LE, Meier K, Mellert H, Pabla S, Pallavajjalla A, Pestano G, Salgado R, Samara R, Sokol ES, Stafford P, Stenzinger A, Tom W, Valkenburg KC, Weigman V, Xie M, Xie Q, Zehir A, Zhao C, Zhao Y, Stewart MD, Allen J on behalf of the TMB Consortium. Aligning Tumor Mutational Burden (TMB) quantification across diagnostic platforms: Phase 2 of the Friends of Cancer Research TMB Harmonization Project. Annals of Oncology 32(12): 1626-1636, 2021.

25. Mansfield AS, Wei Z, Mehra R, Shaw AT, Lieu CH, Forde PM, Drilon A, Mitchell EP, Wright JJ, Takebe N, Sharon E, Hovelson D, Tomlins S, Zeng J, Poorman K, Malik N, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Crizotinib in patients with tumors harboring ALK or ROS1 rearrangements in the NCI-MATCH trial. npj Precision Oncology 6(13), 2022. [doi: https://www.nature.com/articles/s41698-022-00256-w]

26. Sankaran H, Negi S, McShane LM, Zhao Y, Krushkal J. Pharmacogenomics of in vitro response of the NCI-60 cancer cell line panel to Indian natural products. BMC Cancer 22: 512, 2022. [doi: https://doi.org/10.1186/s12885-022-09580-7]

27. Damodaran S, Zhao F, Deming DA, Mitchell EP, Wright JJ, Doyle LA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Suga JM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase 2 study of copanlisib in patients with tumors with PIK3CA mutations: results from the NCI-MATCH ECOG-ACRIN trial (EAY131) sub-protocol Z1F. Journal of Clinical Oncology, published online February 8, 2022. [doi: https://ascopubs.org/doi/full/10.1200/JCO.21.01648]

28. Krop IE, Jegede OA, Grilley-Olson JE, Lauring JD, Mitchell EP, Zwiebel JA, Doyle LA, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Kono SA, Ford JM, Garcia AA, Sui XD, Siegel RD, Slomovitz BM, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. A phase II study of taselisib in PIK3CA-mutated solid tumors other than breast and squamous lung cancer: results from the NCI-MATCH ECOG-ACRIN trial (EAY131) sub-protocol I. JCO Precision Oncology, published online February 9, 2022. [doi: http://ascopubs.org/doi/full/10.1200/PO.21.00424]

29. Henry NL, Somerfield MR, Dayao Z, Elias A, Kalinsky K, McShane LM, Moy B, Ho Park B, Shanahan KM, Sharma P, Shatsky R, Stringer-Reasor E, Telli M, Turner NC, DeMichele A. Biomarkers for systemic therapy in metastatic breast cancer: ASCO Guideline Update. Journal of Clinical Oncology 40(27): 3205-3221, 2022. [doi: https://doi.org/10.1200/JCO.22.01063]

30. Dobbin KK, McShane LM. Sample size methods for evaluation of predictive biomarkers. Statistics in Medicine 41: 3199-3210, 2022. [doi: https://doi.org/10.1002/sim.9412]

31. Sankaran H, Finnigan S, McShane LM, Seibel NL, Best A. Enrollment of Adolescent and Young Adult patients newly diagnosed with cancer in NCI CTEP-sponsored clinical trials before and after launch of the NCI National Clinical Trials Network. Cancer 128(21): 3843-3849, 2022. [doi: https://doi.org/10.1002/cncr.34402]

32. Bedard PL, Li S, Wisinski KB, Yang ES, Limaye SA, Mitchell EP, Zwiebel JA, Moscow JA, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton DR, Williams PM, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Phase II Study of Afatinib in Patients with Tumors with HER2 Activating Mutations: Results from the NCI-MATCH ECOG-ACRIN Trial (EAY131) sub-protocol EAY131-B. JCO Precision Oncology, in press.

33. Hertz DL, McShane LM, Hayes DF. Defining clinical utility of genetic biomarker tests for toxicity risk: a perspective. Journal of Clinical Oncology 40(16): 1721-1731, 2022. [doi: https://ascopubs.org/doi/full/10.1200/JCO.21.02209]

34. Olaku O, Conley BA, Ivy SP, McShane LM, Staudt LM, King SM, Sansevere M, Kim B, White JD. Survey of lifestyle, past medical history and complementary and alternative medicine use among adult patients participating in the National Cancer Institute's Exceptional Responders Initiative. Translational Oncology 25: 101484, 2022. [doi: https://doi.org/10.1016/j.tranon.2022.101484]

35. Hayes DF, Herbst RS, Myles JL, Topalian SL, Yohe SL, Aronson N, Bellizzi AM, Roy UB, Bradshaw G, Edwards RH, El-Gabry EA, Elvin J, Gajewski TF, Hagenkord J, McShane LM, Oberley M, Philip R, Rimm DL, Rosenbaum JN, Rubin EH, Schlager L, Sherwood SW, Stewart M, Taube JM, Thurin M, Vasalos P, Laser J. Proceedings from the American Society of Clinical Oncology/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit. JCO Precision Oncology 6: e2200454, 2022. [doi: https://doi.org/10.1200/PO.22.00454]

36. Konate MM, Li M-C, McShane LM, Zhao Y. Discovery of pathway-independent protein signatures associated with clinical outcome in human cancer cohorts. Scientific Reports 12: 19283, 2022. [doi: https://doi.org/10.1038/s41598-022-23693-w]

37. Huang EP, O'Connor JPB, McShane LM, Giger ML, Lambin P, Kinahan PE, Siegel EL, Shankar LK. Criteria for the translation of radiomics into clinically useful tests. Nature Reviews Clinical Oncology 20(2): 69-82, 2023. [doi: https://doi.org/10.1038/s41571-022-00707-0]

38. Clark AS, Hong F, Finn RS, DeMichele AM, Mitchell EP, Zwiebel J, Arnaldez FI, Gray RJ, Wang V, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Copur MS, Kasbari SS, Thind R, Conley BA, Artega CL, O'Dwyer PJ, Harris LN, Chen AP, Flaherty KT. Phase II study of palbociclib (PD-0332991) in CCND 1, 2 or 3 amplification: results from the NCI-MATCH ECOG-ACRIN trial (EAY131) sub-protocol Z1B. Clinical Cancer Research 29(8): 1477-1483, 2023. [doi: https://doi.org/0.1158/1078-0432.CCR-22-2150]

39. Meric-Bernstam F, Ford JM, O'Dwyer PJ, Shapiro GI, McShane LM, Freidlin B, O'Cearbhaill RE, George S, Glade-Bender J, Lyman GH, Tricoli JV, Patton D, Hamilton SR, Gray RJ, Hawkins DS, Ramineni B, Flaherty KT, Grivas P, Yap TA, Berlin J, Doroshow JH, Harris LN, Moscow JA, on behalf of ComboMATCH study team. National Cancer Institute Combination Therapy Platform Trial with Molecular Analysis for Therapy Choice (ComboMATCH). Clinical Cancer Research 29(8):1412-1422, 2023. [doi: https://doi.org/10.1158/1078-0432.CCR-22-3334]

40. Rahnenfuhrer J, De Bin R, Benner A, Ambrogi F, Lusa L, Boulesteix A-L, Migliavacca E, Binder H, Michiels S, Sauerbrei W, McShane L for topic group 'High-dimensional data' (TG9) of the STRATOS initiative. Statistical analysis of high-dimensional biomedical data: a gentle introduction to analytical goals, common approaches and challenges. BMC Medicine 21(1): 182, 2023. [doi: https://doi.org/10.1186/s12916-023-02858-y]

41. Wisinski KB, Flamand Y, Wilson M, Luke JL, Tawbi HA, Hong F, Mitchell EP, Zweibel JA, Chen H, Gray RJ, Li S, McShane LM, Rubinstein LV, Patton D, Williams PM, Hamilton SR, Behrens RJ, Pennington KP, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT. Trametinib in patients with NF1, GNAQ or GNA11 mutant tumors: results from the NCI-MATCH ECOG-ACRIN trial (EAY131) subprotocols S1 and S2. JCO Precision Oncology 7: e2200421, 2023. [doi: https://doi.org/10.1200/PO.22.00421]

42. O'Dwyer PJ, Gray RJ, Flaherty KT, Chen AP, Li S, Wang V, McShane LM, Patton D, Tricoli JV, Williams PM, Iafrate AJ, Sklar J, Mitchell EP, Takebe N, Sims DJ, Coffey B, Fu T, Routbort M, Rubinstein LV, Little RF, Arteaga CL, Marinucci D, Hamilton SR, Conley BA, Harris LN, Doroshow JH. The Molecular Analysis for Therapy Choice (NCI-MATCH) Trial: positive findings and perspectives. Nature Medicine 29: 1349-1357, 2023. [doi: https://doi.org/10.1038/s41591-023-02379-4]

43. McShane LM, Rothmann MD, Fleming TR. Finding the (biomarker-defined) subgroup of patients who benefit from a novel therapy: no time for a game of hide and seek. Clinical Trials 20(4): 341-350, 2023. [doi: https://doi.org/10.1177/17407745231169692]

44. Wolff AC, Somerfield MR, Dowsett M, Hammond MEH, Hayes DF, McShane LM, Saphner TJ, Spears PA, Allison KH. Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: ASCO-CAP Guideline Update. Journal of Clinical Oncology 41(22): 3867-3872, 2023. [doi: https://doi.org/10.1200/JCO.22.02864] Co-publication: Archives of Pathology and Laboratory Medicine 147(9): 993-1000, 2023. [doi: https://doi.org/10.5858/arpa.2023-0950-SA]

45. Harris LN, Blanke CD, Erba HP, Ford JM, Gray RJ, LeBlanc ML, Hu-Leiskovan S, Litzow MR, Luger SM, Meric-Bernstam F, O'Dwyer PJ, Othus M, Politi KA, Shephard LE, Allegra CJ, Chen HX, Ivy SP, Korde LA, Little RF, McShane LM, Moscow JA, Patton DC, Thurin M, Yee LM, Doroshow JH. The new NCI precision medicine trials. Clinical Cancer Research 29(23): 4728-4732, 2023. [doi: https://doi.org/10.1158/1078-0432.CCR-23-0917]

Selected Recent Editorials and Commentaries (within last 5 years):

1. McShane LM. Biomarker validation: context and complexities. [Commentary] Journal of Law, Medicine, and Ethics 47(3): 388-392, 2019.

2. Hayes DF, Sauerbrei W, McShane LM. REMARK guidelines for tumour biomarker study reporting: a remarkable history. [Commentary] British Journal of Cancer, published online December 7, 2022. [doi: https://doi.org/10.1038/s41416-022-02046-4]

Selected Recent Books and Book Chapters (within last 5 years):

1. Palmisano A, Krushkal J, Li M-C, Fang J, Sonkin D, Wright G, Yee L, Zhao Y, McShane L. Bioinformatics Tools and Resources for Cancer Immunotherapy Study. In Biomarkers for the Immunotherapy of Cancer, Thurin, Cesano, Marincola (eds.), Springer Protocol, Methods and Protocol Series, Humana Press, New York, NY, 2020.