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Items: 1 to 50 of 136

1.

Ado-trastuzumab emtansine (T-DM1) in patients with HER2-amplified tumors excluding breast and gastric/gastroesophageal junction (GEJ) adenocarcinomas: results from the NCI-MATCH trial (EAY131) subprotocol Q.

Jhaveri KL, Wang XV, Makker V, Luoh SW, 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.

Ann Oncol. 2019 Nov;30(11):1821-1830. doi: 10.1093/annonc/mdz291. Epub 2020 Jan 8.

PMID:
31987089
2.

Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update.

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.

J Clin Oncol. 2020 Jan 13:JCO1902309. doi: 10.1200/JCO.19.02309. [Epub ahead of print]

PMID:
31928404
3.

Estrogen and Progesterone Receptor Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update.

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.

Arch Pathol Lab Med. 2020 Jan 13. doi: 10.5858/arpa.2019-0904-SA. [Epub ahead of print]

PMID:
31928354
4.

Trametinib activity in patients with solid tumors and lymphomas harboring BRAF non-V600 mutations or fusions: results from NCI-MATCH (EAY131).

Johnson DB, Zhao F, Noel MS, Riely GJ, Mitchell EP, Wright JJ, Chen HX, Gray RJ, Li S, McShane LM, Rubinstein L, Patton D, Williams M, Hamilton SR, Conley BA, Arteaga CL, Harris LN, O'Dwyer PJ, Chen AP, Flaherty KT.

Clin Cancer Res. 2020 Jan 10. pii: clincanres.3443.2019. doi: 10.1158/1078-0432.CCR-19-3443. [Epub ahead of print]

PMID:
31924734
5.

THE MOLECULAR ANALYSIS FOR THERAPY CHOICE (NCI-MATCH) TRIAL: LESSONS for GENOMIC TRIAL DESIGN.

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 T, 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 CJ, McCaskill-Stevens W, Caimi P, Takebe N, Datta V, Arteaga CL, Abrams JS, Comis R, O'Dwyer PJ, Conley BA; NCI-MATCH Team.

J Natl Cancer Inst. 2020 Jan 10. pii: djz245. doi: 10.1093/jnci/djz245. [Epub ahead of print]

PMID:
31922567
6.

Nivolumab Is Effective in Mismatch Repair-Deficient Noncolorectal Cancers: Results From Arm Z1D-A Subprotocol of the NCI-MATCH (EAY131) Study.

Azad NS, Gray RJ, 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.

J Clin Oncol. 2020 Jan 20;38(3):214-222. doi: 10.1200/JCO.19.00818. Epub 2019 Nov 25.

PMID:
31765263
7.

Bias in retrospective analyses of biomarker effect using data from an outcome-adaptive randomized trial.

Ji L, McShane LM, Krailo M, Sposto R.

Clin Trials. 2019 Dec;16(6):599-609. doi: 10.1177/1740774519875969. Epub 2019 Oct 3.

PMID:
31581815
8.

Rejoinder.

Ji L, McShane LM, Krailo M, Sposto R.

Clin Trials. 2019 Dec;16(6):613-615. doi: 10.1177/1740774519875971. Epub 2019 Oct 3. No abstract available.

PMID:
31581812
9.

Biomarker Validation: Context and Complexities.

McShane LM.

J Law Med Ethics. 2019 Sep;47(3):388-392. doi: 10.1177/1073110519876169.

PMID:
31560629
10.

Ado-trastuzumab emtansine (T-DM1) in patients with HER2-amplified tumors excluding breast and gastric/gastroesophageal junction (GEJ) adenocarcinomas: results from the NCI-MATCH trial (EAY131) subprotocol Q.

Jhaveri KL, Wang XV, Makker V, Luoh SW, 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.

Ann Oncol. 2019 Nov 1;30(11):1821-1830. doi: 10.1093/annonc/mdz291.

PMID:
31504139
11.

Prospects for Minimal Residual Disease as a Surrogate Endpoint in Pediatric Acute Lymphoblastic Leukemia Clinical Trials.

McShane LM, Smith MA.

JNCI Cancer Spectr. 2018 Dec 19;2(4):pky070. doi: 10.1093/jncics/pky070. eCollection 2018 Oct. No abstract available.

12.

Biostatistical and Logistical Considerations in the Development of Basket and Umbrella Clinical Trials.

Yee LM, McShane LM, Freidlin B, Mooney MM, Korn EL.

Cancer J. 2019 Jul/Aug;25(4):254-263. doi: 10.1097/PPO.0000000000000384.

PMID:
31335389
13.

Analytical validation of a standardised scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections: an international multicentre collaboration.

Leung SCY, Nielsen TO, Zabaglo LA, Arun I, Badve SS, Bane AL, Bartlett JMS, Borgquist S, Chang MC, Dodson A, Ehinger A, Fineberg S, Focke CM, Gao D, Gown AM, Gutierrez C, Hugh JC, Kos Z, Laenkholm AV, 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; International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group (BIG-NABCG).

Histopathology. 2019 Aug;75(2):225-235. doi: 10.1111/his.13880. Epub 2019 Jul 8.

PMID:
31017314
14.

In Reply.

Wolff AC, Hammond MEH, Allison KH, Harvey BE, McShane LM, Dowsett M.

Arch Pathol Lab Med. 2019 Apr;143(4):413-414. doi: 10.5858/arpa.2018-0906-LE. Epub 2019 Jan 3. No abstract available.

PMID:
30605367
15.

Reply to C. Murray et al and V. Martin et al.

Wolff AC, Hammond MEH, Allison KH, Harvey BE, McShane LM, Dowsett M.

J Clin Oncol. 2018 Oct 22:JCO1801163. doi: 10.1200/JCO.18.01163. [Epub ahead of print] No abstract available.

PMID:
30346904
16.

Trial Reporting in Immuno-Oncology (TRIO): an American society of clinical oncology-society for immunotherapy of cancer statement.

Tsimberidou AM, Levit LA, Schilsky RL, Averbuch SD, Chen D, Kirkwood JM, McShane LM, Sharon E, Mileham KF, Postow MA.

J Immunother Cancer. 2018 Oct 19;6(1):108. doi: 10.1186/s40425-018-0426-7.

17.

Trial Reporting in Immuno-Oncology (TRIO): An American Society of Clinical Oncology-Society for Immunotherapy of Cancer Statement.

Tsimberidou AM, Levit LA, Schilsky RL, Averbuch SD, Chen D, Kirkwood JM, McShane LM, Sharon E, Mileham KF, Postow MA.

J Clin Oncol. 2019 Jan 1;37(1):72-80. doi: 10.1200/JCO.18.00145. Epub 2018 Oct 19.

18.

An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer.

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.

Mod Pathol. 2019 Jan;32(1):59-69. doi: 10.1038/s41379-018-0109-4. Epub 2018 Aug 24.

19.

Biomarkers in early-phase trials: fundamental issues.

Yee LM, Lively TG, McShane LM.

Bioanalysis. 2018 Jun 1;10(12):933-944. doi: 10.4155/bio-2018-0006. Epub 2018 Jun 20.

20.

HER2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update Summary.

Wolff AC, Hammond MEH, Allison KH, Harvey BE, McShane LM, Dowsett M.

J Oncol Pract. 2018 Jul;14(7):437-441. doi: 10.1200/JOP.18.00206. Epub 2018 Jun 19. No abstract available.

PMID:
29920138
21.

Reporting Recommendations for Tumor Marker Prognostic Studies (REMARK): An Abridged Explanation and Elaboration.

Sauerbrei W, Taube SE, McShane LM, Cavenagh MM, Altman DG.

J Natl Cancer Inst. 2018 Aug 1;110(8):803-811. doi: 10.1093/jnci/djy088. Review.

22.

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.

Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M.

J Clin Oncol. 2018 Jul 10;36(20):2105-2122. doi: 10.1200/JCO.2018.77.8738. Epub 2018 May 30.

PMID:
29846122
23.

Human Epidermal Growth Factor Receptor 2 Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update.

Wolff AC, Hammond MEH, Allison KH, Harvey BE, Mangu PB, Bartlett JMS, Bilous M, Ellis IO, Fitzgibbons P, Hanna W, Jenkins RB, Press MF, Spears PA, Vance GH, Viale G, McShane LM, Dowsett M.

Arch Pathol Lab Med. 2018 Nov;142(11):1364-1382. doi: 10.5858/arpa.2018-0902-SA. Epub 2018 May 30.

PMID:
29846104
24.

Imaging biomarkers exist and they underpin clinical decision-making.

Waterton JC, McShane LM, O'Connor JPB.

Nat Rev Clin Oncol. 2017 Nov;14(11):694. doi: 10.1038/nrclinonc.2017.167. Epub 2017 Oct 17.

PMID:
29039425
25.

Discussion: The role, position, and function of the FDA-The past, present, and future.

Fleming TR, Demets DL, McShane LM.

Biostatistics. 2017 Jul 1;18(3):417-421. doi: 10.1093/biostatistics/kxx023. No abstract available.

26.

Imaging biomarkers exist and they underpin clinical decision-making.

Waterton JC, McShane LM, O'Connor JPB.

Nat Rev Clin Oncol. 2017 Jul;14(7):452. doi: 10.1038/nrclinonc.2017.84. Epub 2017 Jun 13. No abstract available. Erratum in: Nat Rev Clin Oncol. 2017 Oct 17;:.

PMID:
28607515
27.

Myeloma Minimal Residual Disease and Surrogacy.

Little RF, McShane LM, Freidlin B.

JAMA Oncol. 2017 Aug 1;3(8):1136. doi: 10.1001/jamaoncol.2016.5660. No abstract available.

PMID:
28494064
28.

Importance of the distinction between quality of methodology and quality of reporting.

Altman DG, Sauerbrei W, McShane LM.

HPB (Oxford). 2017 Jul;19(7):649-650. doi: 10.1016/j.hpb.2017.02.444. Epub 2017 Apr 21. No abstract available.

29.

Analytical Validation of the Next-Generation Sequencing Assay for a Nationwide Signal-Finding Clinical Trial: Molecular Analysis for Therapy Choice Clinical Trial.

Lih CJ, Harrington RD, Sims DJ, Harper KN, Bouk CH, Datta V, Yau J, Singh RR, Routbort MJ, Luthra R, Patel KP, Mantha GS, Krishnamurthy S, Ronski K, Walther Z, Finberg KE, Canosa S, Robinson H, Raymond A, Le LP, McShane LM, Polley EC, Conley BA, Doroshow JH, Iafrate AJ, Sklar JL, Hamilton SR, Williams PM.

J Mol Diagn. 2017 Mar;19(2):313-327. doi: 10.1016/j.jmoldx.2016.10.007. Epub 2017 Feb 7.

30.

In Pursuit of Greater Reproducibility and Credibility of Early Clinical Biomarker Research.

McShane LM.

Clin Transl Sci. 2017 Mar;10(2):58-60. doi: 10.1111/cts.12449. Epub 2017 Mar 6. No abstract available.

31.

Measure for measure: minimal residual disease in CLL.

Little RF, McShane LM.

Blood. 2016 Dec 15;128(24):2747-2748. No abstract available.

32.

Imaging biomarker roadmap for cancer studies.

O'Connor JP, Aboagye EO, Adams JE, Aerts HJ, Barrington SF, Beer AJ, Boellaard R, Bohndiek SE, Brady M, Brown G, Buckley DL, Chenevert TL, Clarke LP, Collette S, Cook GJ, deSouza NM, Dickson JC, Dive C, Evelhoch JL, Faivre-Finn C, Gallagher FA, Gilbert FJ, Gillies RJ, Goh V, Griffiths JR, Groves AM, Halligan S, Harris AL, Hawkes DJ, Hoekstra OS, Huang EP, Hutton BF, Jackson EF, Jayson GC, Jones A, Koh DM, Lacombe D, Lambin P, Lassau N, Leach MO, Lee TY, Leen EL, Lewis JS, Liu Y, Lythgoe MF, Manoharan P, Maxwell RJ, Miles KA, Morgan B, Morris S, Ng T, Padhani AR, Parker GJ, Partridge M, Pathak AP, Peet AC, Punwani S, Reynolds AR, Robinson SP, Shankar LK, Sharma RA, Soloviev D, Stroobants S, Sullivan DC, Taylor SA, Tofts PS, Tozer GM, van Herk M, Walker-Samuel S, Wason J, Williams KJ, Workman P, Yankeelov TE, Brindle KM, McShane LM, Jackson A, Waterton JC.

Nat Rev Clin Oncol. 2017 Mar;14(3):169-186. doi: 10.1038/nrclinonc.2016.162. Epub 2016 Oct 11. Review.

33.

Issues in developing multivariable molecular signatures for guiding clinical care decisions.

Sachs MC, McShane LM.

J Biopharm Stat. 2016;26(6):1098-1110. Epub 2016 Aug 25.

PMID:
27561083
34.

Reply to D.C. Sgroi et al, T. Sanft et al, M.S. Copur et al, and M.P. Goetz et al.

Harris LN, Ismaila N, McShane LM, Andre F.

J Clin Oncol. 2016 Nov 10;34(32):3946-3948. doi: 10.1200/JCO.2016.68.7020. No abstract available.

PMID:
27551123
35.

Analytical validation of a standardized scoring protocol for Ki67: phase 3 of an international multicenter collaboration.

Leung SCY, Nielsen TO, Zabaglo L, Arun I, Badve SS, Bane AL, Bartlett JMS, Borgquist S, Chang MC, Dodson A, Enos RA, Fineberg S, Focke CM, Gao D, Gown AM, Grabau D, Gutierrez C, Hugh JC, Kos Z, Lænkholm AV, Lin MG, Mastropasqua MG, Moriya T, Nofech-Mozes S, Osborne CK, Penault-Llorca FM, Piper T, Sakatani T, Salgado R, Starczynski J, Viale G, Hayes DF, McShane LM, Dowsett M.

NPJ Breast Cancer. 2016 May 18;2:16014. doi: 10.1038/npjbcancer.2016.14. eCollection 2016.

36.

Glucagon receptor antagonist and GIP agonist combination for diet-induced obese mice.

McShane LM, Irwin N, O'Flynn D, Franklin ZJ, Hewage CM, O'Harte FP.

J Endocrinol. 2016 Jun;229(3):319-30. doi: 10.1530/JOE-15-0463. Epub 2016 Apr 20.

PMID:
27098830
37.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline Summary.

Harris LN, Ismaila N, McShane LM, Hayes DF.

J Oncol Pract. 2016 Apr;12(4):384-9. doi: 10.1200/JOP.2016.010868. Epub 2016 Mar 8. No abstract available.

PMID:
26957642
38.

Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline.

Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM, Hammond EH, Kuderer NM, Liu MC, Mennel RG, Van Poznak C, Bast RC, Hayes DF; American Society of Clinical Oncology.

J Clin Oncol. 2016 Apr 1;34(10):1134-50. doi: 10.1200/JCO.2015.65.2289. Epub 2016 Feb 8. Review.

39.
40.

Refining Prognosis in Lung Cancer: A Report on the Quality and Relevance of Clinical Prognostic Tools.

Mahar AL, Compton C, McShane LM, Halabi S, Asamura H, Rami-Porta R, Groome PA; Molecular Modellers Working Group of American Joint Committee on Cancer.

J Thorac Oncol. 2015 Nov;10(11):1576-89. doi: 10.1097/JTO.0000000000000652.

41.

Metrology Standards for Quantitative Imaging Biomarkers.

Sullivan DC, Obuchowski NA, Kessler LG, Raunig DL, Gatsonis C, Huang EP, Kondratovich M, McShane LM, Reeves AP, Barboriak DP, Guimaraes AR, Wahl RL; RSNA-QIBA Metrology Working Group.

Radiology. 2015 Dec;277(3):813-25. doi: 10.1148/radiol.2015142202. Epub 2015 Aug 12.

42.

Robustness of Next Generation Sequencing on Older Formalin-Fixed Paraffin-Embedded Tissue.

Carrick DM, Mehaffey MG, Sachs MC, Altekruse S, Camalier C, Chuaqui R, Cozen W, Das B, Hernandez BY, Lih CJ, Lynch CF, Makhlouf H, McGregor P, McShane LM, Phillips Rohan J, Walsh WD, Williams PM, Gillanders EM, Mechanic LE, Schully SD.

PLoS One. 2015 Jul 29;10(7):e0127353. doi: 10.1371/journal.pone.0127353. eCollection 2015.

43.

The Fundamental Difficulty With Evaluating the Accuracy of Biomarkers for Guiding Treatment.

Janes H, Pepe MS, McShane LM, Sargent DJ, Heagerty PJ.

J Natl Cancer Inst. 2015 Jun 24;107(8). pii: djv157. doi: 10.1093/jnci/djv157. Print 2015 Aug.

44.

Reply to E.A. Rakha et al.

Wolff AC, Hammond ME, Hicks DG, Allison KH, Bartlett JM, Bilous M, Fitzgibbons P, Hanna W, Jenkins RB, Mangu PB, Paik S, Perez EA, Press MF, Spears PA, Vance GH, Viale G, Dowsett M, McShane LM, Hayes DF.

J Clin Oncol. 2015 Apr 10;33(11):1302-4. doi: 10.1200/JCO.2014.59.7559. Epub 2015 Mar 9. No abstract available.

PMID:
25753441
45.

An international study to increase concordance in Ki67 scoring.

Polley MY, Leung SC, Gao D, Mastropasqua MG, Zabaglo LA, Bartlett JM, McShane LM, Enos RA, Badve SS, Bane AL, Borgquist S, Fineberg S, Lin MG, Gown AM, Grabau D, Gutierrez C, Hugh JC, Moriya T, Ohi Y, Osborne CK, Penault-Llorca FM, Piper T, Porter PL, Sakatani T, Salgado R, Starczynski J, Lænkholm AV, Viale G, Dowsett M, Hayes DF, Nielsen TO.

Mod Pathol. 2015 Jun;28(6):778-86. doi: 10.1038/modpathol.2015.38. Epub 2015 Feb 20.

46.

Leveraging biospecimen resources for discovery or validation of markers for early cancer detection.

Schully SD, Carrick DM, Mechanic LE, Srivastava S, Anderson GL, Baron JA, Berg CD, Cullen J, Diamandis EP, Doria-Rose VP, Goddard KA, Hankinson SE, Kushi LH, Larson EB, McShane LM, Schilsky RL, Shak S, Skates SJ, Urban N, Kramer BS, Khoury MJ, Ransohoff DF.

J Natl Cancer Inst. 2015 Feb 16;107(4). pii: djv012. doi: 10.1093/jnci/djv012. Print 2015 Apr.

47.

Comparison of confidence interval methods for an intra-class correlation coefficient (ICC).

Ionan AC, Polley MY, McShane LM, Dobbin KK.

BMC Med Res Methodol. 2014 Nov 22;14:121. doi: 10.1186/1471-2288-14-121.

48.

Ablation of glucagon receptor signaling by peptide-based glucagon antagonists improves glucose tolerance in high fat fed mice.

McShane LM, Franklin ZJ, O'Harte FP, Irwin N.

Peptides. 2014 Oct;60:95-101. doi: 10.1016/j.peptides.2014.08.002. Epub 2014 Aug 18.

PMID:
25148830
49.

Designing biomarker studies for head and neck cancer.

Kim KY, McShane LM, Conley BA.

Head Neck. 2014 Jul;36(7):1069-75. Review.

50.

Quantitative imaging biomarkers: a review of statistical methods for technical performance assessment.

Raunig DL, McShane LM, Pennello G, Gatsonis C, Carson PL, Voyvodic JT, Wahl RL, Kurland BF, Schwarz AJ, Gönen M, Zahlmann G, Kondratovich MV, O'Donnell K, Petrick N, Cole PE, Garra B, Sullivan DC; QIBA Technical Performance Working Group.

Stat Methods Med Res. 2015 Feb;24(1):27-67. doi: 10.1177/0962280214537344. Epub 2014 Jun 11. Review.

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