`Joyce Ann O'Shaughnessy, M.D.
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`August 2014
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`Home Address:
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`Business Address:
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`Education:
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`1978 – 1982
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`1974 – 1978
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`Post-Graduate Training:
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`1985 – 1988
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`1982 – 1985
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`Board Certification:
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`1987
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`1985
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`1982
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`Licensure:
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`4137 Amherst Avenue
`Dallas, Texas 75225
`(214) 361-0916
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`Texas Oncology and US Oncology
`3410 Worth Street, Ste 400
`Dallas, Texas 75246
`(214) 370-1795
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`Yale University Medical School
`M.D., 1982 Thesis Title: Influence of
`Cytotoxic Drugs and L1210 Suspension
`Culture Density on de novo Purine
`Synthesis, 1982
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`Holy Cross College
`B.A. Biology, 1978
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`Fellowship, National Cancer Institute
`Medical Oncology
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`Internship and Residency
`Internal Medicine
`Massachusetts General Hospital
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`Medical Oncology Board Certification
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`Diplomate, American Board of Internal Medicine
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`Diplomate, National Board of Medical Examiners
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`Texas Medical License K3366
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`Curriculum Vitae – Joyce Ann O’Shaughnessy
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`2000 – 2009
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`1997 – Present
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`1995 – 1997
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`1990 – 1995
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`1988 – 1990
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`1987 – 1988
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`1986 – 1987
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`1980 – 1982
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`Chronology of Employment:
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`2010 – Present
`Medical Director, US Oncology Research
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`2000 – Present
`Co-Chair, Breast Cancer Research, US Oncology
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`Director, Cancer Prevention Program
`Baylor - Charles A. Sammons Cancer Center,
`Dallas, TX
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`Medical Oncologist, Texas Oncology
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`Kentuckiana Medical Oncology Associates
`Louisville, KY
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`Senior Investigator
`Medical Breast Cancer Section
`Division of Cancer Treatment
`National Cancer Institute
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`Special Assistant to the Director
`National Cancer Institute
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`Senior Investigator
`Biologics Evaluation Section
`Investigational Drug Branch
`Cancer Therapy Evaluation Program
`National Cancer Institute
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`Post-doctoral Fellow
`Laboratory of Tumor Virus Biology
`National Cancer Institute
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`Graduate Student
`Laboratory of Cancer Pharmacology
`Yale Medical School
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`Instructor in Electron Microscopy
`Worcester Foundation for Experimental Biology
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`Research Assistant
`Worcester Foundation for Experimental Biology
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`Celebrating Women Endowed Chair in Breast Cancer
`Research, Baylor University Medical Center, Dallas, TX
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`Program Committee, ASCO Breast Cancer Symposium
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`Member, ASCO Nominating Committee
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`Member, AACR Task Force on Cancer Prevention
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`1977 – 1978
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`1976 – 1978
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`Appointments:
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`2009 – Present
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`2009 - 2011
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`2004 – 2007
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`2003 – 2007
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`2003 – Present
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`2003- Present
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`2002 – 2007
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`2000
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`1999 – 2002
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`1999 – 2007
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`1998 – 2007
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`1997 – 2005
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`1997 – 1998
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`1997 – 2003
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`Program Director, The School of Breast Oncology
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`Deputy Editor, Clinical Breast Cancer
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`Member, AACR Clinical Research Advisory Committee
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`Co-Chair, AACR Chemoprevention Annual Meeting
`Symposium
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`Co-Chair, AACR-FDA Intraepithelial Neoplasia Task Force
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`Member, Baylor University Institutional Review Board
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`Medical Advisor
`Susan G. Komen Foundation
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`Chair, Clinical Research Steering Committee, US Oncology
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`NCI Breast Cancer Progress Review Group
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`Clinical Associate Professor of Medicine
`UT Southwestern Medical School
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`Member, Scientific Advisory Board
`US Oncology
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`Member, Jewish Hospital Ethics Committee
`Louisville, KY
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`Clinical Associate Professor
`University of Louisville School of Medicine
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`NCI Breast Cancer Fine Needle Aspirate
`Working Group
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`Member, Breast Cancer Prevention and Treatment
`Committees, Alliant Health Care System, Louisville, KY
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`NCI PDQ Protocol External Advisory Board
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`ASCO Breast Cancer Program Committee
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`Member, Source Evaluation Group for RFP's for
`Chemoprevention Clinical Trials, NIH
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`Member, Scientific Advisory Board
`California Breast Cancer Research Program
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`Member, NCI Institutional Review Board
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`Chair, NCI Division of Cancer Treatment's Women's
`Subcommittee on Clinical Research
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`Curriculum Vitae – Joyce Ann O’Shaughnessy
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`1995 – Present
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`1995 – 1996 and 2002
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`1994 – 1995
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`1997 – Present
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`1996 – 1997
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`1996 – 1997
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`1996
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`1995 – 1997
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`1994
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`1993 – 1995
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`1993 – 1995
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`1993 – 1995
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`1992 – 1995
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`1992 – 1993
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`1992
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`1991
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`1991 – 1995
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`1990 – 1995
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`1990 – 1995
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`1990
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`1989 – 1991
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`1989 – 1990
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`1989
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`1988 – 1990
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`Division of Cancer Treatment Representative to NIH Breast
`Cancer Working Group
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`Division of Cancer Treatment Representative to
`NCI Chemoprevention Working Group
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`National Cancer Institute Representative to the
`District of Columbia Cancer Consortium
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`Clinical Tenure granted at NCI, NIH
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`NCI Representative to the AMA Women's Health Campaign
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`Scientific Advisory Board, Cancer Research Foundation of
`America
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`National Cancer Institute Spokesperson on Breast Cancer
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`Medical Advisor to My Image After Breast Cancer
`Advocacy Group
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`Member, American Joint Commission on Cancer,
`Working Group on Prognostic Factors in Breast Cancer
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`Coordinator for the FDA/NCI Subcommittee on
`Cancer Drug Approval Endpoints
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`Coordinator for the FDA/NCI Drug Development
`Working Group
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`Coordinator of the NCI/FDA Medical Oncology
`Fellowship Program
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`Executive Secretary for the National Cancer Institute
`Advisory Board AIDS Subcommittee
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`NCI Liaison to the NIH AIDS Advisory Committee
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`Holy Cross College Board of Trustees
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`Yale Medical School Council
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`Holy Cross College Santae Crucis Award
`(Distinguished Alumni Award)
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`Public Health Service Special Service Award for
`Development of the Consensus Statement on
`Cancer Drug Approval Endpoints
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`Yale Medical School, Francis Parker Award
`(Faculty Choice for Most Promising Clinician)
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`Curriculum Vitae – Joyce Ann O’Shaughnessy
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`1988 – 1990
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`1988 – 1996
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`1980 – 1982
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`Honors:
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`2003
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`1991
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`1982
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`1982
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`1982
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`1978
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`1978
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`1977
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`Professional Societies:
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`Ad Hoc Editorial Reviewer:
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`Yale Medical School, Cum Laude
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`Medical Honor Society, Alpha Omega Alpha
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`Jesuit Honor Society, Alpha Sigma Nu
`Holy Cross College, Summa Cum Laude
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`Holy Cross Fenwick Scholar (Senior Year of
`Independent Research at Holy Cross College)
`Thesis Title: Ultrastructural microscopic analysis of human
`and murine leukemia cells
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`Holy Cross College, Phi Beta Kappa
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`American Association for Cancer Research
`American Society of Clinical Oncology
`American Medical Women's Association
`Women in Cancer Research
`Texas Medical Association
`American College of Physicians
`American Medical Association
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`Breast Cancer Research and Treatment
`Journal of the National Cancer Institute
`Journal of Clinical Oncology
`New England Journal of Medicine
`Oncology
`Cancer
`Breast
`The Oncologist
`Annals of Oncology
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`PUBLICATIONS
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`1. Cadman E, Benz C, Heimer R, and O'Shaughnessy J. The effect of de novo purine
`synthesis inhibitors on 5-fluorouracil metabolism and cytotoxicity. Biochemical
`Pharmacology 30:2469-2472, 1981.
`
`2. Cadman E, Benz C, Heimer R, and O'Shaughnessy J. The modulation of 5-
`fluorouracil metabolism by inhibitors of de novo purine synthesis: in nucleosides
`and cancer therapy. H.M.N. Tattersall and R.M. Fox, eds., Academic Press, 1981.
`
`3. Bolen J, DeSeau V, O'Shaughnessy J, and Amini S. Analysis of middle tumor
`antigen and pp60 c-src interactions in polyoma virus-transformed rat cells.
`Virology 61:3299,1987.
`
`4. O’Shaughnessy J, DeSeau V, Amini S, Rosen N, and Bolen J. Analysis of the c-src
`gene product structure, abundance and protein kinase activity in human
`neuroblastoma and glioblastoma cells. Oncogene Research 2:1, 1987.
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`5. Veillette A, O'Shaughnessy J, Horak I, DeSeau V, and Bolen J. Coordinate
`alteration of pp60 c-src abundance and c-src RNA expression in human
`neuroblastoma variants. Oncogene 4:421, 1989.
`
`6. Lehrer S, O'Shaughnessy J, Song HK, Levine E, Savoretti P, Dalton J, Lipsztein R,
`Kalnicki S, Bloomer WD. Activity of pp60 c-src protein kinase in human breast
`cancer. Mt Sinai J Med. 1989 Mar;56(2):83-5.
`
`7. O'Shaughnessy J, Moscow J, and Cowan K. Breast cancer into the 1990's in:
`Molecular Foundations of Oncology. Samuel Broder, Editor. Williams and
`Wilkins, Baltimore, 1991, pp. 331-338.
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`8. O'Shaughnessy JA, Wittes RE, Burke G, Friedman MA, Johnson JR, Niederhuber
`JE, Rothenberg ML, Woodcock J, Chabner BA, and Temple R. Commentary
`concerning demonstration of safety and efficacy of investigational anticancer
`agents in clinical trials. J Clin Oncol 9:2225-2232, 1991.
`
`9. Read EJ, O'Shaughnessy JA, Yu MY, Cottler-Fox M, Denicoff AM, Cowan KH,
`Gress RE. Flow cytometric quantitation of circulating hematopoietic progenitor
`cells
`in breast cancer patients on chemotherapy. Prog Clin Biol Res.
`1992;377:523-30.
`
`
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`10. Pierce LJ, Lippman M, Ben-Baruch N, Swain S, O’Shaughnessy J, Bader JL,
`Danforth D, Venzon D, Cowan K. The effect of systemic therapy upon local-
`regional control in locally advanced breast cancer. Int J Radiat Oncol Biol Phys.
`1992;23(5):949-60.
`
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`11. Pestalozzi BC, Sotos GA, Choyke PL, Fisherman JS, Cowan KH, O’Shaughnessy
`JA. Cancer. Typhlitis resulting from treatment with taxol and doxorubicin in
`patients with metastatic breast cancer. Cancer 1993 Mar 1;71(5):1797-800.
`
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`12. Ben-Baruch N, O'Shaughnessy JA, Denicoff AM, Goldspiel BR, Cowan KH. Phase
`II study of fazarabine (NSC 281272) in patients with metastatic colon cancer.
`Invest New Drugs 1993 Feb;11(1):71-4.
`
`
`13. Berg SL, Savarese DMF, Balis FM, Denicoff AM, Hillig M, O'Shaughnessy JA,
`Poplack DG and Cowan KH. Pharmacokinetics of piroxantrone in phase I trial of
`piroxantrone and granulocyte colony-stimulating factor. Cancer Res 53: 2587-
`2590, 1993.
`
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`14. O'Shaughnessy JA, Cowan KH, Wilson W, Bryant G, Goldspiel B, Gress R,
`Nienhuis AW, Dunbar C, Sorrentino B, Stewart FM, et al. Pilot study of high dose
`ICE (ifosfamide, carboplatin, etoposide) chemotherapy and autologous bone
`marrow transplant (ABMT), with neoR-transduced bone marrow and peripheral
`blood stem cells in patients with metastatic breast cancer. Hum Gene Ther. 1993
`Jun;4(3):331-54.
`
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`15. Fisherman JS, McCabe M, Noone M, Ognibene FP, Goldspiel B, Venzon DJ,
`Cowan KH, O'Shaughnessy JA. Phase I study of Taxol, doxorubicin, plus
`granulocyte-colony stimulating factor (G-CSF) in patients with metastatic breast
`cancer. J Natl Cancer Inst Monogr. 1993(15):189-94.
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`16. Savarese DM, Denicoff AM, Berg SL, Hillig M, Baker SP, O'Shaughnessy JA,
`Otterson GA, Balis FM, Poplack DG, and Cowan KH. A phase
`I and
`pharmacokinetics study of high dose piroxantrone along with granulocyte colony-
`stimulating factor (G-CSF). J Clin Oncol 11:1795-1803, 1993.
`
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`17. O'Shaughnessy JA, Cowan KH. Dose-intensive therapy for breast cancer. JAMA.
`1993 Nov 3:270(17):2089-92.
`
`
`18. Goldspiel BR, Kohler DR, Koustenis AG, Wilson WW, Tolcher A, and
`O'Shaughnessy JA. Paclitaxel (Taxol) administration using ambulatory infusion
`pumps. J Clin Oncol 11:2287-2288,1993.
`
`
`19. Dunbar CE, Nienhuis AW, Stewart FM, Quesenberry P, O'Shaughnessy J, Cowan
`K, Cottler-Fox M, Leitman S, Goodman S, Sorrentino BP, et al. Amendment to
`clinical research projects. Genetic marking with retroviral vectors to study the
`feasibility of stem cell transfer and the biology of hematopoietic reconstitution
`after autologous transplantation in multiple myeloma, chronic myelogenous
`leukemia or metastatic breast cancer. Hum Gene Ther. 1993 Apr;4(2):205-22.
`
`
`20. Dunbar CE, Bodine DM, Sorrentino B, Donahue R, McDonagh K, Cottler-Fox M,
`O’Shaughnessy J, Cowan K, Carter C, Doren S, et al. Gene transfer into
`hematopoietic cells. Implications for cancer therapy. Ann NY Acad Sci. 1994 May
`31:716:216-24; discussion 224-7.
`
`
`21. Wilson WH, Berg SL, Bryant G, Wittes RE, Bates S, Fojo A, Steinberg SM,
`Goldspiel BR, Herdt J, O'Shaughnessy JA, et al. Paclitaxel in doxorubicin-
`refractory or mitoxantrone-refractory breast cancer: a phase I/II trial of 96-hour
`infusion. J Clin Oncol. 1994 Aug;12(8):1621-9.
`
`
`22. O'Shaughnessy JA, Fisherman JS, Cowan KH. Paclitaxel and doxorubicin
`combinations in the treatment of breast cancer. Semin Oncol. 1994 Oct;21(5
`Suppl 8):19-23.
`
`
`23. Berg SL, Cowan KH, Balis FM, Fisherman JS, Denicoff AM, Hillig M, Poplack DG,
`O’Shaughnessy JA. Pharmacokinetics of taxol and doxorubicin administered
`alone and in combination by continuous 72-hour infusion. J Natl Cancer Inst.
`1994 Jan 19;86(2):143-5.
`
`
`24. O'Shaughnessy JA, Denicoff AM, Danforth D, Pierce L, Dorr FA, Hillig M, Keegan
`P, Frame J, Mrose H, Goldspiel B, Venzon D and Cowan KH. Combination
`chemotherapy with fluorouracil, leucovorin, doxorubicin and cyclophosphamide
`with granulocyte-macrophage colony-stimulating factor for patients with stage III
`and IV breast cancer. Annals of Oncology 5:709-716, 1994.
`
`
`25. O'Shaughnessy JA, Cowan KH, Nienhuis AW, McDonagh KT, Sorrentino DP,
`Dunbar CE, Chiang Y, Wilson W, Goldspiel B, Kohler D, et al. Retroviral-mediated
`transfer of the human multidrug resistance gene (MDR-1) into hematopoietic stem
`cells during autologous transplantation after
`intensive chemotherapy for
`metastatic breast cancer. Hum Gene Ther. 1994 Jul;5(7):891-911.
`
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`26. Theodossiou C, Kroog G, Tolcher AW, Cowan KH and O'Shaughnessy JA.
`Thromboses associated with interleukin-3 administration. Cancer 74:2808-2810,
`1994.
`
`
`27. Dunbar CE, Bodine DM, Sorrentino B, Donahue R, McDonagh K, Cottler-Fox M,
`O’Shaughnessy J, et al. Gene transfer into hematopoietic cells. Implications for
`cancer therapy. Ann NY Acad Sci 31:216-14, 1994.
`
`
`28. O’Shaughnessy JA, Denicoff AM, Venzon DJ, Danforth D, Pierce LJ, Frame JN,
`Bastian A, Ghosh B, Goldspiel B, Miller L, et al. A dose intensity study of FLAC
`(5-fluorouracil, leucovorin, doxorubicin, Cyclophosphamide) chemotherapy and
`Escherichia coli-derived granulocyte-macrophage colony-stimulating factor (GM-
`CSF) in advanced breast cancer patients. Ann Oncol. 1994 Oct;5(8):709-16.
`
`
`29. Theodossiou C, Kroog G, Ettinghausen S, Tolcher A, Cowan K, O’Shaughnessy J.
`Acute arterial thrombosis in a patient with breast cancer after chemotherapy with
`5-fluorouracil, doxorubicin, leucovorin, Cyclophosphamide, and interleukin-3.
`Cancer. 1994 Nov 15:74(10):2808-10.
`
`
`30. O'Shaughnessy JA, Cowan KH. Current status of paclitaxel in the treatment of
`breast cancer. Breast Cancer Res Treat. 1995:33(1):27-37.
`
`
`31. Tolcher AW, Giusti RM, O'Shaughnessy JA, Cowan KH. Arterial thrombosis
`associated with granulocyte-macrophage colony-stimulating factor (GM-CSF) in
`breast cancer patients treated with dose-intensive chemotherapy: a report of two
`cases. Cancer Invest. 1995:13(2):188-92
`
`
`32. Wakefield LM, Letterio JJ, Chen T, Danielpour O, Allison RS, Pai LH, Denicoff A,
`Noone MH, Cowan KH, O'Shaughnessy JA et al. Transforming growth factor beta
`1 circulates in normal human plasma and is unchanged in advanced breast
`cancer. Clin Cancer Res. 1995 Jan;1(1):129-36.
`
`
`33. Wakefield LM, Letterio JJ, Geiser AG, Flanders KC, O’Shaughnessy J, Roberts
`AB, Sporn MD. Transforming growth factor-beta in mammary tumorigenesis:
`promoters or antipromoters? Prog Clin Biol Res 391:133-48, 1995.
`
`
`34. Dunbar CE, Cottler-Fox M, O'Shaughnessy JA, Doren S, Carter C, Berenson R,
`Brown S, Moen RC, Greenblatt J, Stewart FM, et al. Retrovirally-marked CD34-
`enriched peripheral blood and bone marrow cells contribute to long-term
`engraftment after autologous transplantation. Blood. 1995 Jun 1;85(11)3048-57.
`
`
`35. Berg S, Tolcher A, O'Shaughnessy JA, Denicoff A, Noone MH, Ognibene FP,
`Cowan KH, Balis F. Effect of r-verapamil on the pharmacokinetics of paclitaxel in
`women with breast cancer. J Clin Oncol. 1995 Aug;13(8)2039-42.
`
`
`36. Cottler-Fox M, Cipolone K, Yu M, Berenson R, O'Shaughnessy J, Dunbar C.
`Positive selection of CD34+ hematopoietic cells using an immunoafinity column
`results in T cell-depletion equivalent to elutriation. Exper Hematol. 1995 Apr;320-
`322.
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`37. Mulligan T, Carrasquillo J, Chung, Perentesis P, Milenic D, Schlom J, Curt G,
`Goeckeler W, Fordyce W, Chang R, Cowan KH and O'Shaughnessy JA. Phase I
`study of intravenous lutetium-177 labeled CC49 murine monoclonal antibody in
`patients with advanced adenocarcinomas. Clinical Cancer Res 1:1447-1454, 1995.
`
`
`38. O’Shaughnessy JA, Venzon DJ, Gossard M, Noone MH, Denicoff A, Tolcher A,
`Danforth D, Jacobson J, Keegan P, Miller L, Chow C, Goldspiel B, Cowan KH. A
`phase I study of sequential versus concurrent interleukin-3 and granulocyte-
`macrophage colony-stimulating factor in advanced breast cancer patients treated
`with FLAC
`(5-fluorouracil,
`leucovorin, doxorubicin, cyclophosphamide)
`chemotherapy. Blood. 1995 Oct 15;86(8):2913-21.
`
`
`39. O'Shaughnessy JA, Venzon D, Noone MH, Fox M, Yu M, Denicoff AM, Gossard M,
`Miller L and Cowan KH. Phase I study of FLAC combination chemotherapy plus
`interleukin-3 and granulocyte-macrophage colony stimulating factor in patients
`with advanced breast cancer. J Clin Oncol 14:1173-1184, 1996.
`
`
`40. Tolcher A, Cowan KH, Noone MH, Denicoff AM, Kohler DR, Goldspiel BR, Barnes
`CS, McCabe M, Gossard M, Zujewski J, O'Shaughnessy JA. Phase I study of
`Paclitaxel in combination with cyclophosphamide plus granulocyte colony-
`stimulating factor in patients with metastatic breast cancer. J Clin Oncol. 1996
`Jan;14(1):95-102.
`
`
`41. Tolcher AW, Cowan KH, Solomon D, Ognibene F, Goldspiel B, Chang R, Noone
`MH, Denicoff AM, Barnes CS, Gossard MR, Fetsch PA, Berg S, Balis F, Venzon DJ,
`O'Shaughnessy JA. Phase I crossover study of paclitaxel and R-verapamil in
`patients with metastatic breast cancer. J Clin Oncol. 1996 Apr;14(4):1173-84.
`
`
`42. Schwartz GN, Hakim F, Zujewski J, Szabo JM, Cepada R, Riseberg D, Warren MK,
`Mackall CL, Setzer A, Noone MH, Cowan KH, O'Shaughnessy J, Gress RE. Early
`suppressive effects of chemotherapy and cytokine treatment on committed
`versus primitive haemopoietic progenitors in patient bone marrow. British J
`Haematol. 1996 Mar;92(3):537-47.
`
`
`43. Fisherman JS, Cowan KH, Noone M, Denicoff A, Berg S, Poplack D, Balis F,
`Venzon D, McCabe M, Goldspiel B, Chow C, Ognibene F, O'Shaughnessy J. Phase
`I/II study of 72-hour infusional paclitaxel and doxorubicin with granulocyte
`colony–stimulating factor in patients with metastatic breast cancer. J Clin Oncol.
`1996 Mar;14(3):774-82.
`
`
`44. O'Shaughnessy JA, Tolcher A, Riseberg D, Venzon D, Zujewski J, Noone M,
`Gossard M, Danforth D, Jacobson J, Chang V, Goldspiel B, Keegan P, Giusti R.
`and Cowan KH. Prospective, randomized trial of 5-fluorouracil, leucovorin,
`doxorubicin, and cyclophosphamide chemotherapy in combination with the
`interleukin-3/ granulocyte-macrophage colony-stimulating factor (GM-CSF) fusion
`protein (PIXY321) versus GM-CSF in patients with advanced breast cancer. Blood.
`1996 Mar 15;87(6):2205-11.
`
`
`45. Abati A, Abele J, Bacus SS, Bedrosian C, Beerline D, Bibbo M. et al. The uniform
`approach to breast fine needle aspiration biopsy - a synopsis. Acta Cytologica
`40:1120-1126, 1996.
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`46. O'Shaughnessy JA. Chemoprevention of breast cancer. JAMA. 1996 May
`1;275(17)1349-53.
`
`
`47. Warren MK, Zujewski J, Rose WL, Szabo JM, O'Shaughnessy JA, Halverson DC,
`Cowan KH, Gress RE, Schwartz GN. Early suppressive effects of chemotherapy
`on recovery of bone marrow megakaryocyte precursors: possible relationship to
`platelet recovery. Stem Cells. 1996;14 Suppl 1:31-7.
`
`
`48. Emmons RV, Doren S, Zujewski J, Cottler-Fox M, Carter CS, Hines K,
`O'Shaughnessy JA, Leitman SF, Greenblatt JJ, Cowan KH, Dunbar CE. Retroviral
`gene transduction of adult peripheral blood or marrow-derived CD34+ cells for six
`hours without growth factors or on autologous stroma does not improve marking
`efficiency assessed in vivo. Blood. 1997 Jun 1;89(11):4040-6.
`
`
`49. Tolcher A, Riley JZ, O'Shaughnessy JA, Hakim F, Gress R, Weiss R, and Cowan
`KH. Phase I study of topotecan followed sequentially by doxorubicin in patients
`with advanced malignancies. Clinical Cancer Research 3:755-760, 1997.
`
`
`50. O’Shaughnessy JA. Screening mammograms for women ages 40 to 49. Baylor
`University Medical Center Proceedings 11:67–71, 1998.
`
`
`51. Danforth DN Jr., Zujewski J, O’Shaughnessy J, Riseberg D, Steinberg SM,
`McAtee N, Noone M, Chow C, Chaudhry U, Lippman M, Jacobson J, Okunieff P,
`Cowan KH. Selection of local therapy after neoadjuvant chemotherapy in patients
`with stage IIIA,B breast cancer. Ann Surg Oncol. 1998 Mar;5(2)150-8.
`
`
`52. Schwartz GN, Warren MK, Romwell SW, Zujewski J, Halverson DC, Cowan KH,
`Tolcher A, O’Shaughnessy J, Gress RE. Postchemotherapy and cytokine
`pretreated marrow stromal cell layers suppress hematopoiesis from normal donor
`CD34+ cells. Bone Marrow Transplant. 1998 Sep;22(5):457-68.
`
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`53. Cowan KH, Moscow JA, Huang H, Zujewski JA, O’Shaughnessy J, Sorrentino B,
`Hines K, Carter C, Schneider E, Cusack G, Noone M, Dunbar C, Steinberg S,
`Wilson W, Goldspiel B, Reed EJ, Leitman SF, McDonagh K, Chow C, Abati A,
`Chiang Y, Chang YN, Gottesman MM, Pastan
`I, Nienhuis A. Paclitaxel
`chemotherapy following autologous stem-cell transplantation and engraftment of
`hematopoietic cells transduced with a retrovirus containing the multidrug
`resistance complementary DNA(MDR1) in metastatic breast cancer patients. Clin
`Cancer Res. 1999 Jul:5(7):1619-28.
`
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`54. Zujewski J, Pai L, Wakefield L, Guisti R, Dorr FA, Flanders C, Caruso R, Kaiser M,
`Goodman L, Merino M, Gossard M, Noone MA, Denicoff A, Venzon D, Cowan KH,
`O'Shaughnessy JA. Tamoxifen and fenretinide in women with metastatic breast
`cancer. Breast Cancer Treat. 1999 Oct;57(3):277-83.
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`55. O’Shaughnessy J. Salvage Chemotherapy for Metastatic Breast Cancer. Cancer
`Control. 1999 Sep-Oct;6(5 Suppl 2):22-27.
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`56. O’Shaughnessy JA, Demers LM, Jones SE, Arsenau J, Khandelwal P, George T,
`Gersh R, Mauger D, Manni A. Alfa-difluoromethylornithine as treatment for
`metastatic breast cancer. Clin Cancer Res. 1999 Nov;5(11):3438-44.
`
`
`57. O’Shaughnessy JA. Drugs. Oral alkylating agents for breast cancer therapy.
`1999; 58 Suppl 3:1-9.
`
`
`58. Conley B, O’Shaughnessy J, Prindiville S, Lawrence J, Chow C, Jones E, Merino
`MJ, Kaiser-Kupfer MI, Caruso RC, Podgor M, Goldspiel B, Venzon D, Danforth D,
`Wu S, Noone M, Goldstein J, Cowan KH, and Zujewski J. Pilot trial of the safety,
`tolerability and retinoid levels of N-(4-hydroxyphenyl) retinamide in combination
`with tamoxifen in patients at high risk for developing invasive breast cancer. J
`Clin Oncol. 2000 Jan;18(2):257-83.
`
`
`59. Madden RL, Mulhern JG, Benedetto BJ, O’Shea MH, Germain MJ, Braden GL,
`O’Shaughnessy J, Lipkowitz GS. Completely reversed acute rejection is not a
`significant risk factor for the development of chronic rejection in renal allograft
`recipients. Transpl Int. 2000;13(5):344-50.
`
`
`60. O’Shaughnessy JA. Treating breast precancer. Clinical Breast Cancer 1: Suppl 1,
`S74-79, 2000.
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`
`61. O’Shaughnessy J, Nabholtz JM, Aapro M, Buzdar A, and Tonkin K, eds.
`Capecitabine in the treatment of metastatic breast cancer in breast cancer
`therapy: application of evidence to patient management. Martin Dunitz, Ltd,
`London, pp 107-114, 2000.
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`62. Chow CK, Venzon D, Jones EC, Premkumar A, O’Shaughnessy J, Zujewski J.
`Effect of tamoxifen on mammographic density. Cancer Epidemiol Biomarkers
`Prev. 2000 Sep;9(9):917-21.
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`
`63. O’Shaughnessy JA. High dose chemotherapy for breast cancer: taking stock.
`Oncologist. 2000;5(1):14-7.
`
`
`64. Rosenberg SA, Blaese RM, Brenner MK, Deisseroth AB, Ledley FD, Lotze MT,
`Wilson JM, Cornetta K, Economou JS, Freeman SM, Riddell SR, Brenner M,
`Oldfield E, Gansbach Dunbar C, Walker RE, Schuening FG, Roth JA, Crystal RG,
`Welsh MJ, Culver K, Heslop H, Simons J, Wilmott RW, Boucher Siegler HF,
`Barranger JA, Karlsson S, Kohn D, Galpi Raffel C, Hesdorffer C, Ilan J, Cassileth
`P, O’Shaughnessy J, Kun LE, Das TK, Wong-Staal Sobol RE, Haubrich R, Sznol M,
`Rubin J, Sorcher EJ, Rosenblatt J, Walker R, Brigham K, Vogelzang N, Hersh E,
`Curiel T, Evans CH, Freedman R, Liu J, Simons J, Flotte TR, Holt J, Lyerly HK,
`Whitley CB, Isner JM, Eck SL. Human gene marker/therapy clinical protocols.
`Hum Gene Ther 11(6): 919-979, 2000.
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`
`65. Lawrence JA, Adamson PC, Caruso R, Chow C, Kleiner D, Murphy RF, Venzon DJ,
`Shovlin M, Noone M, Merino M, Cowan KH, Kaiser M, O’Shaughnessy J, Zujewski
`J. Phase I clinical trial of alitretinoin and tamoxifen in breast cancer patients:
`toxicity, pharmacokinetic and biomarker evaluations. J Clin Oncol. 2001 May
`15;19(10):2754-63.
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`66. O’Shaughnessy J, Blum J, Moiseyenko V, Jones SE, Miles D, Bell D, Rosso R,
`Osterwalder B, Burger H-U, Laws S, Mauriac L. Randomized, open-label, phase II
`trial of oral capecitabine (Xeloda®) versus a reference arm of intravenous CMF
`(cyclophosphamide, methotrexate and 5-fluorouracil) as first-line therapy for
`advanced/metastatic breast cancer. Annals of Oncology 12:1247-1254, 2001.
`
`
`67. WC, Ljung BM, Veronesi U, Cazzaniga M, Elledge RM, O’Shaughnessy JA, Kuerer
`HM, Hung DT, Khan SA, Phillips RF, Ganz PA, Euhus DM, Esserman LJ, Haffty BG,
`King BL, Kelley MC, Anderson MM, Schmit PJ, Clark RR, Kass FC, Anderson BO,
`Troyan SL, Arias RD, Quiring JN, Love SM, Page DL, King EB. Ductal lavage for
`detection of cellular atypia in women at high risk for breast cancer. Dooley J Natl
`Cancer Inst. 2001 Nov 7;93(21):1624-32.
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`
`68. Dooley WC, Veronesi U, Elledge R, O’Shaughnessy J, Ljung B, Arias R. Detection
`of premalignant and malignant breast cells by ductal lavage. Obstet Gynecol 97
`(4 Suppl 1): S2, 2001.
`
`
`69. O’Shaughnessy JA, Ljung BM, Dooley WC, Chang J, Kuerer HM, Hung DT, Grant
`MD, Khan SA, Phillips RF, Duvall K, Euhus DM, King BL, Anderson BO, Troyan
`SL, Kim J, Veronesi U, Cazzaniga M. Ductal lavage and the clinical management of
`women at high risk for breast carcinoma: a commentary. Cancer. 2002 Jan
`15;94(2):292-8.
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`70. O’Shaughnessy J. Clinical experience of capecitabine in metastatic breast
`cancer. Eur J Cancer. 2002 Feb;38 Suppl 2:10-4.
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`
`71. O’Shaughnessy JA. Metastatic breast cancer: improving survival. The Female
`Patient Supplement: 18-21, February 2002.
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`72. O’Shaughnessy JA, Kelloff GJ, Gordon GB, Dannenberg AJ, Hong WK, Fabian CJ,
`Sigman CC, Bertagnolli MM, Stratton SP, Lam S, Nelson WG, Meyskens FL,
`Alberts DS, Follen M, Rustgi AK, Papadimitrakopoulou V, Scardino PT, Gazdar AF,
`Wattenberg LW, Sporn MB, Sakr WA, Lippman SM, Von Hoff DD. Treatment and
`prevention of intraepithelial neoplasia: an important target for accelerated new
`agent development. Clin Cancer Res 8: 314-46, 2002.
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`
`73. Torosian M, O’Shaughnessy J, Parker LM, Vogel C. Fulvestrant: clinical
`application of an estrogen receptor downregulator. Clin Ther. 2002;24
`SupplA:A31-40.
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`74. Holmes FA, O’Shaughnessy JA, Vukelja S, Jones SE, Shogan J, Savin M, Glaspy
`J, Moore M, Meza L, Wiznitzer I, Neumann TA, Hill LR, Liang BC. Blinded,
`randomized, multicenter study to evaluate single administration pegfilgrastim
`once per cycle versus daily filgrastim as an adjunct to chemotherapy in patients
`with high-risk stage II or stage III/IV breast cancer. J Clin Oncol. 2002 Feb
`1;20(3):727-31.
`
`
`75. O’Shaughnessy JA. The evolving role of capecitabine in breast cancer. Clinical
`Breast Cancer 3: 260-267, 2002.
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`76. O’Shaughnessy JA, Gennari A, Conte P. Pemetrexed: A promising new treatment
`for breast cancer. Semin Oncol. 2002 Apr;29(2 Suppl 5)36-41.
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`77. Morrow M, Vogel V, Ljung BM, O’Shaughnessy JA. Evaluation and management
`of the woman with an abnormal ductal lavage. J Am Coll Surg. 2002 May;
`194(5):648-56.
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`
`78. O’Shaughnessy J, Vukelja SJ, Marsland T, Kimmel G, Ratnam S, Pippen J.
`Phase II trial of gemcitabine plus trastuzumab in metastatic breast cancer
`patients previously treated with chemotherapy: preliminary results. Clin Breast
`Cancer. 2002 May;3 Suppl 1:17-20.
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`
`79. Holmes FA, Jones SE, O’Shaughnessy J, Vukelja S, George T, Savin M, Richards
`D, Glaspy J, Meza L, Cohen G, Dhami M, Budman DR, Hackett J, Brassard M, Yang
`BB, Liang BC. Comparable efficacy and safety profiles of once-per-cycle
`pegfilgrastim and daily injection filgrastim in chemotherapy-induced neutropenia:
`A multicenter dose-finding study in women with breast cancer. Ann Oncol. 2002
`Jun;13(6)903-9.
`
`
`80. O’Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G,
`Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S,
`Leonard R. Superior survival with capecitabine plus docetaxel combination
`therapy in anthracycline-pretreated patients with advanced breast cancer: phase
`III trial results. J Clin Oncol. 2002 June 15:20(12):2812-23.
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`81. O’Shaughnessy J. Potential of capecitabine as first-line therapy for metastatic
`breast cancer: dosing recommendations in patients with diminished renal
`function. Ann Oncol. 2002 Jun;13(6):983.
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`82. Baum M, O’Shaughnessy JA. Management of premenopausal women with early
`breast cancer: is there a role for ovarian suppression? Clin Breast Cancer. 2002
`Oct;3(4):260-7.
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`
`83. O’Shaughnessy J. Capecitabine and docetaxel in advanced breast cancer:
`analyses of a phase III comparative trial. Oncology (Williston Park). 2002
`Oct;16(10 Suppl12):17-22.
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`
`84. O’Shaughnessy JA. Premetrexed: an active new agent for breast cancer.
`Semin Oncol. 2002 Dec;29(6 Suppl 18):57-62.
`
`
`85. Seidman AD, O’Shaughnessy J, Misset JL. Single-agent capecitabine: a reference
`treatment for taxane-pretreated metastatic breast cancer? Oncologist. 2002;7
`Suppl 6:20-8.
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`
`86. O’Shaughnessy JA. Effects of epoetin alfa on cognitive function, mood, asthenia,
`and quality of
`life
`in women with breast cancer undergoing adjuvant
`chemotherapy. Clin Breast Cancer. 2002 Dec;3 Suppl 3:S116-20.
`
`
`87. O’Shaughnessy J, Twelves C, Aapro M. Treatment for anthracycline-pretreated
`metastatic breast cancer. Oncologist. 2002;7 Suppl 6:4-12.
`
`
`88. O’Shaughnessy JA. Breast Cancer Vaccines. Clinical Breast Cancer 3: (Suppl
`4)S133, 2003.
`
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`89. Buzdar A, O’Shaughnessy JA, Booser DJ, Pippen JE Jr., Jones SE, Munster PN,
`Peterson P, Melemed AS, Winer E, Hudis C. Phase II, randomized, double-blind
`study of two dose levels of arzoxifene in patients with locally advanced or
`metastatic breast cancer. J Clin Oncol. 2003 Mar 15;21(6):1007-14.
`
`
`90. O’Shaughnessy J. Gemcitabine and trastuzumab in metastatic breast cancer.
`Semin Oncol. 2003 Apr;30(2 Suppl 3):22-6.
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`91. O’Shaughnessy JA. The evolving role of capecitabine in breast cancer. Clin
`Breast Cancer. 2003 Apr;4 Suppl 1:S20-5.
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`92. O’Shaughnessy JA. Emerging Strategies in the Management of Breast Cancer.
`Clinical Breast Cancer 30 (4 Suppl 1): S8-S9, 2003.
`
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`93. Kelloff GJ