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Meredith M. Regan, ScD


Researcher

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Meredith M. Regan, ScD

Researcher

  • Associate Professor of Medicine

Contact Information

  • Office Phone Number617-632-2471
  • Fax617-632-5444

Bio

Dr. Regan is Associate Professor of Medicine, Harvard Medical School. She earned her doctorate in Biostatistics from Harvard School of Public Health. After completing a fellowship at the Biometrics Center at Beth Israel Deaconess Medical Center, she joined the faculty at BIDMC, and in 2003 joined the Dana-Farber Cancer Institute Department of Biostatistics and Computational Biology. Dr. Regan was appointed Group Statistician for the International Breast Cancer Study Group (IBCSG) in 2009 and is a member of the IBCSG Scientific Executive Committee.

Research

Statistical Methods in Cancer Research

Dr. Regan’s research focuses on clinical and translational research in breast and genitourinary cancers. She is Director of the Biostatistics and Computational Biology Core of the DF/HCC Prostate Cancer SPORE, past Core Director of the DF/HCC Kidney Cancer SPORE, and Core Co-Director of the DF/HCC Breast Cancer SPORE. In a new initiative led by Dr. Christopher Sweeney, the Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP) Working Group is conducting an individual patient data meta-analysis to evaluate surrogate endpoints for overall survival in randomized clinical trials for localized prostate cancer treatment. 

Dr. Regan is Group Statistician for the International Breast Cancer Study Group (IBCSG). She is the lead statistician for the international randomized clinical trials SOFT and TEXT evaluating the adjuvant endocrine therapy in premenopausal women with early-stage breast cancer. With IBCSG colleagues, her translational research focuses on features of the disease or patient that inform selection of endocrine therapy for individual patients.

Dr. Regan’s statistical research focuses on long-term analysis of randomized clinical trials with selective crossover, in which patients on the control arm are provided the opportunity to take the experimental treatment after first dissemination of the trial’s results; the work is motivated by the international BIG 1-98 and HERA trials adjuvant early breast cancer trials.

Adjuvant Exemestane With Ovarian Suppression in Premenopausal Breast Cancer: Long-Term Follow-Up of the Combined TEXT and SOFT Trials. J Clin Oncol. 2023 Mar 01; 41(7):1376-1382.
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Adjuvant Endocrine Therapy in Premenopausal Breast Cancer: 12-Year Results From SOFT. J Clin Oncol. 2023 Mar 01; 41(7):1370-1375.
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Incidence, characteristics, and management of central nervous system metastases in patients with inflammatory breast cancer. Cancer. 2022 12 01; 128(23):4085-4094.
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HER2-low inflammatory breast cancer: Clinicopathologic features and prognostic implications. Eur J Cancer. 2022 10; 174:277-286.
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Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). J Immunother Cancer. 2022 09; 10(9).
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Early on-treatment transcriptional profiling as a tool for improving pathological response prediction in HER2-positive inflammatory breast cancer. Ther Adv Med Oncol. 2022; 14:17588359221113269.
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A phase III trial of alpelisib + trastuzumab ± fulvestrant versus trastuzumab + chemotherapy in HER2+ PIK3CA-mutated breast cancer. Future Oncol. 2022 06; 18(19):2339-2349.
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Surrogacy Beyond Prognosis: The Importance of "Trial-Level" Surrogacy. Oncologist. 2022 04 05; 27(4):266-271.
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Serum thymidine kinase activity in patients with hormone receptor-positive and HER2-negative metastatic breast cancer treated with palbociclib and fulvestrant. Eur J Cancer. 2022 03; 164:39-51.
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Sensitivity of treatment-free survival to subgroup analyses in patients with advanced melanoma treated with immune checkpoint inhibitors. Melanoma Res. 2022 02 01; 32(1):35-44.
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Effect of dose reductions on clinical outcomes, or of outcomes on dose reductions? Breast. 2022 Apr; 62:179.
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Accelerating progress to innovation for patients: Trial design and risk stratification. Breast. 2022 Mar; 62 Suppl 1:S80-S83.
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Treatment-free Survival after Immune Checkpoint Inhibitor Therapy versus Targeted Therapy for Advanced Renal Cell Carcinoma: 42-Month Results of the CheckMate 214 Trial. Clin Cancer Res. 2021 12 15; 27(24):6687-6695.
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Treatment-free survival over extended follow-up of patients with advanced melanoma treated with immune checkpoint inhibitors in CheckMate 067. J Immunother Cancer. 2021 11; 9(11).
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Prepectoral versus subpectoral implant-based breast reconstruction after skin-sparing mastectomy or nipple-sparing mastectomy (OPBC-02/ PREPEC): a pragmatic, multicentre, randomised, superiority trial. BMJ Open. 2021 09 02; 11(9):e045239.
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Dermal Lymphatic Invasion, Survival, and Time to Recurrence or Progression in Inflammatory Breast Cancer. Am J Clin Oncol. 2021 09 01; 44(9):449-455.
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Prospective Multicenter Comparison of Open and Robotic Radical Prostatectomy: The PROST-QA/RP2 Consortium. J Urol. 2022 01; 207(1):127-136.
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A Grant-Based Experiment to Train Clinical Investigators: The AACR/ASCO Methods in Clinical Cancer Research Workshop. Clin Cancer Res. 2021 10 15; 27(20):5472-5481.
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Circulating tumor cell number and endocrine therapy index in ER positive metastatic breast cancer patients. NPJ Breast Cancer. 2021 Jun 11; 7(1):77.
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Phase I study of JAK1/2 inhibitor ruxolitinib with weekly paclitaxel for the treatment of HER2-negative metastatic breast cancer. Cancer Chemother Pharmacol. 2021 05; 87(5):673-679.
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Neoadjuvant Chemotherapy, Endocrine Therapy, and Targeted Therapy for Breast Cancer: ASCO Guideline. J Clin Oncol. 2021 05 01; 39(13):1485-1505.
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Clinical behavior of recurrent hormone receptor-positive breast cancer by adjuvant endocrine therapy within the Breast International Group 1-98 clinical trial. Cancer. 2021 03 01; 127(5):700-708.
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Cumulative incidence of cardiovascular events under tamoxifen and letrozole alone and in sequence: a report from the BIG 1-98 trial. Breast Cancer Res Treat. 2021 Feb; 185(3):697-707.
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Genomic Aberrations and Late Recurrence in Postmenopausal Women with Hormone Receptor-positive Early Breast Cancer: Results from the SOLE Trial. Clin Cancer Res. 2021 01 15; 27(2):504-512.
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Road Map to Safe and Well-Designed De-escalation Trials of Systemic Adjuvant Therapy for Solid Tumors. J Clin Oncol. 2020 12 01; 38(34):4120-4129.
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Dual Blockade of c-MET and the Androgen Receptor in Metastatic Castration-resistant Prostate Cancer: A Phase I Study of Concurrent Enzalutamide and Crizotinib. Clin Cancer Res. 2020 12 01; 26(23):6122-6131.
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DNA derived from archival tumor specimens can be used for germline pharmacogenetic analyses. Pharmacogenomics. 2020 08; 21(13):899-902.
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Identifying oncogenic drivers associated with increased risk of late distant recurrence in postmenopausal, estrogen receptor-positive, HER2-negative early breast cancer: results from the BIG 1-98 study. Ann Oncol. 2020 10; 31(10):1359-1365.
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Event-Free Survival, a Prostate-Specific Antigen-Based Composite End Point, Is Not a Surrogate for Overall Survival in Men With Localized Prostate Cancer Treated With Radiation. J Clin Oncol. 2020 09 10; 38(26):3032-3041.
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Estimation of historical control rate for a single arm de-escalation study - Application to the POSITIVE trial. Breast. 2020 Oct; 53:1-7.
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Treatment-induced symptoms, depression and age as predictors of sexual problems in premenopausal women with early breast cancer receiving adjuvant endocrine therapy. Breast Cancer Res Treat. 2020 Jun; 181(2):347-359.
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Correction: Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2020 Mar; 122(7):1119.
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DNA methylation markers predict recurrence-free interval in triple-negative breast cancer. NPJ Breast Cancer. 2020 Jan 31; 6(1):3.
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DNA methylation markers predict recurrence-free interval in triple-negative breast cancer. NPJ Breast Cancer. 2020; 6:3.
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Clinical and economic outcomes of treatment sequences for intermediate- to poor-risk advanced renal cell carcinoma. Immunotherapy. 2020 01; 12(1):37-51.
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Estrogen and Progesterone Receptor Testing in Breast Cancer: ASCO/CAP Guideline Update. J Clin Oncol. 2020 04 20; 38(12):1346-1366.
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Estrogen and Progesterone Receptor Testing in Breast Cancer: American Society of Clinical Oncology/College of American Pathologists Guideline Update. Arch Pathol Lab Med. 2020 05; 144(5):545-563.
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Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019 Oct; 30(10):1541-1557.
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Prognosis of medullary breast cancer: analysis of 13 International Breast Cancer Study Group (IBCSG) trials. Ann Oncol. 2012 Nov; 23(11):2843-2851.
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Prognostic and predictive role of ESR1 status for postmenopausal patients with endocrine-responsive early breast cancer in the Danish cohort of the BIG 1-98 trial. Ann Oncol. 2012 May; 23(5):1138-1144.
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Corrections to "De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017". Ann Oncol. 2019 Jul; 30(7):1181.
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Risk stratification according to stage and pathology. Breast. 2019 Nov; 48 Suppl 1:S23-S25.
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Absolute Improvements in Freedom From Distant Recurrence to Tailor Adjuvant Endocrine Therapies for Premenopausal Women: Results From TEXT and SOFT. J Clin Oncol. 2020 04 20; 38(12):1293-1303.
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Estimating the benefits of therapy for early-stage breast cancer: the St. Gallen International Consensus Guidelines for the primary therapy of early breast cancer 2019. Ann Oncol. 2019 10 01; 30(10):1541-1557.
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Treatment-Free Survival: A Novel Outcome Measure of the Effects of Immune Checkpoint Inhibition-A Pooled Analysis of Patients With Advanced Melanoma. J Clin Oncol. 2019 12 10; 37(35):3350-3358.
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Patterns of breast reconstruction in patients diagnosed with inflammatory breast cancer: The Dana-Farber Cancer Institute's Inflammatory Breast Cancer Program experience. Breast J. 2020 03; 26(3):384-390.
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Independent Validation of EarlyR Gene Signature in BIG 1-98: A Randomized, Double-Blind, Phase III Trial Comparing Letrozole and Tamoxifen as Adjuvant Endocrine Therapy for Postmenopausal Women With Hormone Receptor-Positive, Early Breast Cancer. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz051.
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Toronto Workshop on Late Recurrence in Estrogen Receptor-Positive Breast Cancer: Part 1: Late Recurrence: Current Understanding, Clinical Considerations. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz050.
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Toronto Workshop on Late Recurrence in Estrogen Receptor-Positive Breast Cancer: Part 2: Approaches to Predict and Identify Late Recurrence, Research Directions. JNCI Cancer Spectr. 2019 Dec; 3(4):pkz049.
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De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2019 07 01; 30(7):1181.
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Clinical and analytical validation of Ki-67 in 9069 patients from IBCSG VIII?+?IX, BIG1-98 and GeparTrio trial: systematic modulation of interobserver variance in a comprehensive in silico ring trial. Breast Cancer Res Treat. 2019 Aug; 176(3):557-568.
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Reply to K.-D. Yu et al. J Clin Oncol. 2019 06 10; 37(17):1516-1517.
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Quality of life under extended continuous versus intermittent adjuvant letrozole in lymph node-positive, early breast cancer patients: the SOLE randomised phase 3 trial. Br J Cancer. 2019 05; 120(10):959-967.
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Prevalence of germline variants in inflammatory breast cancer. Cancer. 2019 07 01; 125(13):2194-2202.
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Adjuvant Systemic Treatment of Premenopausal Women With Hormone Receptor-Positive Early Breast Cancer: Lights and Shadows. J Clin Oncol. 2019 04 10; 37(11):862-866.
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Prognostic and predictive value of androgen receptor expression in postmenopausal women with estrogen receptor-positive breast cancer: results from the Breast International Group Trial 1-98. Breast Cancer Res. 2019 02 22; 21(1):30.
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Expanded Prostate Cancer Index Composite-26 (EPIC-26) Online: Validation of an Internet-Based Instrument for Assessment of Health-Related Quality of Life After Treatment for Localized Prostate Cancer. Urology. 2019 05; 127:53-60.
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Pembrolizumab plus trastuzumab in trastuzumab-resistant, advanced, HER2-positive breast cancer (PANACEA): a single-arm, multicentre, phase 1b-2 trial. Lancet Oncol. 2019 03; 20(3):371-382.
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A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses. JNCI Cancer Spectr. 2019 Mar; 3(1):pkz002.
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Neoadjuvant Degarelix Versus Triptorelin in Premenopausal Patients Who Receive Letrozole for Locally Advanced Endocrine-Responsive Breast Cancer: A Randomized Phase II Trial. J Clin Oncol. 2019 02 10; 37(5):386-395.
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Clinical and economic outcomes associated with treatment sequences in patients with BRAF-mutant advanced melanoma. Immunotherapy. 2019 03; 11(4):283-295.
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Adjuvant Letrozole and Tamoxifen Alone or Sequentially for Postmenopausal Women With Hormone Receptor-Positive Breast Cancer: Long-Term Follow-Up of the BIG 1-98 Trial. J Clin Oncol. 2019 01 10; 37(2):105-114.
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Association of Somatic Driver Alterations With Prognosis in Postmenopausal, Hormone Receptor-Positive, HER2-Negative Early Breast Cancer: A Secondary Analysis of the BIG 1-98 Randomized Clinical Trial. JAMA Oncol. 2018 10 01; 4(10):1335-1343.
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De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2018 Oct 01; 29(10):2153.
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National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer. J Clin Oncol. 2018 Nov 10; 36(32):3259-3268.
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Quality-adjusted survival of nivolumab plus ipilimumab or nivolumab alone versus ipilimumab alone among treatment-naive patients with advanced melanoma: a quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis. Qual Life Res. 2019 Jan; 28(1):109-119.
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Axillary dissection versus no axillary dissection in patients with breast cancer and sentinel-node micrometastases (IBCSG 23-01): 10-year follow-up of a randomised, controlled phase 3 trial. Lancet Oncol. 2018 10; 19(10):1385-1393.
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Sequential treatment approaches in  the management of BRAF wild-type advanced melanoma: a cost-effectiveness analysis. Immunotherapy. 2018 10; 10(14):1241-1252.
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Prognostic Value of the Progesterone Receptor by Subtype in Patients with Estrogen Receptor-Positive, HER-2 Negative Breast Cancer. Oncologist. 2019 02; 24(2):165-171.
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Tailoring Adjuvant Endocrine Therapy for Premenopausal Breast Cancer. N Engl J Med. 2018 Jul 12; 379(2):122-137.
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Apatorsen plus docetaxel versus docetaxel alone in platinum-resistant metastatic urothelial carcinoma (Borealis-2). Br J Cancer. 2018 05; 118(11):1434-1441.
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Integration of Clinical Variables for the Prediction of Late Distant Recurrence in Patients With Estrogen Receptor-Positive Breast Cancer Treated With 5 Years of Endocrine Therapy: CTS5. J Clin Oncol. 2018 07 01; 36(19):1941-1948.
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Predicting erectile function following external beam radiation therapy or brachytherapy for prostate cancer using EPIC-CP. Pract Radiat Oncol. 2018 Nov - Dec; 8(6):445-451.
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Mutational analysis of triple-negative breast cancers within the International Breast Cancer Study Group (IBCSG) Trial 22-00. Breast Cancer Res Treat. 2018 Jul; 170(2):351-360.
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A randomized phase II study evaluating different maintenance schedules of nab-paclitaxel in the first-line treatment of metastatic breast cancer: final results of the IBCSG 42-12/BIG 2-12 SNAP trial. Ann Oncol. 2018 03 01; 29(3):661-668.
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Efficacy of Chemotherapy for ER-Negative and ER-Positive Isolated Locoregional Recurrence of Breast Cancer: Final Analysis of the CALOR Trial. J Clin Oncol. 2018 04 10; 36(11):1073-1079.
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Reply to 'The St Gallen International Expert Consensus on the Primary Therapy of Early Breast Cancer 2017: the point of view of an International Panel of Experts in Radiation Oncology' by Kirova et al. Ann Oncol. 2018 01 01; 29(1):281-282.
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Reply to Y. Zhu et al. J Clin Oncol. 2018 02 10; 36(5):515-516.
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Extended adjuvant intermittent letrozole versus continuous letrozole in postmenopausal women with breast cancer (SOLE): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2018 01; 19(1):127-138.
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High Expression of FGD3, a Putative Regulator of Cell Morphology and Motility, Is Prognostic of Favorable Outcome in Multiple Cancers. JCO Precis Oncol. 2017; 1.
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Assessing health-related quality of life in patients with breast cancer: a reply to Maratia et al. Qual Life Res. 2018 01; 27(1):149-152.
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Concurrent and sequential initiation of ovarian function suppression with chemotherapy in premenopausal women with endocrine-responsive early breast cancer: an exploratory analysis of TEXT and SOFT. Ann Oncol. 2017 Sep 01; 28(9):2225-2232.
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Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer. J Clin Oncol. 2017 09 20; 35(27):3097-3104.
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De-escalating and escalating treatments for early-stage breast cancer: the St. Gallen International Expert Consensus Conference on the Primary Therapy of Early Breast Cancer 2017. Ann Oncol. 2017 08 01; 28(8):1700-1712.
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Association Between Combined TMPRSS2:ERG and PCA3 RNA Urinary Testing and Detection of Aggressive Prostate Cancer. JAMA Oncol. 2017 Aug 01; 3(8):1085-1093.
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Trial designs and results supporting treatment de-escalation and escalation. Breast. 2017 Aug; 34 Suppl 1:S10-S12.
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Treatment Efficacy, Adherence, and Quality of Life Among Women Younger Than 35 Years in the International Breast Cancer Study Group TEXT and SOFT Adjuvant Endocrine Therapy Trials. J Clin Oncol. 2017 Sep 20; 35(27):3113-3122.
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The Impact of Residual Disease After Preoperative Systemic Therapy on Clinical Outcomes in Patients with Inflammatory Breast Cancer. Ann Surg Oncol. 2017 Sep; 24(9):2563-2569.
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HER2 status predicts for upfront AI benefit: A TRANS-AIOG meta-analysis of 12,129 patients from ATAC, BIG 1-98 and TEAM with centrally determined HER2. Eur J Cancer. 2017 07; 79:129-138.
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External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life. Int J Radiat Oncol Biol Phys. 2017 06 01; 98(2):304-317.
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Cholesterol, Cholesterol-Lowering Medication Use, and Breast Cancer Outcome in the BIG 1-98 Study. J Clin Oncol. 2017 Apr 10; 35(11):1179-1188.
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Reply to L. Moscetti. J Clin Oncol. 2017 05 10; 35(14):1628.
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Clinical Trial Design and Endpoints for Stage IV Melanoma in the Modern Era. Cancer J. 2017 Jan/Feb; 23(1):63-67.
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Cytochrome P-450 2D6 (CYP2D6) Genotype and Breast Cancer Recurrence in Tamoxifen-Treated Patients: Evaluating the Importance of Loss of Heterozygosity. Am J Epidemiol. 2017 01 15; 185(2):75-85.
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Impact of CYP19A1 and ESR1 variants on early-onset side effects during combined endocrine therapy in the TEXT trial. Breast Cancer Res. 2016 11 08; 18(1):110.
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Reply to F. Tomao et al. J Clin Oncol. 2016 12; 34(34):4189-4190.
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Poor Prognosis After Second Locoregional Recurrences in the CALOR Trial. Ann Surg Oncol. 2017 Feb; 24(2):398-406.
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Relief of Urinary Symptom Burden after Primary Prostate Cancer Treatment. J Urol. 2017 02; 197(2):376-384.
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Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding. Int J Radiat Oncol Biol Phys. 2016 11 15; 96(4):770-777.
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Tumor-infiltrating lymphocytes (TILs) are a powerful prognostic marker in patients with triple-negative breast cancer enrolled in the IBCSG phase III randomized clinical trial 22-00. Breast Cancer Res Treat. 2016 07; 158(2):323-31.
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Low-Dose Oral Cyclophosphamide and Methotrexate Maintenance for Hormone Receptor-Negative Early Breast Cancer: International Breast Cancer Study Group Trial 22-00. J Clin Oncol. 2016 10 01; 34(28):3400-8.
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Are SOFT and TEXT results practice changing and how? Breast. 2016 Jun; 27:122-5.
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Adjuvant ovarian function suppression and cognitive function in women with breast cancer. Br J Cancer. 2016 04 26; 114(9):956-64.
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Absolute Benefit of Adjuvant Endocrine Therapies for Premenopausal Women With Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Early Breast Cancer: TEXT and SOFT Trials. J Clin Oncol. 2016 07 01; 34(19):2221-31.
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Adjuvant Tamoxifen Plus Ovarian Function Suppression Versus Tamoxifen Alone in Premenopausal Women With Early Breast Cancer: Patient-Reported Outcomes in the Suppression of Ovarian Function Trial. J Clin Oncol. 2016 05 10; 34(14):1601-10.
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The Genomic Grade Assay Compared With Ki67 to Determine Risk of Distant Breast Cancer Recurrence. JAMA Oncol. 2016 Feb; 2(2):217-24.
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Twelve-Month Estrogen Levels in Premenopausal Women With Hormone Receptor-Positive Breast Cancer Receiving Adjuvant Triptorelin Plus Exemestane or Tamoxifen in the Suppression of Ovarian Function Trial (SOFT): The SOFT-EST Substudy. J Clin Oncol. 2016 05 10; 34(14):1584-93.
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Duration of Androgen Deprivation Therapy for High-Risk Prostate Cancer: Application of Randomized Trial Data in a Tertiary Referral Cancer Center. Clin Genitourin Cancer. 2016 08; 14(4):e299-305.
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ESR1 and ESR2 polymorphisms in the BIG 1-98 trial comparing adjuvant letrozole versus tamoxifen or their sequence for early breast cancer. Breast Cancer Res Treat. 2015 Dec; 154(3):543-55.
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Predictive value and clinical utility of centrally assessed ER, PgR, and Ki-67 to select adjuvant endocrine therapy for premenopausal women with hormone receptor-positive, HER2-negative early breast cancer: TEXT and SOFT trials. Breast Cancer Res Treat. 2015 Nov; 154(2):275-86.
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Mental health research: developing priorities and promoting its utilization to inform policies and services. East Mediterr Health J. 2015 Sep 28; 21(7):517-21.
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The Development of Intermediate Clinical Endpoints in Cancer of the Prostate (ICECaP). J Natl Cancer Inst. 2015 Dec; 107(12):djv261.
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Predicting benefit of endocrine therapy for early breast cancer. Breast. 2015 Nov; 24 Suppl 2:S129-31.
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Genotyping concordance in DNA extracted from formalin-fixed paraffin embedded (FFPE) breast tumor and whole blood for pharmacogenetic analyses. Mol Oncol. 2015 Nov; 9(9):1868-76.
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Relative Effectiveness of Letrozole Compared With Tamoxifen for Patients With Lobular Carcinoma in the BIG 1-98 Trial. J Clin Oncol. 2015 Sep 01; 33(25):2772-9.
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Patient-reported outcomes with adjuvant exemestane versus tamoxifen in premenopausal women with early breast cancer undergoing ovarian suppression (TEXT and SOFT): a combined analysis of two phase 3 randomised trials. Lancet Oncol. 2015 Jul; 16(7):848-58.
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Improved adjuvant endocrine therapy for premenopausal women with endocrine responsive disease. Ecancermedicalscience. 2015; 9:544.
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Cell kinetic studies fail to identify sequentially proliferating progenitors as the major source of epithelial renewal in the adult murine prostate. PLoS One. 2015; 10(5):e0128489.
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CYP19A1 polymorphisms and clinical outcomes in postmenopausal women with hormone receptor-positive breast cancer in the BIG 1-98 trial. Breast Cancer Res Treat. 2015 Jun; 151(2):373-84.
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Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 04 23; 372(17):1673.
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Inflammatory breast cancer and development of brain metastases: risk factors and outcomes. Breast Cancer Res Treat. 2015 May; 151(1):225-32.
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Re: Loss of heterozygosity at the CYP2D6 locus in breast cancer: implications for germline pharmacogenetic studies. J Natl Cancer Inst. 2015 May; 107(5).
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Inflammatory Breast Cancer: Patterns of Failure and the Case for Aggressive Locoregional Management. Ann Surg Oncol. 2015 Aug; 22(8):2483-91.
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Adjuvant ovarian suppression in premenopausal breast cancer. N Engl J Med. 2015 Jan 29; 372(5):436-46.
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The high-dose aldesleukin "select" trial: a trial to prospectively validate predictive models of response to treatment in patients with metastatic renal cell carcinoma. Clin Cancer Res. 2015 Feb 01; 21(3):561-8.
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Exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 10 02; 371(14):1358-9.
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Randomized comparison of adjuvant aromatase inhibitor (AI) exemestane (E) plus ovarian function suppression (OFS) vs tamoxifen (T) plus OFS in premenopausal women with hormone receptor-positive (HR+) early breast cancer (BC): Joint analysis of IBCSG TEXT and SOFT trials. J Clin Oncol. 2014 Jun 20; 32(18_suppl):LBA1.
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Adjuvant exemestane with ovarian suppression in premenopausal breast cancer. N Engl J Med. 2014 Jul 10; 371(2):107-18.
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Cardiovascular risk factors in women with primary Sjögren's syndrome: United Kingdom primary Sjögren's syndrome registry results. Arthritis Care Res (Hoboken). 2014 May; 66(5):757-64.
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Response. J Natl Cancer Inst. 2014 Apr 03; 106(5).
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Comparative effectiveness study of patient-reported outcomes after proton therapy or intensity-modulated radiotherapy for prostate cancer. Cancer. 2014 Apr 01; 120(7):1076-82.
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A phase II study of bevacizumab and high-dose interleukin-2 in patients with metastatic renal cell carcinoma: a Cytokine Working Group (CWG) study. J Immunother. 2013 Nov-Dec; 36(9):490-5.
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Adjuvant treatment of premenopausal women with endocrine-responsive early breast cancer: design of the TEXT and SOFT trials. Breast. 2013 Dec; 22(6):1094-100.
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TOP2A protein by quantitative immunofluorescence as a predictor of response to epirubicin in the neoadjuvant treatment of breast cancer. Future Oncol. 2013 Oct; 9(10):1477-87.
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Measuring and predicting prostate cancer related quality of life changes using EPIC for clinical practice. J Urol. 2014 Mar; 191(3):638-45.
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Concordance between CYP2D6 genotypes obtained from tumor-derived and germline DNA. J Natl Cancer Inst. 2013 Sep 04; 105(17):1332-4.
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Challenges of guarantee-time bias. J Clin Oncol. 2013 Aug 10; 31(23):2963-9.
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Dramatic and prolonged PSA response after retreatment with a PSA vaccine. Clin Genitourin Cancer. 2013 Sep; 11(3):362-4.
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CYP2D6 genotype should not be used for deciding about tamoxifen therapy in postmenopausal breast cancer. J Clin Oncol. 2013 Jul 20; 31(21):2753-5.
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SU-E-T-367: Dosimetric Comparison of VMAT and S&S IMRT Regarding the Dose Delivered to the Skin in Different Cancer Sites. Med Phys. 2013 Jun; 40(6Part16):289.
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Digital quantification of gene expression in sequential breast cancer biopsies reveals activation of an immune response. PLoS One. 2013; 8(5):e64225.
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Axillary dissection versus no axillary dissection in patients with sentinel-node micrometastases (IBCSG 23-01): a phase 3 randomised controlled trial. Lancet Oncol. 2013 Apr; 14(4):297-305.
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Adjuvant pegylated liposomal doxorubicin for older women with endocrine nonresponsive breast cancer who are NOT suitable for a "standard chemotherapy regimen": the CASA randomized trial. Breast. 2013 Apr; 22(2):130-137.
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Relationship of ERCC1 genotype variant with mRNA expression and ERCC1 protein levels in advanced urothelial carcinoma (UC). J Clin Oncol. 2013 Feb 20; 31(6_suppl):260.
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Lupus nephritis: a 15-year multi-centre experience in the UK. Lupus. 2013 Mar; 22(3):328-32.
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Prostate Specific Antigen Working Group guidelines on prostate specific antigen doubling time. J Urol. 2008 Jun; 179(6):2181-5; discussion 2185-6.
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Minimal effect of a low-fat/high soy diet for asymptomatic, hormonally naive prostate cancer patients. Clin Cancer Res. 2003 Aug 15; 9(9):3282-7.
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Increased prevalence of CFTR mutations and variants and decreased chloride secretion in primary sclerosing cholangitis. Hum Genet. 2003 Aug; 113(3):286-92.
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Physician attitudes toward cytotoxic chemotherapy use in patients with advanced prostate carcinoma. Cancer. 2003 May 01; 97(9):2171-9.
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Daily methionine requirements of healthy Indian men, measured by a 24-h indicator amino acid oxidation and balance technique. Am J Clin Nutr. 2003 May; 77(5):1198-205.
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Leucine requirement and splanchnic uptake of leucine in chronically undernourished adult Indian subjects. Am J Clin Nutr. 2003 Apr; 77(4):861-7.
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Effects of normal meals rich in carbohydrates or proteins on plasma tryptophan and tyrosine ratios. Am J Clin Nutr. 2003 Jan; 77(1):128-32.
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A phase I-II study of rituximab, ifosfamide, mitoxantrone and etoposide (R-IME) for B cell non-Hodgkin's lymphoma prior to and after high-dose chemotherapy and autologous stem cell transplantation (HDC-ASCT). Ann Oncol. 2003; 14 Suppl 1:i21-7.
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Lysine requirements of chronically undernourished adult Indian men, measured by a 24-h indicator amino acid oxidation and balance technique. Am J Clin Nutr. 2003 Jan; 77(1):101-8.
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The relationship of prostate gland volume to extended needle biopsy on prostate cancer detection. J Urol. 2003 Jan; 169(1):130-5.
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Precardiopulmonary bypass right ventricular function is associated with poor outcome after coronary artery bypass grafting in patients with severe left ventricular systolic dysfunction. Anesth Analg. 2002 Dec; 95(6):1507-18, table of contents.
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Serum levels of insulin-like growth factor-1 and insulin-like growth factor-1 binding proteins after radical prostatectomy. J Urol. 2002 Nov; 168(5):2249-52.
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Threonine requirements of healthy Indian men, measured by a 24-h indicator amino acid oxidation and balance technique. Am J Clin Nutr. 2002 Oct; 76(4):789-97.
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Lysine requirements of healthy adult Indian subjects receiving long-term feeding, measured with a 24-h indicator amino acid oxidation and balance technique. Am J Clin Nutr. 2002 Aug; 76(2):404-12.
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Intravenously infused 13C-leucine is retained in fasting healthy adult men. J Nutr. 2002 Jul; 132(7):1906-8.
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Threonine requirement of healthy adults, derived with a 24-h indicator amino acid balance technique. Am J Clin Nutr. 2002 Apr; 75(4):698-704.
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Provision of services to asylum seekers. Are there lessons from the experience with Kosovan refugees? J Epidemiol Community Health. 2002 Mar; 56(3):223-6.
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Developmental toxicity study. El-Shaarawi AH, Piegorsch WW, editors. Encyclopedia of Environmetrics. Volume 1. 2002; 515-518.

Combined continuous and discrete outcomes. Aerts M, Geys H, Molenberghs G, Ryan LM, editors. Topics in Modelling of Clustered Data. 2002; 233-261.

Daily requirement for and splanchnic uptake of leucine in healthy adult Indians. Am J Clin Nutr. 2001 Dec; 74(6):747-55.
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Gender bias in the disposition of frozen embryos. Fertil Steril. 2001 Dec; 76(6):1181-4.
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Side effects of influenza vaccination in healthy older people: a randomised single-blind placebo-controlled trial. Gerontology. 2001 Nov-Dec; 47(6):311-4.
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Variability of viral load in plasma of rhesus monkeys inoculated with simian immunodeficiency virus or simian-human immunodeficiency virus: implications for using nonhuman primate AIDS models to test vaccines and therapeutics. J Virol. 2001 Nov; 75(22):11234-8.
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Melatonin treatment for age-related insomnia. J Clin Endocrinol Metab. 2001 Oct; 86(10):4727-30.
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Rituximab and ifosfamide, mitoxantrone, etoposide (RIME) with Neupogen support for B-cell non-Hodgkin's lymphoma prior to high-dose chemotherapy with autologous haematopoietic transplant. Eur J Haematol Suppl. 2001 Jul; 64:56-62.
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Why do older women discontinue hormone replacement therapy? J Womens Health Gend Based Med. 2001 May; 10(4):343-50.
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Lysine requirements of healthy adult Indian subjects, measured by an indicator amino acid balance technique. Am J Clin Nutr. 2001 May; 73(5):900-7.
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Central nervous system vasculitis as a complication of refractory dermatomyositis. J Rheumatol. 2001 Jan; 28(1):207-11.
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Two latent variable risk assessment approaches for mixed continuous and discrete outcomes from developmental toxicity data. J Agric Biol Environ Stat. 2001; 6(3):340-55.

Inhaled albuterol, but not intravenous lidocaine, protects against intubation-induced bronchoconstriction in asthma. Anesthesiology. 2000 Nov; 93(5):1198-204.
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Postoperative atrial tachyarrhythmias in patients undergoing coronary artery bypass graft surgery without cardiopulmonary bypass: a role for intraoperative magnesium supplementation. J Cardiothorac Vasc Anesth. 2000 Oct; 14(5):524-30.
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Effect of oral CDP-choline on plasma choline and uridine levels in humans. Biochem Pharmacol. 2000 Oct 01; 60(7):989-92.
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Regression models and risk estimation for mixed discrete and continuous outcomes in developmental toxicology. Risk Anal. 2000 Jun; 20(3):363-76.
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Kinetics of L-[1-(13)C]leucine when ingested with free amino acids, unlabeled or intrinsically labeled casein. Am J Physiol Endocrinol Metab. 2000 Jun; 278(6):E1000-9.
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Inverse relationship between protein intake and plasma free amino acids in healthy men at physical exercise. Am J Physiol Endocrinol Metab. 2000 May; 278(5):E857-67.
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Oxoproline kinetics and oxoproline urinary excretion during glycine- or sulfur amino acid-free diets in humans. Am J Physiol Endocrinol Metab. 2000 May; 278(5):E868-76.
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Cysteine kinetics and oxidation at different intakes of methionine and cystine in young adults. Am J Clin Nutr. 2000 Feb; 71(2):491-9.
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Starting at the beginning: Designing clinical investigations. ASA 2000 Proceedings of the Section on Statistical Education the Section on Teaching Statistics in the Health Sciences and Section on Statistical Consulting. 2000; 1-8.

Incorporation of urea and ammonia nitrogen into ileal and fecal microbial proteins and plasma free amino acids in normal men and ileostomates. Am J Clin Nutr. 1999 Dec; 70(6):1046-58.
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Echocardiographic predictors of left ventricular outflow tract obstruction and systolic anterior motion of the mitral valve after mitral valve reconstruction for myxomatous valve disease. J Am Coll Cardiol. 1999 Dec; 34(7):2096-104.
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Likelihood models for clustered binary and continuous outcomes: application to developmental toxicology. Biometrics. 1999 Sep; 55(3):760-8.
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Bivariate dose-response modeling and risk estimation in developmental toxicology. J Agric Biol Environ Stat. 1999; 4:217-37.

Evidence for genetic anticipation in nodal osteoarthritis. Ann Rheum Dis. 1998 Sep; 57(9):524-6.
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Models for clustered discrete and continuous outcomes in developmental toxicology [dissertation]. 1998.

The benefits and risks of over-the-counter availability of nicotine polacrilex ("nicotine gum"). Med Care. 1996 May; 34(5):389-402.
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Effects of recombinant human DNase therapy on healthcare use and costs in patients with cystic fibrosis. Ann Pharmacother. 1995 May; 29(5):459-64.
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Cost-effectiveness of enoxaparin vs low-dose warfarin in the prevention of deep-vein thrombosis after total hip replacement surgery. Arch Intern Med. 1995 Apr 10; 155(7):757-64.
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Effects of rilmenidine and clonidine on the electroencephalogram, saccadic eye movements, and psychomotor function. J Cardiovasc Pharmacol. 1995; 26 Suppl 2:S48-54.
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[Chronic constrictive pericarditis. A retrospective study of a series of 84 patients]. Arch Mal Coeur Vaiss. 1994 Feb; 87(2):241-5.
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Treatment of rheumatoid hand synovitis with a regional block technique. Ir J Med Sci. 1993 Apr; 162(4):143-4.
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A proposed minimal rheumatological screening history and examination. The joint answers back. J R Coll Physicians Lond. 1991 Apr; 25(2):111-5.
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Occupational hearing loss in New York dairy farmers. Am J Ind Med. 1991; 20(4):517-31.
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