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Meredith M. Regan, ScD


Researcher

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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.

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 Sep 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 Sep 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. 2021 Aug 26; 101097JU0000000000002176.
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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 Jul 26.
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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 May 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 Mar 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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SOX9 regulates low density lipoprotein receptor-related protein 6 (LRP6) and T-cell factor 4 (TCF4) expression and Wnt/ß-catenin activation in breast cancer. J Biol Chem. 2013 Mar 01; 288(9):6478-87.
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External validation and comparison with other models of the International Metastatic Renal-Cell Carcinoma Database Consortium prognostic model: a population-based study. Lancet Oncol. 2013 Feb; 14(2):141-8.
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Nomogram predicting treatment-related bowel dysfunction for men with localized prostate cancer treated by radical prostatectomy (RP), external-beam radiotherapy (EBRT), and brachytherapy (PI). J Clin Oncol. 2012 Dec; 30(34_suppl):55.
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Nomogram predicting treatment-related urinary incontinence for men with localized prostate cancer treated by radical prostatectomy (RP), external-beam radiotherapy (EBRT), or brachytherapy (PI). J Clin Oncol. 2012 Dec; 30(34_suppl):49.
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Nomogram predicting treatment-related sexual dysfunction for men with localized prostate cancer treated by radical prostatectomy (RP), external-beam radiotherapy (EBRT), and brachytherapy (PI). J Clin Oncol. 2012 Dec; 30(34_suppl):51.
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Prognostic interaction between expression of p53 and estrogen receptor in patients with node-negative breast cancer: results from IBCSG Trials VIII and IX. Breast Cancer Res. 2012 Nov 05; 14(6):R143.
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Obesity and risk of recurrence or death after adjuvant endocrine therapy with letrozole or tamoxifen in the breast international group 1-98 trial. J Clin Oncol. 2012 Nov 10; 30(32):3967-75.
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Uncertainty and perception of danger among patients undergoing treatment for prostate cancer. BJU Int. 2013 Mar; 111(3 Pt B):E84-91.
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A risk score based on histopathological features predicts higher risk of distant recurrence in premenopausal patients with lymph node-negative endocrine-responsive breast cancer. Breast. 2012 Oct; 21(5):621-8.
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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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SU-E-T-387: Validation of a New System for Patient Specific IMRT QA and Comparison with Other Commerical Systems. Med Phys. 2012 Jun; 39(6Part16):3793.
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The effect of a controlled 8-week metabolic ward based lysine supplementation on muscle function, insulin sensitivity and leucine kinetics in young men. Clin Nutr. 2012 Dec; 31(6):903-10.
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Identification of functionally active, low frequency copy number variants at 15q21.3 and 12q21.31 associated with prostate cancer risk. Proc Natl Acad Sci U S A. 2012 Apr 24; 109(17):6686-91.
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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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Effect of a germline polymorphism in the manganese superoxide dismutase (MnSOD) gene on the association of clinically aggressive prostate cancer with plasma selenium levels. J Clin Oncol. 2008; 26(May 20 suppl):abstr 5057.

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Adjuvant letrozole versus tamoxifen according to centrally-assessed ERBB2 status for postmenopausal women with endocrine-responsive early breast cancer: supplementary results from the BIG 1-98 randomised trial. Lancet Oncol. 2008 Jan; 9(1):23-8.
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Higher prostate-specific antigen levels predict improved survival in patients with hormone-refractory prostate cancer who have skeletal metastases and normal serum alkaline phosphatase. Cancer. 2007 Dec 15; 110(12):2709-15.
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Exploration of cost effectiveness of active vaccination in the control of a school outbreak of hepatitis A in a deprived community in the United Kingdom. Euro Surveill. 2007 Dec 01; 12(12):E5-6.
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Potential histologic and molecular predictors of response to temsirolimus in patients with advanced renal cell carcinoma. Clin Genitourin Cancer. 2007 Sep; 5(6):379-85.
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Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J Clin Oncol. 2007 Sep 01; 25(25):3846-52.
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A randomized controlled trial of 503 couples assigned to conventional infertility treatment or an accelerated track to IVF: preliminary results of the fast track and standard treatment (FASTT) trial. Fertil Steril. 2007; 18(Suppl 1):S41 (abstr 0-108; prize paper).

Docetaxel, estramustine, and 15-month androgen deprivation for men with prostate-specific antigen progression after definitive local therapy for prostate cancer. J Clin Oncol. 2006 Dec 01; 24(34):5408-13.
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Chemo-hormonal therapy for biochemical progression of prostate cancer. J Clin Oncol. 2006 Jun 20; 24(18_suppl):4559.
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Impact of patient and physician factors on oncologists' recommendations for adjuvant chemotherapy in stage III colon cancer. J Clin Oncol. 2006 Jun 20; 24(18_suppl):6051.
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Utility of prostate specific antigen doubling time (PSA-DT) at the start of androgen independent prostate cancer (AIPC) and immediately before chemotherapy in predicting efficacy of taxane chemotherapy. J Clin Oncol. 2006 Jun 20; 24(18_suppl):4640.
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Prostate specific antigen doubling time (PSA-DT) and velocity (PSA-V) provide independent prognostic information in androgen independent prostate cancer (AIPC) patients receiving chemotherapy. J Clin Oncol. 2006 Jun 20; 24(18_suppl):4616.
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Response to low-dose ketoconazole and subsequent dose escalation to high-dose ketoconazole in patients with androgen-independent prostate cancer. J Clin Oncol. 2006 Jun 20; 24(18_suppl):4646.
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Low age adjusted free testosterone levels correlate with poorly differentiated prostate cancer. J Urol. 2006 Apr; 175(4):1341-5; discussion 1345-6.
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Impact of patient and physician factors on oncologists’ recommendations for adjuvant chemotherapy in stage III colon cancer. Proc Am Soc Clin Oncol. 2006; 24(18S Part I of II):313s (abstract 6051).

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Randomized phase III trial of high-dose interleukin-2 versus subcutaneous interleukin-2 and interferon in patients with metastatic renal cell carcinoma. J Clin Oncol. 2005 Jan 01; 23(1):133-41.
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Analysis of cystic fibrosis gener product (CFTR) function in patients with pancreas divisum and recurrent acute pancreatitis. Am J Gastroenterol. 2004 Aug; 99(8):1557-62.
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