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James J. Dignam

Professor
jdignam@uchicago.edu
Research Summary
Dr. Dignam's primary research involves the design, conduct, and analysis of cancer clinical trials, including early development (phase I), pilot efficacy and safety (phase II), and definitive evaluation (phase III) trials. He is the Executive Director of the Statistics and Data Management Center for NRG Oncology, a National Cancer Institute sponsored multi-center clinical trials group with over 500 recruitment sites in North America and beyond and over 100 active clinical trials. Dr. Dignam's methodology interests include trial monitoring and early stopping rules, competing risks, hazard function estimation, and prognostic modeling. He also has engaged in and led investigations into sociodemographic factors such as race/ethnicity and BMI/obesity on cancer prognosis and treatment response. Courses taught include introductory biostatistics, clinical trials, survival analysis, and regression modeling methods.
Keywords
survival analysis, clinical trials, competing risks, modeling, health disparities in cancer
Education
  • University of Pittsburgh, Graduate School of Public Health, Pittsburgh, PhD Biostatistics 05/1994
  • Saint Xavier College, Chicago, BA Mathematics 05/1986
Biosciences Graduate Program Association
Awards & Honors
  • 1991 - Inducted Member Delta Omega, National Public Health Honor Society
  • 2019 - Elected Fellow Society for Clinical Trials
  • 2021 - Co-recipient, Statistical Partnership Among Academe, Industry, and Government (SPAIG) Award American Statistical Association
Publications

  1. Predictors of Pneumonitis in Combined Thoracic Stereotactic Body Radiation Therapy and Immunotherapy. Int J Radiat Oncol Biol Phys. 2022 11 15; 114(4):645-654. View in: PubMed

  2. Hematuria following Post-Prostatectomy Radiotherapy: Incidence Increases with Long-Term Followup. J Urol. 2022 06; 207(6):1236-1245. View in: PubMed

  3. Appropriate Systemic Therapy Dosing for Obese Adult Patients With Cancer: ASCO Guideline Update. J Clin Oncol. 2021 06 20; 39(18):2037-2048. View in: PubMed

  4. Statistical Considerations in the Evaluation of Continuous Biomarkers. J Nucl Med. 2021 05 10; 62(5):605-611. View in: PubMed

  5. Validation of a 22-Gene Genomic Classifier in Patients With Recurrent Prostate Cancer: An Ancillary Study of the NRG/RTOG 9601 Randomized Clinical Trial. JAMA Oncol. 2021 04 01; 7(4):544-552. View in: PubMed

  6. Disparities in Breast Cancer: Narrowing the Gap. J Natl Cancer Inst. 2021 04 06; 113(4):349-350. View in: PubMed

  7. Biomarker-Driven Oncology Clinical Trials: Key Design Elements, Types, Features, and Practical Considerations. JCO Precis Oncol. 2019; 3. View in: PubMed

  8. Do reminder emails and past due notifications improve patient completion and institutional data submission for patient-reported outcome measures? Qual Life Res. 2021 Jan; 30(1):81-89. View in: PubMed

  9. Multicenter Clinical Cancer Research After COVID-19: A Perspective From NRG Oncology. Int J Radiat Oncol Biol Phys. 2020 10 01; 108(2):483-485. View in: PubMed

  10. Characteristics of Participation in Patient-Reported Outcomes and Electronic Data Capture Components of NRG Oncology Clinical Trials. Int J Radiat Oncol Biol Phys. 2020 11 15; 108(4):950-959. View in: PubMed

  11. 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. View in: PubMed

  12. Association of Presalvage Radiotherapy PSA Levels After Prostatectomy With Outcomes of Long-term Antiandrogen Therapy in Men With Prostate Cancer. JAMA Oncol. 2020 05 01; 6(5):735-743. View in: PubMed

  13. A Systematic Review and Recommendation for Reporting of Surrogate Endpoint Evaluation Using Meta-analyses. JNCI Cancer Spectr. 2019 Mar; 3(1):pkz002. View in: PubMed

  14. Association of Black Race With Prostate Cancer-Specific and Other-Cause Mortality. JAMA Oncol. 2019 07 01; 5(7):975-983. View in: PubMed

  15. Quality of Life in Patients With Low-Risk Prostate Cancer Treated With Hypofractionated vs Conventional Radiotherapy: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2019 May 01; 5(5):664-670. View in: PubMed

  16. Smoking, age, nodal disease, T stage, p16 status, and risk of distant metastases in patients with squamous cell cancer of the oropharynx. Cancer. 2019 03 01; 125(5):704-711. View in: PubMed

  17. Time Interval to Biochemical Failure as a Surrogate End Point in Locally Advanced Prostate Cancer: Analysis of Randomized Trial NRG/RTOG 9202. J Clin Oncol. 2019 01 20; 37(3):213-221. View in: PubMed

  18. Universal screening for Lynch syndrome in a large consecutive cohort of Chinese colorectal cancer patients: High prevalence and unique molecular features. Int J Cancer. 2019 05 01; 144(9):2161-2168. View in: PubMed

  19. Detecting a Survival Benefit to Dose Escalation-Reply. JAMA Oncol. 2019 01 01; 5(1):110. View in: PubMed

  20. Radiotherapy plus cetuximab or cisplatin in human papillomavirus-positive oropharyngeal cancer (NRG Oncology RTOG 1016): a randomised, multicentre, non-inferiority trial. Lancet. 2019 01 05; 393(10166):40-50. View in: PubMed

  21. Efficacy of Anti-HER2 Agents in Combination With Adjuvant or Neoadjuvant Chemotherapy for Early and Locally Advanced HER2-Positive Breast Cancer Patients: A Network Meta-Analysis. Front Oncol. 2018; 8:156. View in: PubMed

  22. Investigating the Effect of Reirradiation or Systemic Therapy in Patients With Glioblastoma After Tumor Progression: A Secondary Analysis of NRG Oncology/Radiation Therapy Oncology Group Trial 0525. Int J Radiat Oncol Biol Phys. 2018 01 01; 100(1):38-44. View in: PubMed

  23. Metastasis-Free Survival Is a Strong Surrogate of Overall Survival in Localized Prostate Cancer. J Clin Oncol. 2017 09 20; 35(27):3097-3104. View in: PubMed

  24. Duration of Androgen Deprivation in Locally Advanced Prostate Cancer: Long-Term Update of NRG Oncology RTOG 9202. Int J Radiat Oncol Biol Phys. 2017 06 01; 98(2):296-303. View in: PubMed

  25. Flexible modeling of the hazard rate and treatment effects in long-term survival studies. Stat Methods Med Res. 2017 Oct; 26(5):2455-2480. View in: PubMed

  26. Radiation with or without Antiandrogen Therapy in Recurrent Prostate Cancer. N Engl J Med. 2017 02 02; 376(5):417-428. View in: PubMed

  27. Promoting the Appropriate Use of Advanced Radiation Technologies in Oncology: Summary of a National Cancer Policy Forum Workshop. Int J Radiat Oncol Biol Phys. 2017 03 01; 97(3):450-461. View in: PubMed

  28. Impact of ethnic neutropenia disparity analysis in NSABP breast trials of postoperative doxorubicin (A)/cyclophosphamide (C). J Clin Oncol. 2005 Jun; 23(16_suppl):6002. View in: PubMed

  29. Effect of body mass index on outcomes in patients with Dukes B and C colon cancer: An analysis of NSABP randomized trials. J Clin Oncol. 2005 Jun; 23(16_suppl):3533. View in: PubMed

  30. Comparison of futility monitoring guidelines using completed phase III oncology trials. Clin Trials. 2017 Feb; 14(1):48-58. View in: PubMed

  31. Joint modelling of longitudinal and multi-state processes: application to clinical progressions in prostate cancer. Stat Med. 2016 09 30; 35(22):3933-48. View in: PubMed

  32. Randomized Phase III Noninferiority Study Comparing Two Radiotherapy Fractionation Schedules in Patients With Low-Risk Prostate Cancer. J Clin Oncol. 2016 07 10; 34(20):2325-32. View in: PubMed

  33. An Evaluation of Psychosocial and Religious Belief Differences in a Diverse Racial and Socioeconomic Urban Cancer Population. J Racial Ethn Health Disparities. 2017 04; 4(2):140-148. View in: PubMed

  34. Prevention of colorectal cancer and dietary management. Chin Clin Oncol. 2013 Jun; 2(2):13. View in: PubMed

  35. Building firm foundations for therapy development. J Natl Cancer Inst. 2015 Mar; 107(3). View in: PubMed

  36. Variation over time and interdependence between disease progression and death among patients with glioblastoma on RTOG 0525. Neuro Oncol. 2015 Jul; 17(7):999-1006. View in: PubMed

  37. A Multiresolution Hazard Model for Multicenter Survival Studies: Application to Tamoxifen Treatment in Early Stage Breast Cancer. J Am Stat Assoc. 2007 12; 102(480):1145-1157. View in: PubMed

  38. Duration of androgen suppression before radiotherapy for localized prostate cancer: radiation therapy oncology group randomized clinical trial 9910. J Clin Oncol. 2015 Feb 01; 33(4):332-9. View in: PubMed

  39. Assessing treatment benefit with competing risks not affected by the randomized treatment. Stat Med. 2015 Jan 30; 34(2):265-80. View in: PubMed

  40. A tissue biomarker-based model that identifies patients with a high risk of distant metastasis and differential survival by length of androgen deprivation therapy in RTOG protocol 92-02. Clin Cancer Res. 2014 Dec 15; 20(24):6379-88. View in: PubMed

  41. Bayesian approach for flexible modeling of semicompeting risks data. Stat Med. 2014 Dec 20; 33(29):5111-25. View in: PubMed

  42. Multiple imputation methods for nonparametric inference on cumulative incidence with missing cause of failure. Stat Med. 2014 Nov 20; 33(26):4605-26. View in: PubMed

  43. Individualized dynamic prediction of prostate cancer recurrence with and without the initiation of a second treatment: Development and validation. Stat Methods Med Res. 2016 12; 25(6):2972-2991. View in: PubMed

  44. Reply to M.C. Chamberlain. J Clin Oncol. 2014 May 20; 32(15):1634-5. View in: PubMed

  45. A randomized trial of bevacizumab for newly diagnosed glioblastoma. N Engl J Med. 2014 Feb 20; 370(8):699-708. View in: PubMed

  46. Hormone replacement therapy and breast cancer: heterogeneous risks by race, weight, and breast density. J Natl Cancer Inst. 2013 Sep 18; 105(18):1365-72. View in: PubMed

  47. Baseline comorbidities in a skin cancer prevention trial in Bangladesh. Eur J Clin Invest. 2013 Jun; 43(6):579-88. View in: PubMed

  48. Lung volume measurements as a surrogate marker for patient response in malignant pleural mesothelioma. J Thorac Oncol. 2013 Apr; 8(4):478-86. View in: PubMed

  49. NCI-RTOG translational program strategic guidelines for the early-stage development of radiosensitizers. J Natl Cancer Inst. 2013 Jan 02; 105(1):11-24. View in: PubMed

  50. Integrated phase II/III clinical trials in oncology: a case study. Clin Trials. 2012 Dec; 9(6):741-7. View in: PubMed

  51. Disease volumes as a marker for patient response in malignant pleural mesothelioma. Ann Oncol. 2013 Apr; 24(4):999-1005. View in: PubMed

  52. Optimization of response classification criteria for patients with malignant pleural mesothelioma. J Thorac Oncol. 2012 Nov; 7(11):1728-34. View in: PubMed

  53. Predictors of locoregional recurrence after neoadjuvant chemotherapy: results from combined analysis of National Surgical Adjuvant Breast and Bowel Project B-18 and B-27. J Clin Oncol. 2012 Nov 10; 30(32):3960-6. View in: PubMed

  54. A nomogram for individualized estimation of survival among patients with brain metastasis. Neuro Oncol. 2012 Jul; 14(7):910-8. View in: PubMed

  55. Appropriate chemotherapy dosing for obese adult patients with cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2012 May 01; 30(13):1553-61. View in: PubMed

  56. Race and the prognostic influence of p53 in women with breast cancer. Ann Surg Oncol. 2012 Jul; 19(7):2334-44. View in: PubMed

  57. Redesigning radiotherapy quality assurance: opportunities to develop an efficient, evidence-based system to support clinical trials--report of the National Cancer Institute Work Group on Radiotherapy Quality Assurance. Int J Radiat Oncol Biol Phys. 2012 Jul 01; 83(3):782-90. View in: PubMed

  58. Diffusing capacity predicts long-term survival after lung resection for cancer. Eur J Cardiothorac Surg. 2012 May; 41(5):e81-6. View in: PubMed

  59. The use and interpretation of competing risks regression models. Clin Cancer Res. 2012 Apr 15; 18(8):2301-8. View in: PubMed

  60. Multiple imputation methods for inference on cumulative incidence with missing cause of failure. Biom J. 2011 Nov; 53(6):974-93. View in: PubMed

  61. Some additional thoughts on time-varying treatment effects in breast cancer. J Clin Oncol. 2011 Nov 20; 29(33):4469-70; author reply 4470. View in: PubMed

  62. Outcomes among black patients with stage II and III colon cancer receiving chemotherapy: an analysis of ACCENT adjuvant trials. J Natl Cancer Inst. 2011 Oct 19; 103(20):1498-506. View in: PubMed

  63. Patterns of missing mini mental status exam (MMSE) in radiation therapy oncology group (RTOG) brain cancer trials. J Neurooncol. 2011 Nov; 105(2):383-95. View in: PubMed

  64. Bayesian Hierarchical Multiresolution Hazard Model for the Study of Time-Dependent Failure Patterns in Early Stage Breast Cancer. Bayesian Anal. 2007 May 17; 2(3):591-610. View in: PubMed

  65. Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS. J Natl Cancer Inst. 2011 Mar 16; 103(6):478-88. View in: PubMed

  66. Glioma-associated oncogene family zinc finger 1 expression and metastasis in patients with head and neck squamous cell carcinoma treated with radiation therapy (RTOG 9003). J Clin Oncol. 2011 Apr 01; 29(10):1326-34. View in: PubMed

  67. Epidermal growth factor receptor inhibitor gefitinib added to chemoradiotherapy in locally advanced head and neck cancer. J Clin Oncol. 2010 Jul 10; 28(20):3336-43. View in: PubMed

  68. Conditional survival and the choice of conditioning set for patients with colon cancer: an analysis of NSABP trials C-03 through C-07. J Clin Oncol. 2010 May 20; 28(15):2544-8. View in: PubMed

  69. Population-based survival-cure analysis of ER-negative breast cancer. Breast Cancer Res Treat. 2010 Aug; 123(1):257-64. View in: PubMed

  70. Re: Racial disparities in cancer survival among randomized clinical trials of the Southwest Oncology Group. J Natl Cancer Inst. 2010 Feb 24; 102(4):279-80; author reply 280-2. View in: PubMed

  71. p53 as a marker of prognosis in African-American women with breast cancer. Ann Surg Oncol. 2010 May; 17(5):1398-405. View in: PubMed

  72. Predictors of competing mortality in advanced head and neck cancer. J Clin Oncol. 2010 Jan 01; 28(1):15-20. View in: PubMed

  73. Population differences in breast cancer: survey in indigenous African women reveals over-representation of triple-negative breast cancer. J Clin Oncol. 2009 Sep 20; 27(27):4515-21. View in: PubMed

  74. Estimating breast cancer-specific and other-cause mortality in clinical trial and population-based cancer registry cohorts. Cancer. 2009 Nov 15; 115(22):5272-83. View in: PubMed

  75. Prognosis after ipsilateral breast tumor recurrence and locoregional recurrences in patients treated by breast-conserving therapy in five National Surgical Adjuvant Breast and Bowel Project protocols of node-negative breast cancer. J Clin Oncol. 2009 May 20; 27(15):2466-73. View in: PubMed

  76. Hazard of recurrence and adjuvant treatment effects over time in lymph node-negative breast cancer. Breast Cancer Res Treat. 2009 Aug; 116(3):595-602. View in: PubMed

  77. Choice and interpretation of statistical tests used when competing risks are present. J Clin Oncol. 2008 Aug 20; 26(24):4027-34. View in: PubMed

  78. Family history of pancreatic cancer in a high-risk cancer clinic: implications for risk assessment. J Genet Couns. 2008 Aug; 17(4):365-72. View in: PubMed

  79. Comments on: Yin W, Di G, Zhou L, Lu J, Liu G, Wu J, Shen K, Han Q, Shen Z, Shao Z. Time-varying pattern of recurrence risk for Chinese breast cancer patients. Breast Cancer Res Treat. 2009 Jul; 116(1):209-10. View in: PubMed

  80. Uptake and timing of bilateral prophylactic salpingo-oophorectomy among BRCA1 and BRCA2 mutation carriers. Genet Med. 2008 Mar; 10(3):161-166. View in: PubMed

  81. Estrogen receptor alpha, BRCA1, and FANCF promoter methylation occur in distinct subsets of sporadic breast cancers. Breast Cancer Res Treat. 2008 Sep; 111(1):113-20. View in: PubMed

  82. How often do BRCA mutation carriers tell their young children of the family's risk for cancer? A study of parental disclosure of BRCA mutations to minors and young adults. J Clin Oncol. 2007 Aug 20; 25(24):3705-11. View in: PubMed

  83. A pilot study of the vulnerable elders survey-13 compared with the comprehensive geriatric assessment for identifying disability in older patients with prostate cancer who receive androgen ablation. Cancer. 2007 Feb 15; 109(4):802-10. View in: PubMed

  84. Body mass index and outcomes in patients who receive adjuvant chemotherapy for colon cancer. J Natl Cancer Inst. 2006 Nov 15; 98(22):1647-54. View in: PubMed

  85. A missing data approach to semi-competing risks problems. Stat Med. 2007 Feb 20; 26(4):837-56. View in: PubMed

  86. Colorectal cancer model of health disparities: understanding mortality differences in minority populations. J Clin Oncol. 2006 May 10; 24(14):2179-87. View in: PubMed

  87. The ongoing search for the sources of the breast cancer survival disparity. J Clin Oncol. 2006 Mar 20; 24(9):1326-8. View in: PubMed

  88. Effects of obesity and race on prognosis in lymph node-negative, estrogen receptor-negative breast cancer. Breast Cancer Res Treat. 2006 Jun; 97(3):245-54. View in: PubMed

  89. BRCA1 promoter methylation in sporadic breast cancer is associated with reduced BRCA1 copy number and chromosome 17 aneusomy. Cancer Res. 2005 Dec 01; 65(23):10692-9. View in: PubMed

  90. Early viewing of noninferiority trials in progress. J Clin Oncol. 2005 Aug 20; 23(24):5461-3. View in: PubMed

  91. Toward optimal screening strategies for older women. Costs, benefits, and harms of breast cancer screening by age, biology, and health status. J Gen Intern Med. 2005 Jun; 20(6):487-96. View in: PubMed

  92. Colorectal cancer and race: understanding the differences in outcomes between African Americans and whites. Med Clin North Am. 2005 Jul; 89(4):771-93. View in: PubMed

  93. Mammographic density and breast cancer after ductal carcinoma in situ. J Natl Cancer Inst. 2004 Oct 06; 96(19):1467-72. View in: PubMed

  94. Treatment of lymph-node-negative, oestrogen-receptor-positive breast cancer: long-term findings from National Surgical Adjuvant Breast and Bowel Project randomised clinical trials. Lancet. 2004 Sep 4-10; 364(9437):858-68. View in: PubMed

  95. Semiquantitative analysis of dynamic contrast enhanced MRI in cancer patients: Variability and changes in tumor tissue over time. J Magn Reson Imaging. 2004 Jul; 20(1):122-8. View in: PubMed

  96. Benefits and costs of interventions to improve breast cancer outcomes in African American women. J Clin Oncol. 2004 Jul 01; 22(13):2554-66. View in: PubMed

  97. Obesity and breast cancer prognosis: an expanding body of evidence. Ann Oncol. 2004 Jun; 15(6):850-1. View in: PubMed

  98. Semiparametric models for cumulative incidence functions. Biometrics. 2004 Mar; 60(1):182-90. View in: PubMed

  99. Long-term suppression of tumor growth by TNF requires a Stat1- and IFN regulatory factor 1-dependent IFN-gamma pathway but not IL-12 or IL-18. J Immunol. 2004 Mar 01; 172(5):3243-51. View in: PubMed

  100. MYC is amplified in BRCA1-associated breast cancers. Clin Cancer Res. 2004 Jan 15; 10(2):499-507. View in: PubMed

  101. The role of cancer cooperative groups within the spectrum of cancer care. Cancer Control. 2004 Jan-Feb; 11(1):55-63. View in: PubMed

  102. Obesity, tamoxifen use, and outcomes in women with estrogen receptor-positive early-stage breast cancer. J Natl Cancer Inst. 2003 Oct 01; 95(19):1467-76. View in: PubMed

  103. Is patient travel distance associated with survival on phase II clinical trials in oncology? J Natl Cancer Inst. 2003 Sep 17; 95(18):1370-5. View in: PubMed

  104. Prognosis after rectal cancer in blacks and whites participating in adjuvant therapy randomized trials. J Clin Oncol. 2003 Feb 01; 21(3):413-20. View in: PubMed

  105. Tamoxifen, radiation therapy, or both for prevention of ipsilateral breast tumor recurrence after lumpectomy in women with invasive breast cancers of one centimeter or less. J Clin Oncol. 2002 Oct 15; 20(20):4141-9. View in: PubMed

  106. Statistical considerations in assessing molecular markers for cancer prognosis and treatment efficacy. Methods Mol Biol. 2002; 184:169-89. View in: PubMed

  107. Findings from recent National Surgical Adjuvant Breast and Bowel Project adjuvant studies in stage I breast cancer. J Natl Cancer Inst Monogr. 2001; (30):62-6. View in: PubMed

  108. Efficacy of systemic adjuvant therapy for breast cancer in African-American and Caucasian women. J Natl Cancer Inst Monogr. 2001; (30):36-43. View in: PubMed

  109. Prevention of invasive breast cancer in women with ductal carcinoma in situ: an update of the National Surgical Adjuvant Breast and Bowel Project experience. Semin Oncol. 2001 Aug; 28(4):400-18. View in: PubMed

  110. Five versus more than five years of tamoxifen for lymph node-negative breast cancer: updated findings from the National Surgical Adjuvant Breast and Bowel Project B-14 randomized trial. J Natl Cancer Inst. 2001 May 02; 93(9):684-90. View in: PubMed

  111. Prognosis and treatment of patients with breast tumors of one centimeter or less and negative axillary lymph nodes. J Natl Cancer Inst. 2001 Jan 17; 93(2):112-20. View in: PubMed

  112. Differences in breast cancer prognosis among African-American and Caucasian women. CA Cancer J Clin. 2000 Jan-Feb; 50(1):50-64. View in: PubMed

  113. Occurrence of stroke with tamoxifen in NSABP B-24. Lancet. 2000 Mar 04; 355(9206):848-9. View in: PubMed

  114. Outcomes among African-Americans and Caucasians in colon cancer adjuvant therapy trials: findings from the National Surgical Adjuvant Breast and Bowel Project. J Natl Cancer Inst. 1999 Nov 17; 91(22):1933-40. View in: PubMed

  115. Pathologic findings from the National Surgical Adjuvant Breast Project (NSABP) eight-year update of Protocol B-17: intraductal carcinoma. Cancer. 1999 Aug 01; 86(3):429-38. View in: PubMed

  116. Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial. Lancet. 1999 Jun 12; 353(9169):1993-2000. View in: PubMed

  117. Early stopping of a clinical trial when there is evidence of no treatment benefit: protocol B-14 of the National Surgical Adjuvant Breast and Bowel Project. Control Clin Trials. 1998 Dec; 19(6):575-88. View in: PubMed

  118. Lumpectomy and radiation therapy for the treatment of intraductal breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-17. J Clin Oncol. 1998 Feb; 16(2):441-52. View in: PubMed

  119. Tamoxifen and chemotherapy for lymph node-negative, estrogen receptor-positive breast cancer. J Natl Cancer Inst. 1997 Nov 19; 89(22):1673-82. View in: PubMed

  120. Prognosis among African-American women and white women with lymph node negative breast carcinoma: findings from two randomized clinical trials of the National Surgical Adjuvant Breast and Bowel Project (NSABP). Cancer. 1997 Jul 01; 80(1):80-90. View in: PubMed

  121. Coronary heart disease mortality and adjuvant tamoxifen therapy. J Natl Cancer Inst. 1997 Jun 04; 89(11):776-82. View in: PubMed

  122. Five versus more than five years of tamoxifen therapy for breast cancer patients with negative lymph nodes and estrogen receptor-positive tumors. J Natl Cancer Inst. 1996 Nov 06; 88(21):1529-42. View in: PubMed

  123. Sequential methotrexate and fluorouracil for the treatment of node-negative breast cancer patients with estrogen receptor-negative tumors: eight-year results from National Surgical Adjuvant Breast and Bowel Project (NSABP) B-13 and first report of findings from NSABP B-19 comparing methotrexate and fluorouracil with conventional cyclophosphamide, methotrexate, and fluorouracil. J Clin Oncol. 1996 Jul; 14(7):1982-92. View in: PubMed

  124. Methods for bounding the marginal survival distribution. Stat Med. 1995 Sep 30; 14(18):1985-98. View in: PubMed

  125. Breast cancer trials on trial: a case of conflicting ethical interests. Cancer. 1995 Oct 01; 76(7):1294-5. View in: PubMed
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