Sandra J. Lee, ScD

Sandra J. Lee, ScD


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(617) 632-2440


(617) 632-2444




Sandra J. Lee, ScD

Dr. Lee received her ScD from Harvard School of Public Health in 1994 and then completed a postdoctoral fellowship at DFCI. In 1996, she joined the faculty of DFCI. Currently she is a senior research scientist involved in methodological research in biostatistical science and collaborative research in cancer clinical trials. Her statistical research focuses on screening methods for early detection of cancer. She also participates in the Eastern Cooperative Oncology Group and in DFCI statistical consulting.



Principal Research Scientist, Harvard T.H. Chan School of Public Health


    Statistical Issues in Early Detection of Diseases

    There is a growing interest in public health programs targeted at diagnosing chronic diseases earlier-especially breast, cervical, colorectal, ovarian, and prostate cancers. The goal is to diagnose these diseases earlier relative to the stage at diagnosis under usual care with the expectation that mortality will be reduced.In collaboration with Dr. Marvin Zelen, we have developed stochastic models using the natural history of disease to address issues that arise in screening programs. These models have helped to guide public health programs in the choice of examination schedules. The main features of such schedules are the initial age to begin examinations, the number of examinations, and the intervals between them. We have introduced two new ideas, threshold method and schedule sensitivity, that have been used to generate and compare screening examination schedules.We have further expanded the stochastic models by developing a series of probability equations to predict the mortality reduction associated with screening programs. Predicting mortality is a function of the characteristics of the case-finding process and the detection modality. The model makes two basic assumptions: first, that the disease is described by a progressive disease model and second, that potential benefit of early detection arises from a stage shift.The model can be used to predict the mortality benefit of early detection programs. More importantly, however, it can be used to assess proposed schedules for early detection programs which will enable policy makers to compare costs and mortality benefits. We have applied theoretical results mainly to the area of breast cancer screening, but will also apply results to other disease sites such as colon, lung, and prostate cancers.

    Research Departments


      • Granulocyte-Macrophage Colony-Stimulating Factor Influence on Soluble and Membrane-Bound ICOS in Combination with Immune Checkpoint Blockade. Cancer Immunol Res. 2023 08 03; 11(8):1100-1113. View in: Pubmed

      • Granulomatous and Sarcoid-like Immune-Related Adverse Events following CTLA4 and PD1 Blockade Adjuvant Therapy of Melanoma: A Combined Analysis of ECOG-ACRIN E1609 and SWOG S1404 Phase III Trials and a Literature Review. Cancers (Basel). 2023 Apr 29; 15(9). View in: Pubmed

      • Combination Dabrafenib and Trametinib Versus Combination Nivolumab and Ipilimumab for Patients With Advanced BRAF-Mutant Melanoma: The DREAMseq Trial-ECOG-ACRIN EA6134. J Clin Oncol. 2023 01 10; 41(2):186-197. View in: Pubmed

      • Patient-reported tolerability of adjuvant ipilimumab (3 or 10 mg/kg) versus high-dose interferon alfa-2b for resected high-risk stage III-IV melanoma in phase III trial E1609. Qual Life Res. 2022 Aug 27. View in: Pubmed

      • Enhanced immune activation within the tumor microenvironment and circulation of female high-risk melanoma patients and improved survival with adjuvant CTLA4 blockade compared to males. J Transl Med. 2022 06 03; 20(1):253. View in: Pubmed

      • Improved prognosis and evidence of enhanced immunogenicity in tumor and circulation of high-risk melanoma patients with unknown primary. J Immunother Cancer. 2022 01; 10(1). View in: Pubmed

      • Impact of the COVID-19 Pandemic on Breast Cancer Mortality in the US: Estimates From Collaborative Simulation Modeling. J Natl Cancer Inst. 2021 11 02; 113(11):1484-1494. View in: Pubmed

      • Reflecting on 20 years of breast cancer modeling in CISNET: Recommendations for future cancer systems modeling efforts. PLoS Comput Biol. 2021 06; 17(6):e1009020. View in: Pubmed

      • Immune adverse events (irAEs) with adjuvant ipilimumab in melanoma, use of immunosuppressants and association with outcome: ECOG-ACRIN E1609 study analysis. J Immunother Cancer. 2021 05; 9(5). View in: Pubmed

      • Prognostic Gene Expression Profiling in Cutaneous Melanoma: Identifying the Knowledge Gaps and Assessing the Clinical Benefit. JAMA Dermatol. 2020 09 01; 156(9):1004-1011. View in: Pubmed

      • Long-Term Outcomes and Cost-Effectiveness of Breast Cancer Screening With Digital Breast Tomosynthesis in the United States. J Natl Cancer Inst. 2020 06 01; 112(6):582-589. View in: Pubmed

      • Modeling the natural history of ductal carcinoma in situ based on population data. Breast Cancer Res. 2020 05 27; 22(1):53. View in: Pubmed

      • Phase III Study of Adjuvant Ipilimumab (3 or 10 mg/kg) Versus High-Dose Interferon Alfa-2b for Resected High-Risk Melanoma: North American Intergroup E1609. J Clin Oncol. 2020 02 20; 38(6):567-575. View in: Pubmed

      • Cancer Outcomes in DCIS Patients Without Locoregional Treatment. J Natl Cancer Inst. 2019 09 01; 111(9):952-960. View in: Pubmed

      • An updated analysis of 4 randomized ECOG trials of high-dose interferon in the adjuvant treatment of melanoma. Cancer. 2019 09 01; 125(17):3013-3024. View in: Pubmed

      • Clinicopathologic features correlated with paradoxical outcomes in stage IIC versus IIIA melanoma patients. Melanoma Res. 2019 02; 29(1):70-76. View in: Pubmed

      • Validation of Melanoma Immune Profile (MIP), a Prognostic Immune Gene Prediction Score for Stage II-III Melanoma. Clin Cancer Res. 2019 04 15; 25(8):2494-2502. View in: Pubmed

      • Clinicopathologic, misdiagnosis, and survival differences between clinically amelanotic melanomas and pigmented melanomas. J Am Acad Dermatol. 2019 May; 80(5):1292-1298. View in: Pubmed

      • E3611-A Randomized Phase II Study of Ipilimumab at 3 or 10 mg/kg Alone or in Combination with High-Dose Interferon-a2b in Advanced Melanoma. Clin Cancer Res. 2019 01 15; 25(2):524-532. View in: Pubmed

      • The Dana-Farber CISNET Model for Breast Cancer Screening Strategies: An Update. Med Decis Making. 2018 04; 38(1_suppl):44S-53S. View in: Pubmed

      • Comparing CISNET Breast Cancer Incidence and Mortality Predictions to Observed Clinical Trial Results of Mammography Screening from Ages 40 to 49. Med Decis Making. 2018 04; 38(1_suppl):140S-150S. View in: Pubmed

      • Introduction to the Cancer Intervention and Surveillance Modeling Network (CISNET) Breast Cancer Models. Med Decis Making. 2018 04; 38(1_suppl):3S-8S. View in: Pubmed

      • Comparing CISNET Breast Cancer Models Using the Maximum Clinical Incidence Reduction Methodology. Med Decis Making. 2018 04; 38(1_suppl):112S-125S. View in: Pubmed

      • Modeling Ductal Carcinoma In Situ (DCIS): An Overview of CISNET Model Approaches. Med Decis Making. 2018 04; 38(1_suppl):126S-139S. View in: Pubmed

      • Association of Screening and Treatment With Breast Cancer Mortality by Molecular Subtype in US Women, 2000-2012. JAMA. 2018 01 09; 319(2):154-164. View in: Pubmed

      • Distinguishing between CISNET model results versus CISNET models. Cancer. 2018 03 01; 124(5):1083-1084. View in: Pubmed

      • Gene Methylation Biomarkers in Sputum and Plasma as Predictors for Lung Cancer Recurrence. Cancer Prev Res (Phila). 2017 Nov; 10(11):635-640. View in: Pubmed

      • Prospective Validation of Molecular Prognostic Markers in Cutaneous Melanoma: A Correlative Analysis of E1690. Clin Cancer Res. 2017 Nov 15; 23(22):6888-6892. View in: Pubmed

      • Gene methylation biomarkers in sputum as a classifier for lung cancer risk. Oncotarget. 2017 Sep 08; 8(38):63978-63985. View in: Pubmed

      • Using Collaborative Simulation Modeling to Develop a Web-Based Tool to Support Policy-Level Decision Making About Breast Cancer Screening Initiation Age. MDM Policy Pract. 2017 Jul; 2. View in: Pubmed

      • Phase III Randomized Study of 4 Weeks of High-Dose Interferon-a-2b in Stage T2bNO, T3a-bNO, T4a-bNO, and T1-4N1a-2a (microscopic) Melanoma: A Trial of the Eastern Cooperative Oncology Group-American College of Radiology Imaging Network Cancer Research Group (E1697). J Clin Oncol. 2017 Mar 10; 35(8):885-892. View in: Pubmed

      • Sex Differences in Age at Primary Melanoma Diagnosis in a Population-Based Analysis (US Surveillance, Epidemiology, and End Results, 2005-2011). J Invest Dermatol. 2016 09; 136(9):1894-1897. View in: Pubmed

      • Collaborative Modeling of the Benefits and Harms Associated With Different U.S. Breast Cancer Screening Strategies. Ann Intern Med. 2016 Feb 16; 164(4):215-25. View in: Pubmed

      • Copy Number Changes Are Associated with Response to Treatment with Carboplatin, Paclitaxel, and Sorafenib in Melanoma. Clin Cancer Res. 2016 Jan 15; 22(2):374-82. View in: Pubmed

      • MicroRNA expression profiling predicts clinical outcome of carboplatin/paclitaxel-based therapy in metastatic melanoma treated on the ECOG-ACRIN trial E2603. Clin Epigenetics. 2015; 7:58. View in: Pubmed

      • Effects of screening and systemic adjuvant therapy on ER-specific US breast cancer mortality. J Natl Cancer Inst. 2014 Nov; 106(11). View in: Pubmed

      • Multimodality vaccination against clade C SHIV: partial protection against mucosal challenges with a heterologous tier 2 virus. Vaccine. 2014 Nov 12; 32(48):6527-36. View in: Pubmed

      • Benefits, harms, and costs for breast cancer screening after US implementation of digital mammography. J Natl Cancer Inst. 2014 Jun; 106(6):dju092. View in: Pubmed

      • Correlation of somatic mutations and clinical outcome in melanoma patients treated with Carboplatin, Paclitaxel, and sorafenib. Clin Cancer Res. 2014 Jun 15; 20(12):3328-37. View in: Pubmed

      • Serologic evidence of autoimmunity in E2696 and E1694 patients with high-risk melanoma treated with adjuvant interferon alfa. Melanoma Res. 2014 Apr; 24(2):150-7. View in: Pubmed

      • Surrogate endpoints for overall survival in metastatic melanoma: a meta-analysis of randomised controlled trials. Lancet Oncol. 2014 Mar; 15(3):297-304. View in: Pubmed

      • HIV-1 envelope replication and a4ß7 utilization among newly infected subjects and their corresponding heterosexual partners. Retrovirology. 2013 Dec 26; 10:162. View in: Pubmed

      • ECOG phase II trial of graded-dose peginterferon a-2b in patients with metastatic melanoma overexpressing basic fibroblast growth factor (E2602). Clin Cancer Res. 2013 Dec 01; 19(23):6597-604. View in: Pubmed

      • Live attenuated Rev-independent Nef¯SIV enhances acquisition of heterologous SIVsmE660 in acutely vaccinated rhesus macaques. PLoS One. 2013; 8(9):e75556. View in: Pubmed

      • Pediatric melanoma: analysis of an international registry. Cancer. 2013 Nov 15; 119(22):4012-9. View in: Pubmed

      • Randomized, double-blind, placebo-controlled, phase III chemoprevention trial of selenium supplementation in patients with resected stage I non-small-cell lung cancer: ECOG 5597. J Clin Oncol. 2013 Nov 20; 31(33):4179-87. View in: Pubmed

      • Expression of drug targets in patients treated with sorafenib, carboplatin and paclitaxel. PLoS One. 2013; 8(8):e69748. View in: Pubmed

      • Multicenter, randomized phase II trial of GM-CSF (GM) plus ipilimumab (Ipi) versus Ipi alone in metastatic melanoma: E1608. J Clin Oncol. 2013 Jun 20; 31(18_suppl):CRA9007. View in: Pubmed

      • Phase III trial of carboplatin and paclitaxel with or without sorafenib in metastatic melanoma. J Clin Oncol. 2013 Jan 20; 31(3):373-9. View in: Pubmed

      • Pathologic characteristics of second breast cancers after breast conservation for ductal carcinoma in situ. Cancer. 2012 Dec 15; 118(24):6022-30. View in: Pubmed

      • Tipping the balance of benefits and harms to favor screening mammography starting at age 40 years: a comparative modeling study of risk. Ann Intern Med. 2012 May 01; 156(9):609-17. View in: Pubmed

      • Modeling the impact of population screening on breast cancer mortality in the United States. Breast. 2011 Oct; 20 Suppl 3:S75-81. View in: Pubmed

      • Schistosoma mansoni enhances host susceptibility to mucosal but not intravenous challenge by R5 Clade C SHIV. PLoS Negl Trop Dis. 2011 Aug; 5(8):e1270. View in: Pubmed

      • Vaccination against heterologous R5 clade C SHIV: prevention of infection and correlates of protection. PLoS One. 2011; 6(7):e22010. View in: Pubmed

      • Prime-boost vaccination with heterologous live vectors encoding SIV gag and multimeric HIV-1 gp160 protein: efficacy against repeated mucosal R5 clade C SHIV challenges. Vaccine. 2011 Aug 05; 29(34):5611-22. View in: Pubmed

      • Relative transmissibility of an R5 clade C simian-human immunodeficiency virus across different mucosae in macaques parallels the relative risks of sexual HIV-1 transmission in humans via different routes. J Infect Dis. 2010 Apr 15; 201(8):1155-63. View in: Pubmed

      • Presence of tumor-infiltrating lymphocytes and a dominant nodule within primary melanoma are prognostic factors for relapse-free survival of patients with thick (t4) primary melanoma: pathologic analysis of the e1690 and e1694 intergroup trials. Am J Clin Pathol. 2010 Apr; 133(4):646-53. View in: Pubmed

      • Effects of mammography screening under different screening schedules: model estimates of potential benefits and harms. Ann Intern Med. 2009 Nov 17; 151(10):738-47. View in: Pubmed

      • Failure of three novel regimens to improve outcome for patients with relapsed or refractory acute myeloid leukaemia: a report from the Eastern Cooperative Oncology Group. Br J Haematol. 2010 Jan; 148(2):217-25. View in: Pubmed

      • Expression of sorafenib targets in melanoma patients treated with carboplatin, paclitaxel and sorafenib. Clin Cancer Res. 2009 Feb 01; 15(3):1076-85. View in: Pubmed

      • Durable protection from Herpes Simplex Virus-2 transmission following intravaginal application of siRNAs targeting both a viral and host gene. Cell Host Microbe. 2009 Jan 22; 5(1):84-94. View in: Pubmed

      • Acute Schistosoma mansoni infection increases susceptibility to systemic SHIV clade C infection in rhesus macaques after mucosal virus exposure. PLoS Negl Trop Dis. 2008 Jul 23; 2(7):e265. View in: Pubmed

      • Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol. 2008 Feb 01; 26(4):527-34. View in: Pubmed

      • Comparison of plasma viremia and antibody responses in macaques inoculated with envelope variants of single-cycle simian immunodeficiency virus differing in infectivity and cellular tropism. J Virol. 2008 Jan; 82(1):321-34. View in: Pubmed

      • Mortality modeling of early detection programs. Biometrics. 2008 Jun; 64(2):386-95. View in: Pubmed

      • Coinfection with Schistosoma mansoni reactivates viremia in rhesus macaques with chronic simian-human immunodeficiency virus clade C infection. Infect Immun. 2007 Apr; 75(4):1751-6. View in: Pubmed

      • An siRNA-based microbicide protects mice from lethal herpes simplex virus 2 infection. Nature. 2006 Jan 05; 439(7072):89-94. View in: Pubmed

      • Intensified induction chemotherapy in adult acute myeloid leukemia followed by high-dose chemotherapy and autologous peripheral blood stem cell transplantation: an Eastern Cooperative Oncology Group trial (E4995). Leuk Lymphoma. 2005 Jan; 46(1):55-61. View in: Pubmed

      • Early detection of disease and scheduling of screening examinations. Stat Methods Med Res. 2004 Dec; 13(6):443-56. View in: Pubmed

      • Modified VAD and PSC-833 in the treatment of resistant or relapsing chronic lymphocytic leukemia (E4996): a trial of the Eastern Cooperative Oncology Group. Leuk Res. 2004 Aug; 28(8):813-9. View in: Pubmed

      • Mitoxantrone, etoposide, and cytarabine with or without valspodar in patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome: a phase III trial (E2995). J Clin Oncol. 2004 Mar 15; 22(6):1078-86. View in: Pubmed

      • Proliferation responses to HIVp24 during antiretroviral therapy do not reflect improved immune phenotype or function. AIDS. 2004 Mar 05; 18(4):605-13. View in: Pubmed

      • Modelling the early detection of breast cancer. Ann Oncol. 2003 Aug; 14(8):1199-202. View in: Pubmed

      • Most antiviral CD8 T cells during chronic viral infection do not express high levels of perforin and are not directly cytotoxic. Blood. 2003 Jan 01; 101(1):226-35. View in: Pubmed

      • Statistical models for screening: planning public health programs. Cancer Treat Res. 2002; 113:19-36. View in: Pubmed

      • Models and the early detection of disease: methodological considerations. Cancer Treat Res. 2002; 113:1-18. View in: Pubmed


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