• Researcher Profile

    Richard D. Gelber, PhD

     
    Richard D. Gelber, PhD
     
    Professor of Pediatrics (Biostatistics), Harvard Medical School; Professor of Biostatistics, Harvard School of Public Health

    Office phone: 617-632-3603
    Fax: 617-632-2444
    Email: gelber@jimmy.harvard.edu

    Preferred contact method: office phone
     
     

    Research Department

    Biostatistics and Computational Biology

    Area of Research

    Q-TWIST, Quality-Adjusted Survival, and Cancer Clinical Trials

    Dana-Farber Cancer Institute
    450 Brookline Avenue
    CLS 11072
    Boston, MA 02215

    Biography

    Dr. Gelber received his PhD in operations research (major field: applied probability and statistics) from Cornell University in 1975. He has been at DFCI since 1977 and served as director of the Pediatric AIDS Clinical Trials Group from 1988 to 1998. In 1993, he was elected a fellow of the American Statistical Association. He is the statistical director for the International Breast Cancer Study Group and the DFCI Pediatric Acute Lymphoblastic Leukemia Consortium.

    Recent Awards

    • Jacqueline Seroussi Memorial Foundation for Cancer Research Award, 2005
    • European Institute of Oncology Award for Breast Cancer Research, 2002

    Research

    Q-TWIST, Quality-Adjusted Survival, and Cancer Clinical Trials

    Treatment decision-making requires an assessment of risks and benefits. For chronic diseases such as cancer and AIDS, this involves balancing the potential for controlling the disease and improving survival with the burdens of toxic side effects of treatment.

    Our group developed a method to incorporate quality of life (QOL) considerations into comparisons of therapies. The Q-TWiST (quality-adjusted time without symptoms of disease and toxicity of treatment) method obtains a patient-oriented assessment of treatment differences. Q-TWiST has been applied to compare treatments for breast cancer, rectal cancer, HIV infection, brain tumors, melanoma, and childhood leukemia.

    Recently we also developed a new statistical method called STEPP (subpopulation treatment effect pattern plot), which estimates the magnitude of treatment benefit for a sequence of patient subgroups defined by a characteristic of interest, such as age. By examining the pattern of treatment differences, the method can enhance interpretation of clinical trial results for individual patient decision-making.

    Treatment regimens developed at DFCI during the past three decades have increased the success rate for children with acute lymphoblastic leukemia from 30% in the early 1970s to more than 80% today. Therapies used to achieve these exceptional results, however, are associated with acute and late toxic effects. Longitudinal assessment of QOL is necessary for understanding how these effects influence patients' lives. With coinvestigators in Pediatric Oncology, we are conducting clinical research programs to reduce treatment side effects and improve QOL without compromising overall survival for children with cancer.

    Development of effective adjuvant therapies for breast cancer represents another important initiative. The International Breast Cancer Study Group (IBCSG, formerly the Ludwig Group) has been conducting large, randomized phase III clinical trials evaluating these therapies since 1978. Our group is the Statistical Center for the IBCSG. Having conducted trials to investigate the timing and duration of chemotherapy, the IBCSG has made significant contributions to our understanding of the role of combined chemoendocrine treatments.

    Studies that integrate clinical outcomes with potential biologically based predictors of treatment response are also a high priority for the IBCSG. Recently our Statistical Center initiated three large-scale clinical trials for very young women with breast cancer. These trials (known as SOFT, TEXT, and PERCHE) represent a major global collaboration involving North American and worldwide participation.

    Select Publications

    • Lipshultz SE, Rifai N, Dalton VM, Levy DE, Silverman LB, Lipsitz SR, Colan SD, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin MA, Gelber RD, Sallan SE. The effect of dexrazoxane on myocardial injury in doxorubicin-treated children with acute lymphoblastic leukemia. N Engl J Med 2004;351:145-53.
    • Castiglione-Gertsch M, O'Neill A, Price KN, Goldhirsch A, Coates AS, Colleoni M, Nasi ML, Bonetti M, Gelber RD; International Breast Cancer Study Group. Adjuvant chemotherapy followed by goserelin versus either modality alone for premenopausal lymph node-negative breast cancer: a randomized trial. J Natl Cancer Inst 2003;95:1833-46.
    • Dalton VK, Rue M, Silverman LB, Gelber RD, Asselin BL, Barr RD, Clavell LA, Hurwitz CA, Moghrabi A, Samson Y, Schorin M, Tarbell NJ, Sallan SE, Cohen LE. Height and weight in children treated for acute lymphoblastic leukemia: relationship to CNS treatment. J Clin Oncol 2003;21:2953-60.
    • Cunningham CK, Balasubramanian R, Delke I, Maupin R, Mofenson L, Dorenbaum A, Sullivan JL, Gonzalez-Garcia A, Thorpe E, Rathore M, Gelber RD. The impact of race/ethnicity on mother-to-child HIV transmission in the United States in Pediatric AIDS Clinical Trials Group Protocol 316. J Acquir Immune Defic Syndr 2004; 36:800-7.
    • Gelber RD, Bonetti M, Castiglione-Gertsch M, Coates AS, Goldhirsch A: International Breast Cancer Study Group (IBCSG). Tailoring adjuvant treatments for the individual breast cancer patient. Breast 2003;12:558-68.
    • Goldhirsch A, Wood WC, Gelber RD, Coates AS, Thurlimann B, Senn H-J. Meeting highlights: updated international expert consensus on the primary therapy of early breast cancer. J Clin Oncol 2003;21:3357-65.
    • Dellapasqua S, Colleoni M, Gelber RD, Goldhirsch A. Adjuvant endocrine therapy for premenopausal women with early breast cancer. J Clin Oncol 2005;23:1736-50.
    • Colleoni M, Viale G, Zahrieh D, Pruneri G, Gentilini O, Veronesi P, Gelber RD, Curigliano G, Torrisi R, Luini A, Intra M, Galimberti V, Renne G, Nole F, Peruzzotti G, Goldhirsch A. Chemotherapy is more effective in patients with breast cancer not expressing steroid hormone receptors: a study of preoperative treatment. Clin Cancer Res 2004;10:6622-8.
    • Bonetti M, Gelber RD. Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 2004;5:465-81.
    • Cole BF, Gelber RD, Gelber S, Mukhopadhyay PA. A quality-adjusted survival model (Q-TWiST) for advanced stage cancer. J Biopharm Stat 2004;14:111-24.