GRACE LU-YAO, PHD, MPH, ASSOCIATE PROFESSOR, DEPARTMENT OF MEDICINE, UMDNJ-ROBERT WOOD JOHNSON MEDICAL SCHOOL

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The Cancer Institute of New Jersey (CINJ), located at 195 Little Albany Street, is the site where we have used a large national database on cancer, crunching hundreds of gigabytes of data in search of answers to unresolved clinical issues related to prostate cancer. This cancer is the most common non-skin cancer among men. However, unlike the majority of other cancers, it often progresses slowly, so has little impact on overall survival for the majority of patients. The slow progression of the disease, in most cases, presents special challenges to oncologists, who need to balance the risks and benefits of intervention in early stage prostate cancers. Our research team, led by Grace Lu-Yao, PhD, MPH, which is defining standards for modern patients diagnosed in the prostate specific antigen (PSA) era, has received international attention in recent years for this work.

Since 2004, Dr. Lu-Yao has been working with the biostatistics team at CINJ. Our group of researchers has refined and applied instrumental variable analytic (IVA) methods to address clinical issues that are unlikely to be solved by clinical trials. IVA is a method of capturing the random component of patient treatment choice and using it to balance treatment groups, so that two different treatments can be compared with minimal bias.

The first major clinical problem that the team tackled was setting out to determine whether use of hormone therapy improves survival among men with prostate cancer that has not spread elsewhere in the body. Hormone therapy is a treatment that suppresses prostate cells and is commonly used for men whose prostate cancer has spread to other parts of the body. This type of therapy highlights a treatment dilemma. In order to treat this type of cancer early, many oncologists have been using hormone therapy in prostate cancer patients even before the disease has spread beyond the prostate. But this practice has generated controversy since its value in such early stage cancer has not been well-established, and this therapy has many undesirable side-effects. Furthermore, randomized clinical trials — the gold standard for evaluating risks and benefits of a therapy — are difficult to conduct in the largely elderly population for which the therapy might be given. The number of patients with localized disease who are treated with hormone therapy tripled between 1989 and 2001 even though there has not been any clinical proof that it works in these circumstances.

LEFT TO RIGHT: ROBERT DIPAOLA, MD; GRACE LU-YAO, PHD, MPH; DIRK MOORE, PHD; YONG LIN, PHD; SIU-LONG YAO, MD; JOE SHIH, MD

Through the use of instrumental variable analysis and a large national database, our team found that hormonal therapy was not clinically beneficial for most men with localized prostate cancer who did not undergo surgery or radiation therapy. However, the team also found that some men with very aggressive disease might benefit. Although many people think that when a patient is diagnosed with cancer, doing something is better than nothing, this may not be true. Because of the potential side effects of the treatment, men with localized, non-aggressive tumors should carefully consider whether hormone therapy is the best option, and they should discuss other options, such as localized radiation therapy, surgery, and active surveillance (watch and wait) with their physicians.

At the 2008 Genitourinary Cancers Symposium in San Francisco, our team gave a presentation that provided benchmarks for conservative management of prostate cancer. In July 2008, we published a study in JAMA comparing the 10-year outcomes of almost 20,000 men older than 66 who had early stage, localized prostate cancer. Approximately 40% of these men were treated with PADT (primary androgen deprivation therapy), which deprives the prostate of the male hormone androgen. At the end of 10 years, the group treated with PADT and the group that was not had similar survival rates. We concluded that hormone-blocking drugs do not improve survival in older men with early-stage prostate cancer. (A small subgroup of men suffering from a very aggressive form of the disease may have derived some benefit from the therapy). The study received wide international coverage and was awarded best faculty research endeavor at Robert Wood Johnson Medical School.

Grace Lu-Yao is an associate professor in the Department of Medicine at Robert Wood Johnson Medical School (RWJMS). Her primary research interests are the study of the epidemiology of prostate cancer and outcomes assessment of prostate cancer therapies. She earned her MPH and PhD from Yale University School of Medicine and was an assistant professor at Dartmouth Medical School before joining CINJ. She has received research funding from the Department of Defense, the NCI, the NIH, and the New Jersey Commission on Cancer Research. Her work has been published in the Journal of the American Medical Association (JAMA), Lancet, the Journal of Urology and the Journal of the National Cancer Institute. She is an elected fellow of the American College of Epidemiology.

Robert DiPaola’s primary research interest is prostate cancer. He is the director of CINJ and a professor in the Department of Medicine at RWJMS. He is chair of the Genitourinary Committee of the Eastern Cooperative Oncology Group (ECOG), an NCI supported cooperative group that develops national and international clinical trials. Dr. DiPaola is a recognized expert on prostate cancer and has authored numerous papers on this topic.

Siu-Long Yao is an adjunct assistant professor of medicine at RWJMS and executive director of oncology clinical research at Schering-Plough Research Institute. In addition to his research interests in prostate cancer, he is responsible for clinical development of promising oncology drugs at Schering-Plough. After completing undergraduate studies at the University of Pennsylvania, he attended Yale University School of Medicine and completed postgraduate studies in internal medicine at Dartmouth-Hitchcock Medical Center and in hematology and oncology at Johns Hopkins Hospital.

Weichung (Joe) Shih is professor and chair of the Department of Biostatistics at UMDNJ-School of Public Health (SPH) and director of the Biometrics Division of CINJ. He received his PhD degree in statistics from the University of Minnesota. His research focuses on statistical methodologies for laboratory and clinical studies. He is an associate editor for several journals, including Statistics in Medicine, Clinical Cancer Research and Statistics in Biopharmaceutical Research.

Dirk Moore has been an associate professor of biometrics at CINJ and at SPH since 2003. He received his PhD in biostatistics from the University of Washington. Before joining CINJ, he was associate professor of statistics at Temple University, where he also collaborated with researchers at the Fox-Chase Cancer Center.

Yong Lin is an associate professor of biometrics at CINJ and at SPH. He received his PhD in statistics from Pennsylvania State University in 1997 and joined UMDNJ in 1999. His research focuses on statistical methodologies; and he does a lot of collaborative work with laboratory and clinical scientists.

Calpurnyia Roberts recently received her doctorate from the University of North Carolina at Chapel Hill. She has a Master’s degree in epidemiology from Harvard School of Public Health and a BS in anthropology and human biology from Emory University. She is a post doctoral fellow whose research interests include understanding, reporting, and reducing health disparities in treatment practices by integrating epidemiology with health policy.

Yu-Hsuan (Joni) Shao is an epidemiologist who recently received her doctorate from SPH. She has a Master’s degree in environmental sciences from Johns Hopkins School of Public Health. She is a post doctoral fellow whose interests include creating clinical algorithms to improve the management of prostate cancer.

The team members above also work closely with Hui Li, analyst and PhD student in biostatistics, and research coordinator Thanusha Puvananayagan, as well as Michael Barry from Harvard Medical School, a past president of the Society of General Internal Medicine, and renowned urologist Peter Albertsen from the University of Connecticut.