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Jinani Jayasekera, PhD
Research Instructor, Statistical Modeling
American Society of Preventive Oncology
Seeking to improve assessment of quality of life and patient outcomes from clinical trial data.
A computer simulation model is tested for its efficiency at predicting the effect of chemotherapy on long-term quality of life measures.
This innovative research will move the field forward by demonstrating how clinical trial simulations can provide missing information in cancer treatment and outcomes.
For newly diagnosed women with estrogen receptor (ER)-positive breast cancer, the Oncotype DX® test is used to determine whether chemotherapy is recommended in addition to anti-estrogen therapy to prevent breast cancer recurrence. The TAILORx trial demonstrated that women with a low or intermediate Oncotype score could safely forego chemotherapy, but a crucial limitation of the trial is that it only followed patients for 5 years. Dr. Jayasekera has developed a simulation model to test whether the TAILORx conclusions hold true longer than 5 years. Initial findings confirm that women in the low risk group maintain a very low risk of recurrence at 15 years without chemotherapy.
Full Research Summary
Oncotype DX® test is useful in the identification of women who have a low risk of recurrence and can safely avoid chemotherapy. However, there are persistent gaps in knowledge on the use of Oncotype testing in treatment decisions to minimize harms and maximize benefits of chemotherapy among women with favorable prognosis breast cancer.
The TAILORx trial is testing the clinical usefulness of Oncotype DX® recurrence score (RS) to omit chemotherapy in patients with favorable prognosis tumors. In 2015, the TAILORx investigators reported very low rates (less than 5 percent) of recurrence and overall mortality at 5 years for those with an Oncotype DX® RS of <11, suggesting that these women may safely omit chemotherapy. In 2018, TAILORx researchers reported that women in the intermediate group (RS 11-25) could also forego chemotherapy. However, late recurrences (after 5-years) account for approximately one half of all distant recurrences in ER+/HER2-, node negative breast cancers.
During the first year of her American Society of Preventive Oncology (ASPO) award supported by BCRF, Dr. Jayasekera built a simulation model to evaluate long-term outcomes in women diagnosed with early-stage, node negative, hormone-receptor positive breast cancer with Oncotype recurrence scores of 0-10. In this low-risk group, the model projections showed that long-term recurrence rates remain low at 15-years of follow-up with omission of adjuvant chemotherapy.
In the coming year, Dr. Jayasekera will conduct similar analyses in other Oncotype risk groups. Overall, this innovative research will move the field forward by demonstrating how clinical trial simulations can provide missing information in cancer treatment and outcomes.
Jinani Jayasekera is a Research Instructor in the Department of Oncology at Georgetown University Medical Center. Her current research focuses on the application of mathematical simulation modeling to extend clinical trials and develop web-based decision support tools to guide treatment decisions in early-stage breast cancer. Her research aims to translate clinical trial findings to clinical practice in the context of genomic advances and personalized health care. She is actively involved in multidisciplinary collaborative research projects, ranging from disparities research, cost-effectiveness analysis, and claims-based analysis evaluating the clinical and economic burden of cancer. Under the mentorship of Drs. Jeanne Mandelblatt, Donald Berry and Clyde Schechter, she recently completed a clinical trial simulation project evaluating non-inferiority in the omission of radiation therapy among women with stage I, node negative, ER positive, HER2 negative breast cancers with a low risk of recurrence.
Dr. Jayasekera holds a Bachelor’s in Pharmacology and obtained a Master’s in Financial Economics at University of Colombo, Sri Lanka. She subsequently earned her Master’s and PhD in Pharmaceutical Health Services Research at the University of Maryland. In 2017, she was the recipient of the American Cancer Society Institutional Young Investigator Award granted by the Georgetown-Lombardi Comprehensive Cancer Center. She has presented her research at several national and international meetings. She is also a recipient of the 2013 Society for Medical Decision Making (SMDM) Lee Lusted Award in Applied Health Economics.
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