Gita Thanarajasingam, M.D.

Why did you choose to study clinical and translational research?

Gita Thanarajasingam, M.D., is a scholar in the CCaTS KL2 Mentored Career Development Program at Mayo Clinic.

As a practicing lymphoma oncologist, I have the privilege of caring for patients during very difficult times in their lives. Cultivating the expertise to treat lymphoma and being a compassionate physician at the bedside is crucial in this role. In addition to the patients I see in the clinic today, I also think of the patients with this disease whom I have yet to see — the ones who will come next year, in the next decade and for years after that.

I chose clinical and translational research because it is the pathway to improving the understanding of cancer and its treatment for the patients with lymphoma who are yet to come. In tandem with providing the best care for my patients now, I am committed to patient-focused clinical research as an essential avenue to making cancer therapy more effective and better tolerated for the patients of the future.

What type of research are you doing?

My research focuses on understanding adverse events of newer cancer treatments.

Historically in cancer clinical trials, researchers focused on the incidence of high-grade or very severe toxicities, as recorded by investigators. When the goal was to ensure that patients could survive intensive, short-duration, cytotoxic chemotherapies, this investigator-driven "maximum-grade" approach was suitable.

More recently, however, treatment for cancer has evolved and includes oral targeted therapies, immune therapies and cellular therapies, among others. Many of these novel treatments are administered chronically — sometimes for months or years at a time. The symptomatic adverse events that patients experience on these treatments are starkly different to conventional chemotherapy.

Immune checkpoint inhibitors in particular bear unique, time-dependent, immune-related adverse events. While the maximum-grade approach remains relevant in assessing the safety of these therapies, it misses up to half of patients' symptoms and does not incorporate the patients' perspectives on the impact of symptomatic adverse events, which can be substantial in patients on immune checkpoint inhibitors. Additionally, the maximum-grade approach provides no information on the time profile of immune-related adverse events.

Symptomatic adverse events over time may have a substantial impact on a drug's tolerability over time and the patient's quality of life while receiving treatment. My goal is to improve the way researchers capture and analyze data on adverse events by incorporating the patient's perspective and evaluating adverse events over time.

While in fellowship, I developed a novel, longitudinal statistical approach to evaluating the toxicity of cancer therapy called the Toxicity over Time (ToxT). Under the mentorship of Dr. Amylou C. Dueck, Ph.D., I have been able to expand this work to include patient-reported toxicity data. I have also led a landmark international commission focused on improving adverse event assessment that defined priorities for work in this area.

In the research for my KL2 award, I am performing a pilot feasibility clinical trial to evaluate a novel approach to collecting data on immune-related adverse events directly and electronically from patients receiving immune checkpoint inhibitors. To do this, I'm using a tool called the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE).

I then plan to analyze this patient-derived toxicity data longitudinally with ToxT to better understand the time profile of immune-related adverse events caused by immune therapies and their impact on a patient's tolerability of treatment over time.

The ultimate goal is that these analyses inform patient and provider education on when adverse events might be expected to occur, how long they will last, and when they will be worst, for example. More importantly, it could improve symptom-control strategies directed at managing adverse events to make the treatment experience better and more tolerable to real-world patients on immune checkpoint inhibitors and other newer, chronically administered cancer therapies.

Why Mayo Clinic?

I first came to Mayo Clinic as a medical student and was struck by the institution's intrinsic philosophy of patient-centeredness. After completing a competitive residency in internal medicine at the Brigham and Women's Hospital and Harvard Medical School, I returned to Mayo Clinic for fellowship because of Mayo's tangible commitment to the needs of the patient.

During my fellowship, as I began to engage in hematology and oncology research, it was apparent that in addition to the top-notch patient care Mayo Clinic provides, we maintain a lofty track record of patient-centered research. Mayo supports the type of multidisciplinary collaboration that Dr. Dueck and I have forged, which ensures the high clinical relevance of the research we perform in hematology, oncology and biostatistics.

In its view of the patient as a whole beyond the disease, Mayo Clinic values health services research, which looks not only at the most effective treatments, but also at patients' experiences and quality of life on treatment.

What are you looking forward to as a KL2 scholar?

As a KL2 scholar, I am looking forward to cultivating skills in biostatistics, clinical research and qualitative research methods.

I am also delighted to formally assemble a committed team of seasoned Mayo Clinic mentors including Dr. Dueck; Thomas E. Witzig, M.D.; Charles L. Loprinzi, M.D.; Jon C. Tilburt, M.D.; and my extra-institutional mentor at the University of North Carolina, Ethan Basch, M.S., M.D., for their guidance in the proposed research and my early career development.

I believe the KL2 program will provide the foundation for me to develop into an independently funded health outcomes clinical investigator focused on improving the patient experience of cancer treatment.

Review Dr. Thanarajasingam's publications on PubMed.