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Views of leading cancer researcher, Dr. Apostolia M. Tsimberidou

Reporter: Ritu Saxena, Ph.D.

Since the inception of personalized medicine, it has been visualized that a patient walking into a doctor’s office would be recommended a treatment tailored around his/her genetic and molecular profile. Although this idea of personalized medicine still seems far-fetched, it is currently being implemented in a few clinics, including that of Apostolia M. Tsimberidou, MD, PhD.

Dr. Tsimberidou is an associate professor in the Department of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center and a member of the American Society of Clinical Oncology (ASCO) Educational Committee. She is also the brains behind a large study of personalized medicine-based cancer treatment. The findings of her successful phase I clinical trial in late-stage cancer patients has attracted a lot of attention. I recently had a chance to interview her and find out her views on the current status, challenges and future of personalized medicine.

Dr. Tsimberidou explains the basis of her study, “We analyze tumors from patients with cancer to identify molecular aberrations, which are then used to select optimal treatment.” On the basis of the molecular aberrations determined, the patients were recommended for treatment with matched anti-cancer therapeutic drugs. The results obtained in terms of clinical outcomes of patients were intriguing. Among patients harboring one molecular aberration, there was a significant improvement in the median survival duration of patients who underwent matched therapy (13.4 months) as compared to patients treated without matched therapy (9 months). Matched therapy patients also showed a better overall response rate of 27% vs. 5% in unmatched patients. Another criteria measured was the time-to-treatment failure which was again longer with matched targeted therapy, 5.2 months compared to 3.1 months with systemic therapy. The results of the study were published recently in Clinical Cancer Research. Essentially, the study concluded that there is a better chance of drug response and longer survival in patients who have been administered drugs according to their molecular signature. This is indeed good news for patients suffering from the disease.

So, how does the success of matched-therapy translate to the clinic? “What we propose is the optimization of treatment by taking into consideration multiple factors, including the genetics and molecular status of tumors, and that the process becomes a part of regular clinical practice,” explains Dr. Tsimberidou.

When Dr. Tsimberidou and her colleagues at MD Anderson Cancer Center started the phase I clinical trial for personalized medicine in 2007, they faced numerous challenges. The biggest challenge she describes was “dealing with the inertia of the existing system”. “It is easy for an insurance company to approve payment for a CAT-scan, but it is still challenging to cover the cost of a new biopsy and tumor molecular analysis from a patient who has suffered from cancer for over 10 years. Hopefully, there will be a shift in the approach.” How could a shift in the approach be achieved? “Researchers need to continue to carefully design prospective clinical trials, including small phase II clinical studies with targeted agents against tumor molecular aberrations.” She emphasizes that “resources–time, energy and funds–to conduct clinical trials are very limited. Using the approach of matched therapy earlier during the course of the disease could give better results.”

Dr. Tsimberidou states, “The most important thing is that we need to take advantage of the available technology to make advances in tumor molecular profiling and drug discovery. We need the technologists, molecular biologists, health care professionals and regulators to work together and expedite the use of the existing technology to identify tumor abnormalities and to discover novel drugs. We need to access, learn and share with each other to determine what the optimal therapeutic approach for every patient is.”

According to the American Cancer Society, the probability that an individual will develop or die from cancer over the course of a lifetime (lifetime risk) in the United States is less than a 1 in 2 for men; and a little more than 1 in 3 for women. Thanks to passionate and committed researchers like Dr. Tsimberidou, personalized medicine-based cancer treatments might take us a few steps closer to curing the disease.  Dr. Tsimberidou concludes, “We have to develop innovative treatment protocols and to offer the best treatment possible for each of our patients”.

Reporter

Ritu Saxena, Ph.D.

Author, Reporter, Curator @ Leaders in Pharmaceutical Business Intelligence

https://pharmaceuticalintelligence.com/

Research article:

Personalized medicine in a phase I clinical trials program: the MD anderson cancer center initiative.

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