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ADVANCE Discourse: Lab

Basket Cases

Published February 27, 2015 4:29 PM by Michael Jones

Thanks to the quick evolution of improved genetic sequencing capabilities, the concept personalized medicine has changed the way clinicians and physicians are thinking about patient treatment. Traditionally, the trial and testing period for clinical drugs going through the FDA approval process can be challenging, lengthy and exhausting for all parties involved – especially the patients. A recent article from the New York Times highlighted a new approach to drug prescriptions for cancer patients focused more on their individual genetic mutations than the specific type or origin of the cancer itself.

According to the article, Erika Hurwitz, a patient with a rare white blood cell cancer, was treated with a drug typically reserved for melanoma patients and somehow recovered despite the odds. The new technique, referred to as “basket studies,” involves screening patients for mutations and applying drugs that target those specific mutations regardless of the drug’s intended use or what part of the body the cancer has affected. Not only have these “blanket studies” been applied in individual healthcare facilities and networks, but the federal government has stepped in to continue the research with a screening program to be introduced in the spring.

Introduced fairly recently as the accessibility and price of genetic sequencing became reasonable, “Basket studies” are typically smaller and without control groups.  The studies have produced results in the extreme on either end of the spectrum, having both dramatically improved patients and shown no effect at all. Despite the black-and-white nature of the results, the article noted the drastically higher response percent of the new approach – a response rate of 50-60 percent as opposed to 10-20 percent in traditional studies, according to Richard Pazdur, MD, of the FDA in the NY Times story.

The NY Times story noted the Memorial Sloan Kettering study, which included Erika Hurwitz, saw several patients respond positively to the melanoma drug, but not everyone’s results were so successful. One stomach cancer patient, Eleni Vavas, entered the study, but didn’t respond to the drug. She passed away in July.

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