Sledge Expects "Big Data" to Generate Big Changes

Anita T. Shaffer @Shaffer1
Published: Wednesday, May 15, 2013
Dr. George W. Sledge

George W. Sledge Jr, MD

The 30th Annual Miami Breast Cancer Conference® provided a forum for exploring the latest research, techniques, and analyses of all aspects of caring for patients with breast cancer, including updates in surgical, medical, and radiation oncology. Physicians’ Education Resource (PER) hosted the conference, which took place March 7-10, 2013, in Miami Beach, Florida. The technological advances in analyzing the human genome have spawned a new era in breast cancer as well as other types of malignancies that will affect oncology practice and will necessitate dramatic changes in the clinical trials system, according to George W. Sledge Jr, MD.

Sledge told attendees at the 30th Annual Miami Breast Cancer Conference that 2012 marked a leap forward in understanding breast cancer as the results of many genomic analyses became available. The range of mutations uncovered in individual tumors will require moving beyond battling cancer by identifying a particular molecular process, as has been the case in the targeted therapy era.

“We’re clearly entering a new age, and that age is what I consider to be the genomic era,” said Sledge, who is chief of the Oncology Division at Stanford University School of Medicine in California and a past president of the American Society of Clinical Oncology. “This is an era of great promise. We’re at the point where we’ll be able to tell an individual what’s driving their cancer, but it’s going to require a whole lot more of us.

In developing new therapeutics, researchers will have to focus not only on qualitative mutations but also quantitative aberrations, Sledge said. “We don’t need a magic bullet, we need a magic shotgun,” he said. “We need something that can shoot pellets at a lot of different targets, and do so more or less simultaneously.”

He said the current clinical trials system is poorly equipped to take advantage of advances in knowledge about cancer genomics, and that many changes are needed. His ideas for overhauling the system include trials designed around multitargeting, greater collaboration among research entities, an information network for clinical trials, a redesigned informed consent process, and a “fundamentally different regulatory apparatus.”

“We have a next-generation sequencing. We need a next-generation clinical trials system, “ Sledge said.

Sledge noted that technological advances have delivered an explosion of information at an ever-decreasing cost. He said the sequencing of the first human genome took 13 years and cost approximately $3 billion; in the next several years, researchers likely will be able to sequence a genome in less than two weeks at a cost of about $1000. He said the price would drop further and that the challenge would be using the information generated.

“The evaluation of that gene chip that you order will be incredibly complicated and will require a significant amount of playing out over the next decade in terms of how we use it,” he said.

In an interview with OncologyLive, Sledge elaborated on his remarks.

Please expand upon your description of the new genomic era in breast cancer, as well as other types of cancer.

We’ve moved through a number of eras in the history of breast cancer. We started off with local-regional therapies, such as surgery and radiation. We then went to systemic therapies with drugs such as chemotherapy. The first targeted therapies were actually hormonal therapies dating back now several decades. In the last decade, the pace of research has picked up as we’ve learned more about the biology of the disease. This has led, of course, to an explosion of new, targeted therapies, not just for breast cancer but for all cancers.

I would argue that we’re moving into a new era. And this genomic era is going to be an era in which big data will come to the fore, where we will do deep sequencing or something like it on every patient’s tumor, and for that matter, on the host genome as well. We will have exquisite details and understanding of what is driving the biology of an individual’s cancer, and, hopefully we’ll have the tools available that will allow us to interfere with that biology on the very individual level.

Now, that’s got real pluses and minuses at the same time. The plus, of course, is that when you truly individualize therapy you won’t be treating the patient with drugs that might make them sick. You will be treating them with drugs that might keep them well. That therapeutic individualization with targeted therapies is certainly what we hope for and what we aspire to.

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