Archive for May, 2010

Genomes to Health: The Path to Better and More Personal Cancer Care

May 20, 2010

We now recognize that most cancers are not one disease, rather they appear to be many complex diseases with distinct causes. Even so, doctors make decisions every day (about 700,000 decisions every year in the U.S. alone) about how to treat individual patients’ cancers without the benefit of tools that could define important underlying characteristics of each and every unique tumor. Much-needed guidance is lacking for choosing among treatment options for the individual.

Genomic information and tools that have emerged in the past decade could change this—starting today. At Duke, we have been wrestling with how to translate genomic science and information into something that can be made practical and accessible to patients and their physicians.

The key to making these novel findings from genomic medicine a part of standard medical practice is to show that they actually improve patient care and disease outcomes. Genome-guided clinical trials and research from a new cancer registry led by the Duke Institute for Genome Sciences & Policy are moving genomics into clinical care for breast, prostate and lung cancer. We plan to expand our efforts in other cancers, as well as other common diseases such as type 2 diabetes. 

Through participation in these trials or the registry, some patients and their physicians at Duke and in an emerging genomic trials network are now getting early access to this kind of genomic information while they help build the future of medicine, which we believe can be both better and more cost effective.

We call this initiative “Genomes to Health”, and here’s how it works. A person with breast, lung or prostate cancer comes to Duke or one of our network partners around the country for evaluation and consents to having a biopsy for genomic and genetic analysis. Based on the characteristics of the patient’s disease, and the results of their biopsy analyses, several options are possible including:

  • The patient is deemed eligible for one of the ongoing genome-guided clinical studies in breast, lung and prostate cancer and is offered the opportunity to enroll in the trial.
  • The patient is not eligible for one of the Duke trials but may be eligible for an ongoing trial outside of Duke and is referred to that study.
  • If the patient is not eligible for an ongoing clinical trial, either at Duke or at an outside institution, the patient can be entered into a registry study in which their clinical outcomes will be followed for future study and possibly future eligibility in a genome-guided study.

For more about ongoing genome-guided clinical trials and the registry, visit

This initiative at Duke is just one of many such efforts around the country to use robust health databases and informatics tools to combine clinical and genetic information to support higher quality, more personalized care.  Innovations like these are part of the answer to containing costs while improving outcomes and the patient experience.

Geoff Ginsburg is director of the Center for Genomic Medicine at the Duke Institute for Genome Sciences & Policy.

Major Studies Highlight Gains in Personalized Medicine for Lung Cancer and Heart Transplant Patients

May 6, 2010

Two important studies announced in recent weeks illustrate how continued progress is personalized medicine is leading to better patient care. 

The first study, published in the New England Journal of Medicine, demonstrated that XDx’s AlloMap® gene test is as effective as biopsies in helping doctors identify organ rejection in heart transplant patients, thereby offering patients a non-invasive alternative to painful routine biopsies of heart muscles. Instead, AlloMap, a blood test based upon 11 genes that regulate immune system processes, allows doctors to determine a patient’s overall risk of rejection.

When presenting the results of the study at a meeting of the International Society for Heart & Lung Transplantation, the lead researcher Michael X. Pham of Stanford University Medical Center said, “We found that you’re not going to harm patients by reducing the number of biopsies.” 

The results of a second landmark study were presented at the annual meeting of the American Association for Cancer Research (AACR). In the BATTLE (Biomarker-integrated Approaches of Targeted Therapy for Lung Cancer Elimination) study conducted by researchers at the University of Texas M.D. Anderson Cancer Center, tumor biopsies were gathered from 255 patients with advanced lung cancer as they enrolled in the clinical trial. The first 40 percent of patients enrolled in the study were randomly assigned one of four therapies: erlotinib (Tarceva), sorafenib (Nexavar), vandetanib (Zactima) or a combination drug, Targretin (erlotinib with bexarotene). After eight weeks (an accepted indicator for overall survival), the researchers used diagnostic imaging to assess the effectiveness of the assigned treatments. Together with information from the biopsies collected at the beginning of the study, this information on outcomes was then used to assign a particular treatment to new patients enrolling in the clinical trial with similar tumor types – therefore, assigning a drug that had worked effectively for earlier patients with the same tumor biomarkers.

By employing an adaptive clinical trial design, the researchers were able to pave the way forward for a treatment approach to be determined based upon the genetic characteristics of the tumor type, thus circumventing a trial-and-error approach that patients facing a deadly disease cannot afford. In the end, almost half the patients achieved disease control in eight weeks, compared to 30 percent when biomarkers are not a part of treatment decisions.

These studies add to the growing list of recent advances in personalized medicine. More advances are on the horizon that will give physicians and patients new tools to select the right treatment for the right patient at the right time.

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