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

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.