Session moderator Laura A. Dawson, MD, of the University of Toronto, commented on this study by Dr. Ross and colleagues for The ASCO Post: “Moving forward, I think we need to change the way we make treatment decisions, no question. Treatment based on profiling is the way of the future. Dr. Ross’ results are very exciting, but at the end of the day, my bias is that we still need to do clinical trials. We need to learn, in a prospective setting, how this targeting may change outcomes compared to the standard of care. We need to incorporate profiling into trials.”

“Off trials,” she added, “we also need a prospective database or registry, where clinicians can share outcome data about their ‘n of ones.’” Unfortunately, we mainly hear about the success stories. Having an actionable mutation does not guarantee that the patient will respond to a targeted therapy, since there are many factors that may impact outcomes, including nontumor factors.”

Dr. Ross agreed that “prospective randomized trials are the final determiner” of the success of this approach. One such trial underway is the Lung-MAP study in advanced squamous cell carcinoma. This trial will sequence up to 1,000 tumors a year using the same assay from this study and will assign patients to second-line treatment based on the genetic profile. Many phase I trials are also using sequencing to identify targets and randomize patients to targeted agents or standard of care. ■

Disclosure: Dr. Dawson reported no potential conflicts of interest.