Time isn't the only limiting factor. It's expensive to collect tumor biopsies and perform these complex assays. But Nevins says the cost isn't a major concern, and it could be borne by funding agencies like the National Cancer Institute and even pharmaceutical companies running drug trials. "That's not the 'make or break'," he says. "The 'make or break' is to work this into a trial that can still recruit patients." Although mandatory biopsies might be seen as "too onerous," the authors say demonstrating the power of biomarker development to guide effective treatments will provide incentives for patients to go the extra step. A recent trial of personalized lung cancer treatment at the University of Texas M.D. Anderson Cancer Center enrolled 200 advanced-stage lung cancer patients and collected biopsies from each of them. Similarly, 377 breast cancer patients gave biopsies in a neoadjuvant breast cancer trial at the University of Medicine and Dentistry of New Jersey.
The idea of personalized medicine in cancer is not new. "Personalizing cancer care" was the theme for the American Society of Clinical Oncology's 2009 annual meeting, yet most of the studies presented there were performed in broad patient cohorts, the authors wrote. "Conducting trials that evaluate drugs in unselected populations of patients, knowing that only a very small fraction of these patients will actually benefit from the drug, is a practice that should stop," they wrote. "We owe it to the patients, and to all of us who potentially will be patients, to change this practice if we are to make meaningful gains in implementing effective cancer therapy and winning the war on cancer. "