SCOTTSDALE—The system of clinical cancer research, including that of head and neck cancer, is in need of an overhaul, but steps are being taken that might lead to more efficient work and will hopefully mean more medical breakthroughs, said David Schuller, MD, the chair in cancer research at the Ohio State University College of Medicine in Columbus, at the Triological Society’s Combined Sections Meeting, held here on Jan. 27.
“It truly is an inefficient process,” said Dr. Schuller, a guest speaker at the meeting. “There are a lot of delays. There is really not much in the way of formal prioritization.”
Federal funding has been stagnant for the past several years, stuck at about $160 million a year, he said. Additionally, he said, there is “extensive, if not excessive, oversight of the process.”
There are now 10 organized cancer cooperative research groups, composed of 14,000 investigators—making for a fierce competition for study subjects.
“They only accrue 25,000 patients a year,” said Dr. Schuller, a co-chair of the National Cancer Institute (NCI) Head and Neck Steering Committee. “And so we have a bunch of physicians that are bumping into one another that are waiting for the next patient to be approved to a trial.” When it comes to more uncommon malignancies, the problem is worse, he said.
But, he said, “there are also possible solutions. It’s not that this has been an unrecognized problem.”
In 2005, the NCI created a series of steering committees tasked with coordinating cancer research throughout the U.S. The steering committee for head and neck cancer was formed in 2007.
At the NCI’s request, the Institute of Medicine (IOM) conducted a review of the Clinical Trials Cooperative Group Program. The IOM released its report in 2010 that included goals for the NCI, including improving the speed and efficiency of trials, incorporating innovative science and trial design, improving prioritization and selection of trials and better incentivizing for physicians and patients who participate.
To do this, the IOM recommended consolidating some research groups using pre-defined metrics to make those choices; downsizing disease-site committees; consolidating back-office operations; better coordinating and streamlining protocol development and increasing reimbursements in high-ranked trials.
The IOM also recommended the implementation of a national inventory of biosamples, a suggestion that Dr. Schuller said was particularly important.
“We are increasingly recognizing the importance of biorepositories,” Dr. Schuller said. “On a national level, though, we really don’t have a good system of coordinating that to maximize the use of these preciously important samples.”
The NCI, in response, is recommending that the 10 Cooperative Adult Research Groups be combined into four. It noted that the four pediatric research groups previously were combined into one, and that group should remain.
According to the NCI, the new system will be able to perform better in cases of less common malignancies; in studies requiring sophisticated imaging; in those that require rapid molecular characterization of tumors and in those that involve access to nationally overseen tissue resources. And it will prioritize studies, taking into account all diseases and methods of care.
Dr. Schuller applauded these goals. “They really have important relevance to the challenges we have to do in this kind of work as we deal with these relatively infrequent malignancies,” he said.
As for the Head and Neck Steering Committee’s work, in 2008, after a two-day planning meeting, members concluded that HPV-positive and HPV-negative cancers must be considered two separate diseases requiring separate trials. The committee also recommended that a central reference lab be used for fast turnaround and that the treatment of choice should be intensity-modulated radiation therapy. That work is about to yield benefits, Dr. Schuller said.
In February, the Radiation Therapy Oncology Group is due to begin a Phase III trial in which radiotherapy plus cetuximab is measured against chemoradiotherapy in HPV-associated oropharynx cancer. The results could lead to wider use of radiotherapy and cetuximab, a less toxic alternative.
“We’re quite excited about this first-ever trial,” he said, “that hopefully is going to lead the way for us to really truly analyze the role of this therapy in this favorable group of HPV-associated cancers.”
William Shockley, MD, chief of facial plastic and reconstructive surgery at the University of North Carolina in Chapel Hill, said the new approach to research brings high hopes. “[Dr. Schuller’s] main point was that there are many organizations that have overlapping functions. And I think that one of the big things that he pointed out was that we are gong to see consolidation,” he said. “And, hopefully, as we consolidate some of our efforts, some of our tissue banks, some of our organizations, we’ll be able to see some improvements of efficiency in how quickly we can study things, how well we can study the treatment of cancer.”