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Evidence-Based Oncology September/October 2013

Challenges in Oncology Practice

A Discussion With Anupama Kurup Acheson, MD, 2013-2014 Chair of the ASCO Clinical Practice Committee
It’s very encouraging that the FDA is using regulatory flexibility to speed up the approval process for breakthrough therapies for life-threatening diseases. ASCO supports this and has worked closely, for example, with the agency’s Office of Hematology and Oncology Products to host workshops to advance surrogate end points for use in specific cancer types to enable use of the accelerated approval mechanism. In each case, how quickly these drugs are approved depends on the data and how easy they are to collect. The FDA has demonstrated the ability to approve agents on the basis of trials that involve a relatively small number of participants. This translates to earlier access to the agents, but this does place the responsibility on us as clinicians to closely monitor patients for unexpected side effects and on organizations like ASCO to advise our members that they may have to change treatment plans if there are adverse effects or drugs are not working. We also need to keep a close eye on information from clinical trials, understanding that use of agents in this setting is experimental, even if the agent is already approved for a different indication.  Particularly in the case of agents approved via the accelerated approval mechanism, the approval is granted on the basis of a surrogate end point that is reasonably likely to predict clinical benefit. We need to stay in touch with confirmatory studies and data from these trials to understand whether the agent meets the clinical benefit expectation.

Are independent oncologists enrolling their patients in clinical trials? What are the practice implications?

Independent oncologists are interested in enrolling their patients in clinical trials, and just over a quarter of practices say they are involved in them. But there are significant additional costs associated with conducting clinical trials, and the National Cancer Institute (NCI) doesn’t adequately reimburse for trials conducted through the Cooperative Group system. Changes the NCI and Cooperative Groups are implementing are helping to streamline the system and standardize the process, but the costs of conducting NCI-funded trials are not adequately compensated. This means practices lose money. In ASCO’s survey on the sequester, a quarter of practices polled said they  had stopped participating in them because of funding costs. Patients who are enrolled in trials need to be closely monitored, and nurses and other staff must take the time to counsel them. In addition, clinical trial participation involves staff with specialized expertise, increased data collection, facilities to store records and investigational agents, and time and space to accommodate auditors. On another note, ASCO is in the process of developing recommendations that will help design trials with more clinically meaningful outcomes. We are hoping that trial sponsors will use these recommendations to prioritize development of trials with outcomes that hold greater clinical benefit. In addition, another ASCO group is examining eligibility criteria with the goal of limiting exclusionary criteria that prevent patients from qualifying for trials. If eligibility is so stringent, it makes screening incredibly challenging and raises questions about how widely applicable a given treatment is down the road.

How are oncologists improving the quality and value of the care they provide, and how are they measuring their performance?

The QOPI is the first national program in oncology. It covers the spectrum of practice/diagnosis, treatment, and assessment—and a range of services, including psychological counseling and end-of-life care. QOPI includes 160 quality measures, including 26 core measures. There are 17 standards alone for safely administering chemotherapy. It’s a rigorous process, but it gives practices that participate detailed reports on how they’re performing compared with national averages. And it’s an excellent way to manage quality care and a valuable learning tool. To date, 850 practices are registered with QOPI and 180 have gone through the process and received certification. On the quality front, ASCO has just launched a prototype health information computer network called CancerLinQ that will collect and analyze individualized patient data from millions of visits and provide practitioners clinical guidance for real-time personalized care. For example, by inputting tumor characteristics, the provider would receive recommendations on what personalized therapies to pursue based on expert guidelines. This is a new way to get doctors information they can use in real time. They can also explore the database, which includes data on patient characteristics, treatments, and outcomes from a variety of sources to identify real-world trends. The system will also provide feedback on the services performed based on QOPI quality measures.

What is the impact of genetic testing on both oncology practice and care?

Tests such as companion diagnostics, biomarker tests, and next-generation sequencing allow us to provide more personalized care. These tests hold incredible promise to help us deliver molecularly targeted agents to the appropriate patient population, particularly with next-gen sequencing tests; however, they are not always available to community-based oncologists, and also may not be eligible for insurance coverage. We also need to be mindful of clinical utility. Some tests and use of molecularly targeted agents are of questionable applicability. It’s important to be clear about tests and procedures that provide meaningful clinical information to direct choice of treatment. We are in an era of rapidly expanding knowledge of the molecular basis of cancer, and it is important that we are clear about the difference between research, emerging data, and evidencebased care, so that we accurately present risk and benefit information to patients. As part of the American Board of Internal Medicine’s “Choosing Wisely” campaign, ASCO developed a “Top 5” list of procedures and tests whose use should be questioned. More generally, everyone looks to genetic testing for simple answers, but they are not always available. Just because we know A, B, C, and even D about a patient, there maybe other factors driving their cancer, including environmental inputs. Going forward, this is another area where CancerLinQ should shed some light as we are able to aggregate data quickly on treatment outcomes in the larger population of cancer patients.

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