Chicago, IL—Clinical pathways have an important role in the integration of new cancer drugs into clinical practice. Between January 2015 and mid-2017, the FDA granted more than 60 new approvals in oncology, with new drugs accounting for the vast majority (as opposed to new indications). Staying abreast of new drugs and new indications for specific types of cancer requires much time, which presents an extra burden on community oncologists.
“I’m a specialist in thoracic medical oncology,” said Edward S. Kim, MD, FACP, Chair, Solid Tumor Oncology and Investigational Therapeutics, Levine Cancer Institute (LCI), Carolinas HealthCare System, Charlotte, NC.
“I can’t imagine having to keep track of other major tumor types. I have a deep breadth of knowledge in thoracic oncology. General oncologists have an interest in certain subsets of tumors, but they have a very broad range of knowledge to bring to their patients,” he said. Dr Kim discussed this topic at the 2017 American Society of Clinical Oncology (ASCO) annual meeting.
“It is very daunting to have to keep up with the number of drugs, the number of full approvals that have occurred, and now even the biomarkers that have been identified and the alterations that have been identified,” he added.
Pathways in Clinical Practice
Clinical pathways organize the vast amount of information about cancer management and provide direction for the use of the growing number of cancer drugs available. Once limited to specialists and academic or tertiary care centers, clinical pathways have evolved into mainstream clinical practice. In the process, increasing information about developing and implementing clinical pathways has become available to oncologists everywhere.
The Institute of Medicine published a document describing a clinical pathway process, said Dr Kim. Some vendors of electronic medical records have incorporated clinical pathways into their software. Individual health systems have developed system-specific pathways. ASCO published a clinical pathway checklist to help practicing oncologists and ancillary professionals determine whether all aspects of a pathway are in place and functioning properly.
“Clinical pathways are not perfect,” said Dr Kim. “You can’t govern everything there is about medicine. I’m a thoracic oncologist. I now have to be able to make sure that our general oncologists, who are practicing at multiple places across our region, are going to practice a similar type of medicine, standard of care, for a presumptive diagnosis of non–small-cell lung cancer [NSCLC]. The challenge is to minimize variation from standard practice.”
The Levine EAPathways
An “academically minded but community-facing system,” LCI has a “homegrown” clinical pathway system—Levine EAPathways. Headquartered in Charlotte, NC, LCI has affiliated oncologists located throughout North Carolina and South Carolina. Oncologists access pathways via the Internet and can enter, alter, and update patient information remotely. Revisions and additions to patient records are incorporated in real time.
Using the pathway for NSCLC as an example, Dr Kim reviewed the functionality and connectivity of the Levine EAPathways, which specify 4 preferred systemic drug regimens as initial treatment for nonsquamous NSCLC:
- Pembrolizumab (Keytruda), carboplatin, and pemetrexed (Alimta)
- Carboplatin, pemetrexed, and bevacizumab (Avastin)
- Carboplatin, paclitaxel (Abraxane, Taxol), and bevacizumab
- Carboplatin plus pemetrexed.
The Levine EAPathways also identifies 3 acceptable regimens—carboplatin plus paclitaxel; carboplatin plus gemcitabine; and carboplatin plus docetaxel.
“Once oncologists choose a regimen, they get all of the documentation needed to start a patient on the pathway,” said Dr Kim. “This is standardized across the system. Nurses like it, because even though it takes a little time to register a patient, once they have entered a patient and choose a treatment, they have all the documents needed, including order sets needed to treat the patient.”
Linking Pathways to Clinical Trials
Clinical trial icons appear throughout the pathway to indicate whether a relevant clinical trial is available, and the enrollment status of the trial is updated daily. Oncologists interested in a particular clinical trial can get more information, including contract information, by selecting the trial’s icon.
Icons inform pathway users about tissue and blood specimen requirements and requests, and help maintain assay consistency to avoid variability, Dr Kim explained. Oncologists and their designated users can connect directly with the LCI biospecimen repository to obtain information or documentation, including patient informed consent.
LCI has weekly molecular tumor boards, reviewing every gene panel performed. Clinicians can request a discussion of specific cases, which are submitted electronically. The board reviewed 103 cases in the past year.
“We have received more than 7500 specimens from more than 20 different sites, which shows the pathways are engaging doctors and successfully encouraging them to collect blood and tissue specimens,” said Dr Kim.
The connectivity and engagement generated by the pathways have a major role in the ongoing development of a multisite phase 1 clinical trial program within the LCI network. The program will build on the success of LCI’s participation in the ASCO-sponsored Targeted Agent and Profiling Utilization Registry (TAPUR) clinical trial designed to match patients with specific tumor genomics and mutations to available drugs that target those specific genes and their associated drugs. LCI has enrolled more patients in TAPUR than any other participating site, and half the LCI enrollments have come from sites other than the home center in Charlotte.
“Pathways are for generalists, not specialists,” said Dr Kim. “When you want to practice medicine and reduce practice variability, you need pathways. Providers should be able to weigh in and have input. This is part of delivering quality care and having cost-containment. We will pare down our drug list over time. This will allow us to focus on fewer drugs and on cost- containment and, at the same time, stay up to date.”