Using CTCAE to Report Immunotherapy Adverse Events
Although immunotherapy is changing the face of cancer care, it’s not exempt from side effects.
As researchers and clinicians work to understand immune-related adverse events (irAEs) and how to manage them, a new challenge is emerging: reporting and grading them to get an accurate grasp on incidence rates and to standardize care to ensure better outcomes for patients. The Common Terminology Criteria for Adverse Events (CTCAE) is one tool that’s helping researchers and bedside nurses do just that.
The Importance of CTCAE
CTCAE isn’t a new tool for researchers or healthcare providers: it’s been in use in different ways since the 1980s. Simply defined, it’s a list of adverse events terms commonly encountered during cancer treatment, offering a standardized way to report adverse events by assigning uniformed terminology and a grading system to note severity. It’s a living, changing document that the National Cancer Institute regularly updates (https://wiki.nci.nih.gov/display/VKC/Common+Terminology+Criteria+for+Adverse+Events).
According to oncology nurse scientist and ONS member Joanne Riemer, RN, BSN, from Johns Hopkins University in Baltimore, MD, CTCAE is crucial to understanding the trajectory of symptoms through cancer treatment.
“CTCAE is a reference that grades symptoms or side effects known as adverse events. By grading the symptoms or adverse events at baseline—and as someone goes through treatment—it’s possible to quantify those symptoms and capture improvement or deterioration,” Riemer says. “Quantifying information allows researchers and clinicians to determine the efficacy and toxicities related to specific treatments.”
ONS member RuthAnn Gordon, MSN, FNP-BC, OCN®, nurse leader of clinical trials at Memorial Sloan Kettering Cancer Center in New York, NY, notes the importance of measuring adverse event severity with CTCAE so clinicians can correctly address it.
“One of the key things to managing adverse events is to identify how severe it is,” Gordon says. “We use CTCAE to determine that. We assess the symptom, determine how severe it is, and—based on that information—we follow a standard algorithm that recommends interventions for grade one, two, and three events.”
Both Gordon and Riemer recognize the importance of standardizing the language for symptom reporting through CTCAE. It provides a lexicon that works for all providers.
“In general, CTCAE ensures that we all speak the same language,” Gordon says. “All clinicians should be able to go in and objectively measure an event based on the criteria that’s outlined in CTCAE. Then, they can decide if they want to develop a new algorithm or if they’re interested in what the standardized interventions are for that event. Ultimately, it helps us speak a universal language in terms of how we measure a symptom or adverse event.”
Incorporating Immunotherapies Into CTCAE
The rapid surge in use of immunotherapies for different disease types and indications created a challenge for reporting and cataloging the associated adverse events. Because irAEs differ from those found in chemotherapy—and need to be addressed differently—providers have been left to figure out how to report irAEs with CTCAE.
“In the past, CTCAE did not offer information specific to irAEs. It was possible to work around this limitation, but it was still challenging,” Riemer says. “CTCAE version 5.0, published in November 2017, added terminology that’s helpful when reporting on immunotherapy clinical trials.”
Considering how much we have to learn about irAEs and long-term effects from immunotherapy, incorporating associated treatment events into CTCAE is crucial for advising researchers and providers on grading severity and follow up for their patients.
“Frequently, patients treated with immunotherapies have vague symptoms that don’t point to a specific irAE. Nurses can use CTCAE to grade symptoms and report it to providers to address an algorithm to further work up and treat the irAE,” Riemer says. “Algorithms established by pharmaceutical companies, the National Comprehensive Cancer Network, the American Society of Clinical Oncology, and others use CTCAE grading to guide evaluation, treatment, and follow up. When responding to adverse events, consulting CTCAE is step one, using algorithms is step two.”
With healthcare organizations working to provide practitioners with immunotherapy guidelines for practice, the new CTCAE is a key resource that’s informing the way adverse events are graded and reported.
“Providers should know that the published guidelines for managing irAEs already use CTCAE,” Gordon says. “Understanding how to identify and grade an event can help oncology nurses use the existing guidelines and formulas to address those issues. Moreover, it can help nurses recognize which irAEs are categorized as severe events and act accordingly for their patients’ safety and well-being.”
Using CTCAE in Your Practice
Although primarily used in research settings and for clinical trials, CTCAE can be helpful for oncology nurses in the clinical setting too. Because communication is key to guiding treatment and managing symptoms, incorporating a standardized language like CTCAE to report adverse events among the interprofessional team can help drive successful patient-centered care.
“CTCAE removes the subjective language that we might use to describe symptoms, and it gives us a set of terminology that all providers understand,” Gordon explains.
Riemer says that all oncology nurses can benefit from CTCAE by tracking symptoms and easily communicating them to their nurse colleagues, especially when patients change hands between appointments.
“As a research nurse, I put symptom grades in my notes to help me recognize whether something is improving or worsening from visit to visit,” Riemer says. “I believe it would help chairside nurses as well. It’s common that different nurses are treating patients from visit to visit, and CTCAE can communicate severity of a patient’s symptoms from nurse to nurse—and across disciplines as well—by using a standard set of terms. It can determine when to watch and wait, and when further action or treatment is needed.”
Beyond providing a standard set of terminology that’s recognized across the healthcare spectrum, CTCAE is a valuable tool for tracking symptom severity and adjusting the specifics of a treatment protocol.
“The information collected through the use of CTCAE can guide future treatments, dosages, schedules, sequencing, and more,” Riemer says. “It can also guide patients in their decision-making process to participate in clinical trials.”
What CTCAE Means for Future Side Effect Reporting
As immunotherapy regimens increasingly become the standard of care for different cancer types, recording, managing, and understanding their adverse events will be key to guiding patients through treatment and into survivorship.
“Clinical trials have avenues established to report serious adverse events (SAEs). And as more and more immunotherapy treatments move to standard of care, it’s going to be very important to capture data from these populations, especially related to their SAEs,” Riemer notes. “I’ve been working in immuno-
oncology since 2011, and we’ve come to recognize that many of the side effects or irAEs from immunotherapy occur long after treatment has been discontinued.”
Gordon stresses the importance of CTCAE in all aspects of treatment. It’s a valuable tool to help providers guide symptom management and the necessary interventions for immunotherapy, as well as other cancer treatments.
“It has helped me tremendously when managing patients. I’ve referenced it constantly and followed it closely to determine the level of intervention to take with my patients,” Gordon says. “It’s made that portion of care much easier to manage, and it’s important to remember it’s not just for one type of treatment event. We can use it for immunotherapy, but it’s more than that too. It’s there for any symptoms, and providers should use CTCAE to their benefit.”