Oral oncolytic drugs have a multitude of benefits for patients, including ease of use, improved quality of life, fewer clinic visits, and no need for IV therapy. However, one of the biggest challenges associated with these drugs is ensuring patient adherence. But according to Sharon Gentry, MSN, RN, HON-ONN-CG, AOCN, CBCN, program director at the Academy of Oncology Nurse & Patient Navigators (AONN+), personalized strategies can drastically improve adherence to oral anticancer therapies for patients with early and advanced breast cancer.
It is predicted that in 2022, the United States will see 287,850 new cases of invasive breast cancer and over 51,000 diagnoses of early-stage breast cancer. “But about 3.8 million breast cancer survivors are currently living in the US,” she said at the 2022 AONN+ Midyear Conference in Austin, TX. “And those 3.8 million got to that stage because of the current therapies we’ve had available over the last several years.”
An oral oncologic is defined as a self-administered medication providing patients a level of control over their cancer treatment. These drugs have exploded in the cancer landscape in recent years; oral oncolytics make up 25% to 35% of oncology drugs currently in development, and nearly half of the 300 medications in phase 2 and 3 clinical trials are oral medications.
“Postpandemic projections state that the FDA will probably approve 1 new oral oncolytic every 4 months,” she said. “That’s a lot of stuff coming down the pipeline.”
While oral anticancer therapies have led to great progress in the treatment of breast cancer, ensuring patient adherence can be challenging for a number of reasons. Not only are patients on oral drugs responsible for keeping track of complicated dosing schedules and side effects, but the cost can be prohibitive for a significant proportion of individuals. Oral agents can range from $10,000 to $100,000 per year for a course of therapy, leading many to skip doses or take less than prescribed. Navigators play a pivotal role in breaking down these barriers, improving adherence to these drugs, and fostering better patient outcomes.
Ms Gentry noted that the shift to oral oncolytics is new territory for navigators as well as for patients. “We used to capture them in the infusion room, and when they were in that chemo chair, they were ours to teach and ours to work with. But now they’re out in the community,” she said. “It’s not that we’re giving away control; we’re asking the patients and families to take on a little bit more power and control over how these medications are given.”
According to the International Society for Pharmacoeconomics and Outcomes Research, adherence is defined as the degree or extent of conformity to the recommendations about day-to-day treatment by the provider with respect to timing, dosage, and frequency for the duration of time from initiation to discontinuation of therapy.
“You as a navigator play a critical role in addressing this,” she said. “You not only address adherence, but you also address safe administration for your oral oncolytics.”
A patient is considered to be nonadherent if he or she misses doses, takes more doses than prescribed, or takes doses either in the wrong quantity or at the wrong time. But adherence is not always as easy as it seems. Studies of adherence have shown that patients reported lower rates of oral chemotherapy adherence, as low as 16%, compared with patients under the supervision of clinicians delivering infusion. Also, adherence is not the same for each patient, and studies report variation in adherence rates from 17% to 100%.
“We estimate that across the US, 20% to 30% of prescriptions do not get filled,” she said. “And of those filled, 50% are usually not taken as prescribed. We also know that when drugs aren’t taken correctly, it’s costing our healthcare system $100 billion to $289 billion annually.”
Adherence is crucial to achieving disease-free survival and progression-free survival, and in the United States, it is estimated that 125,000 deaths per year are due to poor adherence to medications. This is a major hurdle with oral oncolytics; when navigators do not know whether their patients are taking their medications, it is impossible to maintain proper documentation and monitor patient progress and/or adverse events.
In addition to alarming outcomes like poor survival, ineffectiveness of oral regimens, unnecessary changes in treatment, and increased hospital stays, patients on cancer clinical trials who display poor adherence can actually impact the results of these studies, resulting in misleading findings, inconsistent response rates, and incorrect dose rates.
“So you can see how it really starts affecting how we prescribe future medications if we have problems with adherence,” she said.
First, navigators should identify a patient’s barriers to adherence, keeping in mind that there is a difference between intentional nonadherence (often due to lack of understanding/education about the drug) and nonintentional nonadherence (forgetting/getting confused about dosage).
Engage the entire patient, the provider, and the caregiver. “Put the patient in the middle, with all of your team members around them,” she said. “How can you give them the best quality of care?”
Patient education from nursing and pharmacy is a huge component of ensuring drug adherence. When possible, it is important to determine what, exactly, is causing side effects like sleep disturbance, cognitive dysfunction, or fatigue. Is it the drugs, or perhaps the cancer itself? “They can start intertwining, and it’s often hard to pull some of these out,” she noted.
If a patient is apprehensive about starting an oral regimen, do not belittle their concerns. Ask them to explain more about their worries and hesitations, and attempt to reach a compromise (ie, starting the drug on a trial basis), she advised. “Explain how the medication works, acknowledge the side effects and how you’ll handle them,” she said. “Work with them at their level and see how you can increase their adherence.”
Implementing processes for monitoring adherence and toxicity are crucial to making sure patient adherence is maintained. She encourages navigators to follow up with patients at set intervals after starting them on oral medication. At 3 days, call and ask the patient if they received the medication, how they are doing, and if they have any questions. At 7 to 10 days, follow up on how the patient is doing, review any questions they might have about dosing and adherence, and determine whether they need to be seen again in the clinic, she advised.
The Role of the Navigator
Whether they are nurse or patient navigators, people from all walks of navigation are critical to helping patients with cancer adhere to their oral medications. They provide resources, facilitate communication between members of the healthcare team (including arranging tests/bloodwork closer to the patient’s home when possible), and provide psychosocial support. They may not be psychologists or psychiatrists (although they can make referrals), but they can always provide an ear to listen to what the patients and their families have to say. All navigators provide education, but nurse navigators can provide a more disease-specific and drug-specific education.
Navigators are often the members of the team able to identify the barriers standing in the way of adherence; these astute observations can prompt them to provide referrals and resources that mitigate those barriers, and to notify the appropriate member of the healthcare team in case of adverse events (nurse navigators can also assist with symptom management). Often, pharmacists are the hidden members of the team who might be able to get through to a patient about the importance of adherence.
“Pharmacists have that 3-second opinion,” she said. “They’re verifying that this is a great medication for you, and they want you to take it correctly and get the most benefit you can.”
Financial navigators are skilled at looking at the patient’s prescribed oral drug and determining whether it is covered by their insurance, as well as their responsibility for out-of-pocket costs, total costs of traveling to the clinic, lost wages from time off work, risk of becoming unemployed, etc.
“Financial navigators often go to a deeper level when finding these “third-party costs” that come along with cancer and treatment,” she said. “But they’re wonderful about identifying the best resources we can use in overcoming these financial barriers.”
Employing Tools and Technology
Shared decision-making plays a role in increasing patient adherence. “If patients are aware of the importance of taking their medication, and they agree with the goals that we set with them, then they’re going to be more likely to take that medication,” she said.
Ms Gentry encourages navigators to look to pharma for helpful visual aids and dedicated resources for oral oncolytics that can encourage drug adherence. “What can you put in front of them to better explain the medications they may be taking?” she asked. Other organizations like the Oncology Nursing Society and the Association of Community Cancer Centers also offer useful oral adherence tools.
Pillboxes, paper calendars, alarms/text messages (if the patient knows how to set/turn off the alarm), diaries, and mobile apps—as well as actual people—are all useful tools in promoting drug adherence.
“My favorite thing to use—because it empowers the patient and their family—is people,” she said. “Have a one-on-one conversation with your patient and ask who can remind them and help them take their medication, even if they don’t live in the same home.”