Adherence to Oral Therapies

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Adherence to Oral Therapies

Posted 6/1/2009

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There are an increasing number of oral treatments (pills) for all cancers, and the general belief is that they are effective and easier on patients than IV therapies. For women with breast cancer, these treatments are most often hormonal therapies (tamoxifen or one of the AIs) or one of several treatments used for Stage IV/meatstatic breast cancer.It is an unfortunate fact that many women who are prescribed oral therapy do not take the pills for the full duration of treatment. There are a lot of reasons for this, including cost (especially for women on Medicare, this can be an issue), side effects from the pills, reluctance to take medication for years when one seems to be doing fine.

Here is a short report from ASCO (see yesterday's blog) on this topic:

Education Session Explores Patient Adherence to Oral Cancer Therapies

Oral therapies offer new chances for success against cancer — success that depends overwhelmingly on the ability and willingness of patients to take their medicine correctly. Appropriate patient adherence to oral cancer therapy regimens has enormous influence on the success of these drugs both in clinical trials and in routine care; however, there often are many barriers that prevent patients from adherence, and these factors can alter whether a drug is effective.

"Oral therapies are going to make life so much easier for our patients," Angela DeMichele, MD, of the University of Pennsylvania, said in an interview with

<>ASCO Daily News. "They certainly are a good thing, but we really need to be very aware of these adherence issues when we test them and when we dispense them."

As Chair of today's Education Session, "Compliance and Cost: Bitter Pills to Swallow in the Era of Oral Cancer Treatment," Dr. DeMichele will help attendees explore and understand the wide range of issues that can affect patient compliance with oral therapies and what these challenges can mean for the future of oral treatments, clinical trials, and drug development. Ann H. Partridge, MD, of Dana-Farber Cancer Institute, and Pamela Kato, EdM, PhD, of University Medical Center Utrecht, The Netherlands, also will discuss adherence challenges and provide practical solutions during this session. "In the past, we have been really focused on intravenous therapies for our patients. We control the administration of the drugs and, although there is some variability with this method, it is variability that we can measure," Dr. DeMichele said. "When it comes to oral treatments, there's a whole new level of variability — are the patients taking the drug, are they taking it on time, are they taking the correct dosage, with or without food, or at the right time of day? There are levels of detail that we don't have any information about that may determine whether treatment is effective."

However, despite these immeasurable levels of detail, oncologists continue to interpret the success or failure of a treatment regimen based on how well the patient appears to perform while receiving treatment. If patients are not taking their medication or are not taking it as recommended, then these appearances can be deceiving.

"We make assumptions that the patient is taking the drug just as we prescribed it or according to the protocol," Dr. DeMichele said. "If the patient has been taking the drug and we don't see a good response, then the treatment is declared ineffective. However, if the patient hasn't been taking the drug, of course we're not going to see a good response. We may attribute that response to failure of the drug, not to the patient's nonadherence to the treatment regimen."

Barriers to Adherence

A broad range of factors can influence a patient's ability to adhere to a treatment regimen, such as the difficulty of taking the drug, the treatment's side effects, the cost of the medication, or a simple slip of mind. Dr. Partridge will explore the barriers to adherence that many patients face and how these challenges can affect the outcomes of treatments and clinical trial results. "Barriers to optimal adherence are multifact-orial," Dr. Partridge said in an interview with

ASCO Daily News."They can usually be grouped into categories of patient issues, regimen issues, and system issues."

Patient issues range from depression or other unfavorable states of mind to the patient's view on whether the drug will actually help fight disease. Regimen issues mostly revolve around the ease and simplicity of treatment regimens — the more complex the regimen, the more difficult it may be for patients to properly comply with the treatment. In addition, the drug may have negative side effects that could affect a patient's desire to continue its use. Systems issues usually relate to patients' perceptions of the quality of medical care they are receiving, such as their levels of comfort in the medical setting or the amount of trust they place in their oncologists, as well as how easy it is to procure refills. Dr. Partridge said that all of these issues should be addressed and monitored in research and clinical settings.

"Studies have shown that multiprong approaches have the greatest success in improving adherence," Dr.Partridge said. According to Dr. DeMichele, it is important not only to recognize the potential for treatment nonadherence but also to measure the degrees and patterns of adherence for a particular therapy, and the varying outcomes that can result. This Session will discuss different techniques for measuring adherence in clinical and research settings. Some existing methods include asking patients about taking their medication, asking them to keep a treatment diary, taking pill counts, or any combination of these techniques. Some studies have employed the technology of a MEMS cap, in which a computer chip fits into the cap of a medicine bottle and monitors the date and time that the bottle was opened. Other trials monitor the drug intermediates in a patient's system.

The Session also will offer strategies for improving patient compliance in the clinical setting. In her work with pediatric patients with cancer, Dr. Kato has developed a number of strategies for getting more patients to correctly adhere to their treatments. Recently, she developed a video game designed to teach adolescent patients the importance of taking their medications and remaining adherent to therapies. She will demonstrate this video game in the session and describe other ways to address adherence in oncology.

Dr. DeMichele feels that adherence to therapy is a major component of the personalization of cancer care. It is one of the most patient-specific issues in understanding how well treatments can and do work. "Adherence is an intensely personal issue. It could be related to your lifestyle, your worldview, your belief system, or cultural outlook. It also speaks to the fact that treatments really have different effects in different people," she said. "Understanding anything that can disrupt the delivery of therapy to the tumor is one of the major challenges of personalized medicine. Certainly, getting patients to optimally adhere to treatment< is a big part of that."

"Compliance and Cost: Bitter Pills to Swallow in the Era of Oral Cancer Treatment" will be held today at 9:45 AM-11:00 AM in the Valencia Room, W415A.

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