Oral cancer drugs are not all they're cracked up to be.

Health and medicine explained.
Oct. 21 2008 1:09 PM

Take a Chill, Pill

Why oral cancer drugs are not all they're cracked up to be.

Pills. Click image to expand.
Pills

In the past few years, the world—or at least the portion of it dealing with cancer and its treatment—has gone gaga for oral drugs. Ever since the stunning success of Gleevec, a once-daily anti-leukemia capsule, patients, doctors, and drug companies have been wooed by the siren call of pill-based medicine. Numerous such drugs have been approved in the past few years for several major cancers, and at least one-quarter of new cancer drugs in the pipeline are for oral formulations.

These oral drugs appear to herald a new era for cancer as a chronic illness—not a deadly disease, but a pesky condition like high blood pressure that simply requires swallowing a few pills every week. The convenience of taking pills at home instead of sitting at the cancer clinic with an IV tube stuck in your vein for hours on end is obvious. In part, pill-based therapy is a consequence of medical advancement. Traditional chemotherapy, which attacks all fast-growing cells (tumors, hair, bone marrow), requires a period of recovery between doses. Most new drugs are designed to kill only cancer cells and their enablers. Doing so practically requires that the medicine be in a take-home pill form because it means your body needs constant exposure to the medication.

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But oral cancer drugs are hardly the dream treatment that many believe them to be. A host of problems means their use could end up in calamity, causing a far bigger headache than lying in a chair at a cancer clinic ever could.

First off is the elusive question of adherence: How likely are cancer patients to follow their at-home regimens correctly? Failure to follow prescriptions is a perennial conundrum of modern medicine that no one seems to quite understand. It might seem that cancer patients, coping with such a severe diagnosis, would be immune to that particular problem. Not so. The difficult regimens many treatments require can easily lead to missed doses. One study found that even among patients prescribed Gleevec—just one pill a day, no muss, no fuss—only half took their pills exactly as instructed.

On the flip side, some patients may be too willful. Fixated on the idea that they will die if they don't take their medicine, they may push themselves to endure debilitating side effects that really call for at least a change in dose. A breast cancer patient with an "I can get through this" mentality might not report diarrhea to her doctor on Friday, continue to take Xeloda over the weekend, and by Monday face life-threatening dehydration that could easily have been prevented. The assumption that cancer treatment equals suffering—as suggested by TV shows, movies, friends' and family members' experiences—may also lead patients to postpone a call to the doctor. When a patient expects to feel miserable during therapy, it might even seem silly to inform the clinic about side effects.

All of which leads to the question: Are cancer patients able to doctor themselves? That is essentially what is happening for many oral-drug takers. Patients need to be carefully instructed about what side effects to expect, how to know whether or not they are serious, and what to do if they are. There also needs to be an infrastructure to ensure that patients taking treatment at home are safe and well-cared-for in the absence of a doctor's or nurse's careful watch. A recent study found that few of those safeguards are in place at cancer centers around the country. How those safeguards will get there is anyone's guess, since there are no budgets for installing such measures nor are such expenses reimbursed.

The ramifications of the pill trend also extend to the clinic. The extra counseling on the drugs and their side effects is time-consuming (although many pharmacists are relieved to serve a purpose beyond counting pills). But the real issue for clinics is with—surprise!—insurance. Unlike traditional chemotherapy drugs, oral drugs require prior authorization. The insurer needs to approve a prescription before it's filled, a task that regularly forces nurses, administrators, and even doctors to spend hours of nonreimbursed time on the telephone.

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