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Oral Chemotherapy Treatment Brings New Hope to Women with Advanced Breast Cancer

By Susan Perloff, for LBBC

Researchers are developing novel treatments for women with advanced breast cancer that not only target disease but improve quality of life. Among the developments are oral chemotherapy drugs.

Xeloda (pronounced zeh-LOE-duh), a chemotherapeutic agent for patients with metastatic breast cancer, is one oral cancer-fighting drug that has recently shown promise in clinical trials (see upper right). It became available to the public in April 1998. The hallmark of Xeloda’s quality-of-life benefits is that it is a pill, not a continuous IV (intravenous infusion). Because patients conveniently swallow pills at home, they have all day and all night to lead their normally busy lives. Clinical trials have shown Xeloda to be just as effective as IV chemotherapy.

What it is.

Xeloda is an oral medication that is selectively converted at sites in the tumor to a chemotherapeutic agent called 5-FU (5-fluorouracil; pronounced flew-oro-YOU-racil).

5-FU was one of the earliest chemotherapeutic drugs, says Ruth Oratz, MD, who treats women with breast cancer at her private oncology practice in New York. It is very effective when given by continuous infusion, the traditional way of administering 5-FU, says Oratz, "traditional" meaning an IV line with medication pumped into the patient for several hours. But traditional might mean hospitalization or, more recently, wearing or carrying a device the size of a CD player that infuses the 5-FU at all times.

Xeloda (generic name: capecitabine [pronounced kappa-SITta-bean])takes advantage of the presence of an enzyme, thymidine phosphorylase, that tends to be present in higher concentrations in tumors. Normally, the enzymes would encourage a tumor to grow. But Xeloda interferes with its synthesis. When Xeloda is present, the enzyme instead converts the oral chemotherapeutic agent to 5-FU.

Like other forms of chemotherapy, Xeloda is administered in treatment cycles. In each cycle, the patient takes Xeloda twice daily for 14 days, followed by a seven-day period with no drug. The doctor prescribes a specific dose and treatment regimen for each cycle, adjusting the dose if the patient experiences uncomfortable side effects.

Why patients like Xeloda.

Maria Sepe, MD (pictured above), a physician with a family-medicine practice on Long Island, is a survivor of advanced breast cancer. After another treatment stopped working two years ago, she began taking Xeloda. She attributes her astounding energy to the oral chemotherapy drug. During her previous treatment, she did not need to take time off from work. But with Xeloda, free of IV poles and hours-long drips, she could accomplish even more. She quit working for other physicians and set up her own independent practice.

"The breakthrough," says Oratz, the oncologist, "is that this medication is available in pill form. Xeloda can achieve the same effect as an IV."

Ninety percent of patients prefer the oral route to IV as long as the effectiveness is similar, says Jeffrey Scott, MD, a hematologist and oncologist with the International Oncology Network, a national group of 2,600 physicians. That may be because oral chemotherapy drugs allow people like Sepe to spend more time with their families, at their jobs and enjoying life.

Xeloda is approved for use only in women with metastatic breast cancer for whom chemotherapy containing anthracyclines (such as Adriamycin and Epirubicin) and taxanes (like Taxol and Taxotere) has not worked or has ceased to work. When Xeloda is the right drug at the right time, it can free patients from hospital stays and IV drips.

What are the side effects?

Every medication, even aspirin and lip balm, has side effects. But Oratz says that when the dosage of Xeloda is adjusted for each person, it is easy to tolerate and has few side effects. For example, patients are unlikely to experience hair loss.

According to Roche Pharmaceuticals, manufacturer of Xeloda, these are common side effects of Xeloda monotherapy (when it is taken without another chemotherapy drug):

Frequently patients can have mild gastrointestinal (GI) upset, including diarrhea, nausea, vomiting, stomatitis (sores of the lining of the mouth and throat), abdominal pain, upset stomach, constipation, loss of appetite and dehydration (excessive loss of water from the body). These side effects are more common in patients 80 or older. Oratz says they are uncommon when the dosage is correct for the patient.

Rather common is hand-and-foot syndrome, a cluster of symptoms that can affect the hands or feet or both. It tends to start with numbness, tingling, redness and painless swelling and can progress to painful swelling. At its most severe, it brings blistering and peeling. When caught early, it is easily managed. Rashes; dry, itchy or discolored skin; and nail problems sometimes appear. Again, says Oratz, if the patient is on the best dose for her, the reaction should not be severe.

"Hand-and-foot syndrome is an annoyance, but it’s a side-effect, not a disease," Sepe says. "The disease is the cancer. Numbness in your fingers doesn’t matter. It’s pesty, but who cares? It’s a small price to pay for getting your life back."

Very uncommon side effects include tiredness, weakness, dizziness, headache, fever, pain (such as chest, back, joint and muscle), trouble sleeping and taste problems.

For complete information about Xeloda, including possible risks and benefits, talk with your doctor. You can also ask your pharmacist or doctor for information about Xeloda that is written for health care professionals.

Why doctors like Xeloda.

Most chemotherapeutic drugs are given intravenously, which entails enduring needle sticks and spending time in doctors’ offices. Jeffrey Scott likes Xeloda because "It offers patients a lot of convenience: They don’t have to come to my office; they can take the pills wherever they are."

Oratz agrees. "As a clinician, I find oral Xeloda a flexible and convenient way to give the medication. The standard is to give a patient pills continuously for 14 days, followed by a break so the normal cells can recover. I still check my patients’ responses and blood tests, and then I can raise or lower the dose. I can make all kinds of adjustments."

For doctors, there is an issue of patient compliance, a challenge with any kind of oral medication. Many physicians fear patients get their prescriptions filled but forget to take them. On the other hand, some physicians, including Scott, believe, "When my patients are sick, they take their pills."

Physician-and-patient Sepe has never missed a dose. "How do I remember to take my morning and evening pills? They’re like vitamins. I gotta take ‘em. Once in a while I take a pill two hours late, but I never miss. It’s too important."

How insurance gets involved.

The greatest snag in oral chemotherapy is the cost to the patient. Private insurers vary. Most have prescription plans that cover whatever the doctor orders, at least within chemotherapy drugs, leaving the patient to pay either a co-pay or a percentage of the cost. Some plans do not pay a penny for oral products, chemotherapeutic or not.

Historically, Scott says, Medicare paid for injectable chemotherapy but not for oral prescriptions, leaving many patients no choice but injections. But more recently Medicare has begun paying for oral medications such as Xeloda. It covers 80 percent of the cost of Xeloda, he says, but the patient’s 20-percent co-pay can run as high as $200 to $400 a month, a substantial out-of-pocket expense. Happily, 70 to 80 percent of women on Medicare have supplemental insurance.

Medicaid, which varies from state to state, is more likely than Medicare to cover oral chemotherapies. It has a far smaller co-pay, usually single-digit dollars per month. But for women entitled to Medicaid, even that sum can be tough to manage. Women with financial problems should contact Roche Pharmaceuticals’ Patient Assistance Program toll-free at 800.443.6676. Help may be available.

If you speak with your doctor about Xeloda, you should mention all medications you take. It is especially important to alert your doctor if you take blood thinners like warfarin (Coumadin). Xeloda may increase the effect of blood thinners. If you take both Xeloda and blood thinners, your doctor will more frequently check how fast your blood clots and adjust the dose of the blood thinner, if needed.

This article was found in the following newsletter:

Insight, Fall 2002

In this special fall 2002 issue of Insight, we focus on living well with advanced breast cancer. Hear from three women managing metastatic disease and learn about the oral chemotherapy medication Xeloda. Other articles focus on depression and anxiety and news from the 2002 meeting of the American Society of Clinical Oncology.

View entire newsletter

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