Xeloda Doesn’t Seem to Reduce Recurrence Risk

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Adjuvant chemotherapy is chemotherapy given after surgery to lower the risk of the cancer coming back (recurrence). Adjuvant chemotherapy isn't routinely recommended for all women diagnosed with early-stage breast cancer, but often will be recommended if the breast cancer has a higher-than-average risk of recurrence.

Xeloda (chemical name: capecitabine) is a chemotherapy medicine used to treat advanced-stage breast cancer. It's not typically used as adjuvant chemotherapy for early-stage breast cancer and isn't approved by the U.S. Food and Drug Administration to be used that way. Still, a number of studies have been looking at whether adding Xeloda to an adjuvant chemotherapy regimen might help reduce the risk of recurrence in women diagnosed with early-stage breast cancer with a high risk of recurrence. Xeloda is a pill taken by mouth.

A study found that the risk of recurrence was the same whether or not Xeloda was added to a standard adjuvant chemotherapy regimen for early-stage breast cancer with a high risk of recurrence. Adding Xeloda slightly increased the chances of being alive in the 5 years after treatment. Still, the women treated with Xeloda were more likely than women who didn't get Xeloda to have certain serious side effects. The results were presented at the 2010 San Antonio Breast Cancer Symposium (SABCS).

In this study, 2,611 women were diagnosed with early-stage breast cancer with a higher-than-average risk of recurrence because the cancer had one or more of the following characteristics:

  • cancer was found in nearby underarm (axillary) lymph nodes
  • the cancer was larger than 2 cm (about 4/5 inch)
  • the cancer was larger than 1 cm (about 2/5 inch) and was hormone-receptor-negative

The women were about 50 and about half of them were premenopausal when they were diagnosed.

  • 36% of the cancers were hormone-receptor-negative
  • 30% of the cancers were triple-negative (HER2-negative, estrogen-receptor-negative, and progesterone-receptor-negative)
  • 12% of the cancers were HER2-positive

All the women were treated with a standard chemotherapy regimen of Adriamycin (chemical name: doxorubicin) and Cytoxan (chemical name: cyclophosphamide), followed by Taxotere (chemical name: docetaxel). This combination is also called ACT.

While getting Taxotere, half the women also got Xeloda and the other half didn't.

During 5 years of follow-up:

  • 89% of the women who got Xeloda were alive with no recurrence (disease-free survival) compared to 87% of the women who didn't get Xeloda
  • 94% of the women who got Xeloda were alive (overall survival) compared to 92% of the women who didn't get Xeloda

Better overall survival was more likely in women diagnosed with hormone-receptor-negative cancer, triple-negative cancer, or cancer that had spread to the lymph nodes.

Painful mouth sores, called stomatitis, can be a side effect of some chemotherapy medicines, including Xeloda.

Some chemotherapy medicines, especially Xeloda, also may cause hand-foot syndrome. Hand-foot syndrome happens when a small amount of medicine leaks out of the capillaries (small blood vessels), usually on the palms of the hands and soles of the feet. The medicine that has leaked out can damage the surrounding tissues. Hand-foot syndrome can be painful and can affect daily living. Symptoms include:

  • numbness
  • tingling, burning, or itching
  • redness (like a sunburn)
  • swelling
  • discomfort
  • tenderness
  • rash

In severe cases, hand-foot syndrome can cause:

  • cracked, flaking, or peeling skin
  • blisters, ulcers, or sores
  • intense pain
  • difficulty walking or using your hands

In this study, both stomatitis -- sometimes severe -- and hand-foot syndrome were more common in the women who got Xeloda.

Half the women who got Xeloda developed stomatitis compared to only 30% of the women who didn't get Xeloda; some of the women who got Xeloda had to have a lower dose of the medicine because of severe stomatitis.

Nearly 50% of the women who got Xeloda developed hand-foot syndrome compared to only 10% of the women who didn't get Xeloda.

The researchers are still following the women in this study and will report results again in 2012.

If you've been diagnosed with early-stage breast cancer, you and your doctor will discuss whether chemotherapy after surgery makes sense for you based on the characteristics of the cancer and your unique situation. If adjuvant chemotherapy will be part of your treatment plan, your doctor will consider several chemotherapy regimens that have been shown to lower the risk of recurrence. Based on earlier research, some doctors think adding Xeloda to a standard chemotherapy regimen may make sense for some women. Still, other doctors are concerned that the risks of serious side effects caused by Xeloda may outweigh its benefits. More research is needed before doctors can know for sure if Xeloda is a good treatment option for some women diagnosed with early-stage breast cancer.

You can learn more about chemotherapy and possible side effects in the Breastcancer.org Chemotherapy section.

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