Xeloda Reduces Recurrence Risk After Surgery but Causes More Serious Side Effects

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Adjuvant chemotherapy is chemotherapy given after surgery to lower the risk of the cancer coming back (recurrence). A study looked at women diagnosed with early-stage breast cancer and found that adjuvant chemotherapy regimens that included Xeloda (chemical name: capecitabine) reduced the risk of recurrence more than regimens that didn't include Xeloda. Still, Xeloda caused more serious side effects and increased the risk that chemotherapy might be stopped because of side effects.

Xeloda is used to treat advanced-stage breast cancer. It's not typically used to treat early-stage breast cancer and is not approved by the U.S. Food and Drug Administration to be used that way. But because Xeloda can help treat advanced-stage breast cancer, researchers wanted to know if adding Xeloda to a chemotherapy regimen might help reduce the risk of recurrence in women diagnosed with early-stage breast cancer. Xeloda is a pill taken by mouth.

In this Finnish study, 1,500 women diagnosed with early-stage breast cancer were split into two groups:

  • half the women got one of two standard adjuvant chemotherapy regimens and Xeloda
  • half the women got one of two standard adjuvant chemotherapy regimens without Xeloda

The women were followed for almost 3 years after diagnosis.

Most women -- no matter which group they were in -- didn't have a recurrence during the nearly 3 years of follow-up, but the women who got Xeloda had a better chance of not having a recurrence:

  • 93% of the women who got Xeloda didn't have a recurrence
  • 89% of the women who didn't get Xeloda didn't have a recurrence

Still, the women who got Xeloda were more likely to have some serious side effects:

  • 6% of the women who got Xeloda had severe (grade 3 or 4) diarrhea; 3% of the women who didn't get Xeloda had severe diarrhea
  • 11% of the women who got Xeloda developed hand-foot syndrome; less than 1% of the women who didn't get Xeloda had hand-foot syndrome

Some chemotherapy medicines, especially Xeloda, 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 hands

In this study, 24% of the women who got Xeloda stopped adjuvant chemotherapy treatment because of treatment-related side effects such as hand-foot syndrome. Only 3% of the women who didn't get Xeloda stopped chemotherapy because of side effects.

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 details of the cancer and your unique situation. If adjuvant chemotherapy will be part of your treatment, your doctor will consider several chemotherapy regimens that have been shown to lower the risk of recurrence. This study suggests a regimen with Xeloda may have some promise. Still, the risk of serious side effects with Xeloda may outweigh its benefits. More research is needed before doctors know for certain if Xeloda is a good treatment for early-stage breast cancer.

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

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