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One Year of Low-Dose Xeloda After Surgery for Triple-Negative Breast Cancer Seems to Reduce Recurrence Risk

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Taking a low dose of the chemotherapy medicine Xeloda (chemical name: capecitabine) for one year after surgery to remove early-stage triple-negative breast cancer and standard post-surgery chemotherapy seems to reduce the risk of the cancer coming back (recurrence), according to a study.

The research is part of the virtual program for the 2020 American Society of Clinical Oncology Annual Meeting. Read the abstract of “Phase III trial of metronomic capecitabine maintenance after standard treatment in operable triple-negative breast cancer (SYSUCC-001).”

“Metronomic” means a lower than standard dose of treatment is given on a regular schedule, usually over a long time. For this study, people took about half the regular dose of Xeloda twice per day for 1 year.

About Xeloda

Xeloda is an antimetabolite chemotherapy. It kills cancer cells by acting as false building blocks in a cancer cell’s genes, causing the cancer cell to die as it gets ready to divide.

Xeloda is a pill taken by mouth.

About triple-negative breast cancer

Triple-negative breast cancer is:

  • estrogen-receptor-negative
  • progesterone-receptor-negative
  • HER2-negative

So the growth of triple-negative disease isn’t driven by the hormones estrogen or progesterone or by the presence of too many HER2 receptors. This means that triple-negative breast cancer doesn’t respond to hormonal therapy (such as tamoxifen or an aromatase inhibitor) or therapies that target HER2 receptors, such as Herceptin (chemical name: trastuzumab), Kadcyla (chemical name: T-DM1 or ado-trastuzumab emtansine), Nerlynx (chemical name: neratinib), Tykerb (chemical name: lapatinib), or Perjeta (chemical name: pertuzumab).

About 10% to 20% of breast cancers — more than one out of every 10 — are triple-negative. Triple-negative breast cancer tends to be more aggressive than other types of breast cancer and generally has a higher risk of recurrence.

Triple-negative breast cancer usually is treated with a combination of surgery, radiation therapy, and chemotherapy. Researchers are constantly working to find new medicines to treat triple-negative breast cancer and reduce the risk of recurrence, which is why the researchers did this study.

About the study

This Chinese study included 434 people diagnosed with early-stage triple-negative breast cancer that was removed with surgery. After surgery, all the people were treated with a standard chemotherapy regimen for triple-negative breast cancer.

After standard chemotherapy, the people were randomly assigned to one of two groups:

  • 221 people took a low-dose of Xeloda twice per day for 1 year
  • 213 people were monitored for any cancer recurrence

The researchers looked to see which group had better disease-free survival rates and also looked at overall survival rates.

Disease-free survival is how long people live without the cancer coming back.

After about 5 years of follow-up:

  • 83% of people treated with 1 year of Xeloda were alive with no recurrence
  • 73% of people being monitored were alive with no recurrence

This difference was statistically significant, which means that it was likely due to the difference in treatment and not just because of chance.

Overall survival was:

  • 85% for people treated with 1 year of Xeloda
  • 81% for people being monitored

Overall survival means the people were alive, whether or not the cancer came back.

This difference in overall survival was not statistically significant, which means that it could have been due to chance.

So a year of low-dose Xeloda reduced the risk of recurrence, but offered only slightly better overall survival.

The most common side effects caused by Xeloda were:

  • hand-foot syndrome
  • low white blood cell counts
  • liver problems
  • stomach pain

None of these side effects were serious.

What this means for you

The results of this study are encouraging and suggest that a year of low-dose Xeloda after surgery and standard chemotherapy for early-stage triple-negative breast cancer can help reduce the risk of recurrence.

Still, the study was relatively small, and overall survival was only slightly better for the group treated with Xeloda. More research is necessary before Xeloda maintenance therapy for early-stage triple-negative breast cancer becomes the standard of care.

If you’ve been diagnosed with early-stage triple-negative breast cancer and have had surgery, completed standard chemotherapy, and are very concerned about the cancer coming back, you may want to talk to your doctor about this study. You can discuss the potential risks and benefits of a year of maintenance Xeloda and also look to see if there are any other clinical trials using Xeloda in this way that may be a good fit for you. Together, you and your doctor can make the best choices for you and your unique situation.

For more information, visit the page on Xeloda.

Written by: Jamie DePolo, senior editor

Reviewed by: Brian Wojciechowski, M.D., medical adviser

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