Treating Residual Disease With Xeloda Improves Survival in Women With Early-Stage, HER2-Negative Disease

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Xeloda (chemical name: capecitabine) is a chemotherapy medicine often used in combination with other anticancer medicines. Typically, it’s used to treat advanced-stage breast cancer that has stopped responding to certain other chemotherapy medicines. Xeloda is taken orally as a pill.

Treatment given before surgery to weaken or shrink the cancer is called neoadjuvant treatment. Neoadjuvant treatment often is recommended when the breast cancer is large, aggressive, and/or has spread beyond the breast to surrounding tissue.

One way doctors judge the effectiveness of neoadjuvant treatment is to look at the tissue removed during surgery to see if any cancer cells are present. If no cancer cells are there, doctors call it a “pathologic complete response.” If there are cancer cells in the tissue removed, doctors say there is “residual disease” because it’s likely that there may still be some cancer cells in the body. Many doctors believe that a pathologic complete response to neoadjuvant treatment means the cancer is less likely to come back.

A Japanese study has found that women diagnosed with early-stage, HER2-negative breast cancer with residual disease who were treated with Xeloda after surgery had better survival compared to women who didn’t get chemotherapy after surgery.

The study was presented on Dec. 9, 2015 at the 2015 San Antonio Breast Cancer Symposium. Read the abstract of “A phase III trial of adjuvant capecitabine in breast cancer patients with HER2-negative pathologic residual invasive disease after neoadjuvant chemotherapy (CREATE-X, JBCRG-04).”

Disease-free survival is how long a woman lives without the cancer coming back (recurrence). Overall survival is how long a woman lives with or without the cancer coming back.

In the study, 885 women diagnosed with HER2-negative breast cancer that was stage I to stage IIIB received neoadjuvant chemotherapy with a regimen that contained an anthracycline and/or a taxane chemotherapy medicine and were found to have residual disease after surgery.

Adriamycin (chemical name: doxorubicin) and Ellence (chemical name: epirubicin) are examples of anthracyclines. Taxol (chemical name: paclitaxel) and Taxotere (chemical name: docetaxel) are examples of taxanes.

After surgery, the women were randomly assigned to receive either:

  • standard treatment: radiation and hormonal therapy (if the cancer was hormone-receptor-positive), but no chemotherapy
  • standard treatment plus eight cycles of Xeloda

Half the women in the study were younger than 48 and half were older; 58% of them were premenopausal. About 63% of the cancers were hormone-receptor-positive.

After about 5 years of follow-up, the researchers found that women who were treated with Xeloda after surgery had better disease-free survival than women who didn’t get chemotherapy after surgery:

  • 74.1% of the women treated with Xeloda were alive with no recurrence
  • 67.7% of the women who didn’t get chemotherapy were alive with no recurrence

Xeloda also improved overall survival:

  • 89.2% of the women treated with Xeloda were alive
  • 83.9% of the women who didn’t get chemotherapy were alive

When the researchers grouped the women by age, hormone-receptor-status, cancer grade, or type of neoadjuvant chemotherapy, they found that Xeloda still improved survival.

"Overall survival was significantly improved by capecitabine adjuvant therapy for non-pathologic complete response or node-positive patients after neoadjuvant chemotherapy," said Masakazu Toi, M.D., Ph.D., of Kyoto University Hospital. "The balance of benefit and toxicity would favor the use of capecitabine in the post-neoadjuvant chemotherapy situation, but prediction for the therapeutic benefit needs to be investigated further."

Like most chemotherapy medicines, Xeloda can cause side effects.

In the study, 45% of the women completed all eight cycles of Xeloda. About 30% of the women had to take a lower dose of Xeloda because of side effects and 22.5% of the women stopped taking Xeloda because of side effects.

The most common side effects in the study were:

  • neutropenia (low white blood cell count)
  • diarrhea
  • hand-foot syndrome

If you’ve been diagnosed with early-stage, HER2-negative breast cancer and did not have a pathologic complete response to neoadjuvant chemotherapy, you might want to talk to your doctor about this study, especially if the cancer was large or involved more than one or two lymph nodes. While using Xeloda in this way isn’t the standard of care, you and your doctor can figure out if Xeloda after surgery might be a good fit for you and your unique situation.

For more information, including common regimens and side effects, visit the Breastcancer.org Chemotherapy section.

Read more Research News from the 2015 San Antonio Breast Cancer Symposium:



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