Xeloda Improves Survival in Women With Early-Stage, HER2-Negative Disease Who Have Residual Disease After Chemotherapy Before Surgery

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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 a pill taken by mouth.

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.

At the 2015 San Antonio Breast Cancer Symposium, Japanese researchers presented early results showing 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.

Now the same researchers have more mature results and the results continue to look good: Xeloda seems to improve both disease-free and overall survival in women diagnosed with early-stage, HER2-negative disease who have residual disease after neoadjuvant chemotherapy.

The research was published in the June 1, 2017 issue of The New England Journal of Medicine. Read the abstract of “Adjuvant Capecitabine for Breast Cancer after Preoperative Chemotherapy.”

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, 887 women diagnosed with stage I to stage IIIB, HER2-negative breast cancer 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 (444 women)
  • standard treatment plus six or eight cycles of Xeloda (443 women; 159 women were treated with six cycles of Xeloda and 283 were treated with eight cycles)

The women enrolled in the study between February 2007 and July 2012:

  • all the women were from Japan and South Korea
  • half the women were younger than 48 and half were older
  • about half the women were postmenopausal
  • about 40% of the women were diagnosed with stage IIIA or stage IIIB breast cancer
  • 32.2% of the women were diagnosed with triple-negative disease (estrogen-receptor, progesterone-receptor, and HER2-receptor negative)
  • 95.3% of the women had been treated with both an anthracycline and a taxane before surgery

Half the women were followed for more than 3.6 years and half the women were followed for a shorter time. The researchers found that women who were treated with Xeloda after surgery had better disease-free survival than women who weren’t treated with Xeloda.

After 3 years of follow-up:

  • 82.8% of women treated with Xeloda were alive with no recurrence
  • 73.9% of women who didn’t get Xeloda were alive with no recurrence

After 5 years of follow-up:

  • 74.1% of women treated with Xeloda were alive with no recurrence
  • 67.6% of women who didn’t get Xeloda were alive with no recurrence

Xeloda also improved overall survival.

After 3 years of follow-up:

  • 94.0% of women treated with Xeloda were alive
  • 88.9% of women who didn’t get Xeloda were alive

After 5 years of follow-up:

  • 89.2% of women treated with Xeloda were alive
  • 83.6% of women who didn’t get Xeloda 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. Still, the benefits of Xeloda were the most notable among women diagnosed with triple-negative breast cancer:

  • 79% of women with triple-negative disease treated with Xeloda were alive after 5 years
  • 70% of women with triple-negative disease who didn’t get Xeloda were alive after 5 years

Like most chemotherapy medicines, Xeloda can cause side effects.

In the study, about 45% of the women completed all planned 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:

  • hand-foot syndrome: 73.4% of the women
  • neutropenia (low white blood cell count): more than 40% of the women
  • diarrhea: more than 20% of the women

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 yet, 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 chemotherapy regimens and side effects, visit the Breastcancer.org Chemotherapy section.


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