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Adding Experimental Medicine to Xeloda Seems to Improve Metastatic Breast Cancer Outcomes

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A Chinese study suggests that adding the experimental medicine utidelone to Xeloda (chemical name: capecitabine) can improve progression-free survival more than Xeloda alone in women diagnosed with metastatic breast cancer that had stopped responding to anthracycline and taxane chemotherapy medicines.

The research was published in the March 2017 issue of The Lancet Oncology. Read the abstract of “Utidelone plus capecitabine versus capecitabine alone for heavily pretreated metastatic breast cancer refractory to anthracyclines and taxanes: a multicentre, open-label, superiority, phase 3, randomised controlled trial.”

Experimental utidelone is an epothilone, a type of chemotherapy medicine. Ixempra (chemical name: ixabepilone) is another epothilone chemotherapy used to treat breast cancer. Utidelone works by interfering with cancer cells’ ability to divide. Utidelone is given intravenously.

Utidelone is not approved by the U.S. Food and Drug Administration (FDA) and is not yet available. This and other studies are looking to see if utidelone can be used successfully to treat breast cancer. Some earlier research suggests that utidelone has anticancer properties and may cause fewer side effects.

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

Metastatic breast cancer is advanced-stage cancer that has spread to parts of the body away from the breast -- the bones, liver, or brain, for example.

Progression-free survival is how long the women lived before the cancer grew.

Adriamycin (chemical name: doxorubicin) and Ellence (chemical name: epirubicin) are anthracyclines. Taxol (chemical name: paclitaxel), Taxotere (chemical name: docetaxel), and Abraxane (chemical name: albumin-bound or nab-paclitaxel) are taxanes.

This study was done at 26 hospitals in China and included 405 women diagnosed with metastatic breast cancer that had stopped responding to anthracycline and taxane chemotherapy medicines. About 40% of the women had received three or more previous treatments for metastatic breast cancer. The most common places the breast cancer had metastasized to were the lymph nodes, lungs, bones, and liver.

The women were randomly assigned to receive one of two treatments. Each treatment cycle lasted for 21 days:

  • utidelone intravenously once per day on days 1-5, plus Xeloda orally twice per day on days 1-14 (270 women)
  • Xeloda alone twice per day on days 1-14 (135 women)

The women were followed for about 6 months.

Progression-free survival was:

  • 8.44 months for women treated with utidelone and Xeloda
  • 4.55 months for women treated with Xeloda alone

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

The researchers also looked to see if there were differences in side effects between the two treatment groups:

  • 22% (58 women) of women treated with utidelone and Xeloda had severe peripheral neuropathy compared to 0.007% (1 woman) treated with Xeloda alone; peripheral neuropathy is pain, numbness, tingling, or loss of feeling in the hands and feet
  • 8% (10 women) of women treated with Xeloda alone had hand-foot syndrome (also called palmar-plantar erythrodysesthesia) compared to 7% (18 women) of women treated with utidelone and Xeloda; hand-foot syndrome is a skin reaction that happens when a small amount of medicine leaks out of small blood vessels, usually on the palms of the hands and soles of the feet, causing redness, swelling, pain, numbness, and a rash

Serious side effects were reported by 16 women treated with utidelone and Xeloda; diarrhea was the most common. Serious side effects were reported by 14 women treated with Xeloda alone; diarrhea, low red blood cell counts, and liver problems were the most common.

The researchers concluded: “Despite disease progression with previous chemotherapies, utidelone plus capecitabine was more efficacious compared with capecitabine alone for the outcome of progression-free survival, with mild toxicity except for peripheral sensory neuropathy, which was manageable. The findings from this study support the use of utidelone plus capecitabine as an effective option for patients with metastatic breast cancer.”

While the results of this study are promising, more research is needed before utidelone is approved to treat metastatic breast cancer. It’s not clear when Beijing Biostar Technologies, the company that makes utidelone, will apply for FDA approval.

Stay tuned to Research News for the latest information on utidelone and other experimental treatments for metastatic breast cancer.

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