Dose-Dense Ellence Regimen Better for High-Risk Breast Cancer Than Early-Stage Breast Cancer

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Dose-dense chemotherapy means that the chemotherapy medicines are given every 2 weeks, instead of the standard schedule of every 3 weeks. Doctors may recommend a dose-dense regimen for some women because other research has shown that this approach can improve survival and decrease the risk of recurrence (the cancer coming back) more effectively than a standard chemotherapy schedule.

Dose-dense chemotherapy doesn't allow as much time for the immune system and red blood cells to recover between chemotherapy doses. Doctors sometimes use the medicines Neupogen (chemical name: filgrastim) or Neulasta (chemical name: pegfilgrastim) to strengthen the immune system during dose-dense chemotherapy.

Two studies looked at a dose-dense regimen of Ellence (chemical name: epirubicin) compared to a standard schedule to treat different types of breast cancer.

The studies were presented at the 2012 San Antonio Breast Cancer Symposium.

The first study, the TACT2 (Trial of Accelerated Chemotherapy) trial, wanted to know if a dose-dense regimen of Ellence would be better than the standard regimen for people diagnosed with early-stage breast cancer.

The TACT2 study randomly assigned 4,391 people (including 20 men) to get one of two chemotherapy regimens:

  • four cycles of Ellence given every 3 weeks (standard regimen)
  • four cycles of Ellence given every 2 weeks along with Neulasta given on day two of the chemotherapy cycle (dose-dense regimen)

After 5 years, both groups had the same rate of recurrence in the breast area (loco-regional recurrence). This means that the more intense dose of Ellence didn’t reduce the risk of recurrence compared to the standard dose.

The overall survival rate (how long the people lived whether or not the cancer grew) also was the same for both groups, so the more intense dose of Ellence also didn’t improve overall survival.

The dose-dense group had more side effects, including:

  • hand-foot syndrome; the numbness, tingling or redness that happens when a small amount of the medicine leaks out of the small blood vessels in the body, usually on the palms of the hands and the soles of the feet
  • low white blood cell count

The second study randomly assigned 1,284 German women diagnosed with high-risk breast cancer – cancer was found in at least four lymph nodes in all the women – to get one of two chemotherapy regimens:

  • four cycles of Ellence and Cytoxan (chemical name: cyclophosphamide) given every 3 weeks followed by four cycles of Taxol (chemical name: paclitaxel) every 3 weeks (standard regimen)
  • three cycles of a higher dose of Ellence, followed by a higher dose of Taxol, followed by a higher dose of Cytoxan every 2 weeks (dose-dense regimen)

After an average of 10 years of follow-up, the researchers found that the dose-dense regimen improved both overall survival and disease-free survival (the time the women lived without the cancer growing).

The women in the dose-dense group also were randomly assigned to get either Procrit (chemical name: epoetin alfa) or a placebo (sugar pill) to see if it would safely reduce the need for red blood cell transfusions during the dose-dense chemotherapy.

The women who got Procrit had a higher risk of blood clots, but the medicine didn’t affect recurrence risk or survival.

Ellence is more commonly used in Europe, so these studies may not affect standards of care in the United States. A typical U.S. dose-dense chemotherapy regimen is more likely to involve Adriamycin (chemical name: doxorubicin) and Cytoxan, followed by Taxol.

If you’ve been diagnosed with breast cancer that has a high risk of recurrence, it’s likely that chemotherapy will be part of your treatment plan. This and other studies suggest that a dose-dense chemotherapy regimen may offer more benefits than a standard regimen. After you consider all the characteristics of the cancer, as well as your unique situation and preferences, you and your doctor can make the best choices for you.

Visit the Chemotherapy section to learn more about what to expect during chemotherapy.

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