Patients with early-stage node-positive breast cancer who receive dose-dense adjuvant chemotherapy with Ellence® (epirubicin), Cytoxan® (cyclophosphamide), and Taxol® (paclitaxel) may have improved disease-free survival. These findings were released online by the journal The Lancet.
Node-positive breast cancer means that cancer cells from the breast have been found in the lymph nodes under the arm. Although the breast cancer is removed during surgery, the presence of cancer cells in the lymph nodes means that there is a higher chance of the cancer returning and spreading. To reduce risk of cancer spreading, patients with early-stage node-positive disease are often giving additional treatment following surgery (adjuvant therapy).
Researchers in Italy recently conducted a Phase III trial to evaluate adding fluorouracil to Ellence, Cytoxan, and Taxol as adjuvant treatment in early-stage node-positive breast cancer. They also compared both of these treatment combinations (with and without fluorouracil) on a dose-dense and standard treatment schedule.
Between 2003 and 2006, the researchers recruited 2,091 patients with operable, node-positive, early-stage breast cancer. Participants were between 18 and 70 years old. The researchers divided them into the following treatment groups:
- One group received dose-dense chemotherapy with fluorouracil plus Ellence, Cytoxan, and Taxol or Ellence, Cytoxan, and paclitaxel without fluorouracil every two weeks.
- Patients in the other group received one of the same treatments, but at the standard (not dose dense) schedule of every three weeks.
The researchers compared the two dosing schedules (every two weeks and every three weeks) and the type of chemotherapy (Ellence, Cytoxan, and Taxol or Ellence, Cytoxan, and Taxol with and without fluorouracil) to determine disease-free survival for each.
They followed the patients for a median of seven years. The following numbers of patients on each treatment plan were alive without disease at this time:
- 140 (26%) of 545 patients on Ellence, Cytoxan, and Taxol without fluorouracil given every three weeks
- 157 (29%) of 544 patients given fluorouracil plus Ellence, Cytoxan, and Taxol every three weeks
- 111 (22%) of 502 patients given Ellence, Cytoxan, and Taxol without fluorouracil every two weeks
- 113 (23%) of 500 patients given fluorouracil plus Ellence, Cytoxan, and Taxol every two weeks
After five years of treatment, the dose-dense (treatment every two weeks) schedule appeared to improve disease-free survival. Among patients treated every two weeks, 81% treated with either combination were alive without disease compared with 76% of patients treated every three weeks. Overall survival was also higher among the dose-dense treatment groups: 94% versus 89%.
Outcomes were similar between the different types of chemotherapy (Ellence, Cytoxan, and Taxol with and without fluorouracil). At five years, 79% of those treated without fluorouracil were alive without disease compared with 78% of those who received fluorouracil. Overall survival was 91% without fluorouracil and 92% with fluorouracil.
Patients on the every-two-week dose-dense treatment schedule tended to have an increased rate of some side effects (anemia, liver complications, and muscle pain), but a decreased rate of neutropenia (low count of neutrophils, a type of white blood cell that helps fight infections). The addition of fluorouracil also increased the rate of side effects, including: neutropenia, fever, nausea, and vomiting.
These findings suggest that for patients with early node-positive breast cancer, giving adjuvant chemotherapy on a dose-dense schedule may improve disease-free survival. Adding fluorouracil, however, to an adjuvant treatment combination of Ellence, Cytoxan, and Taxol does not appear to improve disease-free survival among these patients.
Reference: Del Mastro L, De Placido S, Bruzzi P, et al. Fluorouracil and Dose-Dense Chemotherapy in Adjuvant Treatment of Patients with Early-Stage Breast Cancer: an Open-Label, 2?×?2 Factorial, Randomised Phase 3 Trial. The Lancet [early online publication]. March 1, 2015.
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