HANNOVER, GermanyAn intensive sequential adjuvant
chemotherapy regimen has proven safe and tolerable in breast cancer
patients with 10 or more positive lymph nodes. The regimen,
consisting of epirubicin
(Ellence), paclitaxel (Taxol), and cyclophosphamide, has been
associated with four recurrences in the first 36 patients treated and
followed for a median of 75 weeks.
The results follow evidence of improved survival with the
regimen in patients who have had up to nine positive nodes,
Ursula Scholz, MD, of Hannover Medical School, Germany, said at the
San Antonio symposium. It is still too early to judge the
efficacy of this regimen, Dr. Scholz said. We need to
evaluate the regimen for a longer period of time and in a larger
number of patients. We also have not determined the optimal regimen.
Dr. Scholz and her colleagues have evaluated 36 patients treated with
two different dosages of the combination, which is repeated three
times every 2 weeks with growth factor support on days 3 to 12.
Fifteen patients received epirubicin 120 mg/m², paclitaxel 200
mg/m², and cyclophosphamide 2,000 mg/m². The remaining 21
patients received epirubicin 150 mg/m², paclitaxel 250
mg/m², and cyclophosphamide 2,500 mg/m².
Pretreatment in all cases consisted of dexamethasone, clemastine, and
ranitidine prior to paclitaxel, and dexamethasone and ondansetron
(Zofran) prior to epirubicin and cyclophosphamide.
The median age of the 36 patients was 48. They had a median of 22
lymph nodes evaluated and a median of 13 positive nodes.
Investigators excluded patients who had a history of significant
cardiac disease, metastatic breast cancer, or psychiatric disorders.
Thus far, four patients have had disease recurrences. One patient
developed lung and bone metastases and died a year after treatment
with the sequential therapy. A second patient developed meningiosis
carcinomatosa and died a year after treatment.
One patient developed a liver metastasis 6 months after therapy and
has been maintained for more than a year without further progression.
The fourth patient had a locoregional recurrence with nodal
involvement and has remained alive more than 18 months after recurrence.
Grade 3-4 hematologic toxicity consisted of leukopenia in 10
patients, thrombocytopenia in five patients, and anemia in four
patients. No grade 3-4 nonhematologic toxicity occurred in any
patient. Grade 1-2 alopecia, nausea-vomiting, and peripheral
neuropathy occurred in all 36 patients. No patient discontinued
therapy because of toxicity.