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Breast Cancer Regimen Is Dose Dense, Dose Intense

Breast Cancer Regimen Is Dose Dense, Dose Intense

 NEW ORLEANS—A German study has provided more support for a dose-dense
chemotherapy approach as adjuvant therapy for high-risk breast cancer. The
investigators found improvements in disease-free and overall survival with
sequential dose-dense therapy, compared with conventionally scheduled
sequential chemotherapy. Speaking at the 40th Annual Meeting of the American
Society of Clinical Oncology (abstract 513), Volker J. Möbus, MD, of
Staedtisches Klinikum, Frankfurt, reported 28-month interim results from the
multi-center phase III trial of the German AGO (Arbeitsgemeinschaft fuer
Gynaekologische Onkologie) group. Dr. Möbus called the experimental regimen
"dose intense" as well as "dose dense," as the individual doses were
intensified and the drugs were given more frequently.

The study randomized 1,284 patients age 65 or less with four or more
positive nodes to receive standard therapy with four courses of epirubicin (Ellence)
(90 mg/m2) and cyclophosphamide (600
mg/m2), followed by four courses of
paclitaxel (175 mg/m2) (ECT) every 3 weeks—or to three courses of sequential
dose-dense/dose-intense chemotherapy using higher doses of epirubicin (150
mg/m2), paclitaxel (225 mg/m2), and cyclophosphamide (2,500 mg/m2) (ETC) every
2 weeks with G-CSF (Neupogen) support. Additional randomization in the
dose-dense, dose-intense arm also evaluated patients with and without epoetin
alfa support (Epogen, Procrit).

At a median follow-up of 28 months, with data available on 1,169 patients,
significantly fewer patients in the sequential dose-dense arm had relapsed: 94
vs 127 with conventional therapy (P = .0009), for a relative risk reduction of
36%. For patients with 10 or more positive nodes, the relative risk reduction
for relapse was 50%. The difference in relapse-free survival was highly
significant, resulting in an estimated 3-year survival of 80% with dose-dense
therapy vs 70% with standard therapy (P = .00009).

Mortality Rates

Mortality rates also favored the dose-dense arm, with 43 deaths with the
dose-dense approach vs 60 with conventional therapy (P = .03), yielding an
estimated 3-year overall survival of 90% vs 87%, respectively, Dr. Möbus
reported.

The results appear to support those of the previous CALGB 9741 study, which
showed a benefit for a dose-dense (every 2 week) schedule of doxorubicin/paclitaxel/cyclophosphamide,
compared with a conventional every-3-week regimen in women with node-positive
stage II/IIIa breast cancer. The new study, Dr. Möbus said, provides positive
data from a second trial, thus potentially swaying oncologists to begin using
the dose-dense regimen in their own practices.

Use of epoetin alfa improved tolerability of the dose-dense regimen, and
there were no differences in relapse-free or overall survival between the
dose-dense patients receiving and not receiving epoetin alfa. While red blood
cell transfusions were necessary in 28% of the overall experimental arm, they
were reduced to 12% in the group randomized to receive epoetin alfa (P =
.0001). "There was a preventive effect of epoetin alfa for anemia," he said.

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