Source: DGNews  |  Posted 10 years ago

By Robert H. Carlson

SAN ANTONIO, TX -- December 14, 2001-- A dose-dense eight-week schedule of doxorubicin and docetaxel chemotherapy before surgery for breast cancer was as safe and well-tolerated as a sequential 24-week schedule of doxorubicin and cyclophosphamide followed by docetaxel.

The findings are from an interim analysis of a large randomised trial, the German Pre-operative Adriamycin Docetaxel Trial (GEPAR-DUO-TRIAL), which evaluates the two schedules when given before surgery in women with operable breast cancer.

The "neoadjuvant chemotherapy" strategy aims to reduce tumor volume before surgical resection so as to increase the possibility that the woman can have breast conservation surgery.

The first author on this interim study, Christian Jackisch, MD, Department of Obstetrics and Gynecology, University of Muenster, in Muenster, Germany, said there is increasing evidence that docetaxel has a role to play in the neoadjuvant setting, but the optimal docetaxel-based regimen has yet to be defined.

In this trial, 783 women were randomized to receive one of two regimens before surgery: a dose-dense eight-week schedule of doxorubicin and docetaxel (ADOC) regimens; or a sequential 24-week schedule of doxorubicin and cyclophosphamide followed by docetaxel (AC-DOC).

ADOC included doxorubicin 50 mg/m? and docetaxel 75 mg/m? given every two weeks for four cycles, for a total of eight weeks of therapy.

AC-DOC involved a doxorubicin (Adriamycin) dose of 60 mg/m? and cyclophosphamide 600 mg/m? for four 21-day cycles, followed by docetaxel 100 mg/m? for four additional 21-day cycles; a total of 24 weeks of therapy.

The regimens were approximately equal in the rate of adverse side effects, said Dr. Jackisch, who presented interim safety data on the first 206 patients in a poster presentation at the 24th Annual San Antonio Breast Cancer Symposium, in San Antonio, Texas.

Grade 3/4 toxicity rates for ADOC and AC-DOC patients, respectively, were anemia in 2 percent of patients in each group; neutropenia in 33.0 percent and 54.8 percent; thrombocytopenia in zero percent and 1.1 percent; nausea in 3.9 percent and 2.2 percent; alopecia in 91.9 percent and 98.9 percent; and neurotoxicity in 1.0 percent and 4.3 percent.

There were no cases of severe cardiac toxicity, although one patient died after having a fulminant pulmonary embolism.

The number of early drop-outs from the trial was approximately the same in both groups -- 15 in the ADOC group and 18 with AC-DOC. Breast conservation surgery was performed in 80.3 of patients and the overall pathological complete response rate was 13.1 percent.