[Preoperative chemotherapy in primary operable breast cancer with a dose-dense combination of doxorubicin and docetaxel (ADoc) - Experience of the GEPARDO-GABG study group].
OBJECTIVE
The German Adjuvant Breast Cancer Study Group (GABG) conducts trials of preoperative chemotherapy in patients with primary breast cancer using a combination of doxorubicin and docetaxel (ADoc). -


METHODS
We conducted a parallel-grouped phase IIa-study with 42 patients with a conventionally dosed and a dose-dense ADoc-schedule (4 cycles of Doxorubicin 50 mg/m(2), Docetaxel 75 mg/m(2) i. v. day 1, q day 15 or 22; G-CSF day 3-15 only for the dose-dense schedule) and a randomized phase IIb-study (GEPARDO-Study) with 250 patients with ADoc +/- Tamoxifen. Biological factors were determined immunohistochemically on 197 core biopsies before treatment. A comparison to a sequential AC-Doc regimen including 913 patients has been completed recently. -


RESULTS
ADoc can be applicated on schedule in 93 % of all patients. The dose-dense regimen shows a tendency to more toxicity but also to more efficacy. The rate of complete pathological remissions (pCR) was 9.7 %. No difference was found between chemo- and chemoendocrine treatment. Clinically negative lymphnodes and a negative estrogen receptor status is predictive for a higher pCR-rate. To date no differences in toxicity could be found between ADoc and AC-Doc. -


CONCLUSIONS
The dose-dense ADoc regimen is well tolerated and highly effective as preoperative therapy of breast cancer.
von Minckwitz
G
G
Universitäts-Frauenklinik Frankfurt am Main. minckwitz@em.uni-frankfurt.de
Raab
G
G
Schütte
M
M
Hilfrich
J
J
Blohmer
J U
JU
Gerber
B
B
Costa
S D
SD
Merkle
E
E
Eidtmann
H
H
Lampe
D
D
Jackisch
C
C
du Bois
A
A
Tulusan
A H
AH
Gademann
G
G
Sinn
H P
HP
Caputo
A
A
Graf
E
E
Kaufmann
M
M
D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000601:surgery; D002277:Carcinoma / Q000188:drug therapy* / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005858:Germany; D006801:Humans; D015337:Multicenter Studies as Topic; D020360:Neoadjuvant Therapy; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016032:Randomized Controlled Trials as Topic; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage; D043823:Taxoids; D016896:Treatment Outcome
D043823:Taxoids; D013629:Tamoxifen; D000077143:Docetaxel; D004317:Doxorubicin; D017239:Paclitaxel