The combination of docetaxel (Taxotere) and doxorubicin is highly
effective in breast cancer, but it presents relatively high
hematologic toxicity. Recent data have suggested advantages for the
weekly administration of docetaxel regarding the safety profile of
this combination. Our objective was to evaluate (response rate and
safety) the docetaxel/doxorubicin combination administered as a new
schedule as first-line treatment of breast cancer.
Doxorubicin, dosed at 50 mg/m² as a 15-minute IV infusion on day
1, was followed by docetaxel (1 hour later) at 36 mg/m² as a
30-minute IV infusion on days 1, 8, and 15, every 4 weeks.
Premedication included oral dexamethasone 8 mg the night before,
morning of, and evening after each docetaxel infusion. In patients
with operable (denoted O) breast cancer, four cycles were
administered, followed by radical treatment; those patients with
inoperable advanced or metastatic (denoted A) breast cancer received
A total of 62 patients (21 O/41 A) were included, all of whom were
evaluable for toxicity and 43 of whom (15 O/28 A) were evaluable for
response (19 too early). The median age was 52 years (range:
2976 years). The median ECOG (Eastern Cooperative Oncology
Group) performance status was 0 (range: 02). Metastatic sites
(A) included soft tissues (50% of patients), bone (32%), liver (29%),
and lung (24%). Seventy (O) and 212 (A) cycles were administered:
18/70 (O) and 68/212 (A) cycles had dose reductions; 23/70 (O) and
39/212 (A) cycles were delayed.
The main hematologic toxicity was neutropenia, classified as grade
3/4 in 7% of cycles and as febrile neutropenia in 4%. The main grade
3 nonhematologic toxicities were alopecia (46% of cycles), asthenia
(8%), nausea/vomiting (4%), nail disorders (3%), pulmonary (1%), and
stomatitis (1%). No grade 4 nonhematologic toxicity was observed.
There were 15/21 patients (O) and 28/41 patients (A) evaluable for
response; of these, 5/15 (O) and 4/28 (A) achieved complete
remission, and 9/15 (O) and 14/28 (A) partial remission. Given an
overall response rate of 93% of evaluable patients (O) and 64% of
evaluable patients (A), 1/15 (O) and 8/28 (A) had no changes and 0/15
(O) and 2/28 (A) experienced progressive disease.
CONCLUSION: This weekly docetaxel/doxorubicin combination appears to
have a high efficacy in breast cancer, with mild hematologic toxicity.