Salvage treatment of metastatic breast cancer with docetaxel and carboplatin. A multicenter phase II trial.
OBJECTIVE
To evaluate the efficacy and safety of docetaxel in combination with carboplatin as salvage treatment in women with metastatic breast cancer (MBC).


METHODS
Chemotherapy-pretreated women with MBC were treated with docetaxel 75 mg/m(2) as 1-hour i.v. infusion followed by carboplatin AUC 6 mg/ml.min, using the Calvert's formula, as 30-min i.v. infusion. Cycles were repeated on an outpatient basis every 3 weeks.


RESULTS
Thirty-six patients received a total of 210 chemotherapy cycles (median 6 cycles/patient). All but one patient had previously received anthracyclines for the treatment of metastatic disease and half of the patients had failed to respond to front-line treatment. Twenty-eight (78%) patients had visceral disease. On an intention-to-treat analysis there were three (8%) complete and 19 (53%) partial responses for an overall response rate of 61% (95% CI: 45.2-77.0%). The response rate was 44% (2 CRs, 6 PRs) among 18 patients who had progressive or stable disease as best response to front-line treatment. The median duration of response was 8 months, the median time to tumor progression 10 months, and the probability of 1-year survival 66%. Grade 3-4 neutropenia was the main hematologic toxicity occurring in 16 (45%) patients or 36 (17%) cycles. Seven (19%) patients developed 8 (4%) febrile neutropenic episodes. Grade 3 thrombocytopenia occurred in 4 (11%) patients or 6 (3%) cycles. Non-hematologic toxicity was generally mild. G-CSF was used in 19 (53%) patients or 134 (64%) cycles. There was one sudden death possibly related to the treatment.


CONCLUSIONS
The docetaxel-carboplatin combination is an active outpatient salvage regimen for the treatment of women with MBC relapsing or not responding to anthracycline-based front-line therapy.
Mavroudis
D
D
Department of Medical Oncology, University General Hospital of Heraklion, PO Box 1352, GR-71110 Heraklion, Crete, Greece. mavrudis@med.uoc.gr
Alexopoulos
A
A
Malamos
N
N
Ardavanis
A
A
Kandylis
C
C
Stavrinidis
E
E
Kouroussis
Ch
Ch
Agelaki
S
S
Androulakis
N
N
Bozionelou
V
V
Georgoulias
V
V
D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D000903:Antibiotics, Antineoplastic / Q000494:pharmacology; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016190:Carboplatin / Q000008:administration & dosage; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016879:Salvage Therapy / Q000379:methods*; D016019:Survival Analysis; D043823:Taxoids; D017211:Treatment Failure; D016896:Treatment Outcome
D000903:Antibiotics, Antineoplastic; D043823:Taxoids; D000077143:Docetaxel; D016190:Carboplatin; D017239:Paclitaxel