A phase II study of the effectiveness of docetaxel (Taxotere) in women with advanced breast cancer previously treated with polychemotherapy. Hellenic Cooperative Interhospital Group in Oncology.
OBJECTIVE
The aim was to study the effectiveness of docetaxel (Taxotere) in patients with advanced breast cancer treated previously with polychemotherapy.


METHODS
Forty-nine patients received docetaxel (100 mg/m2; 1-h i.v. infusion) and corticosteroid premedication. Forty-one patients who had received previous anthracycline treatment were divided into anthracycline-refractory and anthracycline-resistant (early and late) groups.


RESULTS
Of 45 evaluable patients, 66.7% had a partial response (PR) and 2.2% a complete response (CR), giving an overall response rate (ORR) of 68.9%. The ORR in anthracycline-refractory patients was 60% versus 82.6% in anthracycline-resistant patients; the difference was not significant. The ORR in early-resistance patients was 62.5% versus 93.4% in late-resistance patients (0.05 < P < 0.1). The median response duration and overall survival was 8 months (range, 4-23 + months) and 11.5 months (range, 4-31 + months), respectively, in 39 patients treated previously for metastatic disease. For 295 courses, grade 3/4 neutropenia developed in 28.6% of patients (12.5% of courses) and was febrile in 26.5% of patients (6.1% of courses), including one septic death. Hypersensitivity reactions (HSR) developed in 16.3% of patients, and fluid retention developed in 34.7% of patients (11.9% of courses).


CONCLUSIONS
Docetaxel is an active second-line drug in advanced breast cancer. The time of relapse after cessation of anthracycline treatment may be a significant prognostic factor.
Alexopoulos
C G
CG
Department of Medical Oncology, Evangelismos Hospital, Athens, Greece.
Rigatos
G
G
Efremidis
A P
AP
Papacharalambous
A
A
Alexopoulos
A
A
Vassilomanolakis
M
M
Patila
E
E
D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D043823:Taxoids
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel