Safety and efficacy of weekly docetaxel in frail and/or elderly patients with metastatic breast cancer: a phase II study.
This phase II study was designed to evaluate the safety and efficacy of weekly docetaxel (36 mg/m) for the treatment of metastatic breast cancer in 47 frail and/or elderly patients who were ineligible for the standard 3-weekly docetaxel (100 mg/m) regimen. Reasons for ineligibility to the latter were age > or = 70 years (10 patients), poor hematological reserves (15 patients), impaired liver function (eight patients), intolerance to previous taxanes administered 3-weekly without demonstrated resistance (five patients) or any combination of these reasons (nine patients). There was a median of two prior chemotherapy regimens and more than 60% had a WHO performance score at baseline of 2-3. A total of 408 weekly administrations were given over a period of 525 weeks (78% of the intended dose intensity) and the median cumulative dose of docetaxel per patient was 278 mg/m. The incidence of serious adverse events was low. Grade 3 neutropenia occurred in six patients and grade 4 in four patients. Of these 10 patients, eight had pre-existing hematological abnormalities and four developed neutropenic fever. Neurotoxicity was mild and grade 3 paraesthesia occurred in one patient. The overall objective response rate in 37 evaluable patients was 30% and responses were observed in all subgroups of patients. We conclude that weekly docetaxel (36 mg/m) is active, safe and well tolerated in heavily pre-treated frail/elderly patients with poor prognostic features, including low performance scores and multiple metastatic sites, who would not be eligible for treatment with the standard 3-weekly regimen.
D'hondt
Randal
R
Department of Oncology, University Hospital Gasthuisberg, Catholic University of Leuven, Leuven, Belgium.
Paridaens
Robert
R
Wildiers
Hans
H
Pauwelyn
Karen
K
Thomas
Jose
J
Dumez
Herlinde
H
Van Oosterom
Allan T
AT
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000077143:Docetaxel; D005260:Female; D016330:Frail Elderly; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome
D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel