BARCELONA, SpainIn patients with metastatic breast
cancer, weekly dosing with docetaxel (Taxotere) appears to provide benefits
equal to those of every-3-week dosing, according to results of a
multicenter, randomized, European phase II trial presented at a poster
session of the 38th Annual Meeting of the American Society of Clinical
Oncology (abstract 205). Both schedules are currently used in treating these
"We decided to do a trial to be sure docetaxel
administered every week was as effective and safe as the every-3-week
schedule," said Josep Tabernero, MD, Oncologia Medica, Vall d’Hebron Hospital, Barcelona. "We
performed a randomized clinical trial with an objective to compare the grade
3-4 adverse events and time to treatment failure between the two arms."
All of the patients had received cyclophosphamide- and/or
anthracycline-based chemotherapy, either in the adjuvant or in the
metastatic setting. One prior chemotherapy regimen in the metastatic setting
and previous paclitaxel (Taxol) were allowed.
Investigators randomized the 82 participants into two
arms. One group received docetaxel 100 mg/m² every 3 weeks. The other arm
was given docetaxel 40 mg/m² weekly, with 6 weeks on and 2 weeks off.
Patients were give prophylactic dexamethasone or an equivalent drug. The
chemotherapy was administered until the disease progressed, intolerable
toxicity developed, the patient withdrew, or the investigator believed it
was in the patient’s best interest to stop treatment.
The participants’ median age was 55 years (range, 25 to
72 years); 79.5% of patients were postmenopausal. Fifty-five percent had
received prior radiation, 65% prior hormonal therapy, and all but two, prior
The median number of weeks on treatment for patients in
the weekly docetaxel cohort was 16 (range, 8 to 80) and for the every-3-week
arm, 18 (range, 3 to 36).
The overall response rate was 40.9%: 43.9% in the weekly
cohort and 38.1% in the every-3-week arm. The median time to treatment
failure was 3.7 months in the weekly group and 4.4 months in the