BARCELONA, SpainIn patients with metastatic breast cancer, weekly dosing with docetaxel(Drug information on 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 patients.
"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(Drug information on 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(Drug information on 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(Drug information on 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 chemotherapy.
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 every-3-week cohort.