Weekly and Every-3-Week Docetaxel Equally Effective

July 2, 2002

BARCELONA, Spain-In 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

BARCELONA, Spain—In 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 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- 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 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.

Grade 3-4 adverse events were noted in 8% of the patients in the weekly cohort and 14.4% in the every-3-week arm. Neutropenia occurred in 2.5% of patients on the weekly arm and 17.9% of those on the every-3-week arm. The percents for neutropenic fever were 5% and 17.9%, respectively.

Nonhematologic grade 3-4 toxicities included stomatitis (7.5% in the weekly group vs 17.9% in the every-3-week cohort), fatigue (15% vs 7.7%), nausea and vomiting (10% vs 15.4%), neurosensory problems (0% vs 15.4%), and edema (2.5% vs 10.3%). Nail changes, all grades, were seen in 57.5% of patients in the weekly arm and 56.4% of those in the every-3-week group.

"Both regimens had equally effective response rates, equal times to treatment failure, and equal safety profiles," Dr. Tabernero said. The researchers concluded that the frequency of docetaxel chemotherapy could safely depend on patient preference and on schedule convenience for use of the agent in combination with other anticancer drugs.