• J. Clin. Oncol. · Mar 2000

    Clinical Trial

    Docetaxel administered on a weekly basis for metastatic breast cancer.

    • H J Burstein, J Manola, J Younger, L M Parker, C A Bunnell, R Scheib, U A Matulonis, J E Garber, K D Clarke, L N Shulman, and E P Winer.
    • Breast Oncology Center, Boston, MA, USA.
    • J. Clin. Oncol. 2000 Mar 1; 18 (6): 1212-9.

    PurposeTo evaluate the safety and efficacy of weekly docetaxel in women with metastatic breast cancer.Patients And MethodsTwenty-nine women were enrolled onto a study of weekly docetaxel given at 40 mg/m(2)/wk. Each cycle consisted of 6 weeks of therapy followed by a 2-week treatment break, repeated until disease progression or removal from study for toxicity or patient preference. Fifty-two percent of patients had been previously treated with adjuvant chemotherapy; 21% had received prior chemotherapy for metastatic breast cancer, and 31% had previously received anthracyclines. All patients were assessable for toxicity; two patients were not assessable for response but are included in an intent-to-treat analysis.ResultsPatients received a median of 18 infusions, with a median cumulative docetaxel dose of 720 mg/m(2). There were no complete responses. Twelve patients had partial responses (overall response rate, 41%; 95% confidence interval, 24% to 61%), all occurring within the first two cycles. Similar response rates were observed among subgroups of patients previously treated either with any prior chemotherapy or with anthracyclines. An additional 17% of patients had stable disease for at least 6 months. The regimen was generally well tolerated. There was no grade 4 toxicity. Only 28% of patients had any grade 3 toxicity, most commonly neutropenia and fatigue. Acute toxicity, including myelosuppression, was mild. Fatigue, fluid retention, and eye tearing/conjunctivitis became more common with repetitive dosing, although these side effects rarely exceeded grade 2. Dose reductions were made for eight of 29 patients, most often because of fatigue (n = 5).ConclusionWeekly docetaxel is active in treating patients with metastatic breast cancer, with a side effect profile that differs from every-3-weeks therapy.

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