Journal of Clinical Oncology · 2000 · 261 citations · 24 references
MedicineOncologyPharmacotherapyBreast OncologyChemotherapyMedical OncologyAdjuvant ChemotherapyAdjuvant TherapyBreast Cancer PharmacotherapyMetastatic Breast CancerMetastatic Disease TreatmentToxicity ManagementAnthracycline-based ChemotherapyBreast Cancer ChemotherapyBreast Cancer Response AssessmentIntent-to-treat EffectMetastatic Breast Cancer TreatmentStable Disease AssessmentWeekly Scheduling
PURPOSE: To evaluate the safety and efficacy of weekly docetaxel in women with metastatic breast cancer. PATIENTS AND METHODS: Twenty-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. RESULTS: Patients 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). CONCLUSION: Weekly 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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Jean‐Marc Nabholtz, H.-J. Senn, W.R. Bezwoda et al. · Journal of Clinical Oncology · 1999 · 506 citations
Medicine, Oncology, Pharmacology +12
Vicente Valero, Frankie A. Holmes, R S Walters et al. · Journal of Clinical Oncology · 1995 · 388 citations