Journal of Chemotherapy · 2005 · 15 citations · 7 references
MedicineOncologyPharmacologyCancer Drug Toxicity ManagementChemotherapyOncology PharmacotherapyChemotherapy Toxicity In Older AdultsChemotherapy Toxicity ManagementDose SchedulingGeriatric OncologyMetastatic Breast CancerToxicity ManagementChemotherapy Dose OptimizationChemotherapy Dose-limiting ToxicityGeriatric Chemotherapy ToxicityMetastatic Breast Cancer TreatmentWeekly Scheduling
Standard dose docetaxel is burdened by severe toxicity. Weekly schedules have been shown to be active as standard scheme with reduced side effects. In 20-30% of elderly patients (pts) the classic 6-week schedule induces grade 3/4 fatigue and other cumulative toxicities. We carried out this safety study in order to evaluate whether a modified weekly docetaxel schedule would improve the toxicity profile. Twenty-one untreated elderly (> or = 70 years) pts suffering from metastatic breast cancer were enrolled in the study. Pts were treated with a weekly dose of 35 mg/m2 docetaxel for 6 weeks, followed by a 2-week rest. Further cycles were performed with this modified schedule: docetaxel days 1, 8 and 15 every 29 days. All pts received at least the first cycle (6 weeks). A total of 261 doses were delivered. No toxic deaths occurred. The toxicity was mild: we recorded 1 episode of grade 3 neutropenia and severe asthenia in only 2 pts (10%). We recorded an overall response rate of 33% (1 CR, 6 PR). Our data showed a reduced incidence of severe asthenia (2/21), obtained with a light modification of a weekly docetaxel schedule.
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Optimal two-stage designs for phase II clinical trials
Richard Simon · Controlled Clinical Trials · 1989 · 3.6K citations
Jean‐Marc Nabholtz, H.-J. Senn, W.R. Bezwoda et al. · Journal of Clinical Oncology · 1999 · 506 citations
Medicine, Oncology, Pharmacology +12
Nail changes secondary to docetaxel
Gunnar Wasner, Felix Hilpert, Ralf Baron et al. · The Lancet · 2001 · 64 citations · Full text