Abstract
The aim of this study was to evaluate the efficacy and toxicity of paclitaxel given at the same dose intensity and administered weekly (arm A) or every 3 weeks (arm B). and to assess the safety of intravenous steroids versus standard peroral premedication. Two hundred and eight patients with advanced ovarian cancer previously treated with no more than one platinum-containing regimen were randomized to receive either a weekly infusion of paclitaxel or an infusion every 3 weeks. The median delivered dose intensity was 77.6 mg/m2/week in the weekly arm, and 72.7 mg/m2/week in the every 3 weeks arm. WHO grade 3-4 hematological and non-hematological toxicity occurred more frequently in arm B. No difference in number of severe events of hypersensitivity, response rate, time to progression or survival between arms was observed. Weekly paclitaxel at a dose of 67 mg/m2/week was found to have a better safety profile and seemed to be as effective as the equivalently dosed schedule every 3 weeks. Intravenous steroids are a safe alternative to oral steroids.
Publication types
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Clinical Trial
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Comparative Study
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Multicenter Study
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Randomized Controlled Trial
MeSH terms
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Administration, Oral
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Adult
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Aged
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Antineoplastic Agents, Phytogenic / administration & dosage
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Antineoplastic Agents, Phytogenic / adverse effects
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Antineoplastic Agents, Phytogenic / therapeutic use*
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Antineoplastic Combined Chemotherapy Protocols / pharmacology
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Carcinoma / drug therapy*
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Cimetidine / therapeutic use
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Clemastine / therapeutic use
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Dexamethasone / administration & dosage
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Dexamethasone / therapeutic use*
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Disease-Free Survival
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Drug Administration Schedule
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Drug Hypersensitivity / etiology
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Drug Resistance, Neoplasm
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Female
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Hematologic Diseases / chemically induced
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Humans
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Infusions, Intravenous
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Injections, Intravenous
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Life Tables
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Middle Aged
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Muscular Diseases / chemically induced
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Nervous System Diseases / chemically induced
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Organoplatinum Compounds / administration & dosage
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Organoplatinum Compounds / pharmacology
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Ovarian Neoplasms / drug therapy*
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Paclitaxel / administration & dosage
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Paclitaxel / adverse effects
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Paclitaxel / therapeutic use*
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Premedication*
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Salvage Therapy*
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Survival Analysis
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Treatment Outcome
Substances
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Antineoplastic Agents, Phytogenic
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Organoplatinum Compounds
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Dexamethasone
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Cimetidine
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Clemastine
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Paclitaxel