European-Canadian randomized trial of paclitaxel in relapsed ovarian cancer: high-dose versus low-dose and long versus short infusion.

摘要: PURPOSETaxol (paclitaxel; Bristol-Myers Squibb, Wallingford, CT) is a new anticancer agent with activity in number of human tumors, including epithelial ovarian cancer. In nonrandomized trials, doses studied have ranged from 135 mg/m2 to 250 administered over 24 hours premedication avoid hypersensitivity reactions (HSRs). This study addressed two questions: the dose-response relationship Taxol relapsed cancer and safety short infusion given premedication.METHODSWomen platinum-pretreated measurable recurrent disease were randomized bifactorial design receive either 175 or 3 hours. Major end points frequency significant HSRs objective response rate. Secondary progression-free overall survival.RESULTSOf 407 patients randomized, 391 eligible 382 assessable for response. Analysis was performed according design. Severe we...