title: Paclitaxel in a novel formulation containing less Cremophor EL as first-line therapy for advanced breast cancer: a phase II trial.
abstract: Paclitaxel (Taxol) is formulated in 50% Cremophor EL (CrEL)/absolute ethanol for clinical use. In order to reduce vehicle-related side effects, Genetaxyl was developed to have paclitaxel formulated in a solution containing lesser amounts of CrEL and ethanol plus 2 other solvents. The purpose of the study was to evaluate the efficacy and safety of Genetaxyl as first-line therapy to treat breast cancer patients. Patients with newly diagnosed stage III (N = 8) or IV (N = 10), or recurrent (N = 11) breast cancer received single-agent Genetaxyl at 175 mg/m(2) administered in a 3-h infusion every 3 weeks for 3-6 cycles. A total of 148 cycles were delivered to 29 patients. The overall response rate was 41.4% (95% confidence interval, 23.4 to 59.2%), and that of patients with metastatic disease (N = 20) was 30%. Median survival for all patients was 32.4 months and 24.3 months for patients having metastatic disease. The toxicity profile seems favorable, especially regarding myelosuppression and myalgia/arthralgia. No severe hypersensitivity reaction occurred. These phase II trial results demonstrate that a 60% reduction of CrEL by Genetaxyl's formulation does not affect the activity of paclitaxel and could allow for better control of several CrEL-related toxicities.
authors.affiliation: Division of Medical Oncology, Department of Medicine, Taipei Veteran General Hospital, Taipei 112, Taiwan, R.O.C..
authors.forename: Ta-Chung
authors.initials: TC
authors.lastname: Chao
authors.forename: Zyting
authors.initials: Z
authors.lastname: Chu
authors.forename: Ling-Ming
authors.initials: LM
authors.lastname: Tseng
authors.forename: Tzeon-Jye
authors.initials: TJ
authors.lastname: Chiou
authors.forename: Ruey-Kuen
authors.initials: RK
authors.lastname: Hsieh
authors.forename: Wei-Shu
authors.initials: WS
authors.lastname: Wang
authors.forename: Chueh-Chuan
authors.initials: CC
authors.lastname: Yen
authors.forename: Muh-Hwa
authors.initials: MH
authors.lastname: Yang
authors.forename: Liang-Tsai
authors.initials: LT
authors.lastname: Hsiao
authors.forename: Jin-Hwang
authors.initials: JH
authors.lastname: Liu
authors.forename: Po-Min
authors.initials: PM
authors.lastname: Chen
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D002626:Chemistry, Pharmaceutical; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D017239:Paclitaxel / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D017239:Paclitaxel
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