title: Phase II study of docetaxel in patients with epithelial ovarian carcinoma refractory to platinum.
abstract: We analyzed the efficacy and toxicity of docetaxel in patients with ovarian cancer who failed previous chemotherapy with platinum. Fifty-five patients with measurable ovarian cancer were entered in this Phase II study at The University of Texas M. D. Anderson Cancer Center. Treatment consisted of 100 mg/m2 docetaxel given i.v. every 3 weeks. Because of hypersensitivity reactions, premedication with steroids and antihistamine was initiated during the study. Twenty-two (40%) patients responded (there were 3 complete responders and 19 partial responders). Twenty-one (38%) patients had stable disease. The median survival was 10 months. The main toxicity was neutropenia (98% of patients), with 13 episodes of neutropenic fever. Cumulative fluid retention was the main reason for dose modification and required a combination of diuretics and steroids for palliation. Other side effects were alopecia (100%); anemia (87%); dermatitis (67%); gastrointestinal disorders (53%); stomatitis (49%); neurotoxicity (45%); excessive lacrimation (33%); and hypersensitivity reactions (11%), which in one case were life threatening (loss of consciousness, fluid resuscitation). Docetaxel as a single agent proved to be active in heavily pretreated ovarian cancer patients but is associated with significant side effects. Objective toxicity consisted mainly of neutropenia and fluid retention. Neutropenia was dose limiting and required therapy with granulocyte colony-stimulating factor. Fluid retention was improved but not eliminated by diuretics and corticosteroids. Additional studies of docetaxel in ovarian carcinoma are indicated to define the activity in relation to paclitaxel and in platinum combination therapy.
authors.affiliation: Section of Gynecologic Medical Oncology, Division of Diagnostic Imaging, The University of Texas M.D. Anderson Cancer Center, Houston, USA.
authors.forename: J J
authors.initials: JJ
authors.lastname: Kavanagh
authors.forename: A P
authors.initials: AP
authors.lastname: Kudelka
authors.forename: C G
authors.initials: CG
authors.lastname: de Leon
authors.forename: D
authors.initials: D
authors.lastname: Tresukosol
authors.forename: M
authors.initials: M
authors.lastname: Hord
authors.forename: M B
authors.initials: MB
authors.lastname: Finnegan
authors.forename: E E
authors.initials: EE
authors.lastname: Kim
authors.forename: D
authors.initials: D
authors.lastname: Varma
authors.forename: A
authors.initials: A
authors.lastname: Forman
authors.forename: P
authors.initials: P
authors.lastname: Cohen
authors.forename: C L
authors.initials: CL
authors.lastname: Edwards
authors.forename: R S
authors.initials: RS
authors.lastname: Freedman
authors.forename: C F
authors.initials: CF
authors.lastname: Verschraegen
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000627:therapeutic use*; D000077143:Docetaxel; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D008875:Middle Aged; D009375:Neoplasms, Glandular and Epithelial / Q000188:drug therapy* / Q000401:mortality; D009944:Organoplatinum Compounds / Q000627:therapeutic use*; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality; D017239:Paclitaxel / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D015996:Survival Rate; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D009944:Organoplatinum Compounds; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D017239:Paclitaxel