title: A phase II trial of docetaxel (Taxotere) as second-line chemotherapy in patients with metastatic breast cancer.
abstract: The efficacy and tolerability of docetaxel 100 mg/m(2) every 3 weeks as second-line chemotherapy in patients with metastatic breast cancer was investigated. In addition, the efficacy of a 3-day prophylaxis against cumulative dose-related fluid retention was examined with methylprednisolone 32 mg twice daily for 3 days starting 12 and 3 h before the docetaxel infusion together with oral cetirizine 10 mg 12 and 3 h before start of docetaxel for prevention of acute hypersensitivity reactions. According to the intent to treat-analysis 35% (95%CI: 25; 46) of the 94 patients entered responded to therapy. Their median survival was 12 months (range 0-20 months). The respective response rate for the 87 patients eligible for response evaluation was 37% (95%CI: 27; 48). Their median duration of response was 8 months (range 3-12 months), their median time to progression was 4 months (range 1-12 months). The corresponding response rate in the eligible patient cohort with anthracycline-resistant disease was 28% (95%CI: 15; 45) and increased to 44% (95%CI: 30; 59) in the cohort with non-anthracycline-resistant disease. Patients with visceral metastases responded in 36% and patients with > or = 3 organs involved in 33%. In a retrospective analysis, the 3-day premedication of corticosteroids and antihistamines proved to be as effective as the established but more toxic 5-day regimen in delaying and preventing the occurrence of docetaxel derived toxicities especially the cumulative fluid retention. In conclusion, docetaxel represents one of the most active agents for second-line treatment of metastatic breast cancer, especially for anthracycline-resistant patients. Due to comparable effectiveness of the 5-day regimen which is widely used by others and the 3-day premedication tested in this trial the latter proved to be more favourable and was therefore recommended for future therapies.
authors.affiliation: Applied Cancer Research-Institution for Translational Research Vienna (ACR-ITR VIEnna), Vienna, Austria. martina.baur@gmx.net
authors.forename: Martina
authors.initials: M
authors.lastname: Baur
authors.forename: Allan T
authors.initials: AT
authors.lastname: van Oosterom
authors.forename: Véronique
authors.initials: V
authors.lastname: Diéras
authors.forename: Michele
authors.initials: M
authors.lastname: Tubiana-Hulin
authors.forename: R Charles
authors.initials: RC
authors.lastname: Coombes
authors.forename: Thomas
authors.initials: T
authors.lastname: Hatschek
authors.forename: Michael
authors.initials: M
authors.lastname: Murawsky
authors.forename: May
authors.initials: M
authors.lastname: Klink-Alakl
authors.forename: Marcus
authors.initials: M
authors.lastname: Hudec
authors.forename: Christian
authors.initials: C
authors.lastname: Dittrich
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy / Q000556:secondary; D000293:Adolescent; D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D015331:Cohort Studies; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008875:Middle Aged; D012189:Retrospective Studies; D043823:Taxoids / Q000627:therapeutic use*
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel