title: Improvement of safety profile of docetaxel by weekly administration in patients with metastatic breast cancer.
abstract: BACKGROUND
  This is a retrospective cohort study on the safety and efficacy profiles of weekly docetaxel at varying doses in patients with pretreated metastatic breast cancer.
  
  
  METHODS
  Twenty-five anthracycline-pretreated patients received docetaxel administered on a weekly basis, as a one-hour infusion, at various dosage levels (25, 30, 35, 40 mg/m2) depending on their baseline Karnofsky index. Each 8-week cycle consisted of 6 weeks of drug infusion, followed by a 2-week rest period.
  
  
  RESULTS
  Of the 25 patients investigated, none achieved complete response (CR), while 9 patients showed partial response (PR), which corresponds to an overall response rate of 36%. Five patients (20%) maintained stable disease (SD), whereas 11 patients (44%) suffered tumor progression (PD) during treatment. Clinical response (defined as PR+SD) was achieved in 14 patients (56%). Median time to progression was 231 days (95% CI, 187-275). The baseline Karnofsky index was 87% +/- 9% (range: 70-100). Patients pretreated with anthracyclines only tended to have a better response than anthracycline/paclitaxel-pretreated patients (n = 6, p = 0.054). Higher dosages were associated with neurotoxicity, skin/nail toxicity, leukopenia, nausea/vomiting, fatigue/asthenia, peripheral edema, but not with diarrhea and alopecia. The cumulative dose per patient was largest for a weekly docetaxel dosage of 35 mg/m2 and almost as large for 30 mg/m2.
  
  
  CONCLUSIONS
  Balancing toxicity vs. efficacy/cumulative dosage delivered, our results support weekly administration of docetaxel at dosages of 30-35 mg/m2 in metastatic breast cancer. Response in patients pretreated with anthracyclines and taxanes may be poorer than in those pretreated with anthracyclines only.
authors.affiliation: Department of Senology, University of Cologne, Germany. Mathias.Warm@uk-koeln.de
authors.forename: Mathias
authors.initials: M
authors.lastname: Warm
authors.forename: Frank
authors.initials: F
authors.lastname: Nawroth
authors.forename: Ralf
authors.initials: R
authors.lastname: Ohlinger
authors.forename: Marcus
authors.initials: M
authors.lastname: Valter
authors.forename: Ellen
authors.initials: E
authors.lastname: Pantke
authors.forename: Peter
authors.initials: P
authors.lastname: Mallmann
authors.forename: Nadia
authors.initials: N
authors.lastname: Harbeck
authors.forename: Ronald
authors.initials: R
authors.lastname: Kates
authors.forename: Anke
authors.initials: A
authors.lastname: Thomas
mesh_terms: D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy*; D002986:Clinical Trials as Topic; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced / Q000517:prevention & control; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D012189:Retrospective Studies; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects*; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
chemical_list: D000970:Antineoplastic Agents; D043823:Taxoids; D000077143:Docetaxel