title: A phase II trial with docetaxel (Taxotere) in second line treatment with chemotherapy for advanced breast cancer. A study of the EORTC Early Clinical Trials Group.
abstract: BACKGROUND
  Docetaxel, a semisynthetic analog of paclitaxel, made for the needles of the European yew, Taxus baccata, is a potentially important chemotherapeutic agent for the treatment of cancer.
  
  
  METHODS
  In a phase II study patients with advanced and/or metastatic breast cancer and bidimensionally measurable disease, were treated with docetaxel 100 mg/m2 every 3 weeks as a 1 hour infusion without any premedication. Treatment was evaluated after 2 courses and every 2 subsequent courses.
  
  
  RESULTS
  Thirty-nine patients were entered, 32 were eligible. The eligible patients had a median age of 51 years (range 30-73) and a performance status WHO 1 median, (range 0-2). Twenty-eight patients had been treated with surgery, 24 with radiation. Hormonal treatment was previously given in 23, chemotherapy in 32. Of 24 patients treated as second line strategy, 13 achieved a partial remission, 1 a complete remission (overall response rate 58% (95% CI 37%-78%)). Eight patients treated as first line: 2 PR's, 1 CR. The median overall response duration was 38 weeks. The main toxicity consisted of transient grade 4 neutropenia in 149 of 167 evaluable courses (89%). However, the related infection rate was low. Re-treatment at 3 weeks, as scheduled, was nearly always possible. Other toxicities consisted of skin reactions (81%) and nail changes (41%), neurosensory toxicity (59%) and occasionally hypersensitivity reactions (16%). Fluid retention was a toxicity of major concern, observed in 59% of patients.
  
  
  CONCLUSIONS
  Docetaxel is a very active drug against breast cancer. Further studies are required to alleviate the non-hematological toxicities.
authors.affiliation: Netherlands Cancer Institute, Amsterdam.
authors.forename: W W
authors.initials: WW
authors.lastname: ten Bokkel Huinink
authors.forename: A M
authors.initials: AM
authors.lastname: Prove
authors.forename: M
authors.initials: M
authors.lastname: Piccart
authors.forename: W
authors.initials: W
authors.lastname: Steward
authors.forename: T
authors.initials: T
authors.lastname: Tursz
authors.forename: J
authors.initials: J
authors.lastname: Wanders
authors.forename: H
authors.initials: H
authors.lastname: Franklin
authors.forename: M
authors.initials: M
authors.lastname: Clavel
authors.forename: J
authors.initials: J
authors.lastname: Verweij
authors.forename: M
authors.initials: M
authors.lastname: Alakl
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D004334:Drug Administration Schedule; D003875:Drug Eruptions / Q000209:etiology; D005060:Europe; D005260:Female; D006801:Humans; D008875:Middle Aged; D009422:Nervous System Diseases / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D012074:Remission Induction; D043823:Taxoids
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D043823:Taxoids; D000077143:Docetaxel; D017239:Paclitaxel