title: A pilot study of a day one and eight every three weeks administration of docetaxel in metastatic cancer patients.
abstract: OBJECTIVE
  Docetaxel is an active agent in metastatic cancers. The standard administration every 3 weeks frequently causes gastrointestinal toxicity and severe myelosuppression. These are rare with a weekly docetaxel regimen, which instead produces severe asthenia. To develop a new docetaxel schedule associated with mild myelosuppression and less fatigue, we conducted this pilot study to determine the feasibility and the maximum tolerated dose of a day one and eight every three weeks administration of docetaxel.
  
  
  METHODS
  The first 3 patients were treated with a dose of 40 mg/m2 on day one and eight, which was then escalated by increments of 5 mg/m2 on both days up to determine the maximum tolerated dose, defined as the dose level associated with the same dose-limiting toxicity in at least 33% of patients.
  
  
  RESULTS
  Twenty-one metastatic cancer patients entered the study, with a median age of 57 years and a median performance status of 1. The escalation of dose continued up to 55 mg/m2, where 2 of the 6 enrolled patients presented grade 3 diarrhea, which was our dose-limiting toxicity. Myelosuppression was mild, and no febrile neutropenia was observed. None of the patients showed grade 4 non-haematological toxicity. Only 9.5% of them presented grade 3 asthenia, whereas grade 3 diarrhea and mucositis were revealed in 19% and 9.5%, respectively. All grade 3 non-hematological toxicities were observed in heavily pretreated or elderly patients.
  
  
  CONCLUSIONS
  The recommended dose of docetaxel was 50 mg/m2, but the regimen could not be recommended in heavily pretreated patients. However, it could become an option in an outpatient setting after a phase II study that better defines its toxicity profile and evaluate its antitumor activity.
authors.affiliation: Oncology Departement, Livorno Hospital, Livorno, Italy. francesca.martella@gmail.com
authors.forename: Francesca
authors.initials: F
authors.lastname: Martella
authors.forename: Pier Giorgio
authors.initials: PG
authors.lastname: Giannessi
authors.forename: Roberta
authors.initials: R
authors.lastname: Di Marsico
authors.forename: Luigi
authors.initials: L
authors.lastname: Coltelli
authors.forename: Valentina
authors.initials: V
authors.lastname: Safina
authors.forename: Nicola
authors.initials: N
authors.lastname: Giuntini
authors.forename: Alfredo
authors.initials: A
authors.lastname: Falcone
mesh_terms: D000328:Adult; D000368:Aged; D003967:Diarrhea / Q000139:chemically induced; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008297:Male; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D052016:Mucositis / Q000139:chemically induced; D009362:Neoplasm Metastasis / Q000188:drug therapy*; D009369:Neoplasms / Q000150:complications / Q000188:drug therapy* / Q000473:pathology; D010865:Pilot Projects; D043823:Taxoids / Q000008:administration & dosage* / Q000633:toxicity
chemical_list: D043823:Taxoids; D000077143:Docetaxel