title: Weekly paclitaxel and 5-fluorouracil in pretreated patients with metastatic breast cancer: a phase I study.
abstract: BACKGROUND
  Recent studies have shown a good activity/tolerability for weekly paclitaxel and 5-fluorouracil in protracted continuous infusion (p.c.i.) in metastatic breast cancer patients pretreated with anthracyclines.
  
  
  METHODS
  To define the MTD of weekly paclitaxel (days 1-8-15-22, every 4 weeks with a starting dose of 75 mg/m2 and subsequent dose escalation: 90 mg/m2 and 105 mg/m2) in combination with a fixed dose of 5-fluorouracil in p.c.i. (250 mg/m2/day for 3 weeks + 1 week of rest).
  
  
  RESULTS
  Eleven patients were enrolled; on Step III two patients experienced DLT (1 G 3 mucositis and 1 febrile neutropenia). G 3-4 toxicities were: G 3 mucositis (2 out of 11), G 3-4 neutropenia (1 out of 11).
  
  
  CONCLUSIONS
  The recommended schedule for phase II studies is: paclitaxel 90 mg/m2/w + 5-fluorouracil 250 mg/m2 in p.c.i. for 21 days. This is the first phase I trial with the combination of weekly paclitaxel and 5-fluorouracil p.c.i. in advanced breast cancer patients.
authors.affiliation: La Sapienza University, V.le Regina Elena 324, 00161 Rome, Italy.
authors.forename: Enrico
authors.initials: E
authors.lastname: Cortesi
authors.forename: Federico
authors.initials: F
authors.lastname: Grifalchi
authors.forename: Sara
authors.initials: S
authors.lastname: Ramponi
authors.forename: Augusto
authors.initials: A
authors.lastname: Padovani
authors.forename: Andrea
authors.initials: A
authors.lastname: Mancuso
authors.forename: Luca
authors.initials: L
authors.lastname: Paoluzzi
authors.forename: Francesco
authors.initials: F
authors.lastname: Ferrau
authors.forename: Annalisa
authors.initials: A
authors.lastname: Oliva
mesh_terms: D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects
chemical_list: D017239:Paclitaxel; D005472:Fluorouracil