Weekly paclitaxel and 5-fluorouracil in pretreated patients with metastatic breast cancer: A phase I study

Enrico Cortesi, Federico Grifalchi, Sara Ramponi, Augusto Padovani, Andrea Mancuso, Luca Paoluzzi, Francesco Ferrau, Annalisa Oliva

Research output: Contribution to journalArticle

2 Scopus citations

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. Materials and 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). Conclusion: 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.

Original languageEnglish (US)
Pages (from-to)1961-1966
Number of pages6
JournalAnticancer Research
Volume23
Issue number2 C
Publication statusPublished - Mar 1 2003
Externally publishedYes

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Keywords

  • Fluorouracil
  • Metastatic breast cancer
  • Paclitaxel
  • Phase I

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Cortesi, E., Grifalchi, F., Ramponi, S., Padovani, A., Mancuso, A., Paoluzzi, L., ... Oliva, A. (2003). Weekly paclitaxel and 5-fluorouracil in pretreated patients with metastatic breast cancer: A phase I study. Anticancer Research, 23(2 C), 1961-1966.