Phase III study of cyclophosphamide, doxorubicin, and fluorouracil (CAF) plus leucovorin versus CAF for metastatic breast cancer: Cancer and Leukemia Group B 9140. Academic Article Article uri icon

Overview

MeSH

  • Aged
  • Cyclophosphamide
  • Disease Progression
  • Doxorubicin
  • Female
  • Fluorouracil
  • Health Status
  • Humans
  • Leucovorin
  • Middle Aged
  • Neoplasm Metastasis
  • Prognosis
  • Survival
  • Treatment Outcome
  • Viscera

MeSH Major

  • Antineoplastic Combined Chemotherapy Protocols
  • Breast Neoplasms

abstract

  • To determine whether biochemical modulation with LV (leucovorin) enhances the efficacy of CAF (cyclophosphamide, doxorubicin, and fluorouracil) against metastatic breast cancer. Women with histologically confirmed stage IV breast cancer, Cancer and Leukemia Group B (CALGB) performance status 0 to 2, and no prior chemotherapy for metastatic disease were randomly assigned to receive CAF (cyclophosphamide 500 mg/m2 day 1, doxorubicin 40 mg/m2 day 1, and fluorouracil [FU] 200 mg/m2 intravenous bolus days 1 to 5) with or without LV (LV 200 mg/m2 over 30 minutes days 1 to 5 given 1 hour before FU). Two hundred forty-two patients were randomly assigned to treatment; 124 patients had visceral crisis and 40 patients had a CALGB performance status score of 2. The median follow-up was 6 years. The two study arms were similar with regard to serious adverse events; four patients died from treatment-related causes, two patients on each study arm. Predictive variables for time to treatment failure and survival were visceral disease and performance status. The overall response rate was 29% for CAF versus 28% for CAF plus LV. The median time to treatment failure (9 months) and median survival (1.7 years) did not differ by treatment arm. Modulation of CAF with LV improved neither response rates nor survival among women with metastatic breast cancer, compared with CAF alone. Multivariate analyses confirmed the prognostic importance of performance status and visceral crisis. However, the overall and complete response rates, response durations, time to treatment failure, and survival were the same in the two treatment arms.

publication date

  • May 1, 2003

has subject area

  • Aged
  • Antineoplastic Combined Chemotherapy Protocols
  • Breast Neoplasms
  • Cyclophosphamide
  • Disease Progression
  • Doxorubicin
  • Female
  • Fluorouracil
  • Health Status
  • Humans
  • Leucovorin
  • Middle Aged
  • Neoplasm Metastasis
  • Prognosis
  • Survival
  • Treatment Outcome
  • Viscera

Research

keywords

  • Clinical Trial
  • Clinical Trial, Phase III
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial

Identity

Language

  • eng

Digital Object Identifier (DOI)

  • 10.1200/JCO.2003.05.119

PubMed ID

  • 12721259

Additional Document Info

start page

  • 1819

end page

  • 1824

volume

  • 21

number

  • 9