Quality-adjusted survival in a crossover trial of letrozole versus tamoxifen in postmenopausal women with advanced breast cancer

Ann Oncol. 2005 Sep;16(9):1458-62. doi: 10.1093/annonc/mdi275. Epub 2005 Jun 9.

Abstract

Background: Results from a phase III study of postmenopausal women with advanced breast cancer demonstrated longer time to disease progression for patients taking letrozole versus tamoxifen. This analysis compares the trade-offs between progression-free survival and toxicity.

Design: Quality-adjusted survival was calculated using Q-TWiST (quality-adjusted time without symptoms or toxicity). Survival curves were partitioned into three health states: toxicity (TOX), disease progression (PROG) and periods without toxicity or disease progression (TWiST). The utility-weighted sum of the health state durations was derived and compared.

Results: There was not a significant difference in mean duration of serious adverse events prior to progression between the letrozole (n=453) and tamoxifen (n=454) groups (2.2 and 2 months, respectively). For TWiST, the mean duration for letrozole was 11.5 months, versus 8.5 months for tamoxifen (P <0.001). The mean duration of PROG was 11.5 months for letrozole and 12.7 months for tamoxifen (P=0.047). Using utility weights of 0.5 for TOX and PROG resulted in a 2.5-month difference in quality-adjusted survival favoring letrozole (P <0.0001).

Conclusions: The longer time to disease progression with letrozole versus tamoxifen was achieved without increased time with adverse events and resulted in more quality-adjusted survival for patients on letrozole.

Publication types

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

MeSH terms

  • Aged
  • Antineoplastic Agents / therapeutic use*
  • Breast Neoplasms / drug therapy*
  • Cross-Over Studies
  • Double-Blind Method
  • Female
  • Humans
  • Letrozole
  • Middle Aged
  • Nitriles / therapeutic use*
  • Postmenopause*
  • Quality of Life*
  • Survival Analysis*
  • Tamoxifen / therapeutic use*
  • Triazoles / therapeutic use*

Substances

  • Antineoplastic Agents
  • Nitriles
  • Triazoles
  • Tamoxifen
  • Letrozole