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Annals of Oncology Advance Access published online on June 9, 2005
Annals of Oncology, doi:10.1093/annonc/mdi275
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© 2005 European Society for Medical Oncology
Received January 17, 2005
Revised April 15, 2005
Accepted April 29, 2005

Original article

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

W. Irish 1*, B. Sherrill 1, B. Cole 2, C. Gard 3, G. A. Glendenning 4, and H. Mouridsen 4

1 Research Triangle Institute, Research Triangle Park, NC, Denmark
2 Dartmouth-Hitchcock Medical Center, Lebanon, NH, Denmark
3 Novartis Pharmaceutical Corporation, East Hanover, NJ, Denmark
4 Righospitalet, Copenhagen, Denmark

* To whom correspondence should be addressed.
W. Irish, E-mail: wirish{at}rti.org


  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.

Keywords: letrozole; Q-TWiST; quality-adjusted survival; tamoxifen.
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