Annals of Oncology Advance Access originally published online on June 9, 2005
Annals of Oncology 2005 16(9):1458-1462; doi:10.1093/annonc/mdi275
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© 2005 European Society for Medical Oncology
Quality-adjusted survival in a crossover trial of letrozole versus tamoxifen in postmenopausal women with advanced breast cancer
1 Research Triangle Institute, Research Triangle Park, NC 2 Dartmouth-Hitchcock Medical Center, Lebanon, NH 3 Novartis Pharmaceutical Corporation, East Hanover, NJ 4 Righospitalet, Copenhagen, Denmark
* Correspondence to: Dr W. Irish, Research Triangle Institute, 3040 Cornwallis Road, PO Box 6452, Research Triangle Park, NC 27709-2194, USA. Tel: +1-919-541-6452; Fax: +1-919-541-7222; Email: wirish{at}rti.org
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.
Key words: letrozole, Q-TWiST, quality-adjusted survival, tamoxifen
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