Efficacy of First-Line Letrozole Versus Tamoxifen as a Function of Age in Postmenopausal Women with Advanced Breast Cancer

Oncologist - Tập 9 Số 5 - Trang 497-506 - 2004
Henning T. Mouridsen1, Hilary A. Chaudri‐Ross2
1Rigshospitalet, Copenhagen, Denmark
2Novartis Pharma AG, Basel, Switzerland

Tóm tắt

Abstract Learning Objectives After completing this course, the reader will be able to: Identify those patients in both age groups who responded most favorably to first-line therapy with letrozole. Describe the advantages of first-line treatment with letrozole in older patients with advanced breast cancer. Discuss the role of first-line therapy with letrozole in the management of advanced breast cancer. Access and take the CME test online and receive 1 hour of AMA PRA category 1 credit at CME.TheOncologist.com Purpose. To compare the efficacy, in regard to time to progression (TTP) and objective response rate (ORR), of letrozole (Femara®; Novartis Pharma AG; Basel Switzerland), an oral aromatase inhibitor, with that of tamoxifen (Tamofen®; Leiras OY; Turku, Finland) as first-line therapy in younger (<70 years) and older (≥70 years) postmenopausal women with advanced breast cancer. Materials and Methods. Nine hundred seven patients with advanced breast cancer were randomly assigned to receive 2.5 mg letrozole (n = 453) or 20 mg tamoxifen (n = 454) once daily in a double-blind, multicenter, international trial. Among the prospectively planned analyses were analyses of TTP and ORR by age (<70 and ≥70 years). The results of these prospectively planned analyses are reported here. Results. Letrozole was as effective in older postmenopausal women (≥70 years of age) as it was in younger postmenopausal women (<70 years of age). The overall ORR in the older subgroup was significantly higher in patients treated with letrozole (38%) than in patients treated with tamoxifen (18%). In the younger subgroup of postmenopausal patients, the ORRs were not significantly different (letrozole, 26%; tamoxifen, 22%). TTP was significantly longer for letrozole than for tamoxifen in both age groups (younger: letrozole median TTP, 8.8 months; tamoxifen, 6.0 months; older: letrozole median TTP, 12.2 months; tamoxifen, 5.8 months). Although age was independently prognostic of TTP, there was no significant effect of age on ORR in the presence of other factors. Conclusion. The data show that letrozole, 2.5 mg once daily, is as effective in older, postmenopausal women as it is in younger postmenopausal women with advanced breast cancer. In addition, letrozole was more effective than tamoxifen in both younger and older patients.

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Data on file, Novartis Pharma AG

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