Mature results of a randomized phase II multicenter study of exemestane versus tamoxifen as first-line hormone therapy for postmenopausal women with metastatic breast cancer.

Abstract

BACKGROUND:

Women with hormone-responsive metastatic breast cancer (MBC) may respond to or have stable disease with a number of hormone therapies. We explored the efficacy and safety of the steroidal aromatase inactivator exemestane as first-line hormonal therapy in MBC in postmenopausal women.

PATIENTS AND METHODS:

Patients with measurable disease were eligible if they had received no prior hormone therapy for metastatic disease and had hormone receptor positive disease or hormone receptor unknown disease with a long disease-free interval from adjuvant therapy. They were randomized to tamoxifen 20 mg/day or exemestane 25 mg/day in this open-label study.

RESULTS:

Blinded independently reviewed response rates for exemestane and tamoxifen were 41% and 17%, respectively. Fifty-seven per cent of exemestane- and 42% of tamoxifen-treated patients experienced clinical benefit, defined as complete or partial response, or disease stabilization lasting at least 6 months. There was a low incidence of severe flushing, sweating, nausea and edema in women who received exemestane. One exemestane-treated patient had a pulmonary embolism with grade 4 dyspnea.

CONCLUSIONS:

Exemestane is well tolerated and active in the first-line treatment of hormone-responsive MBC. An ongoing EORTC phase III trial is comparing the efficacy, measuring time-to-disease progression, of exemestane and tamoxifen.

• Authors: R Paridaens, L Dirix, C Lohrisch, L Beex, M Nooij, D Cameron, L Biganzoli, T Cufer, L Duchateau, A Hamilton, J P Lobelle, M Piccart, European Organization for the Research and Treatment of Cancer (EORTC)- Investigational Drug Branch for Breast Cancer (IDBBC)
• Journal: Annals of oncology : official journal of the European Society for Medical Oncology (Ann Oncol) Vol. 14 Issue 9 Pg. 1391-8 (Sep 2003) ISSN: 0923-7534 [Print] England
• PMID: 12954578 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Androstadienes
• Antineoplastic Agents, Hormonal
• Tamoxifen
• exemestane

Topics

• Adult
• Aged
• Aged, 80 and over
• Androstadienes (adverse effects, therapeutic use)
• Antineoplastic Agents, Hormonal (adverse effects, therapeutic use)
• Breast Neoplasms (drug therapy, secondary)
• Female
• Humans
• Middle Aged
• Postmenopause
• Tamoxifen (adverse effects, therapeutic use)
• Treatment Outcome