Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment.
Abstract | PURPOSE: PATIENTS AND METHODS: Patients (n = 451) with advanced breast cancer were randomized to receive fulvestrant 250 mg as a once-monthly (one x 5 mL) intramuscular injection or an oral dose of anastrozole 1 mg in this open, parallel-group, multicenter trial. The primary end point was time to progression ( TTP). Secondary end points included objective response (OR) rates, defined as complete response (CR) or partial response (PR), duration of response (DOR), and tolerability. RESULTS: Patients were followed for a median period of 14.4 months. In terms of TTP, fulvestrant was as effective as anastrozole (hazard ratio, 0.98; confidence interval [CI], 0.80 to 1.21; P =.84). Median TTP was 5.5 months for fulvestrant and 5.1 months for anastrozole. OR rates showed a numerical advantage for fulvestrant (20.7%) over anastrozole (15.7%) (odds ratio, 1.38; CI, 0.84 to 2.29; P =.20). Clinical benefit rates (CR + PR + stable disease > or = 24 weeks) were 44.6% for fulvestrant and 45.0% for anastrozole. Median DOR was 14.3 months for fulvestrant and 14.0 months for anastrozole. Both treatments were well tolerated, with 3.2% and 1.3% of fulvestrant- and anastrozole-treated patients, respectively, withdrawn from treatment because of an adverse event. CONCLUSION:
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Authors | A Howell, J F R Robertson, J Quaresma Albano, A Aschermannova, L Mauriac, U R Kleeberg, I Vergote, B Erikstein, A Webster, C Morris |
Journal | Journal of clinical oncology : official journal of the American Society of Clinical Oncology
(J Clin Oncol)
Vol. 20
Issue 16
Pg. 3396-403
(Aug 15 2002)
ISSN: 0732-183X [Print] United States |
PMID | 12177099
(Publication Type: Clinical Trial, Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Antineoplastic Agents, Hormonal
- Estrogen Antagonists
- Nitriles
- Triazoles
- Fulvestrant
- Anastrozole
- Estradiol
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Topics |
- Adult
- Aged
- Aged, 80 and over
- Anastrozole
- Antineoplastic Agents, Hormonal
(adverse effects, therapeutic use)
- Breast Neoplasms
(drug therapy, mortality, pathology)
- Disease-Free Survival
- Estradiol
(adverse effects, analogs & derivatives, therapeutic use)
- Estrogen Antagonists
(adverse effects, therapeutic use)
- Female
- Fulvestrant
- Humans
- Logistic Models
- Middle Aged
- Neoplasm Metastasis
- Nitriles
(adverse effects, therapeutic use)
- Postmenopause
- Quality of Life
- Survival Rate
- Triazoles
(adverse effects, therapeutic use)
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