Abstract | BACKGROUND: METHODS: In a three-arm, randomized, prospective trial, from 1988 through 1995, a total of 161 premenopausal patients with advanced breast cancer were randomly assigned to treatment with buserelin, tamoxifen, or both. Patients with steroid receptor-negative tumors or with tumors of unknown receptor status who had a disease-free interval of less than 2 years were excluded. The median follow-up was 7.3 years, during which 76% of the patients died, all of breast cancer. Patient and tumor characteristics were well balanced among treatment groups. All P values are from two-sided tests. RESULTS: Combined treatment with buserelin and tamoxifen was superior to treatment with buserelin or tamoxifen alone by objective response rate (48%, 34%, and 28% of patients who could be evaluated, respectively; P =.11 [chi(2) test]), median progression-free survival (9.7 months, 6.3 months, and 5.6 months; P =.03), and overall survival (3.7 years, 2.5 years, and 2.9 years; P =.01). Actuarial 5-year survival percentages were 34.2% (95% confidence interval [CI] = 20.4%-48.0%), 14.9% (95% CI = 3.9%-25.9%), and 18.4% (95% CI = 7.0%-29.8%), respectively. No differences in antitumor effects were observed between single-agent treatment groups. During combined treatment or treatment with buserelin alone, plasma estradiol levels were suppressed equally; in contrast, during treatment with tamoxifen alone, plasma estradiol levels increased threefold to fourfold over pretreatment levels. CONCLUSION: Combined treatment with buserelin and tamoxifen was more effective and resulted in longer overall survival than treatment with either drug alone.
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Authors | J G Klijn, L V Beex, L Mauriac, J A van Zijl, C Veyret, J Wildiers, J Jassem, M Piccart, J Burghouts, D Becquart, C Seynaeve, F Mignolet, L Duchateau |
Journal | Journal of the National Cancer Institute
(J Natl Cancer Inst)
Vol. 92
Issue 11
Pg. 903-11
(Jun 07 2000)
ISSN: 0027-8874 [Print] United States |
PMID | 10841825
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Antineoplastic Agents, Hormonal
- Estrogen Receptor Modulators
- Selective Estrogen Receptor Modulators
- Tamoxifen
- Gonadotropin-Releasing Hormone
- Estradiol
- Buserelin
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Topics |
- Adult
- Antineoplastic Agents, Hormonal
(therapeutic use)
- Breast Neoplasms
(blood, drug therapy)
- Buserelin
(therapeutic use)
- Disease-Free Survival
- Drug Therapy, Combination
- Estradiol
(blood)
- Estrogen Receptor Modulators
(therapeutic use)
- Female
- Gonadotropin-Releasing Hormone
(blood)
- Humans
- Menstrual Cycle
(drug effects)
- Middle Aged
- Premenopause
- Prognosis
- Prospective Studies
- Risk Factors
- Selective Estrogen Receptor Modulators
(therapeutic use)
- Survival Analysis
- Tamoxifen
(therapeutic use)
- Time Factors
- Treatment Outcome
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