Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy

Results of a North American trial

C. K. Osborne, J. Pippen, S. E. Jones, L. M. Parker, M. Ellis, S. Come, S. Z. Gertler, J. T. May, G. Burton, I. Dimery, A. Webster, C. Morris, Richard M Elledge, A. Buzdar

Research output: Contribution to journalArticle

509 Citations (Scopus)

Abstract

Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment. Patients and Methods: In this double-blind, double-dummy, parallel-group study, postmenopausal patients were randomized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rate, duration of response (DOR), and tolerability. Results: Patients (n = 400) were followed for a median period of 16.8 months. Fulvestrant was as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14% confidence interval [CI], 0.74 to 1.14; P = .43); median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole. OR rates were 17.5% with both treatments. Clinical benefit rates (complete response + partial response + stable disease ≥ 24 weeks) were 42.2% for fulvestrant and 36.1% for anastrozole (95% CI, -4.00% to 16.41%; P = .26). In responding patients, median DOR (from randomization to progression) was 19.0 months for fulvestrant and 10.8 months for anastrozole. Using all patients, DOR was significantly greater for fulvestrant compared with anastrozole; the ratio of average response durations was 1.35 (95% CI, 1.10 to 1.67; P < 0.01). Both treatments were well tolerated. Conclusion: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant. Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy.

Original languageEnglish (US)
Pages (from-to)3386-3395
Number of pages10
JournalJournal of Clinical Oncology
Volume20
Issue number16
DOIs
StatePublished - Aug 15 2002
Externally publishedYes

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Breast Neoplasms
Therapeutics
Confidence Intervals
anastrozole
fulvestrant
Intramuscular Injections
Tamoxifen
Random Allocation
Double-Blind Method

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

Cite this

Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy : Results of a North American trial. / Osborne, C. K.; Pippen, J.; Jones, S. E.; Parker, L. M.; Ellis, M.; Come, S.; Gertler, S. Z.; May, J. T.; Burton, G.; Dimery, I.; Webster, A.; Morris, C.; Elledge, Richard M; Buzdar, A.

In: Journal of Clinical Oncology, Vol. 20, No. 16, 15.08.2002, p. 3386-3395.

Research output: Contribution to journalArticle

Osborne, CK, Pippen, J, Jones, SE, Parker, LM, Ellis, M, Come, S, Gertler, SZ, May, JT, Burton, G, Dimery, I, Webster, A, Morris, C, Elledge, RM & Buzdar, A 2002, 'Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: Results of a North American trial', Journal of Clinical Oncology, vol. 20, no. 16, pp. 3386-3395. https://doi.org/10.1200/JCO.2002.10.058
Osborne, C. K. ; Pippen, J. ; Jones, S. E. ; Parker, L. M. ; Ellis, M. ; Come, S. ; Gertler, S. Z. ; May, J. T. ; Burton, G. ; Dimery, I. ; Webster, A. ; Morris, C. ; Elledge, Richard M ; Buzdar, A. / Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy : Results of a North American trial. In: Journal of Clinical Oncology. 2002 ; Vol. 20, No. 16. pp. 3386-3395.
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abstract = "Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment. Patients and Methods: In this double-blind, double-dummy, parallel-group study, postmenopausal patients were randomized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rate, duration of response (DOR), and tolerability. Results: Patients (n = 400) were followed for a median period of 16.8 months. Fulvestrant was as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14{\%} confidence interval [CI], 0.74 to 1.14; P = .43); median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole. OR rates were 17.5{\%} with both treatments. Clinical benefit rates (complete response + partial response + stable disease ≥ 24 weeks) were 42.2{\%} for fulvestrant and 36.1{\%} for anastrozole (95{\%} CI, -4.00{\%} to 16.41{\%}; P = .26). In responding patients, median DOR (from randomization to progression) was 19.0 months for fulvestrant and 10.8 months for anastrozole. Using all patients, DOR was significantly greater for fulvestrant compared with anastrozole; the ratio of average response durations was 1.35 (95{\%} CI, 1.10 to 1.67; P < 0.01). Both treatments were well tolerated. Conclusion: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant. Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy.",
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T1 - Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy

T2 - Results of a North American trial

AU - Osborne, C. K.

AU - Pippen, J.

AU - Jones, S. E.

AU - Parker, L. M.

AU - Ellis, M.

AU - Come, S.

AU - Gertler, S. Z.

AU - May, J. T.

AU - Burton, G.

AU - Dimery, I.

AU - Webster, A.

AU - Morris, C.

AU - Elledge, Richard M

AU - Buzdar, A.

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N2 - Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment. Patients and Methods: In this double-blind, double-dummy, parallel-group study, postmenopausal patients were randomized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rate, duration of response (DOR), and tolerability. Results: Patients (n = 400) were followed for a median period of 16.8 months. Fulvestrant was as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14% confidence interval [CI], 0.74 to 1.14; P = .43); median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole. OR rates were 17.5% with both treatments. Clinical benefit rates (complete response + partial response + stable disease ≥ 24 weeks) were 42.2% for fulvestrant and 36.1% for anastrozole (95% CI, -4.00% to 16.41%; P = .26). In responding patients, median DOR (from randomization to progression) was 19.0 months for fulvestrant and 10.8 months for anastrozole. Using all patients, DOR was significantly greater for fulvestrant compared with anastrozole; the ratio of average response durations was 1.35 (95% CI, 1.10 to 1.67; P < 0.01). Both treatments were well tolerated. Conclusion: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant. Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy.

AB - Purpose: To compare the efficacy and tolerability of fulvestrant (formerly ICI 182,780) with anastrozole in the treatment of advanced breast cancer in patients whose disease progresses on prior endocrine treatment. Patients and Methods: In this double-blind, double-dummy, parallel-group study, postmenopausal patients were randomized to receive either an intramuscular injection of fulvestrant 250 mg once monthly or a daily oral dose of anastrozole 1 mg. The primary end point was time to progression (TTP). Secondary end points included objective response (OR) rate, duration of response (DOR), and tolerability. Results: Patients (n = 400) were followed for a median period of 16.8 months. Fulvestrant was as effective as anastrozole in terms of TTP (hazard ratio, 0.92; 95.14% confidence interval [CI], 0.74 to 1.14; P = .43); median TTP was 5.4 months with fulvestrant and 3.4 months with anastrozole. OR rates were 17.5% with both treatments. Clinical benefit rates (complete response + partial response + stable disease ≥ 24 weeks) were 42.2% for fulvestrant and 36.1% for anastrozole (95% CI, -4.00% to 16.41%; P = .26). In responding patients, median DOR (from randomization to progression) was 19.0 months for fulvestrant and 10.8 months for anastrozole. Using all patients, DOR was significantly greater for fulvestrant compared with anastrozole; the ratio of average response durations was 1.35 (95% CI, 1.10 to 1.67; P < 0.01). Both treatments were well tolerated. Conclusion: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant. Fulvestrant represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy.

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