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

被引：473

作者：

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, R

Buzdar, A

机构：

[1] Methodist Hosp, Breast Ctr, Baylor Coll Med, Houston, TX 77030 USA

[2] MD Anderson Canc Ctr, Houston, TX USA

[3] Baylor Sammons Canc Ctr, Dallas, TX USA

[4] Dana Farber Canc Inst, Boston, MA 02115 USA

[5] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[6] Lombardi Canc Ctr, Washington, DC USA

[7] Ottawa Reg Canc Ctr, Ottawa, ON K1Y 4K7, Canada

[8] Haematol Oncol Assoc VA Ltd, Richmond, VA USA

[9] Louisiana State Univ, Hlth Sci Ctr, Shreveport, LA 71105 USA

[10] AstraZeneca, Macclesfield, Cheshire, England

来源：

JOURNAL OF CLINICAL ONCOLOGY | 2002年 / 20卷 / 16期

关键词：

D O I：

10.1200/JCO.2002.10.058

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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 greater than or equal to 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 tomoxifen therapy. (C) 2002 by American Society of Clinical Oncology.

引用

页码：3386 / 3395

页数：10

共 19 条

[1] Reliability and validity of the functional assessment of cancer therapy-breast quality-of-life instrument [J].

Brady, MJ ;

Cella, DF ;

Mo, F ;

Bonomi, AE ;

Tulsky, DS ;

Lloyd, SR ;

Deasy, S ;

Cobleigh, M ;

Shiomoto, G .

JOURNAL OF CLINICAL ONCOLOGY, 1997, 15 (03) :974-986

[2] PHASE-II EVALUATION OF LY156758 IN METASTATIC BREAST-CANCER [J].

BUZDAR, AU ;

MARCUS, C ;

HOLMES, F ;

HUG, V ;

HORTOBAGYI, G .

ONCOLOGY, 1988, 45 (05) :344-345

[3] THE FUNCTIONAL ASSESSMENT OF CANCER-THERAPY SCALE - DEVELOPMENT AND VALIDATION OF THE GENERAL MEASURE [J].

CELLA, DF ;

TULSKY, DS ;

GRAY, G ;

SARAFIAN, B ;

LINN, E ;

BONOMI, A ;

SILBERMAN, M ;

YELLEN, SB ;

WINICOUR, P ;

BRANNON, J ;

ECKBERG, K ;

LLOYD, S ;

PURL, S ;

BLENDOWSKI, C ;

GOODMAN, M ;

BARNICLE, M ;

STEWART, I ;

MCHALE, M ;

BONOMI, P ;

KAPLAN, E ;

TAYLOR, S ;

THOMAS, CR ;

HARRIS, J .

JOURNAL OF CLINICAL ONCOLOGY, 1993, 11 (03) :570-579

[4] Tamoxifen in treatment of intraductal breast cancer: National Surgical Adjuvant Breast and Bowel Project B-24 randomised controlled trial [J].

Fisher, B ;

Dignam, J ;

Wolmark, N ;

Wickerham, DL ;

Fisher, ER ;

Mamounas, E ;

Smith, R ;

Begovic, M ;

Dimitrov, NV ;

Margolese, RG ;

Kardinal, CG ;

Kavanah, MT ;

Fehrenbacher, L ;

Oishi, RH .

LANCET, 1999, 353 (9169) :1993-2000

[5] Tamoxifen for prevention of breast cancer: Report of the National Surgical Adjuvant Breast and Bowel Project P-1 study [J].

Fisher, B ;

Costantino, JP ;

Wickerham, DL ;

Redmond, CK ;

Kavanah, M ;

Cronin, WM ;

Vogel, V ;

Robidoux, A ;

Dimitrov, N ;

Atkins, J ;

Daly, M ;

Wieand, S ;

Tan-Chiu, E ;

Ford, L ;

Wolmark, N .

JOURNAL OF THE NATIONAL CANCER INSTITUTE, 1998, 90 (18) :1371-1388

[6]

Gradishar W, 2000, CANCER, V88, P2047, DOI 10.1002/(SICI)1097-0142(20000501)88:9<2047::AID-CNCR10>3.0.CO

[7]

2-E

[8]

Howell A, 2000, CANCER-AM CANCER SOC, V89, P817, DOI 10.1002/1097-0142(20000815)89:4<817::AID-CNCR14>3.0.CO

[9]

2-6

[10] Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment [J].

Howell, A ;

Robertson, JFR ;

Albano, JQ ;

Aschermannova, A ;

Mauriac, L ;

Kleeberg, UR ;

Vergote, I ;

Erikstein, B ;

Webster, A ;

Morris, C .

JOURNAL OF CLINICAL ONCOLOGY, 2002, 20 (16) :3396-3403

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