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Final Overall Survival: Fulvestrant 500 mg vs 250 mg in the r andomized cONFir M t rial
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TLDR
In patients with locally advanced or metastatic estrogen receptor–positive breast cancer, fulvestrant 500mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrants 250mg, which was well tolerated and no new safety concerns were identified.Abstract:
Background At the time of the initial analysis of overall survival (OS) for the Comparison of Faslodex in Recurrent or Metastatic Breast Cancer (CONFIRM) randomized, double-blind, phase III trial, approximately 50% of patients had died. A final analysis of OS was subsequently planned for when 75% of patients had died. Methods Patients were randomly assigned 1:1 to fulvestrant 500 mg administered as two 5-mL intramuscular injections on days 0, 14, and 28 and every 28 (±3) days thereafter or fulvestrant 250 mg administered as two 5-mL intramuscular injections (one fulvestrant and one placebo [identical in appearance to study drug]) on days 0, 14 (two placebo injections only), and 28 and every 28 (±3) days thereafter. OS was analyzed using an unadjusted log-rank test. No adjustments were made for multiplicity. Serious adverse events (SAEs) and best response to subsequent therapy were also reported. All statistical tests were two-sided. Results In total, 736 women (median age = 61.0 years) were randomly assigned to fulvestrant 500mg (n = 362) or 250mg (n = 374). At the final survival analysis, 554 of 736 (75.3%) patients had died. Median OS was 26.4 months for fulvestrant 500mg and 22.3 months for 250mg (hazard ratio = 0.81; 95% confidence interval = 0.69–0.96; nominal P = .02). There were no clinically important differences in SAE profiles between the treatment groups; no clustering of SAEs could be detected in either treatment group. Type of first subsequent therapy and objective responses to first subsequent therapy were well balanced between the two treatment groups. Conclusions In patients with locally advanced or metastatic estrogen receptor–positive breast cancer, fulvestrant 500mg is associated with a 19% reduction in risk of death and a 4.1-month difference in median OS compared with fulvestrant 250mg. Fulvestrant 500mg was well tolerated, and no new safety concerns were identified.read more
Citations
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NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines
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References
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Everolimus in Postmenopausal Hormone-Receptor–Positive Advanced Breast Cancer
José Baselga,Mario Campone,Martine Piccart,Howard A. Burris,Hope S. Rugo,Tarek Sahmoud,Shinzaburo Noguchi,Michael Gnant,Kathleen I. Pritchard,Fabienne Lebrun,J. Thaddeus Beck,Yoshinori Ito,Denise A. Yardley,Ines Deleu,Alejandra T. Perez,Thomas Bachelot,L. Vittori,Zhiying Xu,Pabak Mukhopadhyay,David Lebwohl,Gabriel N. Hortobagyi +20 more
TL;DR: Everolimus combined with an aromatase inhibitor improved progression-free survival in patients with hormone-receptor-positive advanced breast cancer previously treated with nonsteroidal aromat enzyme inhibitors.
Journal ArticleDOI
Fulvestrant, Formerly ICI 182,780, Is as Effective as Anastrozole in Postmenopausal Women With Advanced Breast Cancer Progressing After Prior Endocrine Treatment
Anthony Howell,John F.R. Robertson,J Quaresma Albano,A. Aschermannova,L. Mauriac,Ulrich R. Kleeberg,Ignace Vergote,B Erikstein,Alan Webster,Charles A. Morris +9 more
TL;DR: Fulvestrant is an additional, effective, and well-tolerated treatment for advanced breast cancer in postmenopausal women whose disease progressed on prior endocrine therapy.
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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
CK Osborne,J. Pippen,S.E. Jones,Leroy M. Parker,M. Ellis,Steven E. Come,Stan Gertler,J.T. May,Gary V. Burton,I. Dimery,A. Webster,C. Morris,Richard M. Elledge,A. Buzdar +13 more
TL;DR: Fulvestrant was at least as effective as anastrozole, with efficacy end points slightly favoring fulvestrant, and represents an additional treatment option for postmenopausal women with advanced breast cancer whose disease progresses on tamoxifen therapy.
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Results of the CONFIRM Phase III Trial Comparing Fulvestrant 250 mg With Fulvestrant 500 mg in Postmenopausal Women With Estrogen Receptor–Positive Advanced Breast Cancer
Angelo Di Leo,Guy Jerusalem,Lubos Petruzelka,Roberto Torres,Igor Bondarenko,Rustem Khasanov,Didier Verhoeven,Jose Luiz Pedrini,Iya Smirnova,Mikhail Lichinitser,Kelly Pendergrass,Sally Garnett,Justin P.O. Lindemann,Francisco Sapunar,Miguel Martin +14 more
TL;DR: Fulvestrant 500 mg was associated with a statistically significant increase in PFS and not associated with increased toxicity, corresponding to a clinically meaningful improvement in benefit versus risk compared with fulvestrant 250 mg.
Journal ArticleDOI
Combination Anastrozole and Fulvestrant in Metastatic Breast Cancer
Rita S. Mehta,William E. Barlow,Kathy S. Albain,Theodore A. Vandenberg,Shaker R. Dakhil,Nagendra R. Tirumali,Danika L. Lew,Daniel F. Hayes,Julie Gralow,Robert B. Livingston,Gabriel N. Hortobagyi +10 more
TL;DR: The combination of anastrozole and fulvestrant was superior to anastozole alone or sequential anast rozoles and ful vestrant for the treatment of HR-positive metastatic breast cancer, despite the use of a dose of fulvestant that was below the current standard.