BACKGROUND:Fulvestrant is an estrogen receptor antagonist with no agonist effects. In the second-line treatment of advanced breast carcinoma, fulvestrant was shown previously to be as effective as the third-generation aromatase inhibitor, anastrozole, in terms of time to disease progression and objective response rates. The authors reported the overall survival results from these studies. METHODS: A prospectively planned, combined, overall survival analysis was performed, including data from two Phase III trials that compared the efficacy and tolerability of fulvestrant (250 mg monthly; n = 428) with anastrozole (1 mg daily; n = 423) in the treatment of postmenopausal women with advanced breast carcinoma who had disease progression after receipt of previous endocrine treatment. RESULTS: At an extended median follow-up of 27.0 months (range, 0-66.9 months), 319 (74.5%) patients in the fulvestrant group and 322 (76.1%) patients in the anastrozole group had died. Prolonged survival was observed with both drugs, with 10-20% of patients still alive > 5 years after randomization. The median overall survival was similar between treatments, being 27.4 months and 27.7 months in fulvestrant and anastrozole-treated patients, respectively (hazards ratio, 0.98; 95% confidence interval, 0.84-1.15; P = 0.809). Fulvestrant continued to be well tolerated, and was associated with a significantly lower incidence of joint disorders compared with anastrozole (P = 0.0234). CONCLUSIONS: The current analysis showed that fulvestrant was similar to anastrozole with respect to overall survival in the second-line treatment of postmenopausal women with advanced breast carcinoma.
RCT Entities:
BACKGROUND:Fulvestrant is an estrogen receptor antagonist with no agonist effects. In the second-line treatment of advanced breast carcinoma, fulvestrant was shown previously to be as effective as the third-generation aromatase inhibitor, anastrozole, in terms of time to disease progression and objective response rates. The authors reported the overall survival results from these studies. METHODS: A prospectively planned, combined, overall survival analysis was performed, including data from two Phase III trials that compared the efficacy and tolerability of fulvestrant (250 mg monthly; n = 428) with anastrozole (1 mg daily; n = 423) in the treatment of postmenopausal women with advanced breast carcinoma who had disease progression after receipt of previous endocrine treatment. RESULTS: At an extended median follow-up of 27.0 months (range, 0-66.9 months), 319 (74.5%) patients in the fulvestrant group and 322 (76.1%) patients in the anastrozole group had died. Prolonged survival was observed with both drugs, with 10-20% of patients still alive > 5 years after randomization. The median overall survival was similar between treatments, being 27.4 months and 27.7 months in fulvestrant and anastrozole-treated patients, respectively (hazards ratio, 0.98; 95% confidence interval, 0.84-1.15; P = 0.809). Fulvestrant continued to be well tolerated, and was associated with a significantly lower incidence of joint disorders compared with anastrozole (P = 0.0234). CONCLUSIONS: The current analysis showed that fulvestrant was similar to anastrozole with respect to overall survival in the second-line treatment of postmenopausal women with advanced breast carcinoma.
Authors: David M Hyams; Arlene Chan; Celia de Oliveira; Raymond Snyder; Jeferson Vinholes; M William Audeh; Victor M Alencar; Janine Lombard; Bijoyesh Mookerjee; John Xu; Kathryn Brown; Paula Klein Journal: Invest New Drugs Date: 2013-06-26 Impact factor: 3.850
Authors: James D Joseph; Beatrice Darimont; Wei Zhou; Alfonso Arrazate; Amy Young; Ellen Ingalla; Kimberly Walter; Robert A Blake; Jim Nonomiya; Zhengyu Guan; Lorna Kategaya; Steven P Govek; Andiliy G Lai; Mehmet Kahraman; Dan Brigham; John Sensintaffar; Nhin Lu; Gang Shao; Jing Qian; Kate Grillot; Michael Moon; Rene Prudente; Eric Bischoff; Kyoung-Jin Lee; Celine Bonnefous; Karensa L Douglas; Jackaline D Julien; Johnny Y Nagasawa; Anna Aparicio; Josh Kaufman; Benjamin Haley; Jennifer M Giltnane; Ingrid E Wertz; Mark R Lackner; Michelle A Nannini; Deepak Sampath; Luis Schwarz; Henry Charles Manning; Mohammed Noor Tantawy; Carlos L Arteaga; Richard A Heyman; Peter J Rix; Lori Friedman; Nicholas D Smith; Ciara Metcalfe; Jeffrey H Hager Journal: Elife Date: 2016-07-13 Impact factor: 8.140
Authors: Xinyi Liu; Indira Jutooru; Ping Lei; KyoungHyun Kim; Syng-Ook Lee; Lisa K Brents; Paul L Prather; Stephen Safe Journal: Mol Cancer Ther Date: 2012-05-02 Impact factor: 6.261