Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial

Nabholtz, Jean‐Marc; Buzdar, Aman U.; Pollak, Michael; Harwin, William N.; Burton, Gary V.; Mangalik, Aroop; Steinberg, Mark L.; Webster, Alan; Euler, Mikael von

doi:10.1200/jco.2000.18.22.3758

Cited by 916 publications

(449 citation statements)

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“…The HR for PFS seen in this 321 study (0·797) is similar to the improvement shown by third-generation AIs over Page 16 tamoxifen. [4][5][6][7][8] In addition to the primary endpoint results, pre-defined subgroup 323 analyses were performed. The test for heterogeneity was not statistically significant 324 across all the subgroups although it was noted that potential enhanced treatment 325 effects with fulvestrant vs anastrozole were seen in some subgroups, including 326 patients with non-visceral disease compared with visceral disease.…”

Section: Page 15mentioning

confidence: 99%

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

et al. 2016

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A note on versions:The version presented here may differ from the published version or from the version of record. If you wish to cite this item you are advised to consult the publisher's version. Please see the repository url above for details on accessing the published version and note that access may require a subscription.For more information, please contact eprints@nottingham.ac.uk The objective of the current study was to confirm the superior PFS advantage for 103 fulvestrant versus anastrozole observed in the FIRST study, in a double-blind Phase 3 104 design. The population for FALCON were postmenopausal women with hormone 105 receptor-positive locally advanced or metastatic breast cancer who had not received 106 prior endocrine therapy, in order to avoid reducing efficacy of the control arm through 107 exposure to adjuvant endocrine therapy. 108 METHODS 109 Study design 110The Fulvestrant and AnastrozoLe COmpared in hormonal therapy Naïve advanced 111 breast cancer (FALCON) trial (Clinicaltrials.gov: NCT01602380) is a Phase 3 112 randomised, double-blind, double-dummy, international, multicentre study that 113 compared the efficacy and tolerability of fulvestrant with anastrozole in 114 postmenopausal women with histologically confirmed ER+ and/or PgR+ locally 115 advanced or metastatic breast cancer. 116 Ethical approval 117The study was conducted in accordance with the Declaration of Helsinki and 118International Conference on Harmonisation/Good Clinical Practice guidelines. An 119 Randomisation and masking 133Patients were randomised sequentially (1:1) to fulvestrant 500 mg or anastrozole 1 mg 134 using a computer-generated randomisation scheme and an integrated voice/web 135 response system. Patients were stratified at randomisation according to locally 136 advanced or metastatic breast cancer; prior or no prior treatment with chemotherapy 137 for locally advanced or metastatic breast cancer; and measurable or non-measurable 138 disease. 139Study drugs were labelled using a unique identifier linked to the randomisation 140 scheme. The active study drug and placebo for fulvestrant (pre-filled syringes) and 141 anastrozole (tablets) were identically packaged to maintain blinding. 142 progression. Safety and tolerability were assessed at each study visit, and for up to 8 154 weeks after the last fulvestrant/placebo injection. HRQoL questionnaires were 155 administered at baseline and at 3-monthly intervals. Following disease progression or 156 treatment discontinuation, HRQoL questionnaires will be administered at 6-monthly 157 until a final OS analysis. 158 Outcomes 159The primary endpoint of the study was to demonstrate the superior PFS of patients 160 treated with fulvestrant vs anastrozole. A progression event was determined based on 161 tumour assessments performed locally by each investigator, and was defined by 162Response Evaluation Criteria in Solid Tumours (RECIST) 1·1, or 163 surgery/radiotherapy for worsening of disease, or death from any cause. 164 OS and ORR were tested using a multiple ...

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Section: Page 15mentioning

confidence: 99%

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

et al. 2016

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“…The median overall survival for the patients relapsing at our institution (40.7 months), was higher than the 10-20 months Months since relapse Proportion of patients surviving reported with first-line metastatic studies in the UK and Europe evaluating metastatic chemotherapy regimens [18,19], but it was fairly comparable with the 20-30 months reported within first-line metastatic aromatase versus tamoxifen studies [9,20]. Although the median figure of £31,403 (Table 4) for treating a relapse is higher than previous UK estimates, the data is more recent and included the 30% of the community cost not previously collected.…”

Section: Discussionmentioning

confidence: 62%

Comparing the cost of adjuvant anastrozole with the benefits of managing less patients with relapsed breast cancer

Thomas

Williams

Glen

et al. 2009

Breast Cancer Res Treat

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Prescribing anastrozole instead of tamoxifen increases initial adjuvant drug costs but there is an eventual saving as fewer patients will relapse. The effect of this saving depends on an accurate understanding of the cost of breast cancer relapse. We identified 232 patients relapsing between March 2000 and 2005. Seventy-seven were randomly selected for analysis of their entire hospital and community management costs from the date of relapse until death, or the end of the evaluation period (01/01/07). The mean cost per patient was £25,186 (95% CI £13,705-£33,821). The median survival from time of relapse was 40.07 months (range 0.5-73 months) and median total cost per patient was £31,402.62. Equating this figure with the difference in relapse rate (4.1%), initial drug cost (£4,773) gives an extra cost of £17,244/life year saved. This was the first adjuvant cost effectiveness analysis which included the community management activity of a subsequent relapse.

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“…As such, even the presence of estrogenic endocrine-active compounds would likely not be able to bypass the effects of tamoxifen [54]. However, due to the side effects (increased osteoporosis and incidence of uterine cancer) of tamoxifen use, there is a push to utilize other treatment strategies, such as aromatase inhibitors [55][56][57]. Aromatase inhibitors block the metabolism and formation of estrogen, thereby reducing the estrogenic signaling capacity or ER, however, leaving the ER intact and fully functional.…”

Section: Are Other Environmental Contaminants Inferring With Disease mentioning

confidence: 99%

Bisphenol A may reduce the efficacy of androgen deprivation therapy in prostate cancer

Hess-Wilson

2009

Cancer Causes Control

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Anastrozole Is Superior to Tamoxifen as First-Line Therapy for Advanced Breast Cancer in Postmenopausal Women: Results of a North American Multicenter Randomized Trial

Cited by 916 publications

References 35 publications

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

Fulvestrant 500 mg versus anastrozole 1 mg for hormone receptor-positive advanced breast cancer (FALCON): an international, randomised, double-blind, phase 3 trial

Comparing the cost of adjuvant anastrozole with the benefits of managing less patients with relapsed breast cancer

Bisphenol A may reduce the efficacy of androgen deprivation therapy in prostate cancer

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