Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma

Bonneterre, Jacques; Buzdar, Aman U.; Nabholtz, Jean-Marc; Robertson, J. F. R.; Thürlimann, B; Euler, Mikael von; Sahmoud, Tarek; Webster, Alan; Steinberg, Mark L.

doi:10.1002/1097-0142(20011101)92:9<2247::aid-cncr1570>3.0.co;2-y

Cited by 554 publications

(265 citation statements)

References 17 publications

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“…Both AN and letrozole seem to offer greater effectiveness than tamoxifen in the first-line treatment of women in menopause and with positive receptors (Bonneterre et al, 2001;Mouridsen et al, 2001). Now there is clear evidence in the international scientific community that these third-generation AIs represent credible therapeutic options such that they can be used in first line at the first relapse in post-menopausal women whether or not they have received adjuvant treatment with tamoxifen.…”

Section: Discussionmentioning

confidence: 99%

Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer

Iaffaioli¹,

Formato²,

Tortoriello³

et al. 2005

Br J Cancer

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Hormonal therapy is the preferred systemic treatment for recurrent or metastatic, post-menopausal hormone-receptor-positive breast cancer. Previous studies have shown that there is no cross-resistance between exemestane and reversible aromatase inhibitors. Exposure to hormonal therapy does not hamper later response to chemotherapy. Patients with locally advanced or metastatic, hormonal receptor positive or unknown, breast cancer were treated with oral anastrozole, until disease progression, followed by oral exemestane until new evidence of disease progression. The primary end point of the study was clinical benefit, defined as the sum of complete responses (CR), partial responses (PR) and 424 weeks stable disease (SD). In all, 100 patients were enrolled in the study. Anastrozole produced eight CR and 19 PR for an overall response rate of 27% (95% CI: 18.6 -36.8%). An additional 46 patients had long-term (424 weeks) SD for an overall clinical benefit of 73% (95% CI: 63.2 -81.4). Median time to progression (TTP) was 11 months (95% CI: 10 -12). A total of 50 patients were evaluated for the second-line treatment: exemestane produced one CR and three PR; 25 patients had SD which lasted X6 months in 18 patients. Median TTP was 5 months. Toxicity of treatment was low. Our study confirms that treatment with sequential hormonal agents can extend the period of time during which endocrine therapy can be used, thereby deferring the decision to use chemotherapy.

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Section: Discussionmentioning

confidence: 99%

Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer

Iaffaioli¹,

Formato²,

Tortoriello³

et al. 2005

Br J Cancer

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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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“…11 More recently, a new group of AIs, referred to as third generation AIs, were shown to be superior to megestrol acetate in second-line treatment of metastatic breast cancer (MBC) and for the first time ever, to tamoxifen in first-line therapy of MBC. [12][13][14][15][16][17] These results led to an extensive development of these agents in early breast cancer. In this article, we will review the role of third generation AIs in the upfront adjuvant management of postmenopausal patients with endocrine sensitive breast cancer.…”

Section: Introductionmentioning

confidence: 99%

Role of aromatase inhibitors in the upfront adjuvant hormonal therapy of postmenopausal patients with breast cancer

Nabholtz

Mouret-Reynier

Durando

et al. 2010

Indian J Surg Oncol

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Tamoxifen has been considered for several decades as the standard upfront hormonal therapy for patients with endocrine-sensitive early breast cancer. The efficacy and favorable toxicity profiles of third-generation aromatase inhibitors (AIs), anastrozole, letrozole and exemestane, in advanced disease led to their development in early breast cancer. Recent trial results consistently showed the superiority of AIs over tamoxifen in using the two following therapeutic approaches: either the upfront strategy (randomization of newly diagnosed patients: tamoxifen for 5 years vu AI for 5 years) or the sequencial strategy (randomization of newly diagnosed patients: tamoxifen (2-3 years) followed by AI or the inverse for a total of 5 years vs upfront AI for 5 years).Despite some common characteristics, a body of evidence on AIs suggests some specific differences between the three agents in terms of efficacy as well as toxicity profiles. Thus, these hormonal agents may not be considered interchangeable in clinical practice. This review will explore available results from AIs trials and will try to define their present role in the upfront adjuvant management of postmenopausal patients with breast cancer.

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Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma

Cited by 554 publications

References 17 publications

Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer

Phase II study of sequential hormonal therapy with anastrozole/exemestane in advanced and metastatic breast cancer

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

Role of aromatase inhibitors in the upfront adjuvant hormonal therapy of postmenopausal patients with breast cancer

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