Download ESMO 2016 Press Release: Targeting Estrogen Receptor Improves

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ESMO 2016 Press Release: Targeting Estrogen
Receptor Improves Progression-free Survival in
Advanced Breast Cancer
Date: 08 Oct 2016
Topic: Breast cancer (/Topics/Breast-cancer) / Anticancer agents & Biologic therapy (/Topics/Anticanceragents-Biologic-therapy)
LUGANO-COPENHAGEN - Fulvestrant significantly increases progression-free survival in women with hormonereceptor-positive advanced breast cancer, particularly those with less aggressive lower-volume disease,
researchers reported at the ESMO 2016 Congress in Copenhagen.
Fulvestrant is a selective estrogen receptor degrader that targets the function of the hormone receptor so, unlike
aromatase inhibitors such as anastrozole, it does not interfere with estrogen levels themselves.
The randomized, double-blind, multi-center phase III trial enrolled 462 women with inoperable locally-advanced or
metastatic ER-positive, HER-negative breast cancer, who had not received prior hormone therapy.
Half the patients (n=230) were randomized to 500mg intramuscular injections of fulvestrant (Days 0, 14, 28, then
every 28 days), or to 1mg of anastrozole daily (n=232), and were also allowed one line of chemotherapy.
After a median follow-up of 25 months, patients treated with fulvestrant had a statistically significant 21%
improvement in progression-free survival compared to those treated with anastrozole (16.6 months vs. 13.8
months, p = 0.048).
However subgroup analysis showed an even greater impact on progression-free survival in patients whose
disease had not spread to the liver or lungs at baseline (22.3 vs. 13.8 months).
“For patients with non-visceral disease whose life isn’t immediately threatened by breast cancer – a group for
whom physicians would typically choose endocrine therapy as a first approach – it looks like fulvestrant could be a
new standard of care compared to anastrozole,” said the study’s principle investigator Dr. Matthew Ellis, from the
Lester and Sue Smith Breast Center, Baylor College of Medicine in Houston, Texas, USA.
Both groups showed a similar health-related quality of life, and the most common adverse events were arthralgia
(joint pain) (16.7% vs. 10.3%) and hot flushes (11.4% vs. 10.3%) for fulvestrant and anastrozole, respectively.
“It’s tolerated as well as anastrozole, and better than other drugs that could potentially be used in this setting such
as chemotherapy or CDK4 inhibitors,” Ellis said.
“In patients for whom you are looking for a low toxicity approach, such as older patients or those with low volume
disease, it looks like a good option.”
Researchers also observed a significantly greater duration of response to treatment in the fulvestrant group
compared to the anastrozole group, which Ellis suggested could account for the increase in progression-free
survival.
Commenting on the study, Dr Nicholas Turner, team leader at the Institute of Cancer Research and Medical
Oncologist at the Royal Marsden, London, UK, said the results represent an important advance in the treatment of
the most common form of breast cancer, and suggest a potential benefit for using fulvestrant earlier in a patient’s
treatment.
“However two factors complicate moving this new finding into routine clinical practice: firstly, the study only
included patients with no prior hormone treatment yet many patients presenting with advanced breast cancer have
previously been treated for the primary breast cancer,” Turner said.
“Secondly, since the design of the study, the standard of care for these women has moved on, with the CDK4/6
inhibitor palbociclib now licensed in US, in combination with an aromatase inhibitor, for the same group of patients.
Further studies will help define the most optimal sequence of therapy for women with advanced breast cancer.”
-END-
Notes to Editors
References
Abstract LBA14_PR - FALCON: a phase III randomised trial of fulvestrant 500 mg vs. anastrozole for hormone
receptor-positive advanced breast cancer ‘, will be presented by Dr Matthew Ellis during the Proffered Paper
Session, Metastatic Breast Cancer on Saturday 8 October, 11:00 to 12:30 (CEST) in Room Vienna.
Disclaimer
This press release contains information provided by the authors of the highlighted abstracts and reflects the
content of those abstracts. It does not necessarily reflect the views or opinions of ESMO and ESMO cannot be
held responsible for the accuracy of the data. Commentators quoted in the press release are required to comply
with the ESMO Declaration of Interests policy and the ESMO Code of Conduct
(http://www.esmo.org/content/download/77064/1412440/file/ESMO_Code_of_Conduct.pdf) .
About the European Society for Medical Oncology
ESMO is the leading professional organisation for medical oncology. Comprising more than 13,000 oncology
professionals from over 130 countries, we are the society of reference for oncology education and information. We
are committed to supporting our members to develop and advance in a fast-evolving professional environment.
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worldwide.
Abstract for LBA14_PR
FALCON: A phase III randomised trial of fulvestrant 500 mg vs. anastrozole for hormone receptor-positive advanced breast
cancer
M.J. Ellis1, I. Bondarenko2, E. Trishkina3, M. Dvorkin4, L. Panasci5, A. Manikhas6, Y. Shparyk7, S. CardonaHuerta8, K-L. Cheung9, M.J. Philco-Salas10, M. Ruiz-Borrego11, Z. Shao12, S. Noguchi13, L.M. Grinsted14, M.
Fazal15, M. Stuart16, J.F. Robertson9
1Lester and Sue Smith Breast Center, Baylor Clinic, Baylor College of Medicine, Houston, TX, USA, 2Oncology
Department, Dnipropetrovsk State Medical Academy, Dnipropetrovsk, Ukraine, 3Department of Oncology,
Leningrad Regional Oncology Centre, St-Petersburg, Russian Federation, 4Department of Oncology, Clinical
Oncology Dispensary, Omsk, Russian Federation, 5Department of Oncology, Jewish General Hospital, Montreal,
QC, Canada, 6City Clinical Oncology Dispensary, City Clinical Oncology Center, St. Petersburg, Russian
Federation, 7Department of Chemotherapy, Lviv State Oncology Regional Treatment and Diagnostic Centre, Lviv,
Ukraine, 8Technologico de Monterrey, Hospital San Jose, Monterrey, Mexico, 9Division of Medical Sciences and
Graduate Entry Medicine, University of Nottingham, Derby, UK, 10Instituto Oncológico de Lima, Unidad de
Investigación, Lima, Peru, 11Department of Oncology, Hospital Universitario Virgen del Rocio, Seville, Spain,
12Shanghai Cancer Center, Fudan University, Shanghai, China, 13Department of Breast and Endocrine Surgery,
Osaka University Graduate School of Medicine, Osaka, Japan, 14Global Medicines Development, AstraZeneca,
Cambridge, UK, 15Global Medicines Development, AstraZeneca, Gaithersburg, MD, USA, 16Global Medicines
Development, AstraZeneca, Macclesfield, UK
Background: This Phase III, randomised, double-blind, multicentre trial (FALCON; NCT01602380) compared the
selective estrogen receptor (ER) degrader (SERD) fulvestrant with anastrozole in patients with ER- and/or
progesterone receptor-positive locally advanced or metastatic breast cancer who had not received prior hormonal
therapy.
Methods: Patients were randomised 1:1 to fulvestrant (500 mg IM on Days 0, 14, 28, then each 28 days) or
anastrozole (1 mg daily). The primary endpoint was progression-free survival (PFS), assessed via RECIST 1.1,
surgery/radiotherapy for disease worsening, or death. Secondary endpoints were: overall survival (OS); objective
response rate (ORR, complete response [CR] or partial response [PR]); duration of response (DoR); expected
DoR (EDoR); clinical benefit rate (CBR; CR, PR, or stable disease ≥24 weeks); duration of clinical benefit (DoCB);
expected DoCB (EDoCB); health-related quality of life (HRQoL); and safety.
Results: In total, 462 patients (fulvestrant, n=230; anastrozole, n=232) were randomised. The primary endpoint
was met as shown by a statistically significant improvement in PFS with fulvestrant vs. anastrozole (hazard ratio
0.797 [95% confidence interval 0.637, 0.999]; p=0.0486; median PFS, 16.6 vs. 13.8 months, respectively).
Secondary outcomes are shown in the Table (OS maturity was 31% at a median follow-up of 25.0 months).
Treatment impact on HRQoL was similar in both treatment groups. The most common adverse events were
arthralgia (16.7% vs. 10.3%) and hot flushes (11.4% vs. 10.3%) for fulvestrant and anastrozole, respectively.
(/var/esmo/storage/images/esmo/esmo-staff/esmo-2016-press-images/targeting-estrogen-receptor-improvesprogression-free-survival-in-advanced-breast-cancer/1627716-1-eng-GB/Targeting-estrogen-receptor-improvesprogression-free-survival-in-advanced-breast-cancer_very_large.jpg)
Conclusions: These results confirm the superior efficacy of fulvestrant over anastrozole in postmenopausal
women with hormone receptor-positive locally advanced or metastatic breast cancer who have not received prior
hormonal therapy.
Clinical trial identification: ClinicalTrials.gov identifier: NCT01602380
Legal entity responsible for the study: AstraZeneca
Funding: AstraZeneca
Disclosure:
M.J. Ellis: Employment, leadership, stock or other ownership, patents, royalties or intellectual property Bioclassifier LLC; Consulting or advisory role - AstraZeneca, Pfizer, Novartis, Celgene.
K-L. Cheung: Honoraria, speakers bureau - Chugai: Research Funding – AstraZeneca.
S. Noguchi: Honoraria, consulting or advisory role – AstraZeneca, Chugai, Nippon Kayaku, Novartis, Pfizer, Taiho;
Research funding – AstraZeneca, Chugai, Nippon Kayaku, Novartis, Pfizer, Taiho, Takeda; Patents, royalties or
intellectual property – Sysmex.
L.M. Grinsted: Employment, stock or other ownership – AstraZeneca.
M. Fazal: Employment – AstraZeneca.
M. Stuart: Former employment, and current stock or other ownership – AstraZeneca; Current employment –
Kingston Oncology Ltd.
J.F. Robertson: Stock or other ownership – Oncimmune; Honoraria, consulting or advisory role, travel or expenses
– AstraZeneca, Bayer AG; Research funding – AstraZeneca, Bayer AG, Novartis; Expert testimony –
AstraZeneca.
All other authors have declared no conflicts of interest.
Keywords: fulvestrant, anastrozole, breast cancer - metastatic, endocrine-naïve