ACT-FASTER, a Prospective Cohort Study Exploring Treatment Patterns with Fulvestrant and Exemestane in Postmenopausal Patients with Advanced Hormone Receptor-Positive Breast Cancer under Real-Life Conditions in Germany.

Advanced breast cancer Endocrine therapy Exemestane Fulvestrant

Journal

Breast care (Basel, Switzerland)
ISSN: 1661-3791
Titre abrégé: Breast Care (Basel)
Pays: Switzerland
ID NLM: 101254060

Informations de publication

Date de publication:
Dec 2019
Historique:
entrez: 15 1 2020
pubmed: 15 1 2020
medline: 15 1 2020
Statut: ppublish

Résumé

Endocrine therapy is recommended for the treatment of postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer (ABC). ACT-FASTER was a German prospective non-interventional cohort study in postmenopausal women with HR+ ABC receiving fulvestrant 500 mg as first line (1 L), second line (2 L) or third line (3 L), or exemestane (any line) in the real-world palliative setting. Primary study objectives included the effectiveness of fulvestrant according to line of palliative treatment measured by time to progression (TTP), and real-life data on the epidemiology and management of these patients. Of 498 evaluable patients (mean age 67.5 years), 99% were estrogen receptor-positive. On study, 86.7% of patients received fulvestrant 500 mg and 13.3% exemestane. Median TTP was 9.7 months in patients receiving fulvestrant 1 L; 6.8 months for 2 L; and 6.7 months for 3 L. The comparison between fulvestrant 1 L palliative treatment and 2 L or 3 L showed that early initiation of treatment prolonged TTP (hazard ratio 1.26; 95% confidence interval 1.08-1.48). Treatments were well tolerated. Fulvestrant 500 mg was administered successfully to patients under daily practice conditions, and both medications were well tolerated. TTP was longest in patients treated with fulvestrant 500 mg 1 L compared with 2 L and 3 L in the palliative care setting.

Sections du résumé

BACKGROUND BACKGROUND
Endocrine therapy is recommended for the treatment of postmenopausal women with hormone receptor-positive (HR+) advanced breast cancer (ABC).
METHODS METHODS
ACT-FASTER was a German prospective non-interventional cohort study in postmenopausal women with HR+ ABC receiving fulvestrant 500 mg as first line (1 L), second line (2 L) or third line (3 L), or exemestane (any line) in the real-world palliative setting. Primary study objectives included the effectiveness of fulvestrant according to line of palliative treatment measured by time to progression (TTP), and real-life data on the epidemiology and management of these patients.
RESULTS RESULTS
Of 498 evaluable patients (mean age 67.5 years), 99% were estrogen receptor-positive. On study, 86.7% of patients received fulvestrant 500 mg and 13.3% exemestane. Median TTP was 9.7 months in patients receiving fulvestrant 1 L; 6.8 months for 2 L; and 6.7 months for 3 L. The comparison between fulvestrant 1 L palliative treatment and 2 L or 3 L showed that early initiation of treatment prolonged TTP (hazard ratio 1.26; 95% confidence interval 1.08-1.48). Treatments were well tolerated.
CONCLUSION CONCLUSIONS
Fulvestrant 500 mg was administered successfully to patients under daily practice conditions, and both medications were well tolerated. TTP was longest in patients treated with fulvestrant 500 mg 1 L compared with 2 L and 3 L in the palliative care setting.

Identifiants

pubmed: 31933587
doi: 10.1159/000493882
pii: brc-0014-0401
pmc: PMC6940445
doi:

Types de publication

Journal Article

Langues

eng

Pagination

401-408

Informations de copyright

Copyright © 2019 by S. Karger AG, Basel.

Déclaration de conflit d'intérêts

PK, HO, HT received remuneration from AstraZeneca. LM is an employee of AstraZeneca. HO and DB have undertaken consultant/advisory roles, and HO has received funding from and owns stocks in AstraZeneca. NM and KP declare that they have no competing interests.

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Auteurs

Nicolai Maass (N)

Klinik für Gynäkologie und Geburtshilfe, UKSH, Kiel.

Helmut Ostermann (H)

Medizinische Klinik und Poliklinik III, Klinikum der Universität München-Großhadern, München.

Kurt Possinger (K)

Medizinische Klinik mit Schwerpunkt Onkologie und Hämatologie, Charité Campus Mitte, Berlin.

Peter Klein (P)

d.s.h. Statistical Services GmbH, Rohrbach.

Hans Tesch (H)

Onkologische Gemeinschaftspraxis, Frankfurt/M.

Lars Mühlenhoff (L)

Medical Affairs, AstraZeneca, Wedel, Germany.

Dirk Bauerschlag (D)

Klinik für Gynäkologie und Geburtshilfe, UKSH, Kiel.

Classifications MeSH