Detail
Článek
Článek online
FT
Medvik - BMČ
  • Je něco špatně v tomto záznamu ?

AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer

SM. Tolaney, A. Chan, K. Petrakova, S. Delaloge, M. Campone, H. Iwata, PF. Peddi, PA. Kaufman, E. De Kermadec, Q. Liu, P. Cohen, G. Paux, L. Wang, N. Ternès, E. Boitier, SA. Im

. 2023 ; 41 (24) : 4014-4024. [pub] 20230622

Jazyk angličtina Země Spojené státy americké

Typ dokumentu randomizované kontrolované studie, klinické zkoušky, fáze II, časopisecké články, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc23016537

PURPOSE: Amcenestrant (oral selective estrogen receptor degrader) demonstrated promising safety and efficacy in earlier clinical studies for endocrine-resistant, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (aBC). PATIENTS AND METHODS: In AMEERA-3 (ClinicalTrials.gov identifier: NCT04059484), an open-label, worldwide phase II trial, patients with ER+/HER2- aBC who progressed in the (neo)adjuvant or advanced settings after not more than two previous lines of endocrine therapy (ET) were randomly assigned 1:1 to amcenestrant or single-agent endocrine treatment of physician's choice (TPC), stratified by the presence/absence of visceral metastases, previous/no treatment with cyclin-dependent kinase 4/6 inhibitor, and Eastern Cooperative Oncology Group performance status (0/1). The primary end point was progression-free survival (PFS) by independent central review, compared using a stratified log-rank test (one-sided type I error rate of 2.5%). RESULTS: Between October 22, 2019, and February 15, 2021, 290 patients were randomly assigned to amcenestrant (n = 143) or TPC (n = 147). PFS was numerically similar between amcenestrant and TPC (median PFS [mPFS], 3.6 v 3.7 months; stratified hazard ratio [HR], 1.051 [95% CI, 0.789 to 1.4]; one-sided P = .643). Among patients with baseline mutated ESR1; (n = 120 of 280), amcenestrant numerically prolonged PFS versus TPC (mPFS, 3.7 v 2.0 months; stratified HR, 0.9 [95% CI, 0.565 to 1.435]). Overall survival data were immature but numerically similar between groups (HR, 0.913; 95% CI, 0.595 to 1.403). In amcenestrant versus TPC groups, treatment-emergent adverse events (any grade) occurred in 82.5% versus 76.2% of patients and grade ≥3 events occurred in 21.7% versus 15.6%. CONCLUSION: AMEERA-3 did not meet its primary objective of improved PFS with amcenestrant versus TPC although a numerical improvement in PFS was observed in patients with baseline ESR1 mutation. Efficacy and safety with amcenestrant were consistent with the standard of care for second-/third-line ET for ER+/HER2- aBC.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc23016537
003      
CZ-PrNML
005      
20231026105737.0
007      
ta
008      
231013s2023 xxu f 000 0|eng||
009      
AR
024    7_
$a 10.1200/JCO.22.02746 $2 doi
035    __
$a (PubMed)37348019
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a xxu
100    1_
$a Tolaney, Sara M $u Dana-Farber Cancer Institute, Boston, MA $1 https://orcid.org/0000000259408671
245    10
$a AMEERA-3: Randomized Phase II Study of Amcenestrant (Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Monotherapy in Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer / $c SM. Tolaney, A. Chan, K. Petrakova, S. Delaloge, M. Campone, H. Iwata, PF. Peddi, PA. Kaufman, E. De Kermadec, Q. Liu, P. Cohen, G. Paux, L. Wang, N. Ternès, E. Boitier, SA. Im
520    9_
$a PURPOSE: Amcenestrant (oral selective estrogen receptor degrader) demonstrated promising safety and efficacy in earlier clinical studies for endocrine-resistant, estrogen receptor-positive/human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer (aBC). PATIENTS AND METHODS: In AMEERA-3 (ClinicalTrials.gov identifier: NCT04059484), an open-label, worldwide phase II trial, patients with ER+/HER2- aBC who progressed in the (neo)adjuvant or advanced settings after not more than two previous lines of endocrine therapy (ET) were randomly assigned 1:1 to amcenestrant or single-agent endocrine treatment of physician's choice (TPC), stratified by the presence/absence of visceral metastases, previous/no treatment with cyclin-dependent kinase 4/6 inhibitor, and Eastern Cooperative Oncology Group performance status (0/1). The primary end point was progression-free survival (PFS) by independent central review, compared using a stratified log-rank test (one-sided type I error rate of 2.5%). RESULTS: Between October 22, 2019, and February 15, 2021, 290 patients were randomly assigned to amcenestrant (n = 143) or TPC (n = 147). PFS was numerically similar between amcenestrant and TPC (median PFS [mPFS], 3.6 v 3.7 months; stratified hazard ratio [HR], 1.051 [95% CI, 0.789 to 1.4]; one-sided P = .643). Among patients with baseline mutated ESR1; (n = 120 of 280), amcenestrant numerically prolonged PFS versus TPC (mPFS, 3.7 v 2.0 months; stratified HR, 0.9 [95% CI, 0.565 to 1.435]). Overall survival data were immature but numerically similar between groups (HR, 0.913; 95% CI, 0.595 to 1.403). In amcenestrant versus TPC groups, treatment-emergent adverse events (any grade) occurred in 82.5% versus 76.2% of patients and grade ≥3 events occurred in 21.7% versus 15.6%. CONCLUSION: AMEERA-3 did not meet its primary objective of improved PFS with amcenestrant versus TPC although a numerical improvement in PFS was observed in patients with baseline ESR1 mutation. Efficacy and safety with amcenestrant were consistent with the standard of care for second-/third-line ET for ER+/HER2- aBC.
650    _2
$a lidé $7 D006801
650    _2
$a ženské pohlaví $7 D005260
650    12
$a nádory prsu $x patologie $7 D001943
650    _2
$a receptory pro estrogeny $x metabolismus $7 D011960
650    _2
$a protokoly protinádorové kombinované chemoterapie $x škodlivé účinky $7 D000971
650    _2
$a receptor erbB-2 $x metabolismus $7 D018719
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a klinické zkoušky, fáze II $7 D017427
655    _2
$a časopisecké články $7 D016428
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Chan, Arlene $u Curtin University, Perth, Australia $1 https://orcid.org/0000000321352286
700    1_
$a Petrakova, Katarina $u Masaryk Memorial Cancer Institute, Brno, Czech Republic
700    1_
$a Delaloge, Suzette $u Institut Gustave Roussy, Villejuif, France $1 https://orcid.org/0000000321069165
700    1_
$a Campone, Mario $u Institut de Cancérologie de l'Ouest, René Gauducheau, Saint-Herblain, France
700    1_
$a Iwata, Hiroji $u Aichi Cancer Center Hospital, Nagoya, Japan $1 https://orcid.org/0000000202424718
700    1_
$a Peddi, Parvin F $u Providence Saint John's Cancer Institute, Santa Monica, CA $1 https://orcid.org/0000000284599828
700    1_
$a Kaufman, Peter A $u University of Vermont Larner College of Medicine, Burlington, VT $1 https://orcid.org/0000000336776807
700    1_
$a De Kermadec, Elisabeth $u Sanofi, Cambridge, MA
700    1_
$a Liu, Qianying $u Sanofi, Cambridge, MA $u Moderna, Inc, Cambridge, MA
700    1_
$a Cohen, Patrick $u Sanofi, Vitry-sur-Seine, France $1 https://orcid.org/0009000811871123
700    1_
$a Paux, Gautier $u Sanofi, Cambridge, MA $1 https://orcid.org/0000000330026351
700    1_
$a Wang, Lei $u Sanofi, Cambridge, MA
700    1_
$a Ternès, Nils $u Sanofi, Chilly-Mazarin, France
700    1_
$a Boitier, Eric $u Sanofi, Chilly-Mazarin, France
700    1_
$a Im, Seock-Ah $u Seoul National University Hospital, Cancer Research Institute, Seoul National University College of Medicine, Seoul National University, Seoul, Republic of Korea $1 https://orcid.org/0000000253966533
773    0_
$w MED00002596 $t Journal of clinical oncology : official journal of the American Society of Clinical Oncology $x 1527-7755 $g Roč. 41, č. 24 (2023), s. 4014-4024
856    41
$u https://pubmed.ncbi.nlm.nih.gov/37348019 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y - $z 0
990    __
$a 20231013 $b ABA008
991    __
$a 20231026105731 $b ABA008
999    __
$a ok $b bmc $g 2000196 $s 1202899
BAS    __
$a 3
BAS    __
$a PreBMC-MEDLINE
BMC    __
$a 2023 $b 41 $c 24 $d 4014-4024 $e 20230622 $i 1527-7755 $m Journal of clinical oncology $n J. clin. Oncol. $x MED00002596
LZP    __
$a Pubmed-20231013

Najít záznam

Citační ukazatele

Možnosti archivace