Analysis of subsequent therapy in Japanese patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer who received palbociclib plus endocrine therapy in PALOMA-2 and -3.
Adult
Aged
Aged, 80 and over
Antineoplastic Agents, Hormonal
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Breast Neoplasms
/ drug therapy
Double-Blind Method
Female
Fulvestrant
/ administration & dosage
Hormone Replacement Therapy
/ methods
Humans
Japan
/ epidemiology
Letrozole
/ administration & dosage
Middle Aged
Piperazines
/ administration & dosage
Postmenopause
Premenopause
Progression-Free Survival
Pyridines
/ administration & dosage
Random Allocation
Receptor, ErbB-2
/ deficiency
Receptors, Estrogen
/ metabolism
Advanced breast cancer
Japanese
Palbociclib
Subsequent therapy
Journal
Breast cancer (Tokyo, Japan)
ISSN: 1880-4233
Titre abrégé: Breast Cancer
Pays: Japan
ID NLM: 100888201
Informations de publication
Date de publication:
Mar 2021
Mar 2021
Historique:
received:
23
06
2020
accepted:
11
09
2020
pubmed:
22
10
2020
medline:
7
10
2021
entrez:
21
10
2020
Statut:
ppublish
Résumé
In the double-blind, phase 3 PALOMA-2 and PALOMA-3 studies, palbociclib plus endocrine therapy (ET) demonstrated significant improvement in progression-free survival versus placebo plus ET in patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer. This analysis assessed subsequent treatment patterns after palbociclib therapy in Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies. PALOMA-2 included postmenopausal women who had not received prior systemic therapy for advanced disease. PALOMA-3 included pre- or postmenopausal women who had progressed on previous ET. Types of subsequent therapy were assessed, and treatment durations of subsequent therapy were estimated using the Kaplan-Meier method. Japanese patients were enrolled in PALOMA-2 (n = 46) and PALOMA-3 (n = 35). In both studies, the most common first subsequent therapy was ET (PALOMA-2, 77% in the palbociclib group and 75% in the placebo group; PALOMA-3, 55% and 43%, respectively), followed by chemotherapy (PALOMA-2, 18% and 8%; PALOMA-3, 32% and 57%). The median (95% CI) duration of first subsequent therapy was 6.4 (2.3‒13.9) months with palbociclib plus letrozole and 6.7 (2.8‒13.0) months with placebo plus letrozole in PALOMA-2 and 3.8 (2.4‒5.7) months with palbociclib plus fulvestrant and 9.7 (1.0‒not estimable) months with placebo plus fulvestrant in PALOMA-3. The types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar. Further evaluation of subsequent therapy data in the real-world setting is warranted considering the small sample size of this analysis.
Sections du résumé
BACKGROUND
BACKGROUND
In the double-blind, phase 3 PALOMA-2 and PALOMA-3 studies, palbociclib plus endocrine therapy (ET) demonstrated significant improvement in progression-free survival versus placebo plus ET in patients with hormone receptor‒positive/human epidermal growth factor receptor 2‒negative advanced breast cancer. This analysis assessed subsequent treatment patterns after palbociclib therapy in Japanese patients enrolled in the PALOMA-2 and PALOMA-3 studies.
METHODS
METHODS
PALOMA-2 included postmenopausal women who had not received prior systemic therapy for advanced disease. PALOMA-3 included pre- or postmenopausal women who had progressed on previous ET. Types of subsequent therapy were assessed, and treatment durations of subsequent therapy were estimated using the Kaplan-Meier method.
RESULTS
RESULTS
Japanese patients were enrolled in PALOMA-2 (n = 46) and PALOMA-3 (n = 35). In both studies, the most common first subsequent therapy was ET (PALOMA-2, 77% in the palbociclib group and 75% in the placebo group; PALOMA-3, 55% and 43%, respectively), followed by chemotherapy (PALOMA-2, 18% and 8%; PALOMA-3, 32% and 57%). The median (95% CI) duration of first subsequent therapy was 6.4 (2.3‒13.9) months with palbociclib plus letrozole and 6.7 (2.8‒13.0) months with placebo plus letrozole in PALOMA-2 and 3.8 (2.4‒5.7) months with palbociclib plus fulvestrant and 9.7 (1.0‒not estimable) months with placebo plus fulvestrant in PALOMA-3.
CONCLUSIONS
CONCLUSIONS
The types of first subsequent therapy received by Japanese patients in the palbociclib plus ET and placebo plus ET groups were similar. Further evaluation of subsequent therapy data in the real-world setting is warranted considering the small sample size of this analysis.
Identifiants
pubmed: 33085032
doi: 10.1007/s12282-020-01162-4
pii: 10.1007/s12282-020-01162-4
pmc: PMC7925474
doi:
Substances chimiques
Antineoplastic Agents, Hormonal
0
Piperazines
0
Pyridines
0
Receptors, Estrogen
0
Fulvestrant
22X328QOC4
Letrozole
7LKK855W8I
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
palbociclib
G9ZF61LE7G
Types de publication
Clinical Trial, Phase III
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
335-345Références
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