Multicentre, phase II study of eribulin in combination with S-1 in patients with advanced breast cancer.
Adult
Aged
Anthracyclines
/ therapeutic use
Antimetabolites, Antineoplastic
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Breast Neoplasms
/ drug therapy
Bridged-Ring Compounds
/ therapeutic use
Disease-Free Survival
Drug Combinations
Female
Furans
/ administration & dosage
Humans
Ketones
/ administration & dosage
Middle Aged
Oxonic Acid
/ administration & dosage
Receptor, ErbB-2
/ metabolism
Receptors, Estrogen
/ metabolism
Taxoids
/ therapeutic use
Tegafur
/ administration & dosage
Breast cancer
Eribulin
Phase II study
S-1
TNBC
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
16 Oct 2019
16 Oct 2019
Historique:
received:
25
01
2019
accepted:
24
09
2019
entrez:
18
10
2019
pubmed:
18
10
2019
medline:
27
2
2020
Statut:
epublish
Résumé
We previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis. Patients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m This study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%). The combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis. Current Controlled Trials UMIN000015049 , date of registration: September 5th 2014.
Sections du résumé
BACKGROUND
BACKGROUND
We previously reported the synergistic effect of S-1 and eribulin in preclinical models. In addition, our phase I study revealed the recommended dose for the phase II study of the combination therapy in advanced breast cancer (ABC) patients pre-treated with anthracycline and taxane. Our current study reports on the efficacy and safety of the combined use of eribulin and S-1 in patients with ABC and poor prognosis.
METHODS
METHODS
Patients with breast cancer who received prior anthracycline- and/or taxane-based therapy were assigned to receive a combination therapy of eribulin (1.4 mg/m
RESULTS
RESULTS
This study enrolled 33 patients. Confirmed ORR was 33.3% (95% CI: 17.3 to 52.8). Median PFS was 7.5 months (95% CI: 4.0 to 14.3). Median OS time was not reached during the current experimental periods. The most common grade 3/4 adverse event was neutropenia (68.8%).
CONCLUSIONS
CONCLUSIONS
The combination of eribulin and S-1 is safe and effective for treatment in patients with ABC and poor prognosis.
TRIAL REGISTRATION
BACKGROUND
Current Controlled Trials UMIN000015049 , date of registration: September 5th 2014.
Identifiants
pubmed: 31619197
doi: 10.1186/s12885-019-6200-5
pii: 10.1186/s12885-019-6200-5
pmc: PMC6796350
doi:
Substances chimiques
Anthracyclines
0
Antimetabolites, Antineoplastic
0
Bridged-Ring Compounds
0
Drug Combinations
0
Furans
0
Ketones
0
Receptors, Estrogen
0
Taxoids
0
S 1 (combination)
150863-82-4
Tegafur
1548R74NSZ
taxane
1605-68-1
Oxonic Acid
5VT6420TIG
ERBB2 protein, human
EC 2.7.10.1
Receptor, ErbB-2
EC 2.7.10.1
eribulin
LR24G6354G
Types de publication
Clinical Trial, Phase II
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
962Subventions
Organisme : Eisai
ID : not applicable
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