A phase I/II trial of olaparib tablet in combination with eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer previously treated with anthracyclines and taxanes.
Adolescent
Adult
Aged
Aged, 80 and over
Anthracyclines
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ pharmacokinetics
Area Under Curve
Drug Resistance, Neoplasm
/ drug effects
Female
Follow-Up Studies
Furans
/ administration & dosage
Humans
Ketones
/ administration & dosage
Lymphatic Metastasis
Maximum Tolerated Dose
Middle Aged
Phthalazines
/ administration & dosage
Piperazines
/ administration & dosage
Prognosis
Salvage Therapy
Survival Rate
Tablets
/ administration & dosage
Taxoids
/ administration & dosage
Tissue Distribution
Triple Negative Breast Neoplasms
/ drug therapy
Young Adult
Eribulin
Metastatic disease
Olaparib
PARP inhibitor
Triple-negative breast cancer
Journal
European journal of cancer (Oxford, England : 1990)
ISSN: 1879-0852
Titre abrégé: Eur J Cancer
Pays: England
ID NLM: 9005373
Informations de publication
Date de publication:
03 2019
03 2019
Historique:
received:
22
08
2018
revised:
09
11
2018
accepted:
10
11
2018
pubmed:
1
2
2019
medline:
22
5
2020
entrez:
1
2
2019
Statut:
ppublish
Résumé
We conducted a multicenter phase I/II trial of olaparib plus eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer (TNBC) to determine the recommended phase II dose (RP2D) (phase I) and to examine the efficacy and safety (phase II) (UMIN00009498) of the combined therapy. In phase I, olaparib tablet was orally administered twice daily from level 1:25 mg BID to level 7:300 mg BID, with 1.4 mg/m One of the 24 patients enrolled in phase I experienced dose-limiting toxicity. The RP2D was established as 300 mg twice daily for olaparib and 1.4 mg/m Combination therapy of olaparib with eribulin shows antitumour activity against advanced or metastatic TNBC, but caution must be exercised in the presence of febrile neutropenia.
Sections du résumé
BACKGROUND
We conducted a multicenter phase I/II trial of olaparib plus eribulin in Japanese patients with advanced or metastatic triple-negative breast cancer (TNBC) to determine the recommended phase II dose (RP2D) (phase I) and to examine the efficacy and safety (phase II) (UMIN00009498) of the combined therapy.
PATIENTS AND METHODS
In phase I, olaparib tablet was orally administered twice daily from level 1:25 mg BID to level 7:300 mg BID, with 1.4 mg/m
RESULTS
One of the 24 patients enrolled in phase I experienced dose-limiting toxicity. The RP2D was established as 300 mg twice daily for olaparib and 1.4 mg/m
CONCLUSIONS
Combination therapy of olaparib with eribulin shows antitumour activity against advanced or metastatic TNBC, but caution must be exercised in the presence of febrile neutropenia.
Identifiants
pubmed: 30703739
pii: S0959-8049(18)31512-0
doi: 10.1016/j.ejca.2018.11.014
pii:
doi:
Substances chimiques
Anthracyclines
0
Furans
0
Ketones
0
Phthalazines
0
Piperazines
0
Tablets
0
Taxoids
0
eribulin
LR24G6354G
olaparib
WOH1JD9AR8
Types de publication
Clinical Trial, Phase I
Clinical Trial, Phase II
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
84-91Informations de copyright
Copyright © 2018 Elsevier Ltd. All rights reserved.