Phase I Study of Combination Therapy With Weekly Nanoparticle Albumin-bound Paclitaxel and Cyclophosphamide in Metastatic Breast Cancer Patients.
Adult
Aged
Albumin-Bound Paclitaxel
/ administration & dosage
Antineoplastic Combined Chemotherapy Protocols
/ administration & dosage
Breast Neoplasms
/ drug therapy
Cyclophosphamide
/ administration & dosage
Drug Administration Schedule
Female
Humans
Middle Aged
Neoplasm Metastasis
Treatment Outcome
Young Adult
Nab-paclitaxel
cyclophosphamide
metastatic breast cancer
Journal
Anticancer research
ISSN: 1791-7530
Titre abrégé: Anticancer Res
Pays: Greece
ID NLM: 8102988
Informations de publication
Date de publication:
Dec 2019
Dec 2019
Historique:
received:
25
09
2019
revised:
08
11
2019
accepted:
11
11
2019
entrez:
8
12
2019
pubmed:
8
12
2019
medline:
18
12
2019
Statut:
ppublish
Résumé
The objective of this phase I study was to determine the maximum-tolerated dose (MTD) and recommended dose (RD) of combination therapy with weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and cyclophosphamide (CPA) in metastatic breast cancer (MBC) patients. Five patients who had human epidermal growth factor receptor 2 (HER2) negative MBC were recruited in this study. They received nab-paclitaxel at dose levels of 100-150 mg once a week for three weeks, repeated every 4 weeks, and CPA (600 mg/m No patient had grade 4 toxicity, however, two patients discontinued protocol treatment due to adverse events at level 2. Thus, the Data and Safety Monitoring Committee recommended the MTD of nab-paclitaxel and CPA to be determined at level 2. The combination therapy with weekly nab-paclitaxel and CPA was tolerable, and the RD for these drugs for MBC were 100 and 600 mg/m
Sections du résumé
BACKGROUND/AIM
OBJECTIVE
The objective of this phase I study was to determine the maximum-tolerated dose (MTD) and recommended dose (RD) of combination therapy with weekly nanoparticle albumin-bound paclitaxel (nab-paclitaxel) and cyclophosphamide (CPA) in metastatic breast cancer (MBC) patients.
PATIENTS AND METHODS
METHODS
Five patients who had human epidermal growth factor receptor 2 (HER2) negative MBC were recruited in this study. They received nab-paclitaxel at dose levels of 100-150 mg once a week for three weeks, repeated every 4 weeks, and CPA (600 mg/m
RESULTS
RESULTS
No patient had grade 4 toxicity, however, two patients discontinued protocol treatment due to adverse events at level 2. Thus, the Data and Safety Monitoring Committee recommended the MTD of nab-paclitaxel and CPA to be determined at level 2.
CONCLUSION
CONCLUSIONS
The combination therapy with weekly nab-paclitaxel and CPA was tolerable, and the RD for these drugs for MBC were 100 and 600 mg/m
Identifiants
pubmed: 31810960
pii: 39/12/6903
doi: 10.21873/anticanres.13910
doi:
Substances chimiques
Albumin-Bound Paclitaxel
0
Cyclophosphamide
8N3DW7272P
Types de publication
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
6903-6907Informations de copyright
Copyright© 2019, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.