Combination chemotherapy with NAB
Albumins
/ therapeutic use
Antimetabolites, Antineoplastic
/ therapeutic use
Antineoplastic Combined Chemotherapy Protocols
/ therapeutic use
Biliary Tract Neoplasms
/ drug therapy
Capecitabine
/ therapeutic use
Deoxycytidine
/ analogs & derivatives
Feasibility Studies
Humans
Paclitaxel
/ therapeutic use
Pilot Projects
Platinum
Quality of Life
Treatment Outcome
Gemcitabine
advanced biliary tract cancer
chemotherapy
cholangiocarcinoma
second-line treatment
Journal
Asia-Pacific journal of clinical oncology
ISSN: 1743-7563
Titre abrégé: Asia Pac J Clin Oncol
Pays: Australia
ID NLM: 101241430
Informations de publication
Date de publication:
Oct 2022
Oct 2022
Historique:
received:
07
02
2021
accepted:
04
03
2021
pubmed:
29
6
2021
medline:
21
9
2022
entrez:
28
6
2021
Statut:
ppublish
Résumé
Advanced biliary tract cancer (ABTC) is a highly aggressive malignancy, with a 5-year overall survival of < 10%. Although preliminary evidence suggests a role of targeted treatments or immunotherapy in a subset of patients, chemotherapy remains the standard second-line treatment in the majority. We conducted a pilot study of second-line chemotherapy with capecitabine and nab-paclitaxel after failure of gemcitabine and platinum. Eligible patients had histologically proven, unresectable biliary tract cancer, which had progressed on a gemcitabine/platinum doublet. In this single-arm, multicenter trial, all patients received capecitabine (825 mg/m Ten patients were enrolled between 2015 and 2016 from four cancer centers in NSW. Treatment was generally well tolerated with grade III toxicities in five patients (including infection, cholangitis, obstruction, and intestinal perforation) and no grade IV toxicity. Median treatment duration was 4.3 months, with a disease control rate of 80% (8/10), and median progression-free and overall survival of 5.7 and 12.1 months, respectively. Quality of life data and specimens for translational research have been collected. Our pilot study demonstrates that combination of capecitabine and nab-paclitaxel is feasible as a second-line treatment in ABTC. Adequate safety and promising early efficacy signals make further assessment of the combination in a formal phase II or III trial reasonable. ACTRN12615000504516.
Sections du résumé
BACKGROUND
BACKGROUND
Advanced biliary tract cancer (ABTC) is a highly aggressive malignancy, with a 5-year overall survival of < 10%. Although preliminary evidence suggests a role of targeted treatments or immunotherapy in a subset of patients, chemotherapy remains the standard second-line treatment in the majority. We conducted a pilot study of second-line chemotherapy with capecitabine and nab-paclitaxel after failure of gemcitabine and platinum.
METHODS
METHODS
Eligible patients had histologically proven, unresectable biliary tract cancer, which had progressed on a gemcitabine/platinum doublet. In this single-arm, multicenter trial, all patients received capecitabine (825 mg/m
RESULTS
RESULTS
Ten patients were enrolled between 2015 and 2016 from four cancer centers in NSW. Treatment was generally well tolerated with grade III toxicities in five patients (including infection, cholangitis, obstruction, and intestinal perforation) and no grade IV toxicity. Median treatment duration was 4.3 months, with a disease control rate of 80% (8/10), and median progression-free and overall survival of 5.7 and 12.1 months, respectively. Quality of life data and specimens for translational research have been collected.
CONCLUSIONS
CONCLUSIONS
Our pilot study demonstrates that combination of capecitabine and nab-paclitaxel is feasible as a second-line treatment in ABTC. Adequate safety and promising early efficacy signals make further assessment of the combination in a formal phase II or III trial reasonable.
CLINICAL TRIAL INFORMATION
BACKGROUND
ACTRN12615000504516.
Substances chimiques
130-nm albumin-bound paclitaxel
0
Albumins
0
Antimetabolites, Antineoplastic
0
Deoxycytidine
0W860991D6
Platinum
49DFR088MY
Capecitabine
6804DJ8Z9U
Paclitaxel
P88XT4IS4D
Gemcitabine
0
Types de publication
Clinical Trial
Journal Article
Multicenter Study
Langues
eng
Sous-ensembles de citation
IM
Pagination
e220-e226Informations de copyright
© 2021 John Wiley & Sons Australia, Ltd.
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