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KML001, an arsenic compound, as salvage chemotherapy in refractory biliary tract cancers: A prospective study

Authors
 Jo, Jung Hyun  ;  Kang, Huapyong  ;  Lee, Hee Seung  ;  Chung, Moon Jae  ;  Park, Jeong Youp  ;  Bang, Seungmin  ;  Park, Seung Woo  ;  Song, Si Young 
Citation
 HEPATOBILIARY & PANCREATIC DISEASES INTERNATIONAL, Vol.18(1) : 62-66, 2019 
Journal Title
 HEPATOBILIARY & PANCREATIC DISEASES INTERNATIONAL 
ISSN
 1499-3872 
Issue Date
2019
Keywords
Biliary tract neoplasms ; Cholangiocarcinoma ; Gallbladder neoplasms ; KML001 ; Sodium meta-arsenite
Abstract
BACKGROUND: Sodium meta-arsenite (NaAsO2, KML001) is a potential oral anticancer agent acting on telomerase and telomere length. This prospective study evaluated its safety, tolerability, and effectiveness as salvage chemotherapy in patients with advanced biliary tract cancer (BTC) resistant to gemcitabine-based chemotherapy. METHODS: Forty-four patients (21 women and 23 men) with advanced BTC and failure history of gemcitabine-based chemotherapy, performance status (PS) 0-2, normal cardiac, hepatic, and renal function were enrolled. Daily dose of KML001 (7.5 mg. p.o.) was administered to eligible subjects for 24 weeks divided into six treatment cycles. Response was evaluated bimonthly using CT. RESULTS: After an average of 1.5 months of treatment (range: 0.5-10.0), 3 patients (6.8%) obtained progression-free status, 23 patients (52.3%) had disease progression, and 18 patients (40.9%) dropped out before evaluation. One patient (2.3%) completed six treatment cycles without progression. During the treatment, morphine dosage kept the same or decreased in 20 patients (47.6%). Nine patients (20.5%) experienced grade-3 adverse events (AEs), while no patient experienced grade-4 AEs. The most common AEs were liver enzyme elevation (11/44, 25%) and anemia (10/44, 22.7%). KML001 was discontinued in six patients (13.6%) due to AEs, including liver toxicity (n = 3), QTc prolongation (n = 2), and abdominal pain (n = 1). CONCLUSIONS: KML001 did not have enough anticancer effect on patients with advanced BTC resistant to gemcitabine. However, KML001 was safe and well-tolerable in terms of AEs and pain control when used as salvage therapy. Further studies are needed to establish arsenic agents as a reliable treatment option in patients with BTC.
Full Text
https://www.sciencedirect.com/science/article/pii/S1499387218302753
DOI
10.1016/j.hbpd.2018.12.009
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Kang, Huapyong(강화평) ORCID logo https://orcid.org/0000-0003-1790-0809
Park, Seung Woo(박승우) ORCID logo https://orcid.org/0000-0001-8230-964X
Park, Jeong Youp(박정엽) ORCID logo https://orcid.org/0000-0003-0110-8606
Bang, Seungmin(방승민) ORCID logo https://orcid.org/0000-0001-5209-8351
Song, Si Young(송시영) ORCID logo https://orcid.org/0000-0002-1417-4314
Lee, Hee Seung(이희승) ORCID logo https://orcid.org/0000-0002-2825-3160
Chung, Moon Jae(정문재) ORCID logo https://orcid.org/0000-0002-5920-8549
Jo, Jung Hyun(조중현) ORCID logo https://orcid.org/0000-0002-2641-8873
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/167440
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