KML001, an arsenic compound, as salvage chemotherapy in refractory biliary tract cancers: A prospective study.
Hepatobiliary Pancreat Dis Int
; 18(1): 62-66, 2019 Feb.
Article
en En
| MEDLINE
| ID: mdl-30612929
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 (7.5â¯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 (nâ¯=â¯3), QTc prolongation (nâ¯=â¯2), and abdominal pain (nâ¯=â¯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.Palabras clave
Texto completo:
1
Bases de datos:
MEDLINE
Asunto principal:
Neoplasias del Sistema Biliar
/
Protocolos de Quimioterapia Combinada Antineoplásica
/
Terapia Recuperativa
/
Compuestos de Sodio
/
Arsenitos
/
Antineoplásicos
Tipo de estudio:
Observational_studies
/
Risk_factors_studies
Límite:
Aged
/
Female
/
Humans
/
Male
/
Middle aged
Idioma:
En
Revista:
Hepatobiliary Pancreat Dis Int
Asunto de la revista:
GASTROENTEROLOGIA
Año:
2019
Tipo del documento:
Article