Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/16364
First-line single-agent regorafenib in frail patients with metastatic colorectal cancer: a pilot phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
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ISSN: 1471-2407
WOS ID: 000470106800002
Scopus EID: 2-s2.0-85066863564
PMID: 31159765
Embase PUI: L627947542
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2019-06-03Document type
research articleCitation
Carrato A, Benavides M, Massuti B, Ferreiro-Monteagudo R, Garcia Alfonso P, Falcó E, et al. First-line single-agent regorafenib in frail patients with metastatic colorectal cancer: a pilot phase II study of the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD). BMC Cancer. 2019 Jun 03;19:533.Abstract
BackgroundTreatment of frail patients with advanced colorectal cancer (CRC) is controversial. This pilot phase II trial aimed to assess the efficacy and safety of regorafenib when administered in first-line to frail patients with advanced CRC.MethodsFrail patients without prior advanced colorectal cancer treatment were included in the study. Definition of frailty was defined per protocol based on dependency criteria, presence of chronic comorbid pathologies and/or geriatric features. Main objective: to assess progression-free survival (PFS) rate at 6months. Treatment consisted of 28-daycycles of orally administered regorafenib 160mg/day (3 weeks followed by 1 week rest).ResultsForty-seven patients were included in the study. Median age was 81years (range 63-89). Frailty criteria: dependency was observed in 26 patients (55%), comorbidities in 27 (57%) and geriatric features in 18 (38%). PFS rate at 6months was 45% (95% confidence interval [CI] 30-60]. Median PFS was 5.6months (95%CI 2.7-8.4). Median overall survival (OS) was 16months (95%CI 7.8-24). Complete response, partial response and stable disease were observed in one, two and 21 patients respectively (objective response rate 6.4%; disease control rate 51%). Thirty-nine patients (83%) experienced grade 3-4 adverse events (AEs). The most common grade 3-4 AEs were hypertension (15 patients; 32%), asthenia (14; 30%), hypophosphatemia (6; 13%); diarrhea (4; 8%), hand-foot-skin reaction (4; 8%). There were two toxic deaths (4.2%) (grade 5 rectal bleeding and death not further specified). Dose reduction was required in 26 patients (55%) and dose-delays in 13 patients (28%).ConclusionsThe study did not meet the pre-specified boundary of 55% PFS rate at 6months. Toxicity observed (83% patients experienced grade 3 and 4 AEs) preclude its current use in clinical practice on this setting. Disease control rate and overall survival results are interesting and might warrant further investigation to identify those who benefit from this approach.Trial registrationThis trial was prospectively registered at EudraCT (2013-000236-94). Date of trial registration: April 9th, 2013.
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https://dx.doi.org/10.1186/s12885-019-5753-7MeSH
Aged, 80 and overAged
Asthenia
Frail Elderly
Dose-Response Relationship, Drug
Spain
Administration, Oral
Follow-Up Studies
Humans
Progression-Free Survival
Hypertension
Middle Aged
Male
Neoplasm Metastasis
Pilot Projects
Female
Pyridines
Colorectal Neoplasms
Treatment Outcome
Phenylurea Compounds
Hypophosphatemia
DeCS
HipofosfatemiaSupervivencia sin Progresión
Resultado del Tratamiento
Neoplasias Colorrectales
Femenino
Metástasis de la Neoplasia
Masculino
Estudios de Seguimiento
Administración Oral
Hipertensión
Piridinas
Proyectos Piloto
Relación Dosis-Respuesta a Droga
Humanos
Persona de Mediana Edad
Astenia
Anciano
Anciano de 80 o más Años
Compuestos de Fenilurea
España
Anciano Frágil
This item appears in following Docusalut collections
Instituto de Investigación Sanitaria Islas Baleares - IDISBA > Comunicación científicaHospital Universitario Son Llàtzer - HUSLL > Comunicación científica