Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/3125
Título : 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)
Autor : Carrato, A.
Benavides, M.
Massutí, B.
Ferreiro-Monteagudo, R.
García Alfonso, P.
Falcó, E.
Reboredo, M.
Cano, T.
Gallego, J.
Viéitez, J.M.
Layos, L.
Salud, A.
Polo, E.
Dotor, E.
Durán-Ogalla, G.
Rodriguez-Garrote, M.
Calvo, A.
Grande, E.
Aranda, E.
Filiación: [Carrato,A] Medical Oncology Department, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERONC, Alcala University, Madrid, Spain. [Benavides,M; Durán-Ogalla,G] Hospital Regional Universitario Virgen de la Victoria, Málaga, Spain. [Massutí,B] Hospital General Universitario de Alicante, Alicante, Spain. [Ferreiro-Monteagudo,R; Rodriguez-Garrote,M; Grande,E] Medical Oncology Department, Hospital Universitario Ramón y Cajal, IRYCIS, CIBERONC, Alcala University, Madrid, Spain. [García Alfonso,P; Calvo,A] Hospital Gregorio Marañón, Madrid, Spain. [Falcó,E] Hospital Son Llatzer, Mallorca, Spain. [Reboredo,M] Complejo Hospitalario Universitario A Coruña, La Coruña, Spain. [Cano,T; Aranda,E] Hospital Universitario Reina Sofia, IMIBIC, University of Córdoba, CIBERONC, Instituto de Salud Carlos III, Córdoba, Spain. [Gallego,J] Hospital General Universitario de Elche, Alicante, Spain. [Viéitez,JM] Hospital Universitario Central de Asturias, Oviedo, Spain. [Layos,L] Hospital Germans Trias i Pujol, ICO, Badalona, Spain. [Salud,A] Hospital de Lleida Arnau de Vilanova, Lérida, Spain. [Polo,E] Hospital Miguel Servet, Zaragoza, Spain. [Dotor,E] Corporació Sanitària Parc Taulí, Barcelona, Spain.
Palabras clave : Regorafenib
Colorrectal cancer
Monotherapy
First-line
Frail patients
Elderly
Neoplasias colorrectales
Anciano
MeSH: Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Administration, Oral
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Aged
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Aged::Aged, 80 and over
Medical Subject Headings::Diseases::Pathological Conditions, Signs and Symptoms::Signs and Symptoms::Asthenia
Medical Subject Headings::Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms
Medical Subject Headings::Phenomena and Processes::Physiological Phenomena::Pharmacological Phenomena::Dose-Response Relationship, Drug
Medical Subject Headings::Check Tags::Female
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Study Characteristics as Topic::Epidemiologic Studies::Cohort Studies::Longitudinal Studies::Follow-Up Studies
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension
Medical Subject Headings::Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Phosphorus Metabolism Disorders::Hypophosphatemia
Medical Subject Headings::Check Tags::Male
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Middle Aged
Medical Subject Headings::Diseases::Neoplasms::Neoplastic Processes::Neoplasm Metastasis
Medical Subject Headings::Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons, Cyclic::Hydrocarbons, Aromatic::Benzene Derivatives::Phenylurea Compounds
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Pilot Projects
Medical Subject Headings::Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds, 1-Ring::Pyridines
Medical Subject Headings::Geographical Locations::Geographic Locations::Europe::Spain
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Medical Subject Headings::Persons::Persons::Age Groups::Adult::Aged::Frail Elderly
Fecha de publicación : 3-Jun-2019
Editorial : BioMed Central
Cita Bibliográfica: Carrato A, Benavides M, Massuti B, Ferreiro-Monteagudo R, Garcia Alfonso P, Falco 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 [Internet]. 2019.doi:10.1186/s12885-019-5753-7
Abstract: Background: Treatment 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. Methods: Frail 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 6 months. Treatment consisted of 28-day cycles of orally administered regorafenib 160 mg/day (3 weeks followed by 1 week rest). Results: Forty-seven patients were included in the study. Median age was 81 years (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 6 months was 45% (95% confidence interval [CI] 30–60]. Median PFS was 5.6 months (95%CI 2.7–8.4). Median overall survival (OS) was 16 months (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%). Conclusions: The study did not meet the pre-specified boundary of 55% PFS rate at 6 months. 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.
URI: http://hdl.handle.net/10668/3125
Versión del editor : https://bmccancer.biomedcentral.com/articles/10.1186/s12885-019-5753-7
DOI: 10.1186/s12885-019-5753-7
ISSN : 1471-2407 (Online)
Appears in Collections:01- Artículos - IMIBIC. Instituto Maimónides de Investigación Biomédica de Córdoba
01- Artículos - Hospital Reina Sofía
01- Artículos - Hospital Virgen de la Victoria

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