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: | E. Falcó, Reyes Ferreiro-Monteagudo, T. Cano, Manuel Benavides, E. Polo, Enrique Aranda, Enrique Grande, Emma Dotor, G. Durán-Ogalla, Alfredo Carrato, Margarita Reboredo, Antonieta Salud, B. Massuti, Mercedes Rodríguez-Garrote, Jose María Vieitez, Aitana Calvo, Laura Layos, P. García Alfonso, Javier Gallego |
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| Přispěvatelé: | [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., Financial support for this research was provided by Bayer Hispania, which has no role in the design of the study, collection, analysis, and interpretation of data, and in writing the manuscript. |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
Male Colorrectal cancer Cancer Research Persons::Persons::Age Groups::Adult::Aged::Frail Elderly [Medical Subject Headings] astenia Colorectal cancer Hypophosphatemia Pyridines health care facilities manpower and services humanos Administration Oral Pilot Projects estudios de seguimiento Chemicals and Drugs::Heterocyclic Compounds::Heterocyclic Compounds 1-Ring::Pyridines [Medical Subject Headings] Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans [Medical Subject Headings] chemistry.chemical_compound 0302 clinical medicine Stable Disease Elderly Neoplasias colorrectales Surgical oncology Medicine Neoplasm Metastasis metástasis neoplásica mediana edad Persons::Persons::Age Groups::Adult::Aged [Medical Subject Headings] Regorafenib Aged 80 and over anciano Analytical Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Drug Therapy::Drug Administration Routes::Administration Oral [Medical Subject Headings] resultado del tratamiento proyectos piloto First-line Middle Aged lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens hipofosfatemia Progression-Free Survival Diarrhea Treatment Outcome Oncology 030220 oncology & carcinogenesis Hypertension Female medicine.symptom Colorectal Neoplasms Diseases::Pathological Conditions Signs and Symptoms::Signs and Symptoms::Asthenia [Medical Subject Headings] Diseases::Nutritional and Metabolic Diseases::Metabolic Diseases::Phosphorus Metabolism Disorders::Hypophosphatemia [Medical Subject Headings] Research Article Colorectal cancer Elderly First-line Frail patients Monotherapy Regorafenib Frail patients medicine.medical_specialty neoplasias colorrectales Frail Elderly Anciano piridinas Check Tags::Male [Medical Subject Headings] lcsh:RC254-282 Diseases::Cardiovascular Diseases::Vascular Diseases::Hypertension [Medical Subject Headings] 03 medical and health sciences Internal medicine 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] Diseases::Neoplasms::Neoplastic Processes::Neoplasm Metastasis [Medical Subject Headings] Genetics Humans Adverse effect neoplasms Analytical Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome [Medical Subject Headings] Aged Geographical Locations::Geographic Locations::Europe::Spain [Medical Subject Headings] Dose-Response Relationship Drug business.industry Phenomena and Processes::Physiological Phenomena::Pharmacological Phenomena::Dose-Response Relationship Drug [Medical Subject Headings] Analytical Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Evaluation Studies as Topic::Pilot Projects [Medical Subject Headings] Phenylurea Compounds Diseases::Neoplasms::Neoplasms by Site::Digestive System Neoplasms::Gastrointestinal Neoplasms::Intestinal Neoplasms::Colorectal Neoplasms [Medical Subject Headings] Persons::Persons::Age Groups::Adult::Middle Aged [Medical Subject Headings] medicine.disease Monotherapy Confidence interval digestive system diseases 030104 developmental biology Check Tags::Female [Medical Subject Headings] chemistry Persons::Persons::Age Groups::Adult::Aged::Aged 80 and over [Medical Subject Headings] Spain Asthenia Chemicals and Drugs::Organic Chemicals::Hydrocarbons::Hydrocarbons Cyclic::Hydrocarbons Aromatic::Benzene Derivatives::Phenylurea Compounds [Medical Subject Headings] hipertensión business compuestos de fenilurea human activities Follow-Up Studies |
| Zdroj: | BMC Cancer r-ISABIAL. Repositorio Institucional de Producción Científica del Instituto de Investigación Biomédica y Sanitaria de Alicante instname r-FISABIO. Repositorio Institucional de Producción Científica r-IGTP. Repositorio Institucional de Producción Científica del Instituto de Investigación Germans Trias i Pujol r-FISABIO: Repositorio Institucional de Producción Científica Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana (FISABIO) BMC Cancer, Vol 19, Iss 1, Pp 1-9 (2019) Zaguán. Repositorio Digital de la Universidad de Zaragoza |
| ISSN: | 1471-2407 |
| Popis: | 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. Financial support for this research was provided by Bayer Hispania, which has no role in the design of the study; collection, analysis, and interpretation of data; and in writing the manuscript. |
| Databáze: | OpenAIRE |
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