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Nintedanib for the treatment of patients with refractory metastatic colorectal cancer (LUME-Colon 1): a phase III, international, randomized, placebo-controlled study
- Source :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, Annals of Oncology
- Publication Year :
- 2018
-
Abstract
- BACKGROUND: Angiogenesis is critical to colorectal cancer (CRC) growth and metastasis. Phase I/II studies have demonstrated the efficacy of nintedanib, a triple angiokinase inhibitor, in patients with metastatic CRC. This global, randomized, phase III study investigated the efficacy and safety of nintedanib in patients with refractory CRC after failure of standard therapies. PATIENTS AND METHODS: Eligible patients (Eastern Cooperative Oncology Group performance status 0-1, with histologically/cytologically confirmed metastatic/locally advanced CRC adenocarcinoma unamenable to surgery and/or radiotherapy) were randomized 1 : 1 to receive nintedanib (200 mg twice daily) or placebo (twice daily), until disease progression or undue toxicity. Patients were stratified by previous regorafenib, time from onset of metastatic disease to randomization, and region. Co-primary end points were overall survival (OS) and progression-free survival (PFS) by central review. Secondary end points included objective tumor response and disease control by central review. RESULTS: From October 2014 to January 2016, 768 patients were randomized; 765 were treated (nintedanib n = 384; placebo n = 381). Median follow-up was 13.4 months (interquartile range 11.1-15.7). OS was not improved [median OS 6.4 months with nintedanib versus 6.0 months with placebo; hazard ratio (HR), 1.01; 95% confidence interval (CI), 0.86-1.19; P = 0.8659]. There was a significant but modest increase in PFS with nintedanib versus placebo (median PFS 1.5 versus 1.4 months, respectively; HR 0.58; 95% CI 0.49-0.69; P
- Subjects :
- 0301 basic medicine
Oncology
Male
Indoles
chemorefractory metastatic colorectal cancer
Placebo-controlled study
Administration, Oral
law.invention
Placebos
chemistry.chemical_compound
0302 clinical medicine
Randomized controlled trial
law
nintedanib
angiogenesis inhibition
Hematology
Fatigue
Hazard ratio
Middle Aged
Progression-Free Survival
Angiogenesis inhibition
Response Evaluation Criteria in Solid Tumors
030220 oncology & carcinogenesis
Disease Progression
Nintedanib
Female
Chemical and Drug Induced Liver Injury
Colorectal Neoplasms
Adult
medicine.medical_specialty
Antineoplastic Agents
Adenocarcinoma
Placebo
03 medical and health sciences
Double-Blind Method
Internal medicine
Regorafenib
Gastrointestinal Tumors
medicine
Humans
Progression-free survival
Protein Kinase Inhibitors
neoplasms
Aged
business.industry
Chemorefractory metastatic colorectal cancer
Original Articles
digestive system diseases
030104 developmental biology
Receptors, Vascular Endothelial Growth Factor
chemistry
business
Subjects
Details
- Database :
- OpenAIRE
- Journal :
- Repositorio Institucional de la Consejería de Sanidad de la Comunidad de Madrid, Consejería de Sanidad de la Comunidad de Madrid, Dipòsit Digital de Documents de la UAB, Universitat Autònoma de Barcelona, Annals of Oncology
- Accession number :
- edsair.doi.dedup.....f41d65dc8d8674d58105961d203252fe