Efficacy and safety of FOLFIRI/aflibercept in second‐line treatment of metastatic colorectal cancer in a real‐world population: Prognostic and predictive markers

Autor: Mónica Jorge Fernández, Maria Luz Pellon Augusto, J. Méndez, Ana Montes, Juan de la Cámara Gómez, Mercedes Salgado Fernández, Margarita Reboredo Lopez, Nieves Martinez Lago, Guillermo Alfonso Quintero Aldana, Paula González Villaroel, Marta Covela Rúa, Jesús García Gómez, Begoña Graña Suárez
Jazyk: angličtina
Rok vydání: 2019
Předmět:
0301 basic medicine
Oncology
Male
Cancer Research
Colorectal cancer
Leucovorin
Biomarkers
Pharmacological
VELOUR
0302 clinical medicine
Antineoplastic Combined Chemotherapy Protocols
Medicine
Aflibercept
Original Research
Aged
80 and over
education.field_of_study
metastatic colorectal cancer
aflibercept
Liver Neoplasms
Middle Aged
Survival Rate
Treatment Outcome
030220 oncology & carcinogenesis
FOLFIRI
Female
Fluorouracil
Colorectal Neoplasms
medicine.drug
Adult
medicine.medical_specialty
Bevacizumab
Recombinant Fusion Proteins
Population
Neutropenia
real‐life study
03 medical and health sciences
Internal medicine
Mucositis
Humans
Radiology
Nuclear Medicine and imaging
education
Aged
Retrospective Studies
business.industry
Surrogate endpoint
Clinical Cancer Research
medicine.disease
030104 developmental biology
routine clinical practice
Receptors
Vascular Endothelial Growth Factor
Camptothecin
business
Zdroj: Cancer Medicine
ISSN: 2045-7634
Popis: Purpose The phase III VELOUR trial demonstrated efficacy with combined FOLFIRI‐aflibercept in patients with metastatic colorectal cancer previously treated with oxaliplatin with or without bevacizumab versus placebo. The effect of FOLFIRI‐aflibercept in routine clinical practice was evaluated. Methods/Patients Overall survival (OS), progression‐free survival (PFS), response and safety were analysed for 78 patients treated with FOLFIRI‐aflibercept at six GITuD institutions. Exploratory analyses of prognostic and predictive markers of efficacy were performed. Results Patients had good general status (PS 0‐1 96.2%), tumours were mostly RAS‐mutant (75.6%), synchronous (71.8%), and left‐sided (71.8%). Prior therapy included bevacizumab (47.4%) and anti‐EGFR agents (12.8%). PFS was longer for metachronous than synchronous tumours (11.0 vs 5.0 months, P = 0.028), and for left‐colon tumours (7.0 vs 3.0 months, P = 0.044). RAS‐mutant status, first‐line treatment and primary tumour surgery did not impact PFS. The disease control rate was 70.5%. The most common grade 3/4 toxicities were neutropenia (15.3%), asthenia (10.3%), diarrhea and mucositis (6.4% each). Dysphonia was reported in 39.7% of patients, and grade 3 hypertension in 3.8%. Development of hypertension (any grade) was significantly associated with a reduced risk of progression by multivariate analysis (HR = 2.7; 95%CI 1.3‐5.4; P = 0.001). Conclusions Efficacy with FOLFIRI‐aflibercept in a real‐life population was in line with results from the pivotal trial and toxicity was manageable with treatment adaptation. Survival outcomes were not impacted by primary tumour location, RAS‐mutant status, first‐line treatment or primary tumour surgery. Hypertension may be a surrogate marker of efficacy in this patient population.
Databáze: OpenAIRE
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