FOLFOXIRI plus bevacizumab versus FOLFOX plus bevacizumab for patients with metastatic colorectal cancer and ?3 circulating tumour cells: the randomised phase III VISNÚ-1 trial
Aranda, Enrique; Viéitez, Jose Maria; Gómez-España, Auxiliadora; Gil Calle, Silvia; Salud-Salvia, Antonieta; Graña Suárez, Begoña; Garcia-Alfonso, Pilar; Rivera, Fernando; QUINTERO ALDANA, GUILLERMO; Reina-Zoilo, Juan José; González-Flores, Encarnación; Salgado Fernández, Mercedes; Guillén-Ponce, Carmen; Garcia-Carbonero, Rocio; Safont, María José; La Casta Munoa, Adelaida; García-Paredes, Beatriz; López López, Rafael; Sastre, Javier; Díaz-Rubio, Eduardo; Spanish Cooperative Group for the Treatment of Digestive Tumors (TTD)
![Thumbnail](/xmlui/themes/Mirage2//images/thumbnails/thumn_cientif.png)
Identificadores![](/xmlui/themes/Mirage2//images/despl_identif.png)
Identificadores
Visualización o descarga de ficheros![](/xmlui/themes/Mirage2//images/despl_contenidos.png)
Visualización o descarga de ficheros
Fecha de publicación
2020Título de revista
ESMO OPEN
Tipo de contenido
Journal Article
DeCS
fluorouracilo | protocolos de quimioterapia antineoplásica combinada | camptotecina | compuestos organoplatino | humanos | leucovorinaMeSH
Organoplatinum Compounds | Humans | Camptothecin | Fluorouracil | Leucovorin | Antineoplastic Combined Chemotherapy ProtocolsResumen
PURPOSE: 5-Fluorouracil/leucovorin, oxaliplatin, irinotecan (FOLFOXIRI) plus bevacizumab is more effective than doublets plus bevacizumab as first-line therapy for metastatic colorectal cancer, but is not widely used because of concerns about toxicity and lack of predictive biomarkers. This study was designed to explore the role of circulating tumour cell (CTC) count as a biomarker to select patients for therapy with FOLFOXIRI-bevacizumab. PATIENTS AND METHODS: VISNU-1 was a multicentre, open-label, randomised, phase III study in patients with previously untreated, unresectable, metastatic colorectal carcinoma and >/=3 CTC/7.5 mL blood. Patients received bevacizumab 5 mg/kg plus FOLFOXIRI (irinotecan 165 mg/m(2), oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2) and 5-fluorouracil 3200 mg/m(2)) or FOLFOX (oxaliplatin 85 mg/m(2), leucovorin 400 mg/m(2), 5-fluorouracil 400 mg/m(2) then 2400 mg/m(2)) by intravenous administration every 2 weeks. The primary outcome was progression-free survival (PFS). RESULTS: The intention-to-treat population comprised 349 patients (FOLFOXIRI-bevacizumab, n=172; FOLFOX-bevacizumab, n=177). Median PFS was 12.4 months (95% CI 11.2 to 14.0) with FOLFOXIRI bevacizumab and 9.3 months (95% CI 8.5 to 10.7) with FOLFOX-bevacizumab (stratified HR, 0.64; 95% CI 0.49 to 0.82; p=0.0006). Grade>/=3 adverse events were more common with FOLFOXIRI-bevacizumab 85.3% vs 75.1% with FOLFOX-bevacizumab (p=0.0178). Treatment-related deaths occurred in 8 (4.7%) and 6 (3.4%) patients, respectively. CONCLUSIONS: First-line FOLFOXIRI-bevacizumab significantly improved PFS compared with FOLFOX-bevacizumab in patients with metastatic colorectal cancer and >/=3 CTCs at baseline, which indicate a poor prognosis. CTC count may be a useful non-invasive biomarker to assist with the selection of patients for intensive first-line therapy.
Excepto si se señala otra cosa, la licencia del ítem se describe como Atribución-NoComercial 4.0 Internacional
![](/xmlui/themes/Mirage2//images/final_lines.png)