RT Journal Article
T1 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.
A1 Aranda, Enrique
A1 Vieitez, Jose Maria
A1 Gomez-España, Auxiliadora
A1 Gil Calle, Silvia
A1 Salud-Salvia, Antonieta
A1 Graña, Begoña
A1 Garcia-Alfonso, Pilar
A1 Rivera, Fernando
A1 Quintero-Aldana, Guillermo Alfonso
A1 Reina-Zoilo, Juan Jose
A1 Gonzalez-Flores, Encarnacion
A1 Salgado Fernandez, Mercedes
A1 Guillen-Ponce, Carmen
A1 Garcia-Carbonero, Rocio
A1 Safont, Maria Jose
A1 La Casta Munoa, Adelaida
A1 Garcia-Paredes, Beatriz
A1 Lopez Lopez, Rafael
A1 Sastre, Javier
A1 Diaz-Rubio, Eduardo
K1 FOLFOX
K1 FOLFOXIRI
K1 bevacizumab
K1 circulating tumor cells
K1 colorectal cancer
AB 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. VISNÚ-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/m2, oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and 5-fluorouracil 3200 mg/m2) or FOLFOX (oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, 5-fluorouracil 400 mg/m2 then 2400 mg/m2) by intravenous administration every 2 weeks. The primary outcome was progression-free survival (PFS). 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. 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.
PB Elsevier BV
YR 2020
FD 2020-08-22
LK http://hdl.handle.net/10668/16545
UL http://hdl.handle.net/10668/16545
LA en
NO Aranda E, Viéitez JM, Gómez-España A, Gil Calle S, Salud-Salvia A, Graña B, et al. 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. ESMO Open. 2020 Nov;5(6):e000944.
DS RISalud
RD Apr 6, 2025