Real-world outcomes and prognostic factors of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer: a multicenter study in Spain
Year: 2026
Type: article
Study design: Observational Study
Abstract: Background: Trifluridine/tipiracil plus bevacizumab (FTD/TPI+BEV) has demonstrated survival benefit in patients with metastatic colorectal cancer (mCRC) after failure of at least two prior treatment regimens in the phase III SUNLIGHT trial (NCT04737187), which compared FTD/TPI+BEV with FTD/TPI monotherapy; however, real-world evidence remains limited. The BeTAS real-world study evaluated the real-world effectiveness and safety of FTD/TPI+BEV in Spanish routine clinical practice. Patients and methods: This ambispective, multicenter observational study included 549 patients with mCRC treated with FTD/TPI+BEV across 19 Spanish university hospitals [retrospectively (2019-2023) and prospectively (from 2024 onward)]. Outcomes included overall survival (OS), progression-free survival (PFS), and tumor response according to RECIST version 1.1. Safety was assessed using Common Terminology Criteria for Adverse Events version 5.0. Univariate and multivariate analyses evaluated baseline and treatment-emergent prognostic factors. Results: mutational status, and prior anti-vascular endothelial growth factor exposure. Improved survival outcomes were observed in patients with lower metastatic burden, longer time from metastatic diagnosis, Eastern Cooperative Oncology Group performance status 0-1, left-sided primary tumors, and favorable baseline prognostic classification. Development of grade 3-4 neutropenia and primary prophylactic granulocyte colony-stimulating factor (G-CSF) use were independently associated with prolonged OS and PFS; however, these findings should be interpreted cautiously given the observational design. Neutropenia was the most frequent grade ≥3 adverse event. Two treatment-related deaths were reported. Conclusions: FTD/TPI+BEV is effective and well tolerated in Spanish real-world clinical practice, consistent with SUNLIGHT. Baseline prognostic classification, performance status, metastatic burden, and treatment-emergent factors were associated with clinical outcomes. The observed associations for grade 3-4 neutropenia and primary prophylactic G-CSF use should be considered exploratory and hypothesis-generating.
Source: ESMO Gastrointestinal Oncology
Authors: N. Martínez-Lago, M. Reboredo López, M.C. Riesco Martínez, S. López Peraita, B. González Gómez, C. Antonilli Pérez, I. Ghanem, M. Pérez Martelo, A. López Alfonso, A. Fernández Montes, S. Agraso Busto, A.M. Jiménez Gordo, M. Melian Sosa, E. Gallardo Martín, L. Cabezón-Gutiérrez, A. Cousillas Castiñeiras, M. LLanos Muñoz, M.P. Ochoa Rivas, D. Gutiérrez Abad, J. de la Cámara Gómez, B. De Frutos González, A.M. López Muñoz, R. Ferreiro Monteagudo
Institutions: Instituto de Investigación Sanitaria de Santiago, Complexo Hospitalario Universitario A Coruña, Hospital Universitario 12 De Octubre, Hospital Universitario de Burgos, Hospital Universitario Lucus Augusti, Hospital Universitario de Gran Canaria Doctor Negrín, Hospital Universitario La Paz, Hospital Universitario Infanta Leonor, Complejo Hospitalario de Ourense, Complejo Hospitalario Universitario de Ferrol, Hospital Universitario Infanta Sofía, Fundación Instituto Valenciano de Oncología, Universidad Francisco de Vitoria, Hospital Universitario de Torrejón, Complejo Hospitalario de Pontevedra, Hospital Universitario de Canarias, Hospital Central de la Defensa Gómez Ulla, Hospital Universitario de Fuenlabrada, Hospital Universitario Ramón y Cajal
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,170
OpenAlex ID: W7204877456