RT Journal Article
T1 Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study
A1 Garcia-Alfonso, Pilar
A1 Muñoz, Andres
A1 Jimenez-Castro, Jeronimo
A1 Jimenez-Fonseca, Paula
A1 Pericay, Carles
A1 Longo-Muñoz, Federico
A1 Reyna-Fortes, Carmen
A1 Argiles-Martinez, Guillem
A1 Gonzalez-Astorga, Beatriz
A1 Gomez-Reina, Maria Jose
A1 Ruiz-Casado, Ana
A1 Rodriguez-Salas, Nuria
A1 Lopez-Lopez, Rafael
A1 Carmona-Bayonas, Alberto
A1 Conde-Herrero, Veronica
A1 Aranda, Enrique
K1 Biomarkers
K1 Chemotherapy
K1 Colorectal cancer
K1 Combination therapy
K1 Real-life
K1 Trifluridine/tipiracil
AB Trifluridine/tipiracil is currently approved for metastatic colorectal cancer (mCRC) refractory to available therapies. However, there is no consensus on factors that predict treatment outcomes in daily practice. We assessed the early clinical experience with trifluridine/tipiracil in Spain and potential survival markers. This was a retrospective cohort study of mCRC patients who participated in the trifluridine/tipiracil early clinical experience programme in Spain. The primary outcome was overall survival (OS). Associations between OS and patient characteristics were assessed using multivariate Cox regression analyses. A total of 379 patients were included in the study. Trifluridine/tipiracil was administered for a median of 3.0 cycles and discontinued mainly due to disease progression (79.2%). The median OS was 7.9 months, with a 12-month OS rate of 30.5%. Cox analyses revealed that the following variables independently enhanced OS: ≤2 metastatic sites, no liver metastasis, alkaline phosphatase < 300 IU, trifluridine/tipiracil dose reductions, and neutrophil/lymphocyte ratio < 5. Grade ≥ 3 toxicities were reported in 141 (37.2%) patients, including mainly afebrile neutropaenia (23.2%), anaemia (12.1%), and thrombocytopaenia (5.3%). This study supports the real-life efficacy and safety of trifluridine/tipiracil for refractory mCRC and identifies tumour burden, liver metastasis, alkaline phosphatase, dose reductions, and neutrophil/lymphocyte ratio as survival markers.
PB MDPI
YR 2021
FD 2021-09-08
LK http://hdl.handle.net/10668/3928
UL http://hdl.handle.net/10668/3928
LA en
NO García-Alfonso P, Muñoz A, Jiménez-Castro J, Jiménez-Fonseca P, Pericay C, Longo-Muñoz F, et al. Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study. Cancers. 2021 Sep 8;13(18):4514
NO This work was supported by the Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD) through a grant provided by Laboratorios Servier S.L. (grant reference number: not applicable)
DS RISalud
RD Apr 12, 2025