Early Clinical Experience with Trifluridine/Tipiracil for Refractory Metastatic Colorectal Cancer: The ROS Study.
Pilar García AlfonsoAndrés Muñoz MartinJerónimo Jiménez-CastroPaula Jiménez-FonsecaCarles PericayFederico Longo-MuñozCarmen Reyna-FortesGuillem Argilés-MartínezBeatriz González AstorgaMaría José Gómez-ReinaAna Ruiz-CasadoNuria Rodríguez-SalasRafael López-LópezAlberto Carmona-BayonasVerónica Conde-HerreroEnrique Arandanull On Behalf Of The Ros Study GroupPublished in: Cancers (2021)
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.
Keyphrases
- metastatic colorectal cancer
- end stage renal disease
- ejection fraction
- newly diagnosed
- chronic kidney disease
- primary care
- healthcare
- prognostic factors
- small cell lung cancer
- randomized controlled trial
- gene expression
- physical activity
- cell death
- dna damage
- patient reported outcomes
- peripheral blood
- risk assessment
- case report
- climate change
- study protocol
- single cell
- risk factors
- reactive oxygen species
- data analysis