Trifluridine/Tipiracil (TAS-102) for refractory metastatic colorectal cancer in clinical practice: a feasible alternative for patients with good performance status
Our aim was to assess efficacy and safety and prognostic factors associated with TAS-102 in clinical practice.
Retrospective, multicenter, and observational study including patients with advanced refractory colorectal cancer who started TAS-102 between March 2016 and August 2018. The primary end point was overall survival (OS). Secondary end points included progression-free survival, toxicity and analyze prognostic factors present at the beginning of TAS-102.
84 patients were evaluable. The median OS was 8.30 (95% CI 6.23–9.87) months and PFS was 2.62 (95% CI 2.36–3.05) months. In multivariate analysis, ECOG 0 and reduced dose combined with more cycles were associated with better prognosis. Patients with an ECOG > 0 had worse prognosis (HR 3.34, 95% CI 1.09–10.27, p = 0.035). 95.2% experienced some type of adverse effect and 45.2% had grade ≥ 3 toxicities.
Results suggest reconsidering TAS-102 in patients with ECOG > 0, something that should be investigated in prospective randomized clinical trials.
KeywordsECOG Multivariate PROGNOSIS Progression-free survival Survival Toxicity
The authors are grateful for the statistical analysis to the Unidad de Consultoría Estadística de los Servicios Científico-Técnicos de la Universidad de Oviedo.
This is an academic study supported by the authors.
Compliance with ethical standards
Conflict of interest
The authors declare that they do not have any conflict of interest that may inappropriately influence this work.
The study has been performed in accordance with the ethical standards of the Declaration of Helsinki and its later amendments. This study is an observational, non-interventionist trial.
Signed informed consent was obtained from all patients.
- 5.Agencia Española de Medicamentos y Productos Sanitarios. Ficha técnica trifluridina/tiperacilo (Lonsurf®). Consultada [2/2019]. Disponible en: https://cima.aemps.es/cima/pdfs/es/ft/1161096001/FT_1161096001.pdf.
- 6.Longo-Muñoz F, Argiles G, Tabernero J, Cervantes A, Gravalos C, Pericay C, et al. Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial. Clin Transl Oncol. 2017;19:227–35.CrossRefGoogle Scholar
- 8.Sforza V, Martinelli E, Cardone C, Martini G, Napolitano S, Vitiello PP, et al. Clinical outcome of patients with chemorefractory metastatic colorectal cancer treated with trifluridine/tipiracil (TAS-102): a single Italian institution compassionate use programme. ESMO Open. 2017;2:e000229.CrossRefGoogle Scholar