Efficacy, safety and quality-of-life data from patients with pre-treated metastatic colorectal cancer receiving trifluridine/tipiracil: results of the TALLISUR trial

• DOI: 10.1016/j.esmoop.2022.100391
• Publication Date: 2022-02-08T10:51:34Z
• Authors: L. Weiss; M. Karthaus; J. Riera-Knorrens...; A. Kretzschmar; M. Welslau; U. Vehling-Kaiser; H. Pelz; T.J. Ettrich; J. Hess; T. Reisländer; A. Klein; V. Heinemann
• Keywords: 03 medical and health sciences; Pyrrolidines; 0302 clinical medicine; Quality of Life; Humans; Prospective Studies; Colorectal Neoplasms; Thymine; Original Research; Trifluridine; 3. Good health

•First patient-reported HRQoL and post-authorisation efficacy safety data from German mCRC patients receiving FTD/TPI.•Results were consistent with results of pivotal phase III other studies.•FTD/TPI prolonged survival delayed progression manageable toxicity profile.•Treatment FTD/TPI was associated maintained HRQoL. IntroductionTrifluridine/tipiracil (FTD/TPI) improved both overall progression-free (OS, PFS) pre-treated metastatic colorectal cancer (mCRC) in the RECOURSE trial. However, health-related quality life (HRQoL) not assessed directly. To this end to generate data, TALLISUR trial conducted.MethodsIn prospective, multi-centre, Germany-wide, IV study, given choice receive either or best supportive care (BSC). A validated questionnaire, EORTC QLQ-C30, employed assess Secondary endpoints included OS, PFS safety.ResultsOf 194 eligible patients, 185 decided 9 BSC. The low number BSC-arm did allow statistically meaningful analyses. On hand, treatment Median OS 6.9 months [95% confidence interval (CI) 6.1-8.2 months] median 2.5 (95% CI 2.1-2.9 months). most frequent treatment-emergent adverse events neutropenia (27.6%) anaemia (22.7%). Febrile occurred 1.1%.ConclusionsTreatment suffering only but also