Evaluation of health-related quality of life (HRQoL) in patients with metastatic colorectal cancer (mCRC): A prospective, multicenter, open-label, double-arm trial of trifluridine/tipiracil (FTD/TPI) versus best supportive care (BSC).

Abstract

TPS726 Background: The RECOURSE trial in pts with refractory mCRC showed improvement in OS (7.1 vs 5.3 mo, p < 0.001), but had no formal assessment of QoL. Thus, the TALLISUR trial is designed to investigate the HRQoL in pts treated with FTD/TPI and those who are treated with BSC alone on patient´s request while being suitable for treatment (Tx) with FTD/TPI prospectively. This novel design of a double-arm trial with BSC as appropriate comparative Tx is addressing assessment requirements (i.e. data on survival, morbidity and QoL) for the German Federal Joint Committee (GBA). Methods: Pts who have been previously treated with, or are not candidates for available Ctx including 5-FU, oxaliplatin, irinotecan, anti-VEGF-, and anti EGFR-agents with adequate organ functions independent from their ECOG status. Tx is FTD/TPI 35 mg/m2 d 1-5 and 8-12 qw d 28 or BSC. Efficacy is documented by PFS (clinical or radiological), OS and an exploratory analysis of RR while safety includes type, incidence and severity of FTD/TPI-related AEs. QoL will be assessed by means of the EORTC QLQ-C30 and EQ-5D-5L questionnaires for one year, close safety observation and/or FU phase. The primary endpoint (EP) is the rate of responders with unchanged or improved HRQoL. Major exclusion criteria include other tumor therapy as Rtx, and intestinal obstruction. Response will be defined as an improvement or stabilization compared to the baseline score of the global health status/QoL scale. Response is calculated as mean of the score of the EORTC QLQ-C30, global health status/QoL scale at all scheduled time points of QoL analysis in the time interval from d -2 before start of Cycle 2 until the end of Tx/close observation compared to the baseline score of the global health status /QoL scale. A RR of 45%±10% is assessed as appropriate in pts with ≥2 cycles FTD/TPI. A total of 195 pts are needed to answer the question with a 2-sided type I error of 5%. The strategy will be regarded successful if the lower boundary of the CI for the RR is ≥35%. TALLISUR started 09/2017 (EudraCT-No 2017-000292-83) and has recruited 160 mCRC pts in total (17th Sep 2018). Clinical trial information: 2017-000292-83.