Clinical and quality of life outcomes with trifluridine/tipiracil: PRECONNECT and TALLISUR studies

Abstract

Background: QLQ-C30 Global Health Status (GHS) and Eastern Cooperative Oncology Group performance status (ECOG PS) data from PRECONNECT and TALLISUR studies were pooled. Materials & methods: Association between changes in ECOG PS and QLQ-C30 GHS in patients with metastatic colorectal cancer (mCRC) receiving trifluridine/tipiracil (FTD/TPI) was evaluated using Cox regression analysis. Results: 1100 patients were included. There was no clinically relevant change from baseline in QLQ-C30 GHS score through cycle 7. 63.0% of patients maintained/improved ECOG PS. The presence of liver metastasis increased the risk of QLQ-C30 GHS score/ECOG PS deterioration. The association between time to ECOG PS deterioration and change in QLQ-C30 GHS score over time was significant (HR 1.71 [95% CI: 1.4, 2.2]). Conclusion: ECOG PS and QLQ-C30 GHS scores were maintained during FTD/TPI treatment, and these measures were associated. Factors that increased the risk of deterioration included the presence of liver/lung metastasis, younger age and shorter time since first metastasis. Clinical Trial Registration: PRECONNECT (EudraCT Number: 2016-002311-18 ) and TALLISUR (EudraCT-Number: 2017-000292-83 ).