Italian results of the PRECONNECT study: safety and efficacy of trifluridine/tipiracil in metastatic colorectal cancer

9 Mar 2021

In this research article from the journal Future Oncology the authors perform a post-hoc safety and efficacy analyses of the PRECONNECT Phase IIIb study. The quality of life (QoL) from a subset of 161 Italian patients with metastatic colorectal cancer (mCRC) was assessed using the EORTC QLQ-C30 GHS (European Organization for Research and Treatment of Cancer Quality of Life Global Health Status) questionnaire. Overall, there were no clinically relevant changes in QoL, although QLQ-C30 score improved in 25.4% of the patients. It was found that median progression-free survival was reached at 3 months, with a disease-control rate of 28.6%. This is the first prospective data on the clinical daily use of trifluridine/tipiracil in Italy and confirm the results reported in the RECOURSE trial and the PRECONNECT global study.

Abstract

Aim: The international PRECONNECT Phase IIIb study demonstrated safety and efficacy of trifluridine/tipiracil in the management of patients with mCRC. Post-hoc analyses in a national context are important due to the differences in disease management across countries. Patients & methods: Post-hoc safety and efficacy analyses in the PRECONNECT Italian patient subset were conducted. Patients’ QoL was assessed from baseline to end of treatment. Results: In Italy, 161 patients were enrolled. The median age was 64 years with a performance status of 0–1. The most common hematological drug-related adverse events ≥grade 3 were neutropenia (41.0%) and anemia (13.7%). The median progression-free survival was reached at 3.0 months, with a disease-control rate of 28.6%. The QLQ-C30 score improved in 25.4% of the patients. Conclusion: Safety, efficacy and QoL results confirmed trifluridine/tipiracil as a feasible and favorable treatment option for mCRC patients.

Lay Abstract

PRECONNECT is an international study that demonstrated the efficacy and tolerability of the drug trifluridine/tipiracil in adult patients with mCRC treated in everyday clinical practice. In this publication, we have conducted an analysis performed on the 161 Italian patients enrolled in this study. These kinds of analyses are important due to the differences that may arise across different countries. The most common contraindications were not dangerous for health. Furthermore, after 3 months from the start of the drug assumption half of the patients did not show a worsening of the disease. The quality of life of the patients during the treatment was maintained.