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Clinical Trial
. 2021 Jun;17(18):2315-2324.
doi: 10.2217/fon-2020-1278. Epub 2021 Mar 5.

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

Alberto Zaniboni  1 , Carlo Antonio Barone  2 , Maria Chiara Banzi  3 , Francesca Bergamo  4 , Livio Blasi  5 , Roberto Bordonaro  6 , Maria Di Bartolomeo  7 , Francesco Di Costanzo  8 , Giovanni Luca Frassineti  9 , Carlo Garufi  10 , Francesco Giuliani  11 , Tiziana Pia Latiano  12 , Erika Martinelli  13 , Nicola Personeni  14   15 , Patrizia Racca  16 , Emiliano Tamburini  17 , Giuseppe Tonini  18 , Marie Georges Besse  19 , Mario Spione  19 , Alfredo Falcone  20
Affiliations
Clinical Trial

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

Alberto Zaniboni et al. Future Oncol. 2021 Jun.

Abstract

The international PRECONNECT Phase IIIb study demonstrated safety and efficacy of trifluridine/tipiracil in the management of patients with metastatic colorectal cancer. Post-hoc analyses in a national context are important because of the differences in disease management across countries. Post-hoc safety and efficacy analyses in the PRECONNECT Italian patient subset were conducted. Patients' quality of life was assessed from baseline to end of treatment. 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 Quality of Life Questionnaire Core 30 score improved in 25.4% of the patients. Safety, efficacy and quality of life results confirmed trifluridine/tipiracil as a feasible and favorable treatment option for metastatic colorectal cancer patients.

Trial registration: ClinicalTrials.gov NCT03306394.

Keywords: colorectal cancer; quality of life; real life; safety; trifluridine/tipiracil.

Plain language summary

Lay abstract PRECONNECT is an international study demonstrating the efficacy and tolerability of the drug combination trifluridine/tipiracil in adult patients with metastatic colorectal cancer treated in everyday clinical practice. For this publication, the authors conducted an analysis performed on the 161 Italian patients enrolled in this study. These kinds of analyses are important because of the differences that may arise across different countries. The most common contraindications were not dangerous to health. Furthermore, 3 months from beginning the medication, half of the patients did not show a worsening of the disease and quality of life during treatment was maintained. Clinical trial registration: NCT03306394 (ClinicalTrials.gov).

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