Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer
Harvard University · Azienda Ospedaliera Universitaria Pisana · +28 more institutions
Abstract
Early clinical trials conducted primarily in Japan have shown that TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride, was effective in the treatment of refractory colorectal cancer. We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients.
In this double-blind study, we randomly assigned 800 patients, in a 2:1 ratio, to receive TAS-102 or placebo. The primary end point was overall survival.
Citation impact
- FWCI
- 48.48
- Percentile
- 100%
- References
- 20
Authors
24- RJRobert J. MayerCorresponding
Harvard University, Azienda Ospedaliera Universitaria Pisana
- EVEric Van Cutsem
Universitair Ziekenhuis Leuven, KU Leuven
- AFAlfredo Falcone
University of Pisa, Azienda Ospedaliera Universitaria Pisana
- TYTakayuki Yoshino
National Cancer Center Hospital East, Japanese Foundation For Cancer Research
- RGRocio García‐Carbonero
Hebron University, Vall d'Hebron Hospital Universitari, Instituto de Biomedicina de Sevilla, Hospital Universitario Virgen del Rocío
Topics & keywords
- Medicine
- Hazard ratio
- Internal medicine
- Leukopenia
- Placebo
- Neutropenia
- Colorectal cancer
- Population
- Good health and well-being