Info

🌱 來自: Metastatic Colon Cancer

RECOURSE

1. Design: Phase 3 double-blind study.
2. Number of patients: 800 patients were randomly assigned, in a 2:1 ratio, to receive TAS-102 or placebo.
3. Patients characteristics: patients with refractory colorectal cancer.
4. Agent: TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride.
5. Treatment line: refractory colorectal cancer.
6. Trial Name/NCT Number: RECOURSE (NCT01607957).
7. Comparison of two groups in a markdown table:

The primary endpoint of OS was met in 800 patients receiving TAS-102 in the third-line setting versus placebo

• (7.1 months vs 5.3 months, respectively; P <.001). Improvement, albeit slight, was also seen in the second- ary endpoint o PFS (2.0 months vs 1.7 months;

Group Outcome	TAS-102	Placebo
Median Overall Survival	7.1 months	5.3 months
Hazard Ratio for Death	0.68	Not reported
P value	<0.001	Not reported
Most frequent clinically significant adverse events	Neutropenia (38%), Leukopenia (21%)	Not reported
Febrile neutropenia	4%	Not reported
Death related to TAS-102	1	Not reported
Median time to worsening performance status	5.7 months	4.0 months
Hazard Ratio for worsening performance status	0.66	Not reported

Randomized Trial of TAS-102 for Refractory Metastatic Colorectal Cancer | NEJM