Safety and efficacy of trifluridine/tipiracil in previously treated metastatic colorectal cancer: final results from the phase IIIb single-arm PRECONNECT study by duration of therapy.

ABSTRACT:

Background

PRECONNECT was an international, phase IIIb trial evaluating the safety and efficacy of trifluridine/tipiracil (FTD/TPI) for metastatic colorectal cancer (mCRC).

Methods

Patients with mCRC received FTD/TPI 35 mg/m² twice-daily on days 1-5 and 8-12 of each 28-day cycle for third- or later-line treatment.

Primary endpoint

safety and time to deterioration of Eastern Cooperative Oncology Group performance status [ECOG PS] to ≥2). Secondary endpoints included progression-free survival (PFS). Potential prognostic factors for PFS were explored.

Results

Of 914 patients, 69% completed 0-3, 24% completed 4-7, and 7% completed ≥8 cycles of FTD/TPI. Drug-related grade ≥ 3 adverse events included neutropenia (38.1%), anaemia (7.2%) and asthenia (3.4%).

SUBMITTER: Taieb J 

PROVIDER: S-EPMC9881327 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature