A phase II study of intrapatient dose escalation of biweekly trifluridine/tipiracil plus bevacizumab for colorectal cancer (E-BiTS study).

ABSTRACT:

Background

Trifluridine/tipiracil (FTD/TPI) plus bevacizumab (BEV) remains a standard of care for refractory metastatic colorectal cancer (mCRC), though hematological toxicities remain a concern. Although a biweekly regimen has shown favorable tolerability, the optimal biweekly dosage has yet to be established. Thus, this study was conducted to evaluate the feasibility and clinical impact of intrapatient dose escalation of biweekly FTD/TPI plus BEV.

Materials and methods

This multicenter, single-arm phase Ⅱ trial included patients with refractory mCRC who had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1. Eligible patients received biweekly FTD/TPI (35 mg/m² twice daily on days 1-5, every 2 weeks) and BEV (5 mg/kg on day 1). The FTD/TPI

SUBMITTER: Wakabayashi M 

PROVIDER: S-EPMC12414899 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature