BETWEEN: Biweekly Bevacizumab + Trifluridine/Tipiracil to Reduce Grade 3-4 Neutropenia in mCRC Patients
brief summary
This study was design to: * To assess the impact of a biweekly (experimental arm) compared to a conventional administration (control arm) on the rate of grade 3-4 neutropenia in metastatic colorectal cancer (mCRC) patients treated with trifluridine/tipiracil plus bevacizumab, and * To identify predictive clinical and biological factors for grade 3-4 neutropenia in this patient population.
detailed description
Trifluridine/tipiracil is effective in refractory metastatic colorectal cancer (mCRC), as shown in phase III trials, including SUNLIGHT, which demonstrated improved PFS and OS when combined with bevacizumab, setting a new third-line standard. However, this combination raises grade 3-4 neutropenia rates to 43-66%, often leading to dose reductions or delays. A biweekly regimen tested in a small phase II trial showed reduced neutropenia (15.9%) but limited generalizability. Neutropenia remains a major concern, with 9.5% mortality. G-CSF may help manage risk, especially in high-risk patients (LONGBOARD).
official title
BEvacizumab Plus Trifluridine/Tipiracil in a Bi-WEEkly Administration to Reduce Grade 3-4 Neutropenia in Patients With mCRC: A Prospective, Multicenter, Comparative, Randomized GERCOR G-124 BETWEEN Phase II Study