A pragmatic, single-arm clinical trial of a dose modification algorithm for preventing cytopenia-related delays during FOLFOX chemotherapy.

ABSTRACT:

Purpose

Unplanned delays are common during FOLFOX chemotherapy. We evaluated a novel FOLFOX dose modification algorithm designed to reduce unplanned delays while maintaining dose intensity.

Methods

We conducted a pragmatic, single-arm clinical trial to evaluate PAGODA, a proactive graduated dose modification algorithm for FOLFOX chemotherapy (NCT04526886). The algorithm prescribes chemotherapy dose reductions and delays based on absolute neutrophil count (ANC) and platelet count. Patients receiving FOLFOX-based chemotherapy were eligible. Participants received standard chemotherapy doses in cycle 1 (bolus 5-FU 400 mg/m², oxaliplatin 85 mg/m², and infusional 5-FU 2400 mg/m²/46 h). The primary outcome was unplanned delay prior to cycle 6 (> 18 

SUBMITTER: Wright HN 

PROVIDER: S-EPMC12439427 | biostudies-literature | 2025 Aug

REPOSITORIES: biostudies-literature