Comparison of efficacy and safety between standard-dose and modified-dose FOLFIRINOX as a first-line treatment of pancreatic cancer.

AIM

To directly compare the efficacy and toxicity of standard-dose FOLFIRINOX (sFOLFIRINOX) and modified-dose FOLFIRINOX (mFOLFIRINOX, 75% of standard-dose) for pancreatic cancer.

METHODS

One hundred and thirty pancreatic cancer patients who received sFOLFIRINOX ( = 88) or mFOLFIRINOX ( = 42) as their first-line chemotherapy from January 2013 to July 2017 were retrospectively reviewed. For efficacy analysis, the objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS) were evaluated and compared using Pearson's chi-square test, Kaplan-Meier plot and log-rank test. The adverse events (AEs) were evaluated, and severe (≥ grade 3) AEs rates of the two groups were compared for toxicity analysis.

RESULTS

The mFOLFIRINOX group included more female patients (30.7% 57.1%; = 0.004) and older patients [age (median), 57 63.5; = 0.018] than the sFOLFIRINOX group. In the efficacy analysis, the ORR and DCR were not significantly different between the two groups (ORR: 39.8% 35.7%; = 0.656; DCR: 80.7% 83.3%; = 0.716). The median PFS and OS were also not different between the groups (PFS: 8.7 mo 8.1 mo, = 0.272; OS: 13.9 mo 13.7 mo, = 0.476). In the safety analysis with severe AEs, the rates of neutropenia (83.0% 66.7%; = 0.044), anorexia (48.9% 28.6%; = 0.029) and diarrhea (13.6% 0.0%; = 0.009) were markedly lower in the mFOLFIRINOX group.

CONCLUSION

mFOLFIRINOX showed comparable efficacy but better safety compared to sFOLFIRINOX. If clinically necessary, initiating FOLFIRINOX with 75% of the standard-dose can alleviate toxicity concerns without compromising efficacy.