Prospective Observational Study Comparing Calcium and Sodium Levofolinate in Combination with 5-Fluorouracil in the FOLFIRI Regimen.

LESSONS LEARNED The use of sodium levofolinate (Na-Lev) is safe in combination with continuous infusion 5-FU in patients with gastrointestinal tumors treated with the FOLFIRI regimen. A comparison with calcium levofolinate (Ca-Lev) showed a similar toxicity profile. The advantages of Na-Lev over Ca-Lev might be the faster drug preparation and the shorter time of drug administration BACKGROUND: To compare the safety profiles of sodium (Na-Lev) and calcium (Ca-Lev) levofolinate in combination with 5-Fluorouracil (5-FU) in the FOLFIRI regimen. To measure the organizational impact of the introduction of Na-Lev on drug production and administration. METHODS Patients with gastrointestinal cancers who were candidates for treatment with the FOLFIRI regimen were included in this non-randomized study. Age ≥18 years, life expectancy >3 months, adequate bone marrow reserve, adequate hepatic and renal function, and an ECOG performance status of 0-2 were required. Patients in the Ca-Lev arm received a 2-hour infusion of Ca-Lev followed by 5-FU, while those in the Na-Lev arm received Na-Lev and 5-FU administered in a single 48-hour pump. RESULTS Sixty patients were enrolled, 30 in each arm. Patient characteristics were balanced (Table 1). Toxicity profiles are shown in Table 2: grade (G)1-2 adverse events occurred in 18 (60.0%) and 19 (63.4%) patients of Na-Lev and Ca-Lev cohorts, respectively, whereas G3-4 adverse events occurred in 12 (40.0%) and 11 (36.6%) patients, respectively. The use of Na-Lev enabled us to save about 13.00 minutes for drug preparation and 2 hours for treatment administration, per patient per cycle. CONCLUSION Na-Lev showed a reassuring toxicity profile and a favorable impact on drug preparation and administration.