Abstract

3690 Background: We conducted a phase I-II study with first line FOLFOXIRI (irinotecan 125–175 mg/sqm on day (d) 1, oxaliplatin 100 mg/sqm d1, LV 200 mg/sqm d1, 5-FU 3800 mg/sqm 48-h IV chronomodulated continuous infusion starting on d1, repeated every 2 weeks) and a phase II study with first line simplified FOLFOXIRI (irinotecan 165 mg/sqm d1, oxaliplatin 85 mg/sqm d1, LV 200 mg/sqm d1, 5-FU 3200 mg/sqm 48-h flat continuous infusion starting on d1, repeated every 2 weeks) respectively in 42 and 32 MCRC pts. Overall response rate, median progression free (PFS) and overall survival (OS) were 71% and 72%, 10.4 months (mos) and 10.8 mos, 26.5 mos and 28.4 mos respectively. A possible concern about the use of all three main active agents up-front is the possibility that this might limit, after progression, disease control with second line treatments. Methods: Among the 70 pts so far progressed 53 (76%) have received second line chemotherapy (22: FOLFIRI, 16: FOLFOXIRI, 5: 5-FU protracted infusion, 3: FOLFOX, ...

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