Weekly administration of 5-fluorouracil (5-FU), folinic acid (FA), oxaliplatin (L-OHP) and irinotecan (CPT-11) [FUFOXIRI] for patients with metastatic gastric or colorectal cancer.

3719 Background: Combination schedules with 5-FU, FA, L-OHP and CPT-11 have shown high efficacy in patients (pts) with metastatic colorectal cancer (CRC). However, significant toxicities jeopardize therapeutic success. As a result of a preceding phase I study, we evaluated the FUFOXIRI regimen with weekly infusional 5-FU/FA, OHP and CPT-11 to define a regimen with improved tolerability and high efficacy.,FUFOXIRI was administered with weekly CPT-11 [80 mg/m; 1h] followed by a 2h-infusion of OHP (50mg/m) and FA (500 mg/m)/2000 mg 5-FU [24h]. All agents were given on days 1, 8, 15, 22; q d 36.,24 pts with metastatic colorectal (n=14) or gastric (n=10) cancer were enrolled: 14/10 m/f, median age 54 yrs [26-64], median Karnofsky PS 90% [70-100]. 5 pts (3 colorectal /2 gastric) had prior chemotherapy. Median duration of treatment was 3 cycles [1-7]. 21 pts. were evaluable for toxicity: No grade 4 toxicity occurred. Main grade 3 toxicities were diarrhea (23%), nausea/vomiting (14%), leukopenia (14%) and neuropathy (9.5%). In 53 % of pts with >1cycle dose-reductions were required, mainly on day 15 and 22. Efficacy analysis of 19 pts. showed PR in 47% of all pts and 58% of CRC pts. Another 53% of all pts and 42% of CRC pts achieved SD. No disease progression was observed. Median PFS was 8 [1-26] mos for all and 8.5 [1-26] mos for CRC pts, respectively. Median OS was 13 [1-54] mos for all and 15.5 [1-54] mos for CRC pts.,FUFOXIRI is an effective regimen for pts with both gastric and colorectal cancer. The favorable toxicity profile is remarkable but was achieved by dose modifications in the majority of pts. Therefore, a further refinement of the administration schedule (d 1 and 8 q d 22) has been initiated in a subsequent trial. [Table: see text].