Oxaliplatin (OXA) with weekly bolus 5-fluorouracil (FU) and low-dose leucovorin (ld-LV) in advanced colorectal cancer (ACRC) patients (pts): Report of safety and efficacy

Abstract

3769 Background: OXA and infused FU plus LV (FOLFOX) has proved to be one of the most active regimens in ACRC. On going trials, adjuvant and metastatic setting, have hypothesized that OXA given with bolus FU plus LV would be equally active and safe as OXA combined with infusional FU regimens. Since OXA registration in our country, constrains related to cost and convenience prompt to develop schedules of OXA/bolus FU/ld-LV. Patients and methods: We assessed retrospectively a cohort of pts with ACRC treated with OXA 85 mg/m2 days 1 and 15 plus LV 20 mg/m2 followed by a 500 mg/m2 bolus dose of FU on days 1, 8, and 15 every 28 days. Data of safety and efficacy are presented. Results: Between 1996 and 2002, 273 pts were treated in two centers. Pts characteristics: median age 56 (22–79), male/female: 151/122, colon/rectum 199/74, median metastatic sites 1 (1–4), first line/second / third (%): 68/ 13/ 3 and 16% received after metastasis resection (R0). 1146 cycles (cy) were administered, median per patient 4 (1–11). Safety: the main grade 3–4 toxicities were (pts): gastrointestinal 28, hematological 18, allergies 2, sepsis 3 pts and severe neurotoxicity 12 pts (4,3%). Toxic deaths occurred in 3 pts (1%) Efficacy: objective response rate (ORR) and time related parameters are summarized as follows: 17 pts initially unresectable ACRC pts were rendered resectable after a 6 (2–11) median cy of treatment. Conclusions: OXA combined with bolus FU and ld-LV seems to be safe and effective. Next multicentre randomized trials will show the comparative value between OXA combined with bolus or infusional FU. No significant financial relationships to disclose.