Irinotecan Combined with Bolus Fluorouracil, Continuous Infusion Fluorouracil, and Low-Dose Leucovorin Every Two Weeks in Patients with Oxaliplatin Pretreated Metastatic Colorectal Cancer.

PURPOSE

To determine the efficacy and tolerance of irinotecan in combination with fluorouracil (5-FU) plus leucovorin (LV) in patients whose disease has progressed after treatment with an oxaliplatin-based therapy.

MATERIALS AND METHODS

Thirty-two patients were enrolled in this study from January 2000 to October 2002. Each patient's disease had progressed under oxaliplatin containing regimen. The new treatment consisted of irinotecan 150 mg/m2 as a 90-minute infusion on day 1, LV 20 mg/m2 bolus, given intravenously, immediately followed by a bolus of 5-FU, 400 mg/m2, and a 22-hour continuous infusion at 600 mg/m2 on day 1 through day 2. Treatment was repeated at 2-week intervals.

RESULTS

Among the assessable 30 patients, median age was 50 years (range: 2967), and dominant sites of metastasis were liver, lung, and lymph nodes. The objective response rate was 20%; all patients registered partial responses; 14 patients were stabilized (46.7%); and 10 had progression of disease (33.3%). Median progression-free survival was 24.6 weeks and median survival was 39.6 weeks. For the 210 cycles analyzed, NCI-CTC grades 3 and 4 hematologic toxicities were leucopenia (10%) and neutropenia (5%). Frequently occurring grade 34 non-hematologic adverse reactions were nausea/ vomiting (10%), diarrhea (6.7%), stomatitis (6.7%), and alopecia (10%). There were no treatment-related deaths.

CONCLUSION

S: TIrinotecan in combination with 5-FU plus LV regimen is safe and effective in oxaliplatin-pretreated advanced colorectal cancer patients.