Irinotecan plus weekly 5-fluorouracil and leucovorin as salvage treatment for patients with metastatic colorectal cancer: A phase II trial.

Purpose: A phase II study was conducted to evaluate the toxicity and efficacy of irinotecan (CPT-11), 5-fluorouracil/leucovorin (5-FU/LV) (AIO regimen) as salvage treatment in patients with metastatic colorectal cancer (MCC).

Patients And Methods: Thirty-three patients relapsing after oxaliplatin-based first line chemotherapy were enrolled. There were 20 males and 13 females with median age of 69 years and WHO performance status (PS) of 0, 1, and 2 in 15, 16 and 2 patients, respectively. CPT-11 was administered on day 1 at 80 mg/m(2) in 60 min i.v. infusion, then LV (500 mg/m(2)) on day 1 as a 2h i.v. infusion, followed by 5-FU (2.600 mg/m(2)) as a 22h i.v. infusion. Treatment was repeated weekly for 6 consecutive weeks, in cycles of 7 weeks (one week rest).

Results: All patients were evaluable for toxicity and response. Complete response (CR) was achieved in 2 (6%) patients and partial response (PR) in 4 (12%) (over-all response rate - ORR: 18%, 95% C.I.: 5.95-35.43); 13 patients (40%) had stable disease (SD) and 14 (42%) progressive disease (PD). After a median follow up period of 9 months the median duration of response was 5 months, the median time to tumor progression (TTP) 7.5 months and the median overall survival (OS) 14 months. Grade 3 and 4 neutropenia occured in 13 (39%) patients, febrile neutropeina in 3 (9%), and grade 4 thrombocytopenia in one (3%). Grade 3/4 diarrhea occured in 12 (36%) patients, grade 3/4 neurotoxicity in 3 (9%), and grade 3 asthenia in 4 (12%). There was no treatment-related death.

Conclusion: The combination of weekly CPT-11 and infusional 5-FU/LV is an active and relatively well-tolerated regimen as salvage treatment in MCC.