Irinotecan and Oxaliplatin Combination,As Second-Line Treatment,In Fluoropyrimidine-Pretreated Advanced Colorectal Cancer. A Phase Ii Study by the Hellenic Cooperative Oncology Group (Hecog)

Abstract

Background

The management of patients with fluoropyrimidine-resistant advanced colorectal cancer remains investigational. Irinotecan and oxaliplatin have proved effective in first-line treatment in combination with 5-fluorouracil.

Study design

From February 1998 to September 2002, 34 patients with 5-fluorouracil-pretreated advanced colorectal cancer were enrolled in the study. Median age was 67 years (range, 32–76) and median performance status was 1. Twenty-one patients had multiple liver metastases. Other sites of disease included lungs, abdomen, pelvis, lymph nodes, bones and skin. They received six 28-day cycles of oxaliplatin (85 mg/m² in a 2-h infusion on days 1 and 15) and irinotecan (80 mg/m² in a 30-minute infusion on days 1,8 and 15 immediately following oxaliplatin).

Results

Thirteen patients (39%) completed treatment. The most common grade III-IV toxicities were diarrhea (27%), anemia (6%), neutropenia (18%), alopecia (6%) and peripheral neuropathy (6%). Thirteen patients (39%) received G-CSF support, and there were 2 episodes of febrile neutropenia. There were no treatment-related deaths. Six patients (18%) had a partial remission and another 11 (33%), disease stabilization. There were no complete remissions. Median time to progression was 6.6 months (range, 0.8–20.1) and median survival 10.6 months (range, 0.8–52.9).

Conclusions

Irinotecan and oxaliplatin combination has modest activity as second line treatment of 5-fluorouracil-resistant advanced colorectal cancer. Further research is warranted for the development of more effective and less toxic regimens in this setting.