Efficacy and tolerability of oxaliplatin plus irinotecan 5-fluouracil and leucovorin regimen in advanced stage colorectal cancer patients pretreated with irinotecan 5-fluouracil and leucovorin.

Objectives: Oxaliplatin has been introduced in the treatment of advanced colorectal cancer during the past few years. The pre-existing treatment of leucovorin-5-fluorouracil-irinotecan (IFL), although reasonably effective, has needed novel, active agents to increase the response rate and overall survival. We planned this phase 2 study in patients pretreated with IFL, adding oxaliplatin as second-line treatment: our objectives were to determine response rate and overall survival.

Therapeutic administration of pegfilgrastim instead of prophylactic use.

Objectives: Pegfilgrastim is a new growth factor which can be administered subcutaneously once (versus multiple doses for days) on the day neutropenia occurs after chemotherapy. Our aims were to determine: (a) the percentage of patients who needed growth factor (pegfilgrastim) supportive treatment, (b) the duration of neutropenia-leukopenia after pegfilgrastim administration, and (c) the safety in using pegfilgrastim as a treatment and not as a prophylactic agent.

Materials And Methods: Ninety-eight patients were evaluated.

Long-term survival of patients with advanced colorectal cancer may not be due to the response to chemotherapy.

Our primary objective was to determine the median and overall survival and secondarily the response rate to first- and second-line chemotherapy of patients with advanced colorectal metastatic disease. Three-hundred and seventy-nine patients (median age 60 years, range 30-87 years) were enrolled from April 1993 to March 2000. Median follow-up was 6 years (range 3-10 years), until July 2003.