Irinotecan(Drug information on irinotecan) {Campo} a new anticancer agent developed by Rhone -Poulenc Rorer Inc, demonstrates significant activity in the treatment of advanced colorectal cancer, according to research presented at the Eighth Annual European Cancer Conference (ECCO-8) in Paris.
"Phase II clinical trials conducted in Europe, the United States, and Japan confirm that Campto has significant activity in advanced colorectal cancer," said Dr. Jean-Pierre Armand from the Institute Gustave Roussy in France, one of the principal clinical investigators of the irinotecan study. "There is a growing body of research that indicates Campto is effective both as a first- and a second-line treatment. No other currently available anticancer drug has demonstrated comparable efficacy as a second-line treatment for advanced colorectal cancer. As a first-line treatment, irinotecan's efficacy can be compared to 5-fluorouracil (5-FU) with folinic acid, the standard chemotherapy treatment."
Irinotecan is now approved and available in France for the treatment of advanced colorectal cancer that has failed to respond to standard chemotherapy with 5-FU and folinic acid.
Clinical Trial Results
Patients experienced a clinically significant response to irinotecan in a multicenter phase II clinical trial completed in France and reported at ECCO-8. Investigators enrolled 213 patients, 178 of whom were evaluable. A total of 130 patients had experienced disease progression despite treatment with 5-FU (irinotecan was thus used as second-line therapy in these patients), whereas 48 had not previously received chemotherapy (first-line therapy). Irinotecan was administered as a 350-mg/m² intravenous infusion every 3 weeks (one treatment cycle).
The overall response rate was 18%. Twenty-eight patients had a partial response (defined as at least a 50% reduction in measurable tumors), and four patients experienced a complete response (total disappearance of all measurable signs of cancer). The median duration of response was 9.1 months, and median survival was 10.6 months.
"Achieving a significant response for an average period of up to 9 months is impressive," said Dr. Philippe Rougier, also a principal investigator at the Institut Gustave Roussy. "Importantly, patients who had progressed during a pretreatment of 5-FU also showed treatment response while on Campto, thus indicating the lack of cross-resistance between the two treatments."
"Campto represents a true advance in the treatment of advanced colorectal cancer, an area where advances have been few and far between. Historically, patients who failed on 5-FU, the standard treatment for colorectal cancer, had no other therapy alternatives," said Dr. Armand.
While about 50% of patients are cured by surgery, the other half develop metastatic disease and require treatment with an anticancer drug. For four decades, 5-FU has been the only effective agent in the treatment of advanced colorectal cancer, with about 10% to 25% of patients experiencing a clinical response. In most cases, however, the disease progresses despite 5-FU treatment.
Irinotecan acts as an inhibitor of topoisomerase I, an enzyme essential for cell division. Inhibition of this enzyme's activity kills cancer cells. As is often seen with cancer chemotherapy agents, side effects of irinotecan have been observed during clinical trials, such as neutropenia and moderate to severe diarrhea. These effects can be controlled through concomitant medications, such as antibiotics and loperamide(Drug information on loperamide).
An additional clinical trial of irinotecan involving patients who failed to respond while on 5-FU treatment has been completed in Belgium, the United Kingdom, the Netherlands, Germany, Switzerland, Austria, and Greece. Advanced clinical trials have begun or are being planned in most European countries.
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