Ateam of European researchers recently reported that the addition of oxaliplatin(Drug information on oxaliplatin) to the standard regimen for advanced colorectal cancer of fluorouracil(Drug information on fluorouracil) (5-FU) and leucovorin doubled the response to therapy and significantly prolonged progression-free survival, compared to leucovorin and 5-FU alone.
The standard regimen produces significant responses in 14% to 33% of patients. However, the average survival time of patients with metastatic colorectal cancer is less than 1 year, and fewer than 5% live 5 years beyond diagnosis. Oxaliplatin is the first drug in its class to show significant activity in the treatment of advanced colorectal cancer. When used by itself, oxaliplatin produces responses in 10% to 24% of patients with metastatic colorectal cancer; however, researchers speculate that this agent may be more effective in combination with other therapies.
Phase III International Trial Conducted
In order to evaluate oxaliplatin as first-line treatment in advanced colorectal cancer, an international phase III clinical trial was conducted in 420 patients aged 18 to 75 years at 35 institutions in nine countries. Patients were treated with either the standard regimen of 5-FU/leucovorin or oxaliplatin combined with 5-FU/leucovorin.
The results of this trial, published in the August 2000 Journal of Clinical Oncology, demonstrated that adding oxaliplatin to a regimen of 5-FU and leucovorin doubled the number of patients with partial or complete responses and prolonged the average time to disease progression by 3 months, compared to treatment with 5-FU and leucovorin alone. Patients treated with oxaliplatin survived an average of 9 months without progression, compared to only 6.2 months for patients treated with 5-FU and leucovorin.
This trial demonstrated one of the longest progression-free survival times of any multicenter trial evaluating treatment of metastatic colorectal cancer. Over half of the patients treated with oxaliplatin survived more than 14.7 months, compared to 12.1 months for patients treated with 5-FU and leucovorin alone.