Ateam of European researchers recently reported that the addition of oxaliplatin to the standard regimen for advanced colorectal cancer of fluorouracil (5-FU) and leucovorin doubled the response to therapy and significantly prolonged progression-free survival, compared to leucovorin and 5-FU alone.
Ateam of European researchers recently reportedthat the addition of oxaliplatin to the standardregimen for advanced colorectal cancer of fluorouracil (5-FU) and leucovorindoubled the response to therapy and significantly prolonged progression-freesurvival, compared to leucovorin and 5-FU alone.
The standard regimen produces significant responses in 14% to33% of patients. However, the average survival time of patients with metastaticcolorectal cancer is less than 1 year, and fewer than 5% live 5 years beyonddiagnosis. Oxaliplatin is the first drug in its class to show significantactivity in the treatment of advanced colorectal cancer. When used by itself,oxaliplatin produces responses in 10% to 24% of patients with metastaticcolorectal cancer; however, researchers speculate that this agent may be moreeffective in combination with other therapies.
Phase III International Trial Conducted
In order to evaluate oxaliplatin as first-line treatment inadvanced colorectal cancer, an international phase III clinical trial wasconducted in 420 patients aged 18 to 75 years at 35 institutions in ninecountries. Patients were treated with either the standard regimen of5-FU/leucovorin or oxaliplatin combined with 5-FU/leucovorin.
The results of this trial, published in the August 2000 Journalof Clinical Oncology, demonstrated that adding oxaliplatin to a regimen of 5-FUand leucovorin doubled the number of patients with partial or complete responsesand prolonged the average time to disease progression by 3 months, compared totreatment with 5-FU and leucovorin alone. Patients treated with oxaliplatinsurvived an average of 9 months without progression, compared to only 6.2 monthsfor patients treated with 5-FU and leucovorin.
This trial demonstrated one of the longest progression-freesurvival times of any multicenter trial evaluating treatment of metastaticcolorectal cancer. Over half of the patients treated with oxaliplatin survivedmore than 14.7 months, compared to 12.1 months for patients treated with 5-FUand leucovorin alone.