Adjuvant chemotherapy in the treatment of colon cancer: randomized multicenter trial of the Italian National Intergroup of Adjuvant Chemotherapy in Colon Cancer (INTACC)

Abstract

In this trial the schedules used showed no statistically significant differences in terms of disease-free survival or overall survival in the treatment of colorectal cancer.

Modulation of 5-fluorouracil as adjuvant systemic chemotherapy in colorectal cancer: the IGCS-COL multicentre, randomised, phase III study

“…Our data are consistent with the results of many randomised trials (O'Connell et al, 1998;Bleeker et al, 2000;Di Costanzo et al, 2003) exploring the efficacy of the addition of FA to a 5FU-based regimen as adjuvant chemotherapy for colon cancer patients, which failed to demonstrate any benefit from the addition of FA. On the other hand, few studies showed the superiority of the combination 5FU þ FA in terms of DFS or OAS when compared to 5FU þ LEV (Wolmark et al, 1999;Arkenau et al, 2003).…”

“…On the other hand, few studies showed the superiority of the combination 5FU þ FA in terms of DFS or OAS when compared to 5FU þ LEV (Wolmark et al, 1999;Arkenau et al, 2003). Overall, such contrasting data are consistent with the hypothesis that the effect of FA on efficacy, if any, is small, while the worsening effect on gastrointestinal toxicity is a common finding, well described in most papers (O'Connell et al, 1998;Bleeker et al, 2000;Porschen et al, 2001;Di Costanzo et al, 2003).…”

“…Conversely, the addition of FA substantially increased toxicity. As many trials published or planned at the beginning of 1990s, we pooled together patients with colon and rectal cancer (Panettiere et al, 1988;Laurie et al, 1989;Quasar Collaborative Group, 2000;Taal et al, 2001) and stage II or III disease (Laurie et al, 1989;Moertel et al, 1990;Wolmark et al 1993Wolmark et al , 1999Quasar Collaborative roup, 2000;Di Costanzo et al, 2003;Andrè et al, 2004). Exploratory subgroup analyses suggest that no significant heterogeneity existed in the effect of both LEV and FA across subgroups that could represent clinically relevant populations.…”

Practice Parameters for the Management of Colon Cancer

“…Pooled data from randomized trials demonstrates a 30% reduction in the risk for recurrence and a 26% reduction in the risk for death with fluoropyrimidine-based therapy administered for 6 months. [97][98][99] More recently, the addition of oxaliplatin to fluoropyrimidine (eg, 5-FU) chemotherapy has been shown to effect an additional approximately 20% reduction in relative risk for recurrence or death corresponding to an approximately 5% absolute survival benefit at 5 years with combination 5-FU and leucovorin (LV) with oxaliplatin in comparison with 5-FU alone. 100,101 Therefore, the first-line adjuvant chemotherapy regimen should include a fluoropyrimidine (5-FU/LV or capecitabine) and oxaliplatin.…”

Expanded Treatment Options in the Adjuvant Therapy of Colon Cancer: Implications for Oncology Nurses

“…The Intergroup-0089 trial studied adjuvant chemotherapy for high-risk stage II and stage III colon cancer and found that when levamisole was added to 5-FU and leucovorin, the combination of the three drugs was not superior to 5-FU and leucovorin alone and that six months of therapy with 5-FU plus leucovorin should become the standard adjuvant treatment for patients with resected, high-risk colon cancer (Haller, Catalano, Macdonald, & Mayer, 1998). Therefore, standard duration of adjuvant therapy could be reduced safely from 12 to 6 months (Cascinu et al, 2003;Di Costanzo et al, 2003;O'Connell).…”