Phase III Study of Capecitabine Plus Oxaliplatin Compared With Continuous-Infusion Fluorouracil Plus Oxaliplatin As First-Line Therapy in Metastatic Colorectal Cancer: Final Report of the Spanish Cooperative Group for the Treatment of Digestive Tumors Trial

Abstract

This randomized study shows a similar TTP of XELOX compared with FUOX in the first-line treatment of MCRC, although there was a trend for slightly lower RR and survival. XELOX can be considered as an alternative to FUOX.

Phase II study of short-course capecitabine plus oxaliplatin (XELOX) followed by maintenance capecitabine in advanced colorectal cancer: XelQuali study

“…Limiting the exposure to XELOX appeared to reduce the risk of severe adverse events; no grade 4 clinical adverse events or grade 3 or 4 haematological adverse events were documented in the present study. Grade 3 neuropathy also occurred infrequently (7% of patients), a rate that compares favourably with rates reported in previous large phase III studies of continuous XELOX (4%, 18%, 8%) [5][6][7]. Switching to single-agent capecitabine was also accompanied by a marked reduction in the frequency of most adverse events (e.g.…”

“…The aim of this treatment strategy was to elicit an initial response with the XELOX regimen, and then maintain this response with a simpler, better-tolerated single-agent regimen which might also improve patient QoL. Both XELOX [5][6][7] and capecitabine monotherapy [12,13] have established efficacy in the firstline treatment of metastatic colorectal cancer, but have not been investigated in this manner previously.…”

“…Oxaliplatin can be combined with either 5-FU/LV [2][3][4] or the oral fluoropyrimidine, capecitabine (Xeloda ® ) [5][6][7], to give an effective first-line regimen for patients with metastatic colorectal cancer. However, oxaliplatin can cause sensory neuropathy, a cumulative, dose-related toxicity, which is generally observed after 4 to 6 months of therapy [2,3,8].…”

Treatment in advanced colorectal cancer: what, when and how?

“…Five phase III RCTs have been reported to establish non-inferiority of CAPOX compared with FOLFOX. Table 6 shows the efficacy results of these studies (Diaz-Rubio et al, 2007;Ducreux et al, 2007;Porschen et al, 2007;Cassidy et al, 2008;Rothenberg et al, 2008). Two studies did not meet the primary objective of demonstrating non-inferiority in PFS with CAPOX compared with FOLFOX (Diaz-Rubio et al, 2007;Porschen et al, 2007).…”

“…Table 6 shows the efficacy results of these studies (Diaz-Rubio et al, 2007;Ducreux et al, 2007;Porschen et al, 2007;Cassidy et al, 2008;Rothenberg et al, 2008). Two studies did not meet the primary objective of demonstrating non-inferiority in PFS with CAPOX compared with FOLFOX (Diaz-Rubio et al, 2007;Porschen et al, 2007). In the third study , a rather permissive non-inferiority margin was used with a primary end point being ORR -a questionable primary efficacy end point for first line advanced CRC trials in the modern era.…”