Comparison of efficacy and safety of capecitabine (CAP) compared with intravenous continuous infusion (CIV) of 5-FU administration in advanced colorectal cancer (CRC).

3591 Background: Standard therapy for CRC involves 5-FU-based regimens such as FOLFOX and FOLFIRI with CIV 5-FU. CAP offers a convenient oral replacement for CIV 5-FU. There are few randomized controlled trials comparing CAP with CIV 5-FU-based therapies for CRC. We compared the safety and efficacy of CAP-based regimens with well-established CIV 5-FU-based regimens.,We collected data on 3224 pts treated on either CIV 5-FU (1815) or CAP (1409) for CRC. This included Phase II or III studies published or available from ASCO, ESMO, ECCO (1997 - 2004) alone, with (XRT, eloxatin, CPT-11), as 1 line and 2 line. Safety was assessed by determining proportion of pts who experienced grade 3/4 adverse effects. Efficacy was assessed by determining RR and their 95% confidence intervals (CI). Chi-square tests and Fisher's Exact tests were used to compare the two regimens. P<0.05 was considered statistically significant. All statistical tests were performed with SAS (9.0).,RR was not significantly higher in pts on CAP vs. CIV 5-FU (34% v 39%; overall RR odds ratio, 0.7917; 95% CI, 0.6784 to 0.9239; P = .999). Average MOS was similar in both regimens (CAP: 14.2 m vs. CIV 5-FU: 14.9 m). Grade 3/4 hematologic toxicity was more frequent in pts on CIV 5-FU vs. CAP (16.31% vs. 3.40%; P < 0.0001), whereas HFS was more frequent in CAP group (9.30% vs. 6.34%; P < 0.999). CAP is associated with a significantly lower incidence of grade 3/4 neutropenia (4.79% vs. 27.7%), leading to significantly less grade 3/4 neutropenic fever (1.16% vs. 7.72%). Thromboses was noticed in 8% of pts on CIV 5-FU and none reported on CAP.,CAP offers a superior toxicity profile and at least equivalent RR, TTP, and MOS compared with CIV 5-FU when used alone or in combination with other agents or XRT in CRC. HFS is more frequent in CAP pts, but never life threatening and can be effectively managed. CAP can replace CIV in regimens to treat CRC. [Figure: see text] No significant financial relationships to disclose.