Toxicity
In terms of the use of the FOLFOX6 regimen in the first-line setting, significantly fewer patients randomised to FOLFOX6 experienced febrile neutropenia, nausea, vomiting and mucositis, whereas more patients experienced neutropenia compared to those randomised to FOLFIRI. No significant differences in the numbers of deaths, diarrhoea or fatigue were observed between the two groups. The author’s state that in the context of first-line treatment, overall, more patients experienced grade 3 or 4 toxicities with FOLFOX6 than FOLFIRI (74% and 53%, respectively, p=0.001), however, more patients had serious adverse events with FOLFIRI than with FOLFOX6 (14% and 5%, respectively, p=0.03). During the first 60 days on treatment, there were 4 deaths in the FOLFIRI group and 3 in the FOLFOX6 group.
In terms of the use of FOLFOX6 in the second-line setting, no significant differences in any of the reported adverse events were observed between patients randomised to FOLFOX6 or FOLFIRI. During the first 60 days on treatment, there were 3 deaths in each treatment group.
There were no reports of discontinuation due to toxicities.
Grade 3 & 4 Toxicities (%) |
First Line |
Second Line |
FOLFIRI |
FOLFOX6 |
Absolute Risk Difference (95% CI) |
FOLFIRI |
FOLFOX6 |
Absolute Risk Difference (95% CI) |
Neutropenia |
24 |
44 |
-18%
(-30%,6%) |
20 |
30 |
-10% (-24%, 4%) |
Anaemia |
3 |
3 |
0%
(-4%,4%) |
4 |
4 |
-1% (-7%, 6%) |
Febrile Neutropenia |
7 |
0 |
6%
(2%,11%) |
0 |
1 |
-1% (-5%, 2%) |
Nausea |
12 |
3 |
9%
(2%,16%) |
6 |
0 |
7% (1%, 13%) |
Vomiting |
10 |
3 |
6%
(0%,13%) |
5 |
4 |
2% (-5%, 9%) |
Diarrhoea |
14 |
11 |
3%
(-6%,11%) |
5 |
12 |
-6% (-15%, 4%) |
Mucositis |
10 |
1 |
8%
(3%,14%) |
4 |
4 |
0% (-6%, 7%) |
Fatigue |
4 |
3 |
1%
(-4%,6%) |
5 |
1 |
5% (-1%, 11%) |