Seven RCTs were included (3,603 participants). All studies scored 4 points on the modified Jadad scale. None of the trials had any description of concealment of treatment allocation and blinding methods. All studies described the randomisation method and withdrawals appropriately. All analyses were performed according to the intention-to-treat principle.
There was no statistically significant difference between groups for complete response (four RCTs; Ι²=59%). For partial response (OR 0.81, 95% CI 0.65 to 1.00; four RCTs; Ι²=0%) and overall response rate (OR 0.85, 95% CI 0.71 to 1.02; five RCTs; Ι²=11%) results were nearly statistically significant in favour of treatment with capecitabine plus oxaliplatin.
There were no statistically significant differences in individual studies for median overall survival and progression-free survival.
Incidence of hand-foot syndrome in the capecitabine plus oxaliplatin group was significantly higher than in the 5-fluorouracil plus oxaliplatin group (five RCTs; Ι²=58%). Stomatitis (three RCTs; Ι²=59%) and neutropenia (four RCTs; Ι²=89%) occurred significantly more frequently in the 5-fluorouracil plus oxaliplatin group. There were no statistically significant differences between groups for nausea, diarrhoea, fever, thrombocytopenia and peripheral neuropathy.