Eighteen RCTs (n=3,517 patients) were included in the review, with sample sizes in the trials ranging from 55 to 566 patients. Randomisation and the reporting of incomplete data outcomes were judged to be adequate in all the included trials. Eleven studies each adequately reported the concealment of allocation and blinding.
There were significant benefits observed in the radiochemotherapy group in response rate (RR1.17, 95% CI 1.11 to 1.23; 12 trials; n=1,928 patients), three-year survival (RR 1.13, 95% CI 1.04 to 1.24; three RCTs; n=709 patients), and five-year survival (RR 1.22, 95% CI 1.13 to 1.31; eight RCTs; n=1,562 patients) compared with radiotherapy alone. There was no heterogeneity observed across the trials for these outcomes.
The authors stated that there were no significant differences between the radiochemotherapy group and the radiotherapy group for rectitis, cystitis, nausea and vomiting and myelosuppression, but that there were higher incidence rates for gastrointestinal adverse events and leukopenia (data not reported).
There was no evidence of publication bias from the visual appraisal of the funnel plot.