Abstract

Aim To weigh the harms and benefits of short-term pre-operative radiotherapy in the treatment of resectable rectal cancer. Methods The benefits (reduction of local recurrence) and harm (increase of short-term complications) of short-term pre-operative radiotherapy are balanced using a model which classifies patients in one of five outcome combinations; 1—benefit without additional harm, 2—benefit with additional harm, 3—no benefit, no additional harm, 4—no benefit but additional harm, 5—mortality due to combined treatment. The results of four randomised clinical trials (RCT) which study the addition of short-term pre-operative radiotherapy in rectal cancer were classified according to this model. Results Five to thirteen percent of the patients have benefit without additional harm of pre-operative radiotherapy, while 0–2% have benefit with additional harm; 74–87% has neither benefit nor additional harm and 6–11% have no benefit but additional harm. A small percentage of patients (1–6%) dies post-operatively as a result of the addition of radiotherapy. Conclusion This model provides a transparent appreciation of the harmful and beneficial effects of any treatment modality investigated by means of a randomised clinical trial. As for short-term pre-operative radiotherapy in resectable rectal cancer is shown, a small percentage of patients benefits from such treatment. Most patients have neither benefit nor additional harm, while a small percentage suffers from additional harm while not receiving any benefit.

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