title: Harm and benefits of short-term pre-operative radiotherapy in patients with resectable rectal carcinomas.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Surgery, Academic Medical Center, University of Amsterdam, The Netherlands. r.bakx@amc.uva.nl
authors.forename: R
authors.initials: R
authors.lastname: Bakx
authors.forename: M
authors.initials: M
authors.lastname: Emous
authors.forename: D A
authors.initials: DA
authors.lastname: Legemate
authors.forename: F A N
authors.initials: FA
authors.lastname: Zoetmulder
authors.forename: G
authors.initials: G
authors.lastname: van Tienhoven
authors.forename: W A
authors.initials: WA
authors.lastname: Bemelman
authors.forename: J J B
authors.initials: JJ
authors.lastname: van Lanschot
mesh_terms: D002277:Carcinoma / Q000532:radiotherapy* / Q000601:surgery; D002423:Cause of Death; D006801:Humans; D015233:Models, Statistical; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control; D011300:Preoperative Care; D011878:Radiotherapy / Q000009:adverse effects; D018714:Radiotherapy, Adjuvant; D016032:Randomized Controlled Trials as Topic; D012004:Rectal Neoplasms / Q000532:radiotherapy* / Q000601:surgery; D018570:Risk Assessment; D015996:Survival Rate; D016896:Treatment Outcome