title: A tool to balance benefit and harm when deciding about adjuvant therapy.
abstract: Adjuvant therapy aims to prevent outgrowth of residual disease but can induce serious side effects. Weighing conflicting treatment effects and communicating this information with patients is not elementary. This study presents a scheme balancing benefit and harm of adjuvant therapy vs no adjuvant therapy. It is illustrated by the available evidence on adjuvant pelvic external beam radiotherapy (RT) for intermediate-risk stage I endometrial carcinoma patients. The scheme comprises five outcome possibilities of adjuvant therapy: patients who benefit from adjuvant therapy (some at the cost of complications) vs those who neither benefit nor contract complications, those who do not benefit but contract severe complications, or those who die. Using absolute risk differences, a fictive cohort of 1000 patients receiving adjuvant RT is categorised. Three large randomised clinical trials were included. Recurrences will be prevented by adjuvant RT in 60 patients, a majority of 908 patients will neither benefit nor suffer severe radiation-induced harm but 28 patients will suffer severe complications due to adjuvant RT and an expected four patients will die. This scheme readily summarises the different possible treatment outcomes and can be of practical value for clinicians and patients in decision making about adjuvant therapies.
authors.affiliation: Department of Quality Assurance and Process Innovation, Academic Medical Center at University of Amsterdam, The Netherlands. a.m.knops@amc.nl
authors.forename: A M
authors.initials: AM
authors.lastname: Knops
authors.forename: A
authors.initials: A
authors.lastname: Goossens
authors.forename: M P M
authors.initials: MP
authors.lastname: Burger
authors.forename: L J A
authors.initials: LJ
authors.lastname: Stalpers
authors.forename: D T
authors.initials: DT
authors.lastname: Ubbink
mesh_terms: D016889:Endometrial Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D005260:Female; D006801:Humans; D018714:Radiotherapy, Adjuvant / Q000009:adverse effects; D016032:Randomized Controlled Trials as Topic; D018570:Risk Assessment; D016896:Treatment Outcome