title: Barriers to inclusion of older adults in randomised controlled clinical trials on Non-Hodgkin's lymphoma: a systematic review.
abstract: BACKGROUND
  The majority of Non-Hodgkin's lymphoma (NHL) patients are over 65 years. Management is challenging, especially for aggressive lymphoma, and appropriate assessment of efficacy and tolerance specific to this population is crucial.
  
  
  OBJECTIVE
  To assess the representation of older patients in randomised controlled trials (RCT) in NHL, examining whether trial eligibility criteria prevent participation, and whether appropriate primary endpoints such as toxicity, quality of life, or geriatric assessment scores are used.
  
  
  METHODS
  We searched Medline for articles published in English or French between 1 January 2005 and 31 December 2011 reporting on phase II/III RCT evaluating therapeutic strategies for NHL. Articles were categorised as including or excluding (directly or indirectly) older adults, and features of RCT that included or excluded older patients are compared.
  
  
  RESULTS
  We identified 87 relevant RCT: 9 (10.3%) focussed exclusively on patients >65 years, 22 (25.3%) directly excluded patients >65 years, 47 (54.0%) indirectly excluded older adults through selective inclusion criteria (ECOG status, liver or kidney function, and comorbidities), and 9 (10.3%) did not directly or indirectly exclude patients >65 years (although two excluded patients >70 years). Proportions of older patients included do not reflect incidence. Trials including older adults were published in journals with lower impact factors and few RCT used appropriate endpoints for older adults.
  
  
  CONCLUSIONS
  Older adults are poorly represented in NHL RCT both due to direct age-based exclusion and restrictive inclusion criteria. This situation needs rapid correction to better represent older patients and thus improve cancer management in this highly prevalent population.
authors.affiliation: Clinical and Epidemiological Research Unit, Institut Bergonié, Comprehensive Cancer Centre, Bordeaux, France. c.bellera@bordeaux.unicancer.fr
authors.forename: Carine
authors.initials: C
authors.lastname: Bellera
authors.forename: Delphine
authors.initials: D
authors.lastname: Praud
authors.forename: Aurélie
authors.initials: A
authors.lastname: Petit-Monéger
authors.forename: Pippa
authors.initials: P
authors.lastname: McKelvie-Sebileau
authors.forename: Pierre
authors.initials: P
authors.lastname: Soubeyran
authors.forename: Simone
authors.initials: S
authors.lastname: Mathoulin-Pélissier
mesh_terms: D000367:Age Factors; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D017322:Clinical Trials, Phase II as Topic; D017326:Clinical Trials, Phase III as Topic; D006801:Humans; D008228:Lymphoma, Non-Hodgkin / Q000401:mortality / Q000473:pathology / Q000628:therapy*; D009367:Neoplasm Staging; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome
keywords: Aged: aged 80 and over; Clinical trial inclusion; Criteria of eligibility; Frail older; Lymphoma; Non-Hodgkin; Randomised controlled trials; Review literature