title: Current palliative chemotherapy trials in the elderly neglect patient-centred outcome measures.
abstract: BACKGROUND
  The elderly comprise the majority of patients newly diagnosed with cancer. Despite this, little evidence-based data are available on the care of the growing number of older patients with cancer. The objective of the current study was to evaluate the characteristics and outcome measures of current clinical trials on palliative chemotherapy in elderly patients.
  
  
  METHODS
  Fourteen international clinical trials registries were searched using the terms "cancer" and "elderly" to identify clinical palliative chemotherapy trials designed specifically for patients aged 70+ years. From the trial protocol, data were extracted on trial characteristics and outcome measures.
  
  
  RESULTS
  Of 127 trials, 81% formulated one or more stringent criteria with respect to organ function; 32% excluded patients with WHO performance status (PS) 2 and 83% with PS3. Functional outcomes, health care utilisation, cognitive function after treatment, and quality of life were reported in 6%, 3%, 6%, and 31% of trials, respectively. In only 16% of trials on palliative cancer treatment, a geriatric assessment was performed at baseline.
  
  
  CONCLUSIONS
  Although recent years have seen a growing evidence base regarding fit older patients, our study suggests a lack of representative cohorts of older patients and patient-centred outcome measures in current palliative treatment trials for the elderly. Research addressing alternative outcome measures, including quality of life and impact of therapy on general functioning, cognition, and preservation of independence, and incorporation of a geriatric assessment are needed to provide elderly patients with cancer and their treating physicians with realistic information about palliative chemotherapy.
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Utrecht, The Netherlands. Electronic address: mvbekku1@diakhuis.nl.
authors.forename: Marlies L
authors.initials: ML
authors.lastname: van Bekkum
authors.affiliation: Department of Geriatric Medicine, Gelre Hospitals, Apeldoorn, The Netherlands; Department of Internal Medicine, Academic Medical Center, Amsterdam, The Netherlands.
authors.forename: Barbara C
authors.initials: BC
authors.lastname: van Munster
authors.affiliation: Department of Internal Medicine, Diakonessenhuis Utrecht, The Netherlands.
authors.forename: Peter L M
authors.initials: PL
authors.lastname: Thunnissen
authors.affiliation: Department of Medical Oncology, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
authors.forename: Carolien H
authors.initials: CH
authors.lastname: Smorenburg
authors.affiliation: Department of Geriatric Medicine, Diakonessenhuis, Utrecht, The Netherlands.
authors.forename: Marije E
authors.initials: ME
authors.lastname: Hamaker
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D002986:Clinical Trials as Topic / Q000592:standards*; D006299:Health Services for the Aged / Q000592:standards*; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy*; D017063:Outcome Assessment, Health Care; D010166:Palliative Care / Q000592:standards*; D018802:Patient-Centered Care / Q000592:standards*
keywords: (Patient centred) outcome measures; Elderly; Palliative chemotherapy