title: Quality of life and patient-reported outcomes in endometrial cancer clinical trials: a call for action!
abstract: BACKGROUND
  There is increasing recognition that quality of life (QoL) and patient-reported outcomes (PROs) are of fundamental importance and particularly relevant given the relatively high likelihood of long-term survival in most women with endometrial cancer (EC). However, there has been relatively little research focused on this topic. Our objective was to analyze our current knowledge and identify research questions to be included in the design of next clinical trials.
  
  
  METHODS
  Analyze and critically assess reported clinical trials in EC that have included QoL and PROs as primary or secondary end points.
  
  
  RESULTS
  Surgery has a significant impact on physical and functional domains of QoL particularly in the first 6 months after diagnosis. Minimally invasive surgery is associated with less acute morbidity than open procedures and this persists over time. Lymphadenectomy is associated with increased incidence of lymphedema, important late effect. Adjuvant external irradiation may cause gastrointestinal and genitourinary symptoms that impact on physical functioning and which can persist over time. In contrast, vaginal brachytherapy has less toxicity and fewer late effects than external irradiation. The impact of treatment on sexuality has been poorly evaluated in EC survivors. There are few published data on QoL and PROs in patients treated with chemotherapy and the long-term impact has not been addressed. There is no evidence that palliative chemotherapy reduces symptoms and improves QoL. There are very few longitudinal studies on survivorship that is an important concern in EC survivors.
  
  
  CONCLUSIONS
  Although there have been some studies addressing QoL and PROs in EC, we have identified deficiencies and gaps in our knowledge. Careful consideration of QoL and PROs end points and how to include them in clinical trials will result in a better appreciation of how treatments can impact on patients QoL and lead to conduct interventions to reduce late effects.
authors.affiliation: *Medical Oncology Department, Clinical Research Department, Centre Francois Baclesse, CHU Côte de Nacre, Inserm "cancer&preventions", University of Basse Normandie, Caen, France; †Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University of British Columbia, Vancouver, British Columbia, Canada; ‡Department of Clinical Oncology, University Medical Center, Leiden, the Netherlands; §Department of Gynaecologic Oncology, Karolinska University Hospital, Stockholm, Sweden; ∥EORTC, Brussells, Belgium; and ¶Department of Medical Oncology, The Prince of Wales Hospital, University of New South Wales Clinical School, Sydney, Australia.
authors.forename: Florence
authors.initials: F
authors.lastname: Joly
authors.forename: Jessica
authors.initials: J
authors.lastname: McAlpine
authors.forename: Remi
authors.initials: R
authors.lastname: Nout
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Åvall-Lundqvist
authors.forename: Emad
authors.initials: E
authors.lastname: Shash
authors.forename: Michael
authors.initials: M
authors.lastname: Friedlander
mesh_terms: D002986:Clinical Trials as Topic; D003131:Combined Modality Therapy; D016889:Endometrial Neoplasms / Q000523:psychology* / Q000628:therapy; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local / Q000523:psychology*; D063868:Patient Outcome Assessment; D011379:Prognosis; D011788:Quality of Life / Q000523:psychology*; D015996:Survival Rate; D017741:Survivors