Article Text

PDF
Quality of Life and Patient-Reported Outcomes in Endometrial Cancer Clinical Trials: A Call for Action!
  1. Florence Joly, MD, PhD*,
  2. Jessica McAlpine, MD,
  3. Remi Nout, MD, PhD,
  4. Elisabeth Åvall-Lundqvist, MD§,
  5. Emad Shash, PhD and
  6. Michael Friedlander, MBChB, FRACP, PhD
  1. *Medical Oncology Department, Clinical Research Department, Centre Francois Baclesse, CHU Côte de Nacre, Inserm“cancer&preventions”, University of Basse Normandie, Caen, France;
  2. Department of Gynecology and Obstetrics, Division of Gynecologic Oncology, University of British Columbia, Vancouver, British Columbia, Canada;
  3. Department of Clinical Oncology, University Medical Center, Leiden, the Netherlands;
  4. §Department of Gynaecologic Oncology, Karolinska University Hospital, Stockholm, Sweden;
  5. EORTC, Brussells, Belgium; and
  6. Department of Medical Oncology, The Prince of Wales Hospital, University of New South Wales Clinical School, Sydney, Australia.
  1. Address correspondence and reprint requests to Florence Joly, MD, PhD, Medical Oncology Department, Clinical Research Department, Centre Francois Baclesse, University of Basse Normandie, CHU Côte de Nacre, 3 avenue General Harris, BP 5026, 14076 Caen Cedex 05, France. E-mail: f.joly@baclesse.fr.

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.

  • Patient-reported outcomes
  • Quality of life
  • Clinical trials
  • Endometrial cancer

Statistics from Altmetric.com

Footnotes

  • The authors declare no conflicts of interest.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.