title: Lower preoperative quality of life increases postoperative risk of adverse events in women with endometrial cancer: results from the LACE trial.
abstract: OBJECTIVE
  To examine the association between preoperative quality of life (QoL) and postoperative adverse events in women treated for endometrial cancer.
  
  
  METHODS
  760 women with apparent Stage I endometrial cancer were randomised into a clinical trial evaluating laparoscopic versus open surgery. This analysis includes women with preoperative QoL measurements, from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, and who were followed up for at least 6 weeks after surgery (n=684). The outcomes for this study were defined as (1) the occurrence of moderate to severe adverse events within 6 months (Common Toxicology Criteria (CTC) grade≥3); and (2) any serious adverse event (SAE). The association between preoperative QoL and the occurrence of AE was examined, after controlling for baseline comorbidity and other factors.
  
  
  RESULTS
  After adjusting for other factors, odds of occurrence of AE of CTC grade≥3 were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.00-1.03, p=0.030), which was driven by physical well-being (PWB) (OR=1.09, 95% CI 1.04-1.13, p=0.0002) and functional well-being subscales (FWB) (OR=1.04, 95% CI 1.00-1.07, p=0.035). Similarly, odds of SAE occurrence were significantly increased with each unit decrease in baseline FACT-G score (OR=1.02, 95% CI 1.01-1.04, p=0.011), baseline PWB (OR=1.11, 95% CI 1.06-1.16, p<0.0001) or baseline FWB subscales (OR=1.05, 95% CI 1.01-1.10, p=0.0077).
  
  
  CONCLUSIONS
  Women with early endometrial cancer presenting with lower QoL prior to surgery are at higher risk of developing a serious adverse event following surgery.
  
  
  BACKGROUND
  Cancer Council Queensland, Cancer Council New South Wales, Cancer Council Victoria, Cancer Council, Western Australia; NHMRC project grant 456110; Cancer Australia project grant 631523; The Women and Infants Research Foundation, Western Australia; Royal Brisbane and Women's Hospital Foundation; Wesley Research Institute; Gallipoli Research Foundation; Gynetech; TYCO Healthcare, Australia; Johnson and Johnson Medical, Australia; Hunter New England Centre for Gynaecological Cancer; Genesis Oncology Trust; and Smart Health Research Grant QLD Health.
authors: Queensland University of Technology, School of Public Health, Institute of Health and Biomedical Innovation, QLD, Australia.
authors: Jannah
authors: J
authors: Baker
authors: Queensland University of Technology, School of Public Health, Institute of Health and Biomedical Innovation, QLD, Australia.
authors: Monika
authors: M
authors: Janda
authors: University of Sydney NHMRC Clinical Trials Centre, Sydney, NSW, Australia.
authors: Val
authors: V
authors: Gebski
authors: University of Newcastle, Priority Research Centre for Gender Health and Ageing, Newcastle, NSW, Australia.
authors: Peta
authors: P
authors: Forder
authors: Westmead Hospital, Department of Gynaecologic Oncology, Sydney, NSW, Australia.
authors: Russell
authors: R
authors: Hogg
authors: Box Hill Hospital, Melbourne, VIC, Australia.
authors: Tom
authors: T
authors: Manolitsas
authors: Queensland Centre for Gynaecological Cancer, QLD, Australia.
authors: Andreas
authors: A
authors: Obermair
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016889:Endometrial Neoplasms / Q000473:pathology / Q000503:physiopathology* / Q000523:psychology / Q000601:surgery*; D005260:Female; D005500:Follow-Up Studies; D013509:Gynecologic Surgical Procedures / Q000009:adverse effects / Q000379:methods; D006801:Humans; D010535:Laparoscopy / Q000009:adverse effects / Q000379:methods; D008875:Middle Aged; D009367:Neoplasm Staging; D011183:Postoperative Complications / Q000209:etiology; D057234:Preoperative Period; D011788:Quality of Life; D011795:Surveys and Questionnaires
keywords: Adverse events; Complications; Endometrial cancer; Quality of life; Randomised trial