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Original research
Clinical trial participation and aggressive care at the end of life in patients with ovarian cancer
  1. Roni Nitecki1,2,
  2. Alexandra S Bercow1,2,
  3. Allison A Gockley3,
  4. Hang Lee4,
  5. Richard T Penson5 and
  6. Whitfield B Growdon6
  1. 1 Department of Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA
  2. 2 Obstetrics and Gynecology, Brigham and Women's Hospital, Boston, Massachusetts, USA
  3. 3 Gynecologic Oncology, Brigham and Women's Hospital, Boston, Massachusetts, USA
  4. 4 Department of Medicine, MGH Biostatistics Center, Massachusetts General Hospital, Boston, Massachusetts, USA
  5. 5 Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts, USA
  6. 6 Division of Gynecologic Oncology, Vincent Obstetrics and Gynecology, Massachusetts General Hospital, Boston, Massachusetts, USA
  1. Correspondence to Dr Roni Nitecki, Department of Gynecologic Oncology and Reproductive Medicine, The University of Texas MD Anderson Cancer Center, Houston, Texas, USA; rnitecki{at}mdanderson.org

Abstract

Objectives In non-gynecologic cancers, clinical trial participation has been associated with aggressive care at the end of life. The objective of this investigation was to examine how trial participation affects end of life outcomes in patients with ovarian cancer.

Methods In a retrospective review of women diagnosed with ovarian cancer at our institution between January 2010 and December 2015, we collected variables identified by the National Quality Forum as measures of aggressive end of life care including chemotherapy in the last 14 days of life, intensive care unit (ICU) admission in the last 30 days of life, or death in the acute care setting. Trials investigating medications but not surgical interventions were included. The primary outcome of this study was the association between trial participation and the National Quality Forum measures of aggressive end of life care in ovarian cancer decedents. Data were analyzed with univariable and multivariable parametric and non-parametric testing, and time to event outcomes were analyzed using the Kaplan–Meier method and Cox’s proportional hazard models.

Results Among 391 women treated for ovarian cancer, 62 patients (16%) participated in a clinical trial. Patients enrolled in clinical trials were more likely to have chemotherapy administered within 14 days of death; however, no association was found with other metrics of aggressive care at the end of life including the initiation of a new chemotherapy regimen in the last 30 days of life, ICU admissions, and death in an acute care setting. Among patients with recurrent ovarian cancer, median overall survival for trial participants was 57 months compared with only 31 months in non-trial participants (p<0.001).

Conclusions In patients with ovarian cancer, clinical trial enrollment is associated with chemotherapy administration within 14 days of death, but not other measures of aggressive care at the end of life. Given the importance of clinical trial participation in improving care for women with ovarian cancer, this study suggests that concerns regarding aggressive care prior to death should not limit clinical trial participation.

  • ovarian cancer
  • quality of life (PRO)/palliative care
  • palliative care

https://doi.org/10.1136/ijgc-2019-000851

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    Footnotes

    • Twitter @AlexBercowMD

    • Contributors RN, AAG, and WBG conceived the idea. RN, WBG, HL, and ASB carried out the implementation. RN took the lead in writing the manuscript. All authors provided critical feedback and helped shape the research, analysis, and manuscript.

    • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

    • Competing interests No financial support was provided for the submitted work. RTP reports unrelated fees from AbbVie, Amgen, AstraZeneca, Clovis Oncology, Eisai, Genentech/Roche, Mersana Therapeutics, Regeneron, Sanofi-Aventis US, Sutro Biopharma, Tesaro, and Vascular Biogenics.

    • Patient consent for publication Not required.

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement No data are available.