COMET (Comparing an Operation to Monitoring, with or without Endocrine Therapy) in DCIS

  • The COMET (Comparing an Operation to Monitoring, with or without Endocrine Therapy) trial:
    • A randomized clinical trial, investigated whether active monitoring is non-inferior to standard treatment (surgery with or without radiation) for low-risk DCIS (ductal carcinoma in situ):
      • Finding that active monitoring is a viable option
  • Study Purpose:
    • The COMET trial aimed to determine if active monitoring, which involves close surveillance with surgery only if DCIS progresses to invasive cancer:
      • Is as effective as the standard treatment of surgery (lumpectomy or mastectomy) with or without radiation and / or hormone therapy for women with low-risk DCIS
  • Study Design:
    • The COMET trial was a randomized controlled trial, meaning participants were randomly assigned to:
      • Either active monitoring or guideline-concordant care (surgery with or without radiation)
  • Eligibility:
    • The study included women aged 40 and older with low-risk DCIS:
      • Defined as grade 1 or 2, hormone receptor-positive, HER2-negative, with no signs of invasive cancer, and the diagnosis confirmed by at least two pathologists
  • Key Findings:
    • After 24 months of follow-up:
      • The two-year cumulative rate of invasive ipsilateral breast cancer was 5.9% in the guideline-concordant care arm and 4.2% in the active monitoring arm:
        • The difference met the threshold for noninferiority:
          • Meaning that neither treatment was deemed inferior to the other
  • Implications:
    • The results suggest that active monitoring is a valid alternative to surgery for women with low-risk DCIS, potentially reducing overtreatment and improving quality of life
  • Patient-Reported Outcomes:
    • The study also found that overall health-related quality of life remained stable from baseline to 2 years and did not differ significantly between the two treatment arms
  • Funding:
    • The COMET study was funded by the Patient-Centered Outcomes Research Institute (PCORI), the Breast Cancer Research Foundation (BCRF), and other organizations
  • Study Location:
    • The study was conducted across multiple sites in the United States

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