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Breast

E28: Patient Reported Outcomes from a multi-site, prospective Pivotal study evaluating pegulicianine fluorescence guided surgery (pFGS) for breast cancer lumpectomy procedures using the Lumicell Direct Visualization System (DVS)

    ePoster Abstract Author(s)

  • Kelly K. Hunt, MD (she/her/hers)

    Professor & Chair
    Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA
    Houston, Texas, United States

    • Author(s)

  • Kelly K. Hunt, MD (she/her/hers)

    Professor & Chair
    Department of Breast Surgical Oncology, MD Anderson Cancer Center, Houston, TX, USA
    Houston, Texas, United States

  • Irene Wapnir, MD

    Professor of Surgery
    Stanford University Medical Center
    Stanford, CA, United States

  • E. Shelley Hwang, MD, MPH

    Mary and Deryl Hart Distinguished Professor of Surgery
    Duke University School of Medicine
    Durham, North Carolina, United States

  • DC

    David Carr, MD

    General Surgeon
    Novant Health, United States

  • PB

    Peter Blumencranz, MD

    General Surgeon
    BayCare Medical Group, United States

    • Submitter(s)

  • KS

    Kate P. Smith, MPH

    Senior Director of Clinical Affairs
    Lumicell, Inc.
    Hudson, Massachusetts, United States

    • Author(s)

  • KS

    Kate P. Smith, MPH

    Senior Director of Clinical Affairs
    Lumicell, Inc.
    Hudson, Massachusetts, United States

  • MC

    Manna Chang, PhD

    Principal Data Scientist
    Lumicell, Inc, United States

  • JF

    Jorge Ferrer, PhD

    Senior Vice President Clinical Research and Strategy
    Lumicell, Inc., United States

  • Barbara L. Smith, MD, PhD

    Professor of Surgery
    Massachusetts General Hospital
    Boston, Massachusetts, United States

Introduction: In pegulicianine fluorescence guided surgery (pFGS), a lumpectomy procedure is performed, and additional tissue is taken from cavity at sites of high pFGS signal. This has shown to reduce 2nd surgeries and remove tumor left by standard surgery, but may remove more tissue, potentially worsening cosmetic outcomes. Patient breast satisfaction surveys were used to assess cosmesis after pFGS.

Methods:

A Pivotal trial of pFGS in women undergoing lumpectomy for breast cancer was conducted. Safety and efficacy of the Lumicell DVS in identifying and removing residual cancer from the lumpectomy cavity in real time was assessed. Patient Reported Outcome Measures (PROM) data was collected. The BREAST-Q, a validated tool that measures patient perspectives after different breast procedures, was used to collect PROM data.  An 11-question BREAST-Q survey was used to measure patients’ breast satisfaction at baseline (pre-surgery) and at multiple timepoints through 6-months post lumpectomy.

Survey results were analyzed by the distribution of patient ratings for each question and the change in ratings over time, with comparison of baseline to post-lumpectomy.  Comparison of patient satisfaction with or without additional pFGS-directed tissue removal was performed with Item Response Theory assuming all items equally discriminative of responding patients. For each timeframe, responses to BREAST-Q items were used to create a response score for each patient. Scaled factor scores (0-100) were compared between groups with and without additional tissue removed during pFGS.

Results:

Of the 357 patients evaluated for efficacy in the primary study, 255 agreed to participate in the surveys (71%). Approximately 60% of the participants completed a pre- and initial post-lumpectomy survey while only 34% completed a pre- and 6-month post-lumpectomy survey. Most patients responded either “Very Satisfied” or “Somewhat Satisfied” across all surveyed timeframes. No significant difference in patient breast satisfaction was found at any time point between the groups with and without additional pFGS-guided shaves removed (p >0.05). 

Conclusions:

Patient perspective of breast satisfaction was not decreased by the amount of extra tissue removed by pFGS. These data suggest that pFGS using the Lumicell DVS does not significantly decrease breast cosmesis. Three of 4 patients with decreased satisfaction had 2nd surgeries, confirming the importance of finding approaches to decrease 2nd surgeries.

Learning Objectives:

  • Define a patient reported outcome measures.
  • List types of patient reported outcome measures.
  • Describe the importance of using a validated tool for collecting survey data.