Cancer Diagnosis by Treatment Group
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Questions and Answers

What is a potential drawback of using frozen section in breast cancer diagnosis?

  • Difficulty in assessing fatty breast tissue
  • Adds significant time to the procedure (correct)
  • Insufficient sensitivity for DCIS
  • Compromises cosmetic outcomes

    • What is the primary benefit of using the Margin Probe system in breast cancer surgery?

  • Enhances palpation of invasive cancer
  • Improves cosmetic outcomes
  • Increases sensitivity for IDC
  • Reduces the need for re-excision surgery (correct)

    • What is a potential consequence of using full cavity shave in breast cancer surgery?

  • Compromises cosmetic outcomes (correct)
  • Improves palpation of invasive cancer
  • Reduces the need for re-excision surgery
  • Increases sensitivity for DCIS

    • What is a limitation of using full cavity shave in breast cancer surgery?

    <p>Thinner shaves can result in reduced success in clearing final margins</p> Signup and view all the answers

    What is the primary goal of using intraoperative imaging in breast cancer surgery?

    <p>To identify positive margins in real-time</p> Signup and view all the answers

    What is a necessary condition for a patient to be enrolled in the pivotal study?

    <p>The patient is at least 18 years old</p> Signup and view all the answers

    What is the purpose of suture marking the center of each of the 6 margins of the main lumpectomy specimen?

    <p>To facilitate palpation and re-excision</p> Signup and view all the answers

    What is the primary purpose of the MarginProbe device in the SOC+Device arm?

    <p>To sample 5-8 points on each face of the excised specimen</p> Signup and view all the answers

    What would disqualify a patient from enrolling in the pivotal study?

    <p>Bilateral disease in both breasts</p> Signup and view all the answers

    What is NOT a step in the resection process of the main lumpectomy specimen?

    <p>The patient is taken to the recovery room</p> Signup and view all the answers

    What is the primary effectiveness endpoint in the study?

    <p>Measurement of all pathologically positive margins on the main specimen being intraoperatively re-excised or “addressed”</p> Signup and view all the answers

    What is the definition of a positive margin in the study?

    <p>A margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked margin</p> Signup and view all the answers

    What is the role of intraoperative imaging in the study?

    <p>To assist in the intraoperative re-excision of positive margins</p> Signup and view all the answers

    How many patients were excluded from the study due to protocol violations or not meeting the inclusion/exclusion criteria?

    <p>7</p> Signup and view all the answers

    What is the total number of patients analyzed in the study?

    <p>293</p> Signup and view all the answers

    How many patients were analyzed in the 'device' arm of the NPL subgroup?

    <p>82</p> Signup and view all the answers

    What was the reason for excluding one patient from the study?

    <p>All of the above</p> Signup and view all the answers

    How many patients were analyzed in the 'control' arm of the study?

    <p>150</p> Signup and view all the answers

    What percentage of patients with long-term 'excellent' or 'good' cosmetic evaluation was similar in both arms?

    <p>76%</p> Signup and view all the answers

    How many margins were re-excised by the surgeons in the entire cohort and NPL subgroup, respectively?

    <p>78% (186/237) of these margins were intraoperatively re-excised</p> Signup and view all the answers

    What percentage of margins in the entire cohort were not re-excised?

    <p>57%</p> Signup and view all the answers

    Why did the surgeons not re-excise the remaining 43% of device-detected positive margins?

    <p>Because they were in the anterior or deep aspect where no breast tissue remained to be resected</p> Signup and view all the answers

    What would have been the consequence of re-excising the remaining 43% of device-detected positive margins?

    <p>The correct ISR for the 'device' arm would have increased to 67%</p> Signup and view all the answers

    What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?

    <p>Nearly 70%</p> Signup and view all the answers

    What is the approximate percentage of patients taken back to the operating room for additional surgery when the device was used?

    <p>Less than 20%</p> Signup and view all the answers

    What percentage of correct intraoperative reactions and reoperation rates were maintained in the control arm?

    <p>40% and 20%</p> Signup and view all the answers

    What is the increase in percentage of patients who were able to intraoperatively re-excise all histologically positive margins when using the device?

    <p>More than 75%</p> Signup and view all the answers

    What is the approximate percentage of patients in the 'device' arm who underwent preoperative image-guided localization?

    <p>Nearly 70% is not mentioned</p> Signup and view all the answers

    What percentage of American women with early-stage breast cancer are treated with BCS?

    <p>75 %</p> Signup and view all the answers

    What is the goal of a lumpectomy procedure in breast cancer treatment?

    <p>Removing the tumor with a margin of surrounding normal breast tissue</p> Signup and view all the answers

    Why is it challenging to accomplish a successful lumpectomy?

    <p>Because the microscopic extent of breast cancer can be difficult to discern</p> Signup and view all the answers

    What is a consequence of involved or positive lumpectomy margins?

    <p>Increased risk of ipsilateral breast tumor recurrence</p> Signup and view all the answers

    What is a common occurrence for patients undergoing lumpectomy?

    <p>At least 20 % of patients undergo more than one procedure</p> Signup and view all the answers

    What was the re-excision rate in the control group in the study by Allweis et al.?

    <p>12.7%</p> Signup and view all the answers

    What was the relative reduction in re-excision rates with the use of MarginProbe?

    <p>56%</p> Signup and view all the answers

    How many patients were enrolled in the study by Thill et al.?

    <p>109</p> Signup and view all the answers

    What was the re-excision rate in the MarginProbe group in the study by Coble et al.?

    <p>10.4%</p> Signup and view all the answers

    What was the study design of the study by Schnabel et al.?

    <p>Prospective, randomized, controlled</p> Signup and view all the answers

    What was the reduction in re-excision rates in the study by Hermann et al.?

    <p>44-17% = 61%</p> Signup and view all the answers

    What was the cosmesis outcome in the study by Geha et al.?

    <p>Favorable</p> Signup and view all the answers

    What was the re-excision rate in the control group in the study by Kupstas et al.?

    <p>18.3%</p> Signup and view all the answers

    What was the relative reduction in re-excision rates with the use of MarginProbe in the study by Cen et al.?

    <p>75%</p> Signup and view all the answers

    What was the study design of the study by Arch et al.?

    <p>Retrospective, single arm</p> Signup and view all the answers

    What is the estimated percentage of cases where reoperation for positive margins after BCS may be necessary?

    <p>50%</p> Signup and view all the answers

    What is the consequence of having tumor cells directly at the margin of the excised specimen?

    <p>Reoperation is required</p> Signup and view all the answers

    What is the recommended course of action for patients not amenable to margin-free lumpectomy?

    <p>Mastectomy</p> Signup and view all the answers

    What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery (BCS)?

    <p>75%</p> Signup and view all the answers

    What is the estimated percentage of main lumpectomy specimens that will have positive or close margins?

    <p>54%</p> Signup and view all the answers

    What is the primary goal of a lumpectomy procedure in breast cancer treatment?

    <p>Removal of the tumor with a margin of surrounding normal breast tissue</p> Signup and view all the answers

    What is the purpose of evaluating margin status during lumpectomy?

    <p>To determine the need for further surgery</p> Signup and view all the answers

    Why is it challenging to accomplish a successful lumpectomy?

    <p>The microscopic extent of the cancer is difficult to discern</p> Signup and view all the answers

    What is the consequence of having involved or positive lumpectomy margins?

    <p>Patient discomfort, increased costs, and poorer cosmetic outcome</p> Signup and view all the answers

    What is the primary goal of breast-conserving surgery (BCS) for breast cancer?

    <p>To obtain clear margins during the operation</p> Signup and view all the answers

    What is a consequence of involved or positive lumpectomy margins?

    <p>Increased risk of ipsilateral breast tumor recurrence</p> Signup and view all the answers

    What is the goal of achieving negative margins during lumpectomy?

    <p>To reduce the need for further surgery</p> Signup and view all the answers

    What is a leading risk factor for local recurrence in breast cancer?

    <p>Failure to obtain clear margins</p> Signup and view all the answers

    What is the role of pathology data in the evaluation of lumpectomy margin status?

    <p>To provide detailed information on margin status</p> Signup and view all the answers

    What is a common occurrence for patients undergoing lumpectomy?

    <p>They undergo multiple procedures to achieve acceptable margins</p> Signup and view all the answers

    What is excluded from the study?

    <p>All of the above</p> Signup and view all the answers

    What was the outcome of using the MarginProbe device in the study?

    <p>A 56% decrease in repeat operations</p> Signup and view all the answers

    What is done to the main lumpectomy specimen?

    <p>It is oriented to delineate the six surfaces of the tissue</p> Signup and view all the answers

    What was the significance of the MarginProbe device in breast cancer surgery?

    <p>It was used to detect tumor cells at the margin of the lumpectomy specimen</p> Signup and view all the answers

    What is the consequence of involved or positive lumpectomy margins?

    <p>Increased risk of local recurrence</p> Signup and view all the answers

    What is obtained from all patients in the study?

    <p>Informed consent</p> Signup and view all the answers

    What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?

    <p>94.4%</p> Signup and view all the answers

    What was the outcome of the study in terms of cosmetic outcome?

    <p>There was no difference in cosmetic outcome between the two arms</p> Signup and view all the answers

    What is a common occurrence for patients undergoing lumpectomy?

    <p>Microscopic involvement of the margins</p> Signup and view all the answers

    What is the primary objective of re-excision in breast-conserving surgery for cancer?

    <p>To optimize local disease control</p> Signup and view all the answers

    What is the typical practice of surgeons and pathologists when dividing a lumpectomy specimen?

    <p>Divide the specimen into 6 aspects</p> Signup and view all the answers

    What is the consequence of involved or positive lumpectomy margins in breast cancer treatment?

    <p>Increased chances of cancer recurrence</p> Signup and view all the answers

    What is the goal of a lumpectomy procedure in breast cancer treatment?

    <p>To remove the tumor and a small amount of surrounding tissue</p> Signup and view all the answers

    Why is it challenging to accomplish a successful lumpectomy?

    <p>Because of the difficulty in obtaining clear margins</p> Signup and view all the answers

    What is the significance of re-excision in breast cancer surgery?

    <p>It optimizes local disease control</p> Signup and view all the answers

    What is the common occurrence for patients undergoing lumpectomy?

    <p>Need for re-excision</p> Signup and view all the answers

    What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery?

    <p>60%</p> Signup and view all the answers

    Study Notes

    Patient Diagnosis by Treatment Group

    • 24 (8.1%) patients in the device group had invasive ductal carcinoma, 22 (7.4%) in the control group, and 7 (10.3%) in the roll-in phase.
    • 26 (8.7%) patients in the device group had invasive lobular carcinoma, 13 (4.4%) in the control group, and 2 (2.9%) in the roll-in phase.
    • 83 (27.9%) patients in the device group had ductal carcinoma in situ, 78 (26.2%) in the control group, and 19 (27.9%) in the roll-in phase.
    • 155 (52.0%) patients in the device group had mixed diagnoses, 179 (60.1%) in the control group, and 39 (57.4%) in the roll-in phase.

    Tumor Stage Results

    • The majority of patients were diagnosed with stage II breast cancer and below.

    Margin Probe

    • The Margin Probe is a device that identifies, in real-time, positive margins by detecting microscopic residual cancer and DCIS at the surface of excised breast tissue.
    • The device enables immediate action by the surgeon, thereby reducing the need for re-excision surgery.

    Limitations of Current Margin Assessment Methods

    • Gross assessment and specimen X-ray cannot palpate/visualize microscopic invasive cancer nor DCIS.
    • Frozen section analysis is difficult due to the fatty nature of breast tissue and may add significant time to the procedure.
    • Full cavity shave can compromise cosmetic outcomes due to the volume of healthy tissue removed.

    Patient Study Inclusion and Exclusion Criteria

    • Inclusion criteria: women histologically diagnosed with carcinoma of the breast, non-palpable malignant lesions, undergoing lumpectomy, and aged 18 years or more.
    • Exclusion criteria: multicentric disease, bilateral disease, neoadjuvant systemic therapy, previous radiation, prior surgical procedure, implants, pregnancy, and lactation.

    Patient Treatment

    • Patients were first enrolled and taken to the operating room for resection of the main lumpectomy specimen.
    • The main lumpectomy specimen and lumpectomy cavity palpation and related re-excisions were performed before patient randomization.
    • Patients were then randomized to either the standard of care (SOC) or SOC+Device arm intraoperatively.

    Study Endpoints

    • The primary effectiveness endpoint is measured as all pathologically positive margins on the main specimen being intraoperatively re-excised or “addressed”.
    • A positive margin is defined as a margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked margin.

    Background

    • Breast cancer is a common disease, and breast-conserving surgery (BCS) is a treatment option.
    • BCS involves removing the tumor and a margin of surrounding normal breast tissue.
    • Complete removal of the malignancy is crucial, but challenging due to the microscopic extent of breast cancer.

    Study Details

    • The study was a randomized, double-arm trial to evaluate the benefit of a novel device (MarginProbe) in intraoperative margin assessment for BCS.
    • 300 patients were enrolled, with 293 patients analyzed (143 in the "device" arm and 150 in the "control" arm).
    • The device was applied to the lumpectomy specimen, and additional tissue was excised according to device readings.

    Results

    • The device group had a higher rate of correct surgical reaction confirmed by histology compared to the control group.
    • In the device group, 76% of patients had "excellent" or "good" cosmetic evaluation, similar to the control group.
    • The device improved intraoperative re-excision of positive margins, with a 75% increase compared to the control arm.
    • In the NPL subgroup, device use reduced reoperation rates by over 50%.

    Non-Palpable Lesions (NPL) Subgroup

    • 168 patients were analyzed in the NPL subgroup (82 in the device arm and 86 in the control arm).
    • The device improved correct intraoperative reaction and reduced reoperation rates in the NPL subgroup.

    Conclusion

    • The study demonstrates the benefit of the MarginProbe device in intraoperative margin assessment for BCS, particularly in the NPL subgroup.
    • The device improves the detection and re-excision of positive margins, reducing reoperation rates and improving cosmetic outcomes.

    MarginProbe Peer-reviewed Literature

    • Significant and consistent reduction in positive margins and re-excision rates across multiple studies:
      • 23% reduction in re-excision rates
      • 56% reduction in positive margins
    • Studies published in various journals, including Am J Surg, Ann Surg, SpringerPlus, and Breast J
    • Study designs: Prospective, randomized, controlled, multicenter, and retrospective
    • Patient populations: 293 to 596 patients
    • Re-excision rates:
      • Control group: 12.7% to 39%
      • MarginProbe group: 5.6% to 18.3%
    • Reduction in re-excision rates: 56% to 88%
    • Cosmesis: favorable in most studies

    Positive Margins and Re-excision Rates

    • Positive margins: significant risk factor for local recurrence
    • Re-excision rates: up to 50% of cases
    • National Comprehensive Cancer Network guidelines: positive lumpectomy margins require reoperation
    • Standard practice: unacceptable to have tumor cells directly at the margin of the excised specimen

    MarginProbe Device

    • Intraoperative probe for positive margin detection in breast-conserving surgery
    • Associated with improved correct surgical reaction and decreased re-excision rates
    • Safe and effective in reducing the rate of repeat operations

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    Description

    This quiz analyzes patient diagnosis by treatment group, including roll-in, device, control, and all phases. It focuses on invasive ductal carcinoma and other types of cancer.

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