75 Questions
What is a potential drawback of using frozen section in breast cancer diagnosis?
Adds significant time to the procedure
What is the primary benefit of using the Margin Probe system in breast cancer surgery?
Reduces the need for re-excision surgery
What is a potential consequence of using full cavity shave in breast cancer surgery?
Compromises cosmetic outcomes
What is a limitation of using full cavity shave in breast cancer surgery?
Thinner shaves can result in reduced success in clearing final margins
What is the primary goal of using intraoperative imaging in breast cancer surgery?
To identify positive margins in real-time
What is a necessary condition for a patient to be enrolled in the pivotal study?
The patient is at least 18 years old
What is the purpose of suture marking the center of each of the 6 margins of the main lumpectomy specimen?
To facilitate palpation and re-excision
What is the primary purpose of the MarginProbe device in the SOC+Device arm?
To sample 5-8 points on each face of the excised specimen
What would disqualify a patient from enrolling in the pivotal study?
Bilateral disease in both breasts
What is NOT a step in the resection process of the main lumpectomy specimen?
The patient is taken to the recovery room
What is the primary effectiveness endpoint in the study?
Measurement of all pathologically positive margins on the main specimen being intraoperatively re-excised or “addressed”
What is the definition of a positive margin in the study?
A margin microscopically measured and reported in the histology report to have cancer within 1 mm or less of the inked margin
What is the role of intraoperative imaging in the study?
To assist in the intraoperative re-excision of positive margins
How many patients were excluded from the study due to protocol violations or not meeting the inclusion/exclusion criteria?
7
What is the total number of patients analyzed in the study?
293
How many patients were analyzed in the 'device' arm of the NPL subgroup?
82
What was the reason for excluding one patient from the study?
All of the above
How many patients were analyzed in the 'control' arm of the study?
150
What percentage of patients with long-term 'excellent' or 'good' cosmetic evaluation was similar in both arms?
76%
How many margins were re-excised by the surgeons in the entire cohort and NPL subgroup, respectively?
78% (186/237) of these margins were intraoperatively re-excised
What percentage of margins in the entire cohort were not re-excised?
57%
Why did the surgeons not re-excise the remaining 43% of device-detected positive margins?
Because they were in the anterior or deep aspect where no breast tissue remained to be resected
What would have been the consequence of re-excising the remaining 43% of device-detected positive margins?
The correct ISR for the 'device' arm would have increased to 67%
What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?
Nearly 70%
What is the approximate percentage of patients taken back to the operating room for additional surgery when the device was used?
Less than 20%
What percentage of correct intraoperative reactions and reoperation rates were maintained in the control arm?
40% and 20%
What is the increase in percentage of patients who were able to intraoperatively re-excise all histologically positive margins when using the device?
More than 75%
What is the approximate percentage of patients in the 'device' arm who underwent preoperative image-guided localization?
Nearly 70% is not mentioned
What percentage of American women with early-stage breast cancer are treated with BCS?
75 %
What is the goal of a lumpectomy procedure in breast cancer treatment?
Removing the tumor with a margin of surrounding normal breast tissue
Why is it challenging to accomplish a successful lumpectomy?
Because the microscopic extent of breast cancer can be difficult to discern
What is a consequence of involved or positive lumpectomy margins?
Increased risk of ipsilateral breast tumor recurrence
What is a common occurrence for patients undergoing lumpectomy?
At least 20 % of patients undergo more than one procedure
What was the re-excision rate in the control group in the study by Allweis et al.?
12.7%
What was the relative reduction in re-excision rates with the use of MarginProbe?
56%
How many patients were enrolled in the study by Thill et al.?
109
What was the re-excision rate in the MarginProbe group in the study by Coble et al.?
10.4%
What was the study design of the study by Schnabel et al.?
Prospective, randomized, controlled
What was the reduction in re-excision rates in the study by Hermann et al.?
44-17% = 61%
What was the cosmesis outcome in the study by Geha et al.?
Favorable
What was the re-excision rate in the control group in the study by Kupstas et al.?
18.3%
What was the relative reduction in re-excision rates with the use of MarginProbe in the study by Cen et al.?
75%
What was the study design of the study by Arch et al.?
Retrospective, single arm
What is the estimated percentage of cases where reoperation for positive margins after BCS may be necessary?
50%
What is the consequence of having tumor cells directly at the margin of the excised specimen?
Reoperation is required
What is the recommended course of action for patients not amenable to margin-free lumpectomy?
Mastectomy
What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery (BCS)?
75%
What is the estimated percentage of main lumpectomy specimens that will have positive or close margins?
54%
What is the primary goal of a lumpectomy procedure in breast cancer treatment?
Removal of the tumor with a margin of surrounding normal breast tissue
What is the purpose of evaluating margin status during lumpectomy?
To determine the need for further surgery
Why is it challenging to accomplish a successful lumpectomy?
The microscopic extent of the cancer is difficult to discern
What is the consequence of having involved or positive lumpectomy margins?
Patient discomfort, increased costs, and poorer cosmetic outcome
What is the primary goal of breast-conserving surgery (BCS) for breast cancer?
To obtain clear margins during the operation
What is a consequence of involved or positive lumpectomy margins?
Increased risk of ipsilateral breast tumor recurrence
What is the goal of achieving negative margins during lumpectomy?
To reduce the need for further surgery
What is a leading risk factor for local recurrence in breast cancer?
Failure to obtain clear margins
What is the role of pathology data in the evaluation of lumpectomy margin status?
To provide detailed information on margin status
What is a common occurrence for patients undergoing lumpectomy?
They undergo multiple procedures to achieve acceptable margins
What is excluded from the study?
All of the above
What was the outcome of using the MarginProbe device in the study?
A 56% decrease in repeat operations
What is done to the main lumpectomy specimen?
It is oriented to delineate the six surfaces of the tissue
What was the significance of the MarginProbe device in breast cancer surgery?
It was used to detect tumor cells at the margin of the lumpectomy specimen
What is the consequence of involved or positive lumpectomy margins?
Increased risk of local recurrence
What is obtained from all patients in the study?
Informed consent
What percentage of patients in the 'device' arm were able to intraoperatively re-excise all histologically positive margins?
94.4%
What was the outcome of the study in terms of cosmetic outcome?
There was no difference in cosmetic outcome between the two arms
What is a common occurrence for patients undergoing lumpectomy?
Microscopic involvement of the margins
What is the primary objective of re-excision in breast-conserving surgery for cancer?
To optimize local disease control
What is the typical practice of surgeons and pathologists when dividing a lumpectomy specimen?
Divide the specimen into 6 aspects
What is the consequence of involved or positive lumpectomy margins in breast cancer treatment?
Increased chances of cancer recurrence
What is the goal of a lumpectomy procedure in breast cancer treatment?
To remove the tumor and a small amount of surrounding tissue
Why is it challenging to accomplish a successful lumpectomy?
Because of the difficulty in obtaining clear margins
What is the significance of re-excision in breast cancer surgery?
It optimizes local disease control
What is the common occurrence for patients undergoing lumpectomy?
Need for re-excision
What percentage of American women with early-stage breast cancer are treated with breast-conserving surgery?
60%
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
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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