A flurry of new articles over at the MolDx website.
#1
Germline
MolDx publishes guides, usually in Excel, for technical assessments of your LDT. The "Inherited Cancer Testing" guide is updated on July 17, 2024. See the TA page here.
#2
Changes to Transplant Testing: On Ice
CMS published a press release at cms.gov that MolDx's LCD for transplant testing would not be revised, at least not, until another version is proposed. MolDx echoes the fact, in fewer words. Here.
#3
Public Meeting on Stratifying DCIS: Transcript
MolDx and its minion MACs held a July 15, 2024, public meeting on stratification tests for DCIS. See the transcript now (and recordings). Here.
The agenda had a detailed roster of 8 probing questions - here. The transcript is a heroic 157 pages long - though it's only 2 hours.
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AI Corner (Chat GPT 4o)
The Medicare Contractor Advisory Committee (CAC) meeting on July 15, 2024, focused on Biomarker Risk Stratification Testing in Ductal Carcinoma In Situ (DCIS) involved an in-depth discussion centered around clinical outcomes, treatment decisions, and the role of biomarker testing in guiding these decisions. Below is a summary of key points discussed during the meeting:
Background and Questions Framework
The meeting was structured around 12 pre-defined questions that sought to clarify various aspects of risk stratification in DCIS patients, particularly concerning the use of Radiation Therapy (RT). The questions explored the relevance of clinical outcomes such as ipsilateral breast tumor recurrence (IBTR), invasive cancer, and mortality as endpoints for treatment decisions. They also addressed the potential of biomarkers to identify low-risk Medicare patients who might be treated with breast-conserving surgery (BCS) alone, without the need for adjuvant RT.
Key Discussions and Findings
Clinical Outcomes and Treatment Decision-Making:
- The panel emphasized that while DCIS itself does not lead to mortality, the recurrence of invasive cancer is a critical endpoint. There was consensus that both IBTR and invasive cancer are important metrics for evaluating treatment efficacy.
- The importance of patient-specific factors, including life expectancy and individual risk tolerance, was highlighted. The panelists noted that clinical decision-making should balance the risks and benefits of RT, with some suggesting that in certain cases, especially for older patients with limited life expectancy, BCS alone might be appropriate.
Role of Biomarkers:
- There was considerable debate regarding the utility of biomarkers in predicting the benefit of RT. While some panelists argued that biomarkers could help identify patients who would not benefit from RT, others expressed skepticism, noting that current biomarker tests, such as the Decision RT test, lack sufficient validation.
- The discussion also touched on the limitations of existing risk stratification tools, such as the Van Nuys Prognostic Index (VNPI) and Oncotype DX, with several panelists questioning their effectiveness in clinical practice.
Utility and Evidence for Biomarker Testing:
- The clinical utility of biomarker tests in guiding treatment decisions for DCIS was a central theme. Panelists pointed out that while biomarkers might offer additional information, their ability to improve patient outcomes over traditional clinical stratification methods remains unproven.
- Concerns were raised about the statistical robustness of studies supporting biomarker use. For instance, the Prelude RT data was criticized for its low power and lack of statistically significant findings, casting doubt on its reliability.
Clinical Practice Implications:
- The panel recognized the complexity of treating DCIS and the need for shared decision-making between physicians and patients. There was agreement that while biomarkers could potentially guide treatment decisions, they should not replace clinical judgment, especially given the current limitations of the evidence.
- The discussion underscored the importance of individualized patient care, where treatment decisions are made based on a combination of clinical, pathological, and potentially biomarker data, tailored to the specific circumstances of each patient.
Conclusion
The workshop highlighted the ongoing challenges in using biomarkers for risk stratification in DCIS. While biomarkers hold promise, the panel stressed the need for further validation and stronger evidence before they can be confidently integrated into clinical practice. The meeting also reaffirmed the importance of using a comprehensive approach that combines clinical insights with available tools to guide treatment decisions, ensuring that they are both evidence-based and patient-centered.
This summary should provide stakeholders with a clear understanding of the key discussions and conclusions from the Medicare CAC meeting on DCIS biomarker testing, focusing on the complex interplay between clinical outcomes, treatment options, and the potential role of biomarkers in improving patient care.
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Risk stratification (typically by tests based on RNA gene expression, such as mitotic biomarkers) - is a standard of care for invasive breast cancer. Does the concensus emerge that this is equally important when it is "just" DCIS, or is the DCIS field further behind, or perhaps will the tests simply not be so successful in DCIS.
During the Medicare Contractor Advisory Committee (CAC) meeting on July 15, 2024, there was a significant discussion around the role of risk stratification in DCIS, particularly in comparison to its established use in invasive breast cancer. Here's a summary of the consensus and key points related to this question:
Risk Stratification in DCIS vs. Invasive Breast Cancer
Current State of Risk Stratification in DCIS:
- The consensus among the panelists was that while risk stratification, particularly through RNA gene expression tests, is a well-established standard of care for invasive breast cancer, its application in DCIS is not as advanced or universally accepted.
- The panel recognized that the evidence supporting the use of such biomarkers in DCIS is less robust compared to invasive breast cancer.
Challenges in DCIS:
- Several panelists highlighted that DCIS poses unique challenges that may limit the success and applicability of risk stratification tests. Unlike invasive breast cancer, where the need for aggressive treatment is clearer, DCIS often presents with a lower immediate risk of progression to invasive cancer, making the benefits of risk stratification less evident.
- There was a strong emphasis on the variability in outcomes for DCIS patients and the current inability of existing biomarkers to consistently predict who would benefit from additional treatments like radiation therapy. This variability and lack of predictive power were seen as significant barriers to adopting risk stratification tests as a standard practice in DCIS.
Future of Risk Stratification in DCIS:
- Despite these challenges, some panelists were cautiously optimistic about the potential for risk stratification tests to eventually play a more significant role in DCIS management. However, they stressed the need for more research and validation studies to establish the clinical utility of these tests in DCIS.
- The discussion indicated that while DCIS is "further behind" compared to invasive breast cancer in terms of risk stratification, there is still a possibility that future advancements could bridge this gap. However, the consensus was that the current evidence does not support the routine use of these tests in DCIS as it does in invasive breast cancer.
Conclusion
The consensus from the meeting suggests that the field of DCIS is indeed behind invasive breast cancer in terms of the integration and success of risk stratification tests. The applicability and effectiveness of these tests in DCIS are still uncertain, with many experts expressing skepticism about their current utility. Therefore, while risk stratification is crucial for invasive breast cancer, its role in DCIS remains limited and less well-established at this time.
