DCISionRT: Assessing Breast Cancer Adjuvant Endocrine Therapy After BCS Chirag Shah MD

DCISionRT: Assessing Breast Cancer Adjuvant Endocrine Therapy After BCS Chirag Shah MD

By Chirag Shah, MD

So this study was an analysis of 926 patients who had undergone breast conserving surgery, with or without radiation therapy and with or without endocrine therapy. They were diagnosed with ductal carcinoma in situ and this came from four groups of patients that were put together. These patients had the DCISionRT assay run on them, and they were broken up into three groups. One was the low-risk group, which was a DCISionRT score of less than or equal to 2.8. One was the elevated risk group, which was a DCISionRT score of 2.8 without the residual risk subtype, and the third group was a residual risk group, which was a DCISionRT score of greater than 2.8, along with a residual risk subtype. Basically, we looked at the impact of these treatments, radiation therapy, endocrine therapy on these different groups. What we learned is that overall endocrine therapy reduced the risk of recurrence at 10 years for all patients overall.

However, when we looked at things more closely, a couple of key things came out. One is, in low-risk patients, there was not a benefit to radiation therapy. Additionally, there was no benefit to endocrine therapy in low-risk patients treated with lumpectomy without radiation therapy. On the other hand, we did see a benefit to endocrine therapy in patients in the elevated and residual risk groups who did not receive radiation therapy. However, patients who were in the elevated and residual risk groups that received radiation therapy had no benefit from endocrine therapy.

Common Questions from Your Colleagues About This Clinical Trial?

Sure, I think the thing I get asked most by my colleagues is how do we use this data to take care of patients with DCIS today? I think first and foremost, that starts with considering offering tumor assays such as this assay in patients with DCIS that are interested in breast conserving surgery. I think that allows for personalized and individualized treatment decisions. People that ask, how can this be used in low-risk patients? And low-risk patients make up about a third to 40% of all the patients that we check with DCIS. And for these women, based on this data as well as previously published data, we can tell them that the data that is available shows no benefit to the addition of radiation therapy and now endocrine therapy.

In patients with elevated risk, which represents about 40% of the population, we can tell patients that radiation therapy drastically reduces the risk of recurrence, and if they receive radiation, they may not need endocrine therapy based on this data. Finally, in patients with residual risk, what we can tell them is that radiation reduces the risk of recurrence, but there is still an increased rate of recurrence compared to the other groups, and so these patients may require further treatment intensification down the road.

Will This Data Affect Clinicians Today?

I do think this data, along with the previous data, looking at this assay are going to impact clinical care. I think first and foremost, it’s going to make clinicians think about discussing this preoperatively so that we can really lay the groundwork with patients about what their treatment approach will look like, not only from a surgical standpoint but from an adjuvant therapy standpoint. There are patients who may sometimes choose, for example, mastectomy to avoid radiation therapy. They may, for example, use this assay and find other low risk and be able to undergo without radiation, without worrying about increased risks of recurrence. So I think this is going to become part and parcel of our preoperative, multidisciplinary discussion with patients so we can personalize and tailor adjuvant treatment decisions following lumpectomy.

What Are The Next Steps For This Clinical Trial?

In terms of the next steps, we continue to accrue patients and do follow-up studies, looking at these benefits and seeing if they’re consistent. Also, moving patients into more modern cohorts. Obviously, to get 10-year follow-up means having to follow these patients for some time. That being said, as we continue to look at more recently treated patients, we continue to make sure that these benefits remain consistent, even in the most modern treated patients.

Final Thoughts on this Clinical Trial

I think that the last thing I would consult my colleagues and peers on is to say that I think this is a rapidly evolving space. And I think, to almost quote the old adage of the three bears and the porridge being too hot, too cold, or just right, I think we continue to look to find that for patients with DCIS and really say which patients can we really do the minimum amount of treatment? And they do well, which patients do the current treatment really work well for them, and can keep that going. And for which patients do we need to intensify therapy. And really, the goal is to both reduce overtreatment but also prevent undertreatment. And I think as this space evolves in the years to come, we’re going to continue to see that happen.

What is the DCISionRT Assay?

DCISionRT is a genomic assay used to predict the risk of recurrence in patients with ductal carcinoma in situ (DCIS) of the breast. DCIS is a non-invasive type of breast cancer that is confined to the milk ducts and has not spread to the surrounding breast tissue.

The DCISionRT assay analyzes the expression of 12 genes in the tumor tissue to determine the risk of recurrence within 10 years of initial diagnosis. The test is performed on a sample of the tumor tissue that has been removed during a biopsy or lumpectomy.

The results of the DCISionRT assay are reported as a genomic risk score (GRS), which ranges from 0 to 100. A higher GRS indicates a higher risk of recurrence. Patients with a low GRS may be candidates for observation without additional treatment, while those with a high GRS may benefit from additional radiation therapy after surgery to reduce the risk of recurrence.

The DCISionRT assay has been validated in multiple clinical studies and has been shown to accurately predict the risk of recurrence in patients with DCIS. The test provides valuable information to help guide treatment decisions and improve outcomes for patients with DCIS.

In summary, the DCISionRT assay is a genomic test that analyzes the expression of 12 genes in DCIS tumor tissue to predict the risk of recurrence. The test provides valuable information to guide treatment decisions and improve outcomes for patients with DCIS.

10 Key Takeaways from this randomized clinical trial

1. Adjuvant endocrine therapy after breast-conserving surgery (BCS) is essential to reduce the risk of recurrence and improve survival in patients with hormone receptor-positive breast cancer.

2. DecisionRT is a software tool that uses machine learning algorithms to predict the benefit of adjuvant endocrine therapy in patients with hormone receptor-positive breast cancer after BCS.

3. DecisionRT takes into account a variety of patient and tumor characteristics, such as age, tumor size, lymph node status, and genomic risk, to make its predictions.

4. The tool was validated in a large cohort of patients and has been shown to be more accurate than current clinical guidelines in predicting the benefit of adjuvant endocrine therapy.

5. DecisionRT can help physicians make more informed treatment decisions for their patients, reducing the risk of under- or overtreatment.

6. The tool can also help identify patients who are unlikely to benefit from adjuvant endocrine therapy, sparing them from unnecessary side effects.

7. DecisionRT is easy to use and provides results quickly, making it a practical tool for use in the clinic.

8. The tool is not a substitute for clinical judgment, and physicians should use their own expertise and knowledge when interpreting the results.

9. DecisionRT is a promising example of how machine learning can be used to improve cancer treatment decisions and outcomes.

10. Further research is needed to evaluate the long-term impact of using DecisionRT in clinical practice and to identify ways to further optimize its accuracy and utility.

How can the DCISionRT genomic assay help patients following breast-conserving surgery with or without radiation?

DCISionRT is a genomic assay that can help patients who have undergone breast-conserving surgery (BCS) with or without radiation. DCISionRT analyzes the genetic makeup of the patient’s tumor tissue to predict the risk of recurrence and the potential benefit of radiation therapy.

DCIS (ductal carcinoma in situ) is a type of breast cancer that is confined to the milk ducts and has not spread to other parts of the breast or body. BCS involves removing only the tumor and a small amount of surrounding healthy tissue, preserving as much of the breast as possible. Radiation therapy is often recommended after BCS to reduce the risk of cancer recurrence.

However, not all patients with DCIS will benefit from radiation therapy, and some may experience side effects from treatment. The DCISionRT test can help identify patients who are at low risk of recurrence and may not need radiation therapy, sparing them from potential side effects and reducing healthcare costs.

Conversely, the test can also identify patients who are at high risk of recurrence and would benefit from radiation therapy, ensuring they receive the appropriate treatment to reduce their risk of cancer returning.

In summary, the DCISionRT genomic assay can provide valuable information for patients who have undergone BCS with or without radiation therapy by predicting the risk of recurrence and helping guide personalized treatment decisions.

Chirag Shah, MD – About The Author, Credentials, and Affiliations

Chirag Shah, MD, is a radiation oncologist, a highly accomplished medical professional who holds the position of Staff in the Department of Radiation Oncology and also serves as the Co-Director of the Comprehensive Breast Program at Cleveland Clinic. In addition, he serves as the Director of Clinical Research and Breast Radiation Oncology in the same department.

Dr. Shah obtained his bachelor’s degree from Youngstown State University and his Medical degree from Northeast Ohio Medical University. He completed his internship and residency at William Beaumont Hospital between 2007 and 2012 and joined the Cleveland Clinic Staff in 2015.

Apart from his clinical duties, Dr. Shah is also an esteemed member of various medical societies and serves as a reviewer for several medical journals. His primary research interests include breast cancer, sarcoma, innovative radiation treatment schedules, and lymphedema prevention. He has actively participated in numerous in-house, pharmaceutical, and cooperative group clinical trials to advance his research interests.