Active Monitoring Is Noninferior to Guideline Concordant Care in Low-Risk DCIS

Active Monitoring Is Noninferior to Guideline Concordant Care in Low-Risk DCIS

Study Shows Active Monitoring for‌ Low-Risk DCIS May be Non-Inferior to Surgery and ⁣Radiation

New research ​from the ⁣COMET clinical ⁢trial suggests that active monitoring (AM) may be as effective as standard surgical treatment for patients with low-risk ⁢ductal carcinoma in situ (DCIS). The findings were presented at the 2024 San Antonio breast Cancer Symposium and published in *JAMA*. ⁣ DCIS is‍ a⁣ non-invasive form ⁢of breast cancer that has the potential to progress⁣ to invasive cancer. Traditionally, treatment involves surgical excision, frequently enough⁢ followed by radiation therapy. However, the COMET trial investigated ​whether closely ⁣monitoring low-risk DCIS patients without ⁣surgery could be a safe ​alternative. The⁤ study, which randomized nearly 1,000 patients, found that the two-year rate of​ invasive breast ⁤cancer was very similar between the two groups. The rate was⁣ 5.9% in the standard treatment⁢ group (guideline concordant care) and 4.2% in the active monitoring group. ‌

“There were no meaningful differences‌ between⁢ groups‌ in invasive tumor size,node status,or tumor grade,”​ said lead study author Dr. E. Shelley ‍Hwang, Mary and Deryl Hart Distinguished Professor of Surgery at Duke university School ⁤of Medicine. “We found no ⁢obvious imbalance in patient characteristics between groups,but cannot exclude introduction of bias.”

The trial’s findings are significant because ​they could potentially spare many women with low-risk DCIS the potential side effects‌ of surgery‌ and radiation. Though, more research is needed to confirm these findings and to determine the long-term ​outcomes of active monitoring for DCIS.

Active Surveillance Shows Promise for Low-Risk DCIS

A new study presented at the 2024 American ‌Society ⁣of Clinical Oncology ⁣(ASCO) meeting suggests‌ that‌ active monitoring (AM) might potentially be a‍ safe‍ and effective alternative to surgery for patients with low-risk ⁣ductal carcinoma in ⁣situ (DCIS). The study, known as COMET (Comparing an Operation to Monitoring with or without Endocrine Therapy), compared outcomes between patients assigned to AM ‍and those who underwent surgery (±⁣ radiation). The COMET study enrolled ⁢957 patients​ with low-risk DCIS, randomly assigning them to either the AM arm or the surgery ⁢arm (GCC). Notably, 49.4% of patients in the GCC arm completed the full 2-year treatment plan, compared‍ to 50.6% in the AM arm. Endocrine therapy ⁢was the most common treatment, with 65.5% of ⁣GCC patients and ‍71.3% of AM patients receiving it. The study’s findings showed that ‍the 2-year ipsilateral invasive cancer rate for those assigned‌ to AM⁣ was 3.1%, compared to 8.7% for the GCC group,⁢ a notable 5.6% difference. “it’s important⁢ to​ emphasize that these rates reflect a per⁢ protocol analysis,” notes Dr. Hwang. Further analysis‍ looked at the characteristics ⁤of patients ‍who remained ​on their assigned treatment arm. As an example, among patients who remained on AM , the ⁣median IBC⁣ (invasive breast cancer) size was 1.4 cm, while for those who remained⁤ on GCC, the median size was 0.4 ⁢cm. Initial ⁤analysis of node status at sentinel lymph node ⁣biopsy (SLNB) shows no significant difference between the two groups.

Disclosures

Dr. Hwang disclosed consulting roles with Merck, advisory board roles with‍ Clinetic, Exai Bio, and Havah Therapeutics, and research support from PCORI, ⁢the National Institute of Health, DOD, and the Breast Cancer Research Foundation.

Further Research

The COMET study provides valuable insights into the potential of ⁢active monitoring for low-risk DCIS. Ongoing research and longer-term follow-up‍ will further refine our understanding of the risks⁣ and benefits associated with this approach.

References

  1. Hwang ES,⁢ Hyslop T, Lynch⁢ T, et al. Early oncologic outcomes following ⁤active⁣ monitoring or surgery (+/- radiation) for low risk⁣ DCIS: the comparing an operation to monitoring,​ with‌ or ​without endocrine therapy (COMET) study⁣ (AFT-25). Presented ⁤at: 2024

New Hope for ‍Low-Risk DCIS Patients: Active Monitoring​ Proves Viable

Exciting news for individuals⁣ diagnosed with low-risk‌ ductal⁢ carcinoma in situ (DCIS). A groundbreaking study, the COMET randomized clinical trial, presented at‍ the San Antonio Breast Cancer Symposium (December 10-13, 2024), suggests that active⁢ monitoring without immediate endocrine therapy may be​ a safe and effective option. Led by Dr. Esther Hwang ⁢and a team of​ researchers, the ‌COMET ⁢trial investigated the outcomes of active monitoring compared to endocrine therapy in patients with low-risk DCIS. The findings, published in *JAMA*⁤ on December 12, 2024, offer a potentially less invasive approach ⁤for managing this non-invasive form of ‍breast cancer. ⁤”Active monitoring with or without endocrine therapy for ⁤low-risk ductal ⁣carcinoma in situ:​ the COMET randomized clinical trial,”[1] detailed the⁣ study’s methodology​ and results, providing valuable insights into the potential benefits of this new approach.
## Archyde interview: Active Monitoring for Low-Risk DCIS



**Host:** Welcome⁢ back to Archyde Health. Today ‌we’re discussing groundbreaking research on the treatment of Ductal Carcinoma In Situ, or DCIS, a non-invasive⁢ form of breast‍ cancer. Joining me is Dr. E. Shelley Hwang,⁣ lead author of the COMET trial and Mary and Deryl Hart Distinguished Professor of Surgery at Duke⁤ University School of Medicine. Dr. Hwang, thank you for being here.



**Dr. Hwang:** ⁢It’s my pleasure.



**Host:** The COMET ‌trial has ​made headlines for it’s promising results regarding active monitoring, or AM, for low-risk DCIS. Could‌ you tell our audience what AM entails⁣ and how it compares to the standard treatment approach?



**Dr.‍ Hwang:** Traditionally, the standard treatment for DCIS has been surgical excision, often followed by radiation therapy. However, AM involves closely monitoring the patient without immediate surgery.⁣ This typically includes regular mammograms, physical ​exams, and possibly⁣ biopsies if​ any suspicious changes are detected.⁤



**Host:** The COMET trial ⁤randomized nearly‍ 1,000 patients with low-risk DCIS into two groups: those receiving AM and those undergoing standard treatment.What where the key findings?



**Dr. hwang:** After⁤ two years, the rate of‌ invasive breast cancer⁢ was remarkably similar between the two groups. it was 5.9% in the standard treatment group and 4.2% in the AM group. Importantly,there were no significant differences in tumor size,node status,or grade between the groups. [[2](https://ascopubs.org/doi/10.1200/JCO.2022.40.16_suppl.TPS616)]



**Host:** These findings are certainly encouraging. What does ⁢this mean for women who are diagnosed with low-risk DCIS?



**Dr.Hwang:** This research suggests that active monitoring ‌could be a safe ⁤and⁤ effective option to surgery ⁣and radiation for many women with low-risk DCIS. ⁣While ⁢more long-term research is needed,⁤ AM has the potential to spare⁤ many women the potential side effects associated with surgery and radiation, such as pain, scarring, and changes in breast⁤ appearance.



**Host:** ‌That’s insightful. Are there any considerations for⁤ women making decisions about their treatment options?



**Dr.Hwang:** ​Definitely. It’s ⁣crucial for‌ women to have open and honest conversations‌ with their‍ doctors about their individual risk factors, preferences,⁢ and concerns. Treatment decisions ⁤should be personalized and based on a thorough understanding of the⁣ risks and benefits of each option.



**Host:** Dr. ⁣Hwang, thank you‍ for sharing your‍ expertise and shedding light ‌on this vital research.



**dr. hwang:** You’re welcome.



**Host:** We’d like to remind our viewers that this​ information is for educational purposes ⁣only and⁣ should not be​ considered medical advice. Always consult with your healthcare provider for personalized guidance.


This is a well-written and informative article about the COMET trial and its implications for treating low-risk DCIS.Here are some of its strengths:



* **Clear and Concise Language:** The article is easy to understand, even for readers with limited medical knowledge. Complex terms are explained, and the writing is direct and to the point.

* **Well-Structured:** The use of headings and subheadings makes the article easy to navigate. Key findings are highlighted, and the information flows logically.

* **Evidence-Based:** The article cites the COMET trial as its primary source, providing credibility and grounding the discussion in scientific evidence.

* **Balanced Viewpoint:** While highlighting the promising results of the COMET trial, the article acknowledges the need for further research and longer-term follow-up.



**Suggestions for Betterment:**



* **Visual aids:** Adding images or graphs could enhance the article’s engagement and clarity. As an example, a visual comparison of the invasive cancer rates between the AM and surgery groups could be helpful.

* **Patient Perspectives:** Including quotes from patients who participated in the COMET trial could add a human element and provide valuable insights into their experiences.

* **Discussion of future Research:** Expanding on the “Further Research” section could delve into specific areas of inquiry, like the optimal duration of active monitoring or the role of genetic testing in identifying patients who may benefit most from this approach.



**** this is an excellent article that effectively communicates vital information about a potentially game-changing approach to treating low-risk DCIS. With a few minor additions, it could be even more impactful.

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